Oncolytics Biotech Inc (ONCY)

[Paulness]

NEWS -- Oncolytics Biotech® Presents Positive Interim Safety Update from Phase 2 Triple-Negative Breast Cancer Trial at the 2021 San Antonio Breast Cancer Symposium

• No safety concerns have been noted in any trial participants
  
  
• Trial builds on prior clinical data demonstrating pelareorep's ability to reverse immunosuppressive tumor microenvironments and upregulate PD-L1 expression in breast cancer

SAN DIEGO, Calif. and CALGARY, AB, Dec. 10, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) announced a positive interim safety update from the investigator-sponsored, phase 2 IRENE trial in a poster presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS).

The IRENE trial is designed to evaluate the safety and efficacy of pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab for second- or third-line treatment of patients with metastatic triple-negative breast cancer (TNBC). Safety data from the trial show that the combination has been well-tolerated, as no safety concerns have been noted in any of the five patients enrolled in the trial at the time of reporting. The trial remains ongoing and will continue to enroll patients at the Rutgers Cancer Institute of New Jersey and the Ohio State University Comprehensive Cancer Center.

Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey, Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, and principal investigator of the trial commented, "Checkpoint inhibitors benefit only a minority of TNBC patients due to immunosuppressive tumor microenvironments (TMEs) and poor PD-L1 expression. Prior clinical studies have shown that pelareorep upregulates tumor PD-L1 expression and reverses immunosuppressive TMEs. These findings suggest that pelareorep can address a pressing unmet need in TNBC by synergizing with PD-1 inhibition to increase the proportion of patients responding to therapy. We look forward to evaluating this hypothesis through the IRENE study's continued advancement and are pleased that the pelareorep-retifanlimab combination has been well-tolerated in each of the patients enrolled in the trial."

In addition to evaluating the safety and efficacy of pelareorep plus retifanlimab, IRENE is also designed to assess changes in PD-L1 expression and correlations between treatment outcomes and changes in peripheral blood T cell populations. This could provide a potential biomarker of pelareorep response that may enable the success of future registrational trials by allowing for the early identification of patients most likely to respond to therapy.

A copy of the SABCS poster titled, "IRENE study: Phase 2 study of Retifanlimab and the oncolytic virus pelareorep in metastatic triple negative breast cancer," will be available on the Posters & Publications page of Oncolytics' website (https://www.oncolyticsbiotech.com/technology/posters-publications) following the conclusion of the symposium.

About IRENE

The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and Incyte's anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) for the second- or third-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and is being conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. Retifanlimab will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression-free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

For more information on the IRENE study, refer to https://clinicaltrials.gov/ct2/show/NCT04445844.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-presents-positive-interim-safety-update-from-phase-2-triple-negative-breast-cancer-trial-at-the-2021-san-antonio-breast-cancer-symposium-301441942.html

SOURCE Oncolytics Biotech® Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/December2021/10/c3919.html

[Paulness]

NEWS -- Oncolytics Biotech® to Present Phase 2 Triple-Negative Breast Cancer Trial Update at the 2021 San Antonio Breast Cancer Symposium

• IRENE study is evaluating pelareorep-anti-PD-1 combination treatment in metastatic TNBC

SAN DIEGO and CALGARY, AB, Nov. 19, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the Company will present an update on the Phase 2 IRENE trial in a poster at the 2021 San Antonio Breast Cancer Symposium (SABCS), which is taking place December 7 – 10, 2021, both virtually and in-person, at the Henry B. González Convention Center in San Antonio, Texas.

Details on the poster and its corresponding abstract, available on the SABCS website (https://www.sabcs.org/2021-SABCS), are shown below.

Program Number: OT2-25-01
Title: IRENE study: Phase 2 study of INCMGA00012 and the oncolytic virus pelareorep in metastatic triple negative breast cancer
Session Name: Ongoing Trials Poster Session 2
Session Date: December 9, 2021
Session Time: 5:00 PM – 6:30 PM CT / 6:00 PM – 7:30 PM ET
Presenter: Dr. Mridula George

About IRENE

The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and Incyte's anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and is being conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. Retifanlimab will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression-free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

For more information on the IRENE study, refer to https://clinicaltrials.gov/ct2/show/NCT04445844.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-present-phase-2-triple-negative-breast-cancer-trial-update-at-the-2021-san-antonio-breast-cancer-symposium-301428864.html

SOURCE Oncolytics Biotech® Inc.

[profiteer11]

It's gonna take more......

[ALLEYCATINHEET]

They beat estimates

[profiteer11]

https://www.prnewswire.com
Global Metastatic Cancer Treatment Market Size Is Forecasted To Reach $111.16 Million By 2027
Nov 03, 2021, 08:45 ET

PALM BEACH, Fla. , Nov. 3, 2021 /PRNewswire/ -- FinancialNewsMedia.com News Commentary - The metastatic cancer treatment systems market is observing high demand attributed to its increasing application in breast, lung, melanoma, prostate, and colorectal cancers. Factors such as increasing incidence of metastatic cancer, rising government initiatives to spread cancer awareness, increase in healthcare expenditure, and growing geriatric population drive the market growth. The changes in demographics and the rise in the geriatric population have also impacted the demand for the market. People of advanced age are more susceptible to the disease and its recurrence, which is driving the market demand. Metastatic cancer is also known as stage IV cancer, and its treatment is generally not curative. Some of the treatments available for the cancer are chemotherapy hormone therapies, surgery and ablation therapy, and radiation therapy, among others. A recent report from EMERGEN Research said that the global metastatic cancer treatment market size is forecasted to reach USD 111.16 Million by 2027 at a CAGR of 7.3%. The report said that By treatment type, chemotherapy accounted for the largest market share of over 42.05 of the metastatic cancer treatment market in 2019. "Chemotherapy denotes over 100 drugs that are used to destroy cancer cells, but generally, chemotherapy prevents the growth or spread of diseases cells. Chemotherapy can be administered alone or in parallel with treatment types. Chemotherapy may shrink the tumor prior to radiation therapy or surgery and may also be prescribed after that to destroy any remaining cancer cells. Based on treatment, chemotherapy may be prescribed to slow the cancer growth, prevent the multiplying of cancer cells, and destroy metastatic cancer cells, among others." Active biotech and pharma companies in the markets this week include Oncolytics Biotech ® Inc. (NASDAQ: ONCY ) (TSX: ONC), Clovis Oncology, Inc. (NASDAQ: CLVS ), Merck (NYSE: MRK ), AstraZeneca PLC (NASDAQ: AZN ), Accuray Incorporated (NASDAQ: ARAY ).

EMERGEN Research continued: "By application, breast cancer accounted for the largest market share of over 31.0% of the metastatic cancer treatment market. Breast cancer is the most commonly occurring cancer type in women. The global breast cancer survival rates vary greatly, ranging from around 80% in North America , Japan , and Sweden to nearby 60% in middle-income nations and lower than 40% in low-income nations. Hence, the implementation of breast imaging to screen and detect malignant cells in the human breast is driving the demand for the mammography system market. About 70.0% of the women population having breast cancer are diagnosed with ER-positive type, and the metastatic ER-positive case survival rate is about 20.0%. North America accounted for the largest market share of 37.5% of the metastatic cancer treatment market. The metastatic cancer treatment market in the North American region held the largest market share, owing to the high adoption of advanced treatment technologies, a rising incidence of disease, established healthcare infrastructure, and undertaking of various initiatives to create awareness about the disease."

Oncolytics Biotech ® Inc. (NASDAQ: ONCY ) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech ® Doses First Patient in Phase 1/2 GOBLET Study Evaluating Pelareorep-anti-PD-L1 Combination Therapies in Gastrointestinal Cancers - Oncolytics Biotech ® today announced that the first patient has been dosed in the phase 1/2 GOBLET trial. The trial is being managed by AIO, a leading academic cooperative medical oncology group based in Germany , and is designed to investigate the use of pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers.

"Fewer than half of gastrointestinal (GI) cancer patients respond to immune checkpoint inhibitor (ICI) monotherapy, creating a pressing unmet need for techniques to enhance the efficacy of these agents," said Dirk Arnold M.D ., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "We believe that pelareorep can address this need and increase the proportion of GI cancer patients responding to ICIs, as clinical studies have shown that it reverses the immunosuppressive tumor microenvironments underlying checkpoint inhibitor resistance. Dosing the first patient in GOBLET represents a crucial step towards the evaluation of this hypothesis, and we look forward to the trial's continued advancement."

The GOBLET study builds on data that was recently presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting that demonstrated clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer ( link to PR, link to poster). It is also supported by prior early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients ( link  to PR, link  to study) and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression ( link  to PR, link  to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may allow selection of the most appropriate patients in future registration studies and increase their likelihood of success. CONTINUED � R ead this full press release and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/

[Paulness]

NEWS -- Oncolytics Biotech® Doses First Patient in Phase 1/2 GOBLET Study Evaluating Pelareorep-anti-PD-L1 Combination Therapies in Gastrointestinal Cancers

• Multi-center trial is being conducted in collaboration with Roche and AIO
• Trial is designed to assess the safety and efficacy of pelareorep-atezolizumab combination therapies across multiple gastrointestinal cancer indications
• Trial builds on prior promising data from pancreatic and colorectal cancer trials

SAN DIEGO and CALGARY, AB, Nov. 3, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the first patient has been dosed in the phase 1/2 GOBLET trial. The trial is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to investigate the use of pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers.

"Fewer than half of gastrointestinal (GI) cancer patients respond to immune checkpoint inhibitor (ICI) monotherapy, creating a pressing unmet need for techniques to enhance the efficacy of these agents," said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "We believe that pelareorep can address this need and increase the proportion of GI cancer patients responding to ICIs, as clinical studies have shown that it reverses the immunosuppressive tumor microenvironments underlying checkpoint inhibitor resistance. Dosing the first patient in GOBLET represents a crucial step towards the evaluation of this hypothesis, and we look forward to the trial's continued advancement."

The GOBLET study builds on data that was recently presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting that demonstrated clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (link to PR, link to poster). It is also supported by prior early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study) and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may allow selection of the most appropriate patients in future registration studies and increase their likelihood of success.

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 15 centers in Germany. The primary endpoint of the study is safety, with overall response rate and biomarker evaluation (T cell clonality and CEACAM6) as exploratory endpoints. Approximately 55 patients are planned to be enrolled in four independent cohorts:

• 1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic pancreatic cancer patients (n=12);
• 2. Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);
• 3. Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
• 4. Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).
  
  About AIO
  
  AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on internal oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
  
  About Gastrointestinal Cancer
  
  Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,270 new cases of colon cancer and 45,230 new cases of rectal cancer expected to be diagnosed in the U.S. in 2021(1). Also, for the 2021 year, the American Cancer Society estimates there will be 60,430 new cases of pancreatic cancer(2) and 9,090 new cases of anal cancer(3) in the U.S.
  
  About Oncolytics Biotech Inc.
  
  Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
  
  Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
  
  References:
  
  1. "Key Statistics for Colorectal Cancer." The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html
  
  2. "Key Statistics for Pancreatic Cancer." The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html
  
  3. "Key Statistics for Anal Cancer." The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/anal-cancer/about/what-is-key-statistics.html
  
  This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
  
  Company Contact
  Jon Patton
  Director of IR & Communication
  [phone]
  mailto://[e-mail]
  
  Investor Relations for Oncolytics
  Timothy McCarthy
  LifeSci Advisors
  [phone]
  mailto://[e-mail]
  
  View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-doses-first-patient-in-phase-12-goblet-study-evaluating-pelareorep-anti-pd-l1-combination-therapies-in-gastrointestinal-cancers-301415176.html
  
  SOURCE Oncolytics Biotech® Inc.
  
  View original content: http://www.newswire.ca/en/releases/archive/November2021/03/c8745.html

[mick]

Oncolytics Biotech I (ONCY)
2.225 ? -0.075 (-3.26%)
Volume: 129,476 @10/22/21 12:22:18 PM EDT
Bid Ask Day's Range
2.22 2.23 2.22 - 2.31
ONCY Detailed Quote

[mick]

Oncolytics Biotech I (ONCY)
2.265 ? 0.025 (1.12%)
Volume: 238,933 @10/20/21 3:24:56 PM EDT
Bid Ask Day's Range
2.26 2.27 2.21 - 2.3299
ONCY Detailed Quote

[Paulness]

NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter Financial Results and Operational Highlights

Conference call and webcast to take place on Friday, November 5, 2021, at 8:00 a.m. ET

SAN DIEGO and CALGARY, AB, Oct. 19, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Friday, November 5, 2021, at 8:00 a.m. ET to discuss a corporate update and financial results for the third quarter of 2021.

Conference Call & Webcast

Date: Friday, November 5, 2021
Time: 8:00 a.m. Eastern Daylight Time
Dial In – North American Toll-Free: [phone]
Dial In – International: [phone]
Conference ID (if needed): 7285-9440
Webcast: https://produceredition.webcasts.com/starthere.jsp?ei=1503123&tp_key=d752d0402b

A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing [phone] (North America) or [phone] (International) and using replay code: 859-440#.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the mode of action and potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes, and benefits of its current or pending clinical trials involving pelareorep; our goals, objectives and strategies; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto:?/[e-mail]

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-third-quarter-financial-results-and-operational-highlights-301403482.html

SOURCE Oncolytics Biotech Inc.

View original content: http://www.newswire.ca/en/releases/archive/October2021/19/c1903.html

[justthefactsmam]

maybe we should be encouraged this was/is not another murine study.

[Paulness]

NEWS -- Oncolytics Biotech®Partner Adlai Nortye Doses First Patient in Chinese Bridging Trial Evaluating Pelareorep-Paclitaxel Combination Treatment in Breast Cancer

• Trial is designed to advance pelareorep's clinical development in China, the world's second-largest pharmaceutical market

SAN DIEGO and CALGARY, AB, Oct. 14, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that its partner Adlai Nortye has initiated dosing in a bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer.

Results from the bridging trial are expected to allow Adlai Nortye to include data from Oncolytics' North American metastatic breast cancer trials in a future submission to Chinese regulators. The first of Oncolytics' randomized phase 2 trials, IND-213, showed that treatment with pelareorep and paclitaxel led to a statistically significant increase in overall survival compared to treatment with paclitaxel alone. Oncolytics' second randomized phase 2 trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor.

"Adlai's bridging trial is an important step forward for pelareorep's clinical development path in China, which has a rapidly growing pharmaceutical market that is currently the second-largest in the world," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "We are very pleased that dosing in the trial has commenced and congratulate our partner on this notable achievement. Looking ahead, we are eager to continue our partnership with Adlai as we work to advance pelareorep towards registration in major global markets."

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the U.S. in 2020.1 In China, breast cancer is now estimated to be the largest subtype of cancer among women, with over 416,000 cases and over 117,000 deaths in 2020.2

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) gets worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Adlai Nortye

Adlai Nortye is a global clinical-stage biopharmaceutical company focused on innovative oncology drugs, with its R&D and global clinical operation centers in both China and the United States. With a strategic emphasis on oncology, the Company has built a global pipeline through collaborations and internal discovery with more than 10 drug candidates in development. Currently, three of them are being investigated in clinical trials, including the FDA Fast-Track designated Buparlisib (AN2025) in a global phase III clinical trial; the FDA Fast-Track designated intravenously administered oncolytic virus Pelareorep (AN1004) to have completed a phase II clinical trial; and an oral EP4 antagonist (AN0025) is in early-stage clinical development in multiple tumor types in combination with other treatment options including chemo-radiation and anti–PD–1/anti–PD–L1 therapies.

The Company has assembled a world-class management team, built its unique immuno-oncology platforms and partnered with multiple top pharmaceutical companies to promote innovation. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. The ultimate goal of the Company is to transform cancer into manageable conditions. For more information, please visit https://www.adlainortye.com.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

References:

1. "Breast Cancer Statistics and Resources." Breast Cancer Research Foundation. https://www.bcrf.org/breast-cancer-statistics-and-resources

2. Cao, Wei, et al; Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020, Chinese Medical Journal: April 5, 2021 - Volume 134 - Issue 7 - p 783-791. doi:10.1097/CM9.0000000000001474; https://journals.lww.com/cmj/Fulltext/2021/04050/Changing_profiles_of_cancer_burden_worldwide_and.5.aspx

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the mode of action and potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; the anticipated timing of completion of enrollment in Oncolytics' BRACELET-1 study; our goals, objectives and strategies; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotechpartner-adlai-nortye-doses-first-patient-in-chinese-bridging-trial-evaluating-pelareorep-paclitaxel-combination-treatment-in-breast-cancer-301400289.html

SOURCE Oncolytics Biotech® Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/October2021/14/c2490.html

[Paulness]

NEWS -- Oncolytics Biotech® Announces Preclinical Data Demonstrating the Synergistic Immunotherapeutic Effects of Pelareorep Combined with Radiotherapy

• Combination treatment with pelareorep and radiotherapy promoted the tumor infiltration of anti-cancer T cells and prolonged survival in a murine cancer model
  
  
• Increased infiltration of anti-cancer T cells was observed both in tumors exposed to local treatment with radiation and pelareorep and in tumors located away from the treatment site

SAN DIEGO and CALGARY, AB, Sept. 20, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced preclinical data demonstrating the synergistic immunotherapeutic effects of pelareorep combined with radiotherapy in a murine cancer model. The data were featured in a poster presentation at The International Conference on Immunotherapy Radiotherapy Combinations (https://www.immunorad.fr/), which took place in Paris, France from September 14 – 17, 2021.

Preclinical studies presented in the poster evaluated various treatment combinations of pelareorep, ionizing radiation (radiotherapy), and anti-PD-1 therapy in mice with two bilateral tumors, each located subcutaneously (under the skin) on a different side of the body. Radiotherapy and/or pelareorep treatment was delivered locally to one tumor (denoted the primary tumor), while the second tumor (denoted the abscopal tumor) was not directly exposed to either therapy. Anti-PD-1 therapy was delivered systemically.

Results showed that in primary tumors, pelareorep monotherapy led to a numerical increase in the number of infiltrating anti-cancer CD8+ T cells, which reached statistical significance when combined with radiotherapy (a 15-fold increase compared to control). In abscopal tumors, both pelareorep monotherapy and pelareorep-radiation combination therapy led to a statistically significant increase in infiltrating anti-cancer CD8+ T cells. This effect was not seen with single-agent radiotherapy in either the primary or the abscopal tumors.

Local delivery of radiotherapy alone and the pelareorep-radiotherapy combination into primary tumors significantly improved survival compared to untreated controls. Compared to single-agent radiotherapy, the pelareorep-radiotherapy combination led to a numerical increase in survival, which reached statistical significance when anti-PD-1 therapy was added to the treatment regimen.

"The observed increases in survival and in the number of anti-cancer immune cells within both primary and abscopal tumors following treatment is indicative of the synergistic immunotherapeutic effects of the pelareorep-radiotherapy combination," said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "This is a compelling finding that has the potential to be broadly applicable across multiple cancer indications and warrants further study. Together with prior clinical and preclinical data, these results also highlight pelareorep's potential as an enabling technology to enhance the efficacy of a wide range of therapies."

A copy of the poster titled, "Combination treatment with radiotherapy and oncolytic reovirus generates CD8+ T cell infiltration in primary and abscopal tumours in an organoid model of basal-like breast cancer," can be found on the Posters & Publications page of Oncolytics' website (https://www.oncolyticsbiotech.com/technology/posters-publications).

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the mode of action and potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; our goals, objectives and strategies; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-preclinical-data-demonstrating-the-synergistic-immunotherapeutic-effects-of-pelareorep-combined-with-radiotherapy-301379841.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/September2021/20/c1442.html

[Paulness]

NEWS -- Oncolytics Biotech® Reports 2021 Second Quarter Development Highlights and Financial Results

• Clinical AWARE-1 trial achieves primary endpoint and confirms that pelareorep is an immunotherapeutic agent which synergizes with checkpoint inhibitors: Validation of clinical development strategy in breast cancer
• Phase 2 BRACELET-1 (breast cancer) trial remains on track for full enrollment in Q4 2021
• Highly encouraging clinical proof-of-concept data in metastatic pancreatic cancer demonstrate pelareorep's broad applicability to a number of different tumor types
• Strong financial foundation with approximately $50.8 million in cash on hand and cash runway into 2023
• Management hosting conference call and webcast today at 8:00 a.m. ET

To view full Press Release click: https://www.prnewswire.com/news-releases/oncolytics-biotech-reports-2021-second-quarter-development-highlights-and-financial-results-301350059.html

[Paulness]

NEWS -- Oncolytics Biotech® to Participate in Virtual Fireside Chat at the Canaccord Genuity 41st Annual Growth Conference

Presentation to take place on Thursday, August 12 at 1:30 p.m. ET

SAN DIEGO and CALGARY, AB, Aug. 6, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the Company will participate in a fireside chat at the Canaccord Genuity 41st Annual Growth Conference, which is taking place virtually from August 10-12, 2021. Presentation details are listed below.

Presenter: Dr. Matt Coffey, President & Chief Executive Officer of Oncolytics Biotech Inc.
Date: Thursday, August 12, 2021
Time: 1:30 p.m. Eastern Daylight Time
Webcast Link: https://wsw.com/webcast/canaccord60/register.aspx?conf=canaccord60&page=oncy&url=https://wsw.com/webcast/canaccord60/oncy/2469060

The Company will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Canaccord Genuity representative or email mailto://[e-mail].

A live webcast of the fireside chat will also be available on the Investor Relations page of Oncolytics' website (https://ir.oncolyticsbiotech.com/events-presentations) and will be archived for 90 days.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-virtual-fireside-chat-at-the-canaccord-genuity-41st-annual-growth-conference-301349912.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/August2021/06/c6494.html

[Paulness]

NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Second Quarter Financial Results and Operational Highlights

• Conference call and webcast to take place on Friday, August 6, 2021, at 8:00 a.m. ET

SAN DIEGO and CALGARY, AB, July 22, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Friday, August 6, 2021, at 8:00 a.m. ET to discuss a corporate update and financial results for the second quarter 2021.

Conference Call & Webcast

Date: Friday, August 6, 2021
Time: 8:00 a.m. Eastern Daylight Time
Dial In – North American Toll-Free: [phone]
Dial In – International: [phone]
Conference ID (if needed): 5114-8191
Webcast: https://produceredition.webcasts.com/starthere.jsp?ei=1480405&tp_key=3c3ee7b8e9

A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking https://ir.oncolyticsbiotech.com/events-presentations, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing [phone] (North America) or [phone] (International) and using reference code: 148-191#.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content:https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-second-quarter-financial-results-and-operational-highlights-301339270.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/July2021/22/c3348.html

[Paulness]

NEWS -- International Stem Cell Corporation Announces Successful Completion of Its Phase 1 Clinical Trial in Parkinson's Disease

CARLSBAD, CA / ACCESSWIRE / June 30, 2021 / International Stem Cell Corporation (OTCQB:ISCO) (https://www.internationalstemcell.com) ("ISCO" or "the Company"), a California-based clinical stage biotechnology company developing stem cell-based therapies and biomedical products, announced today successful completion of its dose escalating phase 1 clinical trial (ClinicalTrials.gov Identifier: NCT02452723) evaluating the safety, tolerability and preliminary efficacy of its lead candidate, ISC-hpNSC® for the treatment of Parkinson's disease (PD).

Dr. Andrew Evans, M.D., Director of Movement Disorders at the Royal Melbourne Hospital, the study's principal investigator commented: "The safety evaluation is based on the initial 12 months of safety data from the first cohort (low dose), the second cohort (mid dose), and the third cohort (high dose). In all three cohorts there have been no serious adverse effects related to the transplanted ISC-hpNSC® cells. Based on all data collected in the clinical trial the therapy is considered safe."

In order to gain initial insight into what dose might show the greatest efficacy we have continued observations on a biannual basis of these patients. All the patients in the clinical trial have now completed at least 24 months of total post-operative observations. Patients treated with the mid dose (cohort 2) have been observed for at least 36 months and patients in the low dose group (Cohort 1) have been followed for 48 months post transplantation.

"We are excited about our phase 1 clinical trial results. Patients, followed for over two years after cell transplantation, have reported, on average, improvements in a Parkinson's Disease specific measures, when compared to baseline evaluations. In this context, the results are very encouraging that the ISC-hpNSC® transplanted cells are not only well tolerated, but also may be effective" commented Dr. Russell Kern, ISCO's Executive Vice President and Chief Scientific Officer.

In terms of preliminary efficacy, where scores are compared against baseline before transplantation, we observed a potential dose-dependent response, with an apparent peak effectiveness at our middle dose. The % OFF-Time, which is the time during the day when levodopa medication is not performing optimally and PD symptoms return, decreased an average 47% from the baseline at 12 months post transplantation in cohort 2. This trend continued through 24 months where the %OFF time in the second cohort dropped by 55% from the initial reading. The same was true for % ON-Time without dyskinesia, which is the time during the day when levodopa medication is performing optimally without dyskinesia. The % ON-Time increased an average of 42% above the initial evaluation at 12 months post-transplantation in the second cohort. The %ON result improved in the second cohort to 65% above the baseline in month 24. The quality of life of the patients as measured by the Parkinson's Disease Quality of Life Score-39 (PDQ-39) Summary Index, improved 43% for the second cohort at twelve months post-transplantation. This improved to a 45% better score in cohort 2 at 48 months.

About the clinical study

The Phase 1 clinical study is a dose escalation safety and preliminary efficacy study of ISC-hpNSC®, intracranially transplanted into patients with Parkinson's disease. The open-label, single center, uncontrolled clinical trial is evaluating three different dose regimens of 30 million to 70 million neural cells. A total of 12 participants with Parkinson's disease were treated. Following transplantation, the patients were monitored for 12 months at specified intervals to evaluate the safety and biologic activity of ISC-hpNSC®. A PET scan was performed at baseline, as part of the screening assessment, and at 6 and 12 months after surgical intervention. Clinical responses compared to baseline after the administration of ISC-hpNSC® will be evaluated using various neurological assessments such as Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr as well as other rating scales. An extension phase of the study will evaluate patients every 6 months for 5 additional years.

About Parkinson's disease

Parkinson's disease is a degenerative disorder of the central nervous system mainly affecting the motor system. The motor symptoms of Parkinson's disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain. Early in the course of the disease, the most obvious symptoms are movement related. These symptoms include shaking, rigidity, slowness of movement and difficulty with walking and gait. Later, thinking and behavioral problems may arise, with dementia commonly occurring in the advanced stages of the disease. Depression is the most common psychiatric symptom. Parkinson's disease is more common in people over the age of 50. There are no approved treatments that restore the damaged dopaminergic neurons. Medications typically used in the treatment of Parkinson's disease, levodopa and dopamine agonists, improve the early symptoms of the disease. As the disease progresses and dopaminergic neurons continue to be lost, the drugs eventually become ineffective, while at the same time frequently producing a complication marked by involuntary writhing movements. There are over 10 million people afflicted with Parkinson's disease, worldwide. In 2013 Parkinson's disease resulted in about 103,000 deaths, globally. In 1990, the death toll recorded was 44,000.

About ISC-hpNSC®

International Stem Cell Corporation's proprietary ISC-hpNSC® consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells. ISC-hpNSC® is a suspension of clinical grade cells manufactured under cGMP conditions that have undergone stringent quality control measures and are free of any microbial and viral contaminants. Preclinical studies in rodents and non-human primates have shown improvement in Parkinson's disease symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC®. ISC-hpNSC® provides neurotrophic support and neuroregeneration to the dying dopaminergic neurons of the recipient Parkinson's disease brain. Additionally, ISC-hpNSC® is safe, well tolerated and has shown not to cause adverse events such as dyskinesia, systemic toxicity or tumors in preclinical models. International Stem Cell Corporation believes that ISC-hpNSC® may have broad therapeutic applications for many neurological diseases affecting the brain, the spinal cord and the eye.

About International Stem Cell Corporation

International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide, through its subsidiary Lifeline Cell Technology (https://www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (https://www.lifelineskincare.com). More information is available at https://www.internationalstemcell.com.

Safe harbor statement

Statements pertaining to anticipated developments, clinical studies expectations, potential additional applications for ISC-hpNSC®, and other opportunities for the Company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the Company's Securities and Exchange Commission filings. The Company disclaims any intent or obligation to update forward-looking statements.

Contacts:

International Stem Cell Corporation
Russell A. Kern, PhD
Phone: [phone]
Email: mailto://[e-mail]

SOURCE: International Stem Cell Corporation

View source version on accesswire.com:
https://www.accesswire.com/653700/International-Stem-Cell-Corporation-Announces-Successful-Completion-of-Its-Phase-1-Clinical-Trial-in-Parkinsons-Disease

[Paulness]

NEWS -- Oncolytics Biotech® to Present at the Ladenburg Thalmann Healthcare Conference

Presentation to take place on Wednesday, July 14 at 4:30 p.m. ET

SAN DIEGO and CALGARY, AB, June 30, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the Company will present a corporate overview at the Ladenburg Thalmann Healthcare Conference, which is taking place virtually from July 13-14, 2021. Presentation details are listed below.

Presenter: Dr. Matt Coffey, President & Chief Executive Officer of Oncolytics Biotech Inc.
Date: Wednesday, July 14, 2021
Time: 4:30 p.m. Eastern Daylight Time
Webcast Link: https://wsw.com/webcast/ladenburg7/oncy/2436435

The Company will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Ladenburg Thalmann representative or email mailto://[e-mail].

A live webcast of the presentation will also be available on the Investor Relations page of Oncolytics' website (https://ir.oncolyticsbiotech.com/events-presentations) and will be archived for 90 days.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

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SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Announces Clinical and Biomarker Data Demonstrating Clinical Proof-of-Concept for Pelareorep-Checkpoint Inhibitor Combination in Pancreatic Cancer

The study achieved a 42% disease control rate in difficult-to-treat, second-line pancreatic cancer patients despite the absence of chemotherapy in the treatment regimen

Pelareorep and pembrolizumab synergize to generate anti-cancer immune responses in patients showing disease control

Clinical response was associated with increased activation of anti-cancer CD8+ T cells

SAN DIEGO, Calif. and CALGARY, AB, May 20, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer. The data will be featured in an upcoming electronic poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place virtually from June 4 – 8, 2021.

The newly announced data are from a phase 2 trial evaluating pelareorep in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®) in pancreatic adenocarcinoma patients who progressed after first-line treatment. Findings from the trial indicate that pelareorep and pembrolizumab synergize and show anti-cancer activity in these difficult-to-treat patients, which is mediated through the complementary immunotherapeutic effects of the two agents.

"These results are very promising, particularly considering the extremely challenging patient population enrolled in the trial. That we saw a response signal in select patients, despite the absence of chemotherapy, provides evidence of the considerable anti-cancer activity of pelareorep-pembrolizumab combination therapy," said Principal Investigator, Devalingam Mahalingam, M.D., Ph.D., Associate Professor of Medicine at The Northwestern University Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "We notably observed an association between treatment-induced anti-cancer immune responses and improved tumor control in some patients, which demonstrates pelareorep's underlying immunologic mechanism of action and validates the strategy of combining it with checkpoint inhibition. I look forward to discussing these data with the scientific community at the upcoming ASCO conference and to the continued evaluation of pelareorep-checkpoint inhibitor combination therapy in select patients with pancreatic and other gastrointestinal cancers."

The data presented in the upcoming ASCO poster represent an update based on additional data that was collected after the cutoff date used for the poster's corresponding abstract. Key data and conclusions that will be featured in this upcoming poster include:

• Disease control was achieved in 42% (5/12) of patients, with one patient achieving a partial response and four patients achieving stable disease
• On-treatment tumor biopsies showed pelareorep replication and increased infiltration of CD8+ T cells and PD-L1+ cells relative to pre-treatment samples
• Patients achieving disease control showed reductions in pro-tumor regulatory T (T­reg) cells in the peripheral blood and tumor tissue compared to those with progressive disease
• Patients achieving disease control showed increased activation of anti-cancer CD8+ T cells in the peripheral blood compared to those with progressive disease
• Pelareorep-pembrolizumab combination therapy was found to be well tolerated, with most treatment-related adverse events being grade 1 or 2

Bin Zhang, M.D., Ph.D., Professor at The Northwestern University Feinberg School of Medicine, commented, "These data show that pelareorep can train the immune system to target pancreatic cancer while simultaneously promoting the infiltration of T cells into the tumor and remodeling the tumor microenvironments (TMEs) to be less immunosuppressive. This positions pelareorep to synergistically combine with both checkpoint inhibitors as well as a broad range of other immuno-oncology agents."

"The findings from this study highlight the broad applicability of pelareorep's immunotherapeutic mechanism of action as they are consistent with what has been seen in clinical trials in other indications such as breast cancer," added Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "The compelling findings from this phase 2 study highlight the potential of pelareorep to address the critical unmet need in pancreatic cancer by reversing the immunosuppressive TMEs that often limit the efficacy of checkpoint inhibitors. The anti-cancer activity demonstrated in this study bodes well for a successful outcome in our GOBLET trial, which includes a cohort evaluating pelareorep and the PD-L1 inhibitor atezolizumab in combination with chemotherapy as first-line therapy in metastatic pancreatic cancer patients."

The electronic poster, titled, "Treatment with pembrolizumab in combination with the oncolytic virus pelareorep promotes anti-tumor immunity in patients with advanced pancreatic adenocarcinoma" will be made available on the ASCO Annual Meeting website at 9:00 a.m. ET on June 4, 2021. A copy of the poster will also be posted on the Posters & Publications page of Oncolytics' website (https://www.oncolyticsbiotech.com/technology/posters-publications).

Oncolytics plans to further develop pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer in collaboration with Roche and AIO-Studien-gGmbH (AIO) through the GOBLET study, a phase 1/2 multi-center trial designed to investigate the use of pelareorep in combination with Roche's anti-PD-L1 inhibitor atezolizumab (Tecentriq®) in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers (link to the GOBLET announcement PR). Oncolytics expects the first patient to be dosed in GOBLET in mid-2021.

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic GI tumors. The study will be conducted at 25 centers in Germany. The primary endpoint of the study is safety, with overall response rate and biomarker evaluation (T cell clonality and CEACAM6) as exploratory endpoints. Approximately 55 patients are planned for enrollment across four separate cohorts:

• Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic pancreatic cancer patients (n=12);
• Pelareorep in combination with atezolizumab in 2nd and 3rd line metastatic colorectal cancer patients that are diagnosed as MSI (microsatellite instability) high (n=19);
• Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
• elareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).

About Gastrointestinal Cancer

Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,610 new cases of colon cancer and 43,340 new cases of rectal cancer diagnosed in the U.S. in 20201. Also, for the 2020 year, the American Cancer Society estimates there will be 57,600 new cases of pancreatic cancer2 and 8,590 new cases of anal cancer 3 in the U.S.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it advances towards a registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

References:

1. "Key Statistics for Colorectal Cancer." The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html

2. "Key Statistics for Pancreatic Cancer." The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html

3. "Key Statistics for Anal Cancer." The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/anal-cancer/about/what-is-key-statistics.html

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; the timing and anticipated content of the presentation of additional data to be given at the 2021 ASCO annual meeting; our plans to further develop pelareorep through collaborations; the anticipated timing of the first patient being dosed under our GOBLET-1 study; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]


Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-clinical-and-biomarker-data-demonstrating-clinical-proof-of-concept-for-pelareorep-checkpoint-inhibitor-combination-in-pancreatic-cancer-301295729.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/May2021/20/c7816.html

[Paulness]

NEWS -- Oncolytics Biotech® to Participate in Virtual Fireside Chat at the 2021 RBC Capital Markets Global Healthcare Conference

Fireside chat to take place on Wednesday, May 19 at 5:25 pm ET

SAN DIEGO and CALGARY, AB, May 13, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the Company will participate in a virtual fireside chat at the 2021 RBC Capital Markets Global Healthcare Conference, which is taking place virtually from May 18-20, 2021. Presentation details are listed below.

Presenter: Dr. Matt Coffey, President & Chief Executive Officer of Oncolytics Biotech Inc.
Date: Wednesday, May 19, 2021
Time: 5:25 pm Eastern Daylight Time
Webcast Link: Please click here (https://event.on24.com/wcc/r/3173476/2066CE1AC5D3697237B612E1FE048E86)

The Company will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please contact your RBC representative or email mailto://[e-mail].

A live webcast of the fireside chat will also be available on the Investor Relations page of Oncolytics' website (https://ir.oncolyticsbiotech.com/events-presentations) and will be archived for two weeks.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-virtual-fireside-chat-at-the-2021-rbc-capital-markets-global-healthcare-conference-301290617.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Announces Voting Results from the Annual General Meeting of Shareholders

SAN DIEGO and CALGARY, AB, May 10, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), today announced the voting results from its Annual General Meeting of Shareholders held on Friday, May 7, 2021. A total of 41.41% of the issued and outstanding common shares of the Corporation were represented either in person or by proxy at the meeting.

On a vote by ballot, the following seven nominees proposed by the Corporation were elected as Directors of Oncolytics to serve until the Corporation's next Annual Meeting of Shareholders or until their successors are elected or appointed, with shares represented at the meeting voting in favor of individual nominees as follows:



In addition to the election of all nominees listed as directors in the management information circular, dated March 23, 2021, Oncolytics shareholders approved all other resolutions placed before the meeting. These included fixing the number of directors of the Corporation for the ensuing year at seven and appointing auditors for the Corporation for the ensuing year.

For more details on the matters covered at the annual meeting, please refer to the Corporation's management information circular available on SEDAR at www.sedar.com. Final voting results on all matters voted on at the annual meeting will also be filed on SEDAR.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-voting-results-from-the-annual-general-meeting-of-shareholders-301287394.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/May2021/10/c7175.html

[Paulness]

NEWS -- Oncolytics Biotech® Reports 2021 First Quarter Development Highlights and Financial Results

• AWARE-1 clinical data validate clinical development strategy by confirming pelareorep's anti-tumor mechanism of action known to be associated with improved patient outcomes and ability to synergize with checkpoint inhibitors
• Preclinical studies show that pelareorep's synergistic benefits extend across multiple classes of immunotherapeutic agents, including novel CAR T approaches in solid tumors
• Phase 2 BRACELET-1 clinical trial on track for full enrollment in Q4-2021
• Strong financial foundation with over $50 million in cash on hand and cash runway to Q4-2022

SAN DIEGO and CALGARY, AB, May 7, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced its financial results and development highlights for the quarter ended March 31, 2021. All dollar amounts are expressed in Canadian currency unless otherwise noted.

"Our continued progress over the past several months has substantially de-risked our lead breast cancer program and validated our broader development strategy," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Clinical data from our AWARE-1 trial show pelareorep alters tumor microenvironments by enabling the infiltration of anti-cancer T cells, shown to be associated with improved cancer patient outcomes, including survival, and demonstrates the synergy between pelareorep and checkpoint inhibitors. These findings support the overall survival benefit observed in our prior phase 2 breast cancer study and suggest that we can deliver additional benefits to patients with HR+/HER2- metastatic breast cancer by combining pelareorep with a checkpoint inhibitor. This hypothesis is currently being evaluated in the BRACELET-1 trial, which remains on track for full enrollment this year."

Dr. Coffey continued, "Alongside our clinical accomplishments, we also generated compelling preclinical data demonstrating pelareorep's potential to synergize with a broad array of immune-oncology (IO) agents such as CAR T cells and bispecific antibodies. These data suggest that pelareorep's clinically demonstrated ability to recruit T cells into tumors may significantly boost the effectiveness of various IO agents in solid cancers, an area where they have shown limited efficacy to date. Looking forward, we plan to pursue pelareorep's development as an enabling technology for multiple classes of IO agents through a partnership strategy, which should allow us to remain primarily focused internally on breast cancer and the execution of our stated clinical milestones."

First Quarter and Subsequent Highlights

Breast Cancer Program

Achieved primary endpoint in AWARE-1 study

An electronic poster at the American Association for Cancer Research (AACR) Annual Meeting 2021 included data from the twenty HR+/HER2- early-stage breast cancer patients included in AWARE-1's first two cohorts (link to PR; link to poster). Results from these patients, treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 inhibitor atezolizumab (Tecentriq®), showed pelareorep and letrozole treatment upregulated tumor PD-L1 expression, induced the generation and expansion of T cell clones, promoted tumor infiltration of CD8+ T cells, and increased CelTIL score, a measure of tumor cellularity and inflammation associated with favorable clinical outcomes. These desired outcomes were further enhanced by the addition of atezolizumab, demonstrating that pelareorep and atezolizumab synergistically combine to generate an anti-cancer immune response in the tumor and peripheral blood. Notably, the trial demonstrated dose-related activity of pelareorep led to the achievement of the primary endpoint, with six of ten patients achieving at least a 30% increase in CelTIL score following treatment in cohort 2. Together, these data support the results of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment in HR+/HER2- patients and the clinical rationale behind the phase 2 BRACELET-1 trial, which is evaluating the safety and efficacy of pelareorep and chemotherapy alone, and in combination with a PD-L1 inhibitor, in HR+/HER2- breast cancer patients.

Additional Immunotherapeutic Combinations and Opportunities

Demonstrated the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors

A preclinical study from the Mayo Clinic showed that loading chimeric antigen receptor (CAR) T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to prior preclinical studies that showed intratumoral infection with the VSV oncolytic virus weakened CAR T cells (link to PR; link to poster). The efficacy of pelareorep-loaded CAR T cell ("CAR/Pela") therapy was further enhanced by subsequently administering a single intravenous dose of pelareorep, which led to the generation of highly persistent CAR T cells, the inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were notably specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Collectively, these data demonstrate the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors, an area where CAR T cell efficacy is currently limited due to immunosuppressive tumor microenvironments that promote T cell exhaustion and exclusion.

Announced preclinical data highlighting pelareorep's ability to synergize with multiple classes of anti-cancer agents

Data presented in two electronic poster presentations at the AACR Annual Meeting 2021 showed that pelareorep enhanced the anti-tumor efficacy of the poly(ADP)-ribose polymerase 1 (PARP-1) inhibitor talazoparib and the cyclin-dependent kinase (CDK) 4/6 inhibitor palbociclib, which are both FDA approved for the treatment of breast cancer. The observed synergistic effects between pelareorep and both talazoparib and palbociclib were notably mediated through immunologic mechanisms rather than through the molecular pathways typically associated with PARP-1 and CDK 4/6 inhibition (link to PR; link to CDK4/6 poster; link to PARP-1 poster). Together, these results suggest that pelareorep may enhance the therapeutic potential of PARP-1 and CDK 4/6 inhibitors by expanding the mechanisms by which they exert anti-tumor effects.

Initiation of a preclinical research collaboration with Leiden University Medical Center (LUMC) and Oncode Institute to evaluate pelareorep-bispecific antibody combination therapies

Collaborative preclinical studies with LUMC will evaluate the combination of pelareorep-CD3-bispecific antibody combinations in breast and pancreatic tumor models. Pelareorep's clinically demonstrated ability to recruit T cells to solid tumors provides a strong rationale for these studies, as CD3-bispecific antibodies are designed to facilitate cancer-killing by simultaneously engaging both T cells and tumor tissue. Prior preclinical studies in breast and pancreatic cancer models also support this collaboration, as they have shown that the addition of pelareorep to CD3-bispecific antibody therapy results in cancer regression and prolonged survival.

Corporate Highlights

Hosted a key opinion leader webinar on AWARE-1 data, the immunotherapeutic effects of pelareorep in breast cancer, and its synergistic activity with CAR T cells in solid tumors

The webinar featured presentations by Key Opinion Leaders (KOLs) Aleix Prat, M.D., Ph.D. (Clínic Barcelona) and Richard Vile, Ph.D., (Mayo Clinic), as well as a corporate update by members of the Oncolytics management team. The formal presentations were followed by a question and answer session. A replay of the event can be accessed by clicking here.

Financial Highlights

• As of March 31, 2021, the Company reported $50.4 million in cash and cash equivalents. The Company raised gross proceeds of $25.8 million during the first quarter through issuing of common stock through its ATM facility.
• Operating expense for the first quarter of 2021 was $3.1 million, compared to $3.0 million in the first quarter of 2020.
• R&D expense for the first quarter of 2021 was $2.8 million, compared to $2.5 million in the first quarter of 2020.
• Net cash used in operating activities for the first quarter of 2021 was $5.6 million, compared to $4.0 million for the first quarter of 2020.
• The net loss for the first quarter of 2021 was $6.4 million, compared to a net income of $0.4 million in the first quarter of 2020, which reflected a $4.2 million non-cash gain in fair value of warrant derivative. The basic and diluted loss per share was $0.13 in the first quarter of 2021, compared to a basic earnings and diluted loss per share of $0.01 and $0.04, respectively, in the first quarter of 2020.

Anticipated Milestones and Catalysts

• Announcement of final data from phase 2 NU 18I01 second-line pancreatic cancer study: H1 2021
• Dosing of the first patient in GOBLET study in gastrointestinal cancer: mid-2021
• Final biomarker data for AWARE-1 breast cancer study in the intended target population for a registrational study: H2 2021
• Completion of enrollment in BRACELET-1 metastatic breast cancer study: Q4 2021
• Interim safety update from IRENE study in triple-negative breast cancer: Q4 2021
• Interim safety data from phase 1 WINSHIP 4398-18 multiple myeloma study: Q4 2021

Olytics expects to provide updates on the timing of the following milestones over the coming months:

• Interim safety update from Phase 2 BRACELET-1 metastatic breast cancer study
• Phase 2 BRACELET-1 metastatic breast cancer study: final data

Update on COVID-19

Oncolytics continues to collaborate with its investigators to ensure the safety of patients and employees, as well as the productivity of its clinical programs. We expect these measures will allow us to build on the positive momentum of 2020, despite any COVID-19-related challenges that may arise. Moving forward, we plan to remain in contact with relevant stakeholders and keep the market apprised of any new information that may materially impact clinical timelines.

Accessing the Annual Corporate Update Presentation

The Annual Corporate Update, which will also discuss first quarter 2021 financial results, beginning immediately following the Annual General Meeting at approximately 12:10 p.m. Eastern Daylight Time, may be accessed via the AGM webcast link, https://web.lumiagm.com/158281614, as a guest or by dialing [phone] for callers in North America and [phone] for International callers. The live webcast of the corporate update section of the call will be accessible on the Investor Relations page of Oncolytics' website at https://ir.oncolyticsbiotech.com/events-presentations and will be archived for three months.



About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

• Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
• Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
• Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
• Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
• Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue is collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day of their mastectomy. Data generated from this study are intended to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.

For more information about the AWARE-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04102618.

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About BRACELET-1

The BRACELET-1(BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer. PrECOG LLC, a leading cancer research network, is managing the study. The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts. A three-patient safety run-in will be conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts will be treated as follows:

• Cohort 1 (n=15): paclitaxel
• Cohort 2 (n=15): paclitaxel + pelareorep
• Cohort 3 (n=18): paclitaxel + pelareorep + avelumab (Bavencio®)

Patients in cohort 1 will receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 will receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 will receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

For more information about the BRACELET-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04215146.

About CAR T cells and CAR T therapy

The CAR T process begins when blood is drawn from a patient and their T cells are separated so they can be genetically engineered to produce chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein or antigen on tumor cells. Once the engineering process is complete, a laboratory can increase the number of CAR T cells into the hundreds of millions. Finally, the CAR T cells will be infused back into the patient where, ideally, the engineered cells further multiply, and recognize and kill cancer cells. Historically, solid tumors have been considered beyond the reach of CAR T therapy due to their tumor microenvironment, which is detrimental to CAR T cell entry and activity, amongst other challenges.1

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

References:

1. National Cancer Institute. CAR T Cells: Engineering Patients' Immune Cells to Treat Their Cancers. Updated July 31, 2019. Accessed February 18, 2021. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding the mode of action, potential and benefits of pelareorep as a cancer therapeutic; expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; expectations as to the enrollment in its various clinical studies; expectations regarding Oncolytics' cash runway; beliefs regarding Oncolytics being positioned for sustained growth; plans to pursue pelareorep's development through a partnership strategy and the anticipated benefits therefrom; Oncolytics upcoming catalysts and milestones and Oncolytics' expectations in relation thereto; our management of our business during the ongoing COVID-19 pandemic; the timing and content of our annual corporation presentation; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-reports-2021-first-quarter-development-highlights-and-financial-results-301286355.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Announces Annual General Meeting

Management will also provide its annual corporate update after the conclusion of the meeting

SAN DIEGO, Calif. and CALGARY, AB, April 30, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), (the "Company") today announced that its upcoming 2021 Annual General Meeting (the "Meeting") will be held virtually at 12:00 p.m. Eastern Daylight Time (ET) on Friday, May 7, 2021. In light of limits on larger gatherings and in the best interest of the health and safety of our employees and shareholders, the Meeting will be held as a virtual-only shareholder meeting. After the Meeting and at the conclusion of shareholder voting, the management team will provide a corporate update and Q&A for institutional investors and analysts, along with a discussion of our first quarter 2021 financial results.

The Company strongly encourages all shareholders, whether or not they plan on virtually attending the Meeting, to vote by completing and submitting their proxies or voting instruction forms, as applicable, well in advance of the Meeting. The deadline for voting or receiving proxies in relation to the Meeting is 12:00 p.m. ET on Wednesday, May 5, 2021. Information on how to vote your shares by proxy is available in the Company's Management Information Circular dated March 23, 2021 in respect of the Meeting. The information circular is available on the investor relations section of the Company's website at https://ir.oncolyticsbiotech.com/reports and can also be accessed under the Company's profile on SEDAR at https://www.sedar.com/ and EDGAR at https://www.sec.gov/edgar.shtml.

Who can Attend and Vote at the Meeting

Registered shareholders (who have not appointed a proxyholder) and duly appointed proxyholders (including non-registered shareholders who appoint themselves as proxyholders) will be able to virtually attend the Meeting, vote and ask questions, all in real-time, provided they are connected to the internet. Non-registered shareholders who have not properly appointed themselves as proxyholder will be able to attend the Meeting as guests, but will not be able to vote or ask questions at the Meeting. Non-registered shareholders who wish to vote and ask questions at the Meeting must appoint themselves as proxyholder and register with our transfer agent, AST Trust Company (Canada) ("AST") as described in the "How to Appoint and Register a Proxyholder" section below.

How to Appoint and Register a Proxyholder

Non-registered shareholders who wish to appoint themselves and all shareholders (registered and non-registered) who wish to appoint a third party (other than the management nominees identified in the form of proxy or voting information form) as proxyholder to attend the Meeting must carefully follow the instructions in the Circular and on their form of proxy or voting instruction form. After submitting their form of proxy or voting instruction form to appoint themselves or a third party as a proxyholder, shareholders MUST also complete the additional step of registering their proxyholder with AST and obtaining a control number for the Meeting by calling AST at [phone] (within North America) or [phone] (outside of North America) no later than 12:00 p.m. ET on May 5, 2021. Failure to register the proxyholder with AST will result in the proxyholder only being able to join the Meeting as a guest, with no ability to vote or ask questions.

Registered shareholders who wish to attend the Meeting themselves do no need to register a proxyholder and can use the control number provided on their proxy form.

How to Attend and Vote at the Virtual Meeting

Step 1 - Log in online to the webcast at https://web.lumiagm.com/158281614. We recommend that shareholders log in to the webcast as early as possible but not later than 15 minutes before the time of the virtual Meeting to confirm that the web browser they are using is compatible.

Step 2 - Follow these instructions:

Registered shareholders:

• Click "I have a Control Number"
• Enter the control number (the control number provided on the form of proxy)
• Enter the password "oncy2021" (case sensitive)

Duly appointed proxyholders:

• Click "I have a Control Number"
• Enter the control number (the control number provided by AST by email after the proxy voting deadline has passed and after following the steps in the "How to Appoint and Register a Proxyholder" section above)
• Enter the password "oncy2021" (case sensitive)

Guests:

• Click "Guest"
• Complete the online form

For shareholders with the ability to vote at the Meeting, they will be revoking all previously submitted proxies by logging into the virtual Meeting and accepting the terms and conditions; however, they will be provided the opportunity to vote by ballot on the matters put forth at the Meeting. If shareholders do not wish to revoke all previously submitted proxies, then they should not accept the terms and conditions and only enter the meeting as a guest.

Accessing the Annual Corporate Update Presentation

The Annual Corporate Update, which will also discuss first quarter 2021 financial results, beginning immediately following the Meeting at approximately 12:10 p.m. ET, may be accessed via the AGM webcast link, https://web.lumiagm.com/158281614, as a guest or by dialing [phone] for callers in North America and [phone] for International callers. The live webcast of the corporate update section of the call will be accessible on the Investor Relations page of Oncolytics' website at https://ir.oncolyticsbiotech.com/events-presentations and will be archived for three months.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-annual-general-meeting-301280795.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/April2021/30/c7616.html

[Paulness]

NEWS -- Oncolytics Biotech® Announces Upcoming Presentation at the American Society of Clinical Oncology Annual Meeting

SAN DIEGO and CALGARY, AB, April 29, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the acceptance of an abstract discussing its pancreatic adenocarcinoma trial at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place virtually from June 4 – 8, 2021. Details on the abstract and a corresponding poster presentation are shown below.

Title: Treatment with pembrolizumab in combination with the oncolytic virus pelareorep promotes anti-tumor immunity in patients with advanced pancreatic adenocarcinoma
Presentation Type: Electronic poster
Session Title: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4144

The abstract will be published on the ASCO Annual Meeting website at 5:00 p.m. ET on May 19, 2021. The corresponding poster will be made available on the meeting website at 9:00 a.m. ET on June 4, 2021.

About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-upcoming-presentation-at-the-american-society-of-clinical-oncology-annual-meeting-301279677.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/April2021/29/c9331.html

[ALLEYCATINHEET]

Buy the rumors sell the news

[Paulness]

NEWS -- Oncolytics Biotech® and SOLTI Achieve Primary Endpoint in AWARE-1 Study

• Pelareorep and atezolizumab synergize the anti-cancer immune response in HR+/HER2- breast cancer patients
• Pelareorep alone and with checkpoint blockade converts tumors to PD-L1 positive classification
• Oncolytics validates that pelareorep significantly improves immunotherapies
• Company management hosting a KOL event today at 2:00 pm ET

SAN DIEGO and CALGARY, Alberta, April 12, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), together with SOLTI, recently announced new clinical data from the AWARE-1 window-of-opportunity breast cancer study showing patients receiving pelareorep plus checkpoint blockade therapy met the trial's primary endpoint. These data are featured in an electronic poster at the American Association for Cancer Research (AACR) Annual Meeting 2021 during Week 1, which is taking place virtually from April 10-15, 2021.

In the poster, data from the twenty HR+/HER2- early-stage breast cancer patients included in AWARE-1's first two cohorts are presented. These patients were treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 inhibitor atezolizumab (Tecentriq®) prior to surgery. Evaluation of cohorts 1 and 2 is the core objective of AWARE-1, as HR+/HER2- is the breast cancer subtype Oncolytics intends to examine in a future registrational study.

Pelareorep treatment in cohort 1 upregulated tumor PD-L1 expression, induced the generation and expansion of T cell clones, promoted tumor infiltration of CD8+ T cells, and increased the CelTIL score, a measure of tumor cellularity and inflammation associated with favorable clinical outcomes. These desired outcomes were further enhanced in cohort 2 patients, demonstrating pelareorep and atezolizumab synergistically combine to generate an anti-cancer immune response in the tumor and peripheral blood. Notably, cohort 2 met the pre-specified success criteria for the study's primary endpoint (50% of patients with ≥ 30% increase in CelTIL score), with six of ten patients achieving at least a 30% increase in CelTIL score following treatment.

"These exciting AWARE-1 data confirm pelareorep promotes a pro-inflammatory tumor microenvironment, allowing it to synergistically interact with checkpoint inhibitors to train the immune system to fight cancer," said Aleix Prat, M.D., Ph.D., Translational Principal Investigator of AWARE-1, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona. "The data show combining pelareorep with anti-PD-L1 therapy led to increases in CelTIL score and an improvement in the ratio between cytotoxic CD8+ T cells to regulatory T cells. These striking immunological changes are associated with greater therapeutic efficacy and improved clinical outcomes. Collectively, the AWARE-1 results highlight pelareorep's potential to address the unmet need for techniques to enhance checkpoint inhibitor efficacy and strongly support the continued clinical evaluation of pelareorep-checkpoint inhibitor combinations."

Key data and conclusions from the AACR poster include:

• Treatment with pelareorep alone or in combination with atezolizumab increased tumor PD-L1 expression and led to the conversion of PD-L1 negative tumors into PD-L1 positive tumors
• Pelareorep profoundly reverses immunosuppressive tumor microenvironments and promotes immune effector cell infiltration into solid tumors, positioning it as an enabling technology for a variety of immunotherapeutic agents
• Tumor-cell specific pelareorep replication was observed in all evaluated patients following intravenous pelareorep administration
• 60% of cohort 2 patients (n=10) saw a CelTIL increase of at least 30% from baseline (pre-pelareorep administration) to surgery (21-days post-administration), exceeding the study's pre-specified success criteria
• 70% of all cohort 1 and 2 patients (n=20) saw an increase in CelTIL from baseline to surgery
• The addition of atezolizumab enhances pelareorep's ability to generate and expand new anti-viral and anti-tumor T cell clones in the tumor and periphery
• Compared to cohort 1, cohort 2 patients had a higher ratio of CD8+ T cells to regulatory T cells, suggesting pelareorep and checkpoint inhibition enhances inflammation within the tumor microenvironment

Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, commented, "Based on these new results, we have successfully achieved two key objectives of the AWARE-1 study. We've demonstrated synergy between pelareorep and checkpoint blockade therapy, and we've shown pelareorep triggers an adaptive T cell immune response specifically targeting tumors."

Matt Coffey, Ph.D., M.B.A., President and Chief Executive Officer of Oncolytics Biotech Inc. added, "Achieving the primary endpoint in AWARE-1 is a key milestone validating our clinical development strategy. Data indicating that pelareorep and atezolizumab synergistically interact de-risks both our lead breast cancer program and our additional clinical trials evaluating pelareorep-checkpoint inhibitor combination therapies. The data also highlight pelareorep's ability to profoundly reverse immunosuppressive tumor microenvironments and promote immune effector cell infiltration into solid tumors, positioning it as an enabling technology for a variety of immunotherapeutic agents. Moving forward, we expect these data to facilitate the advancement of our lead breast cancer program towards a registrational study while simultaneously bolstering our business development efforts across several indications and immunotherapy treatment regimes."

The electronic poster, titled "A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (AWARE-1)" is available for on-demand viewing on the AACR Annual Meeting 2021 e-poster website and on the Posters & Publications page of Oncolytics' website (https://www.oncolyticsbiotech.com/technology/posters-publications).

Key Opinion Leader Event

Oncolytics will host a Key Opinion Leader (KOL) event today at 2:00 pm ET with Aleix Prat, M.D., Ph.D., Translational Principal Investigator of AWARE-1, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona and Dr. Richard Vile, a Professor of Immunology at the Mayo Clinic, who led the preclinical CAR T study with pelareorep presented earlier this year (link to press release (https://ir.oncolyticsbiotech.com/press-releases/detail/527/oncolytics-biotech-reports-preclinical-data-demonstrating), link to poster (https://d1io3yog0oux5.cloudfront.net/_5f22060e41afa8c201e14bfa1c3e70b2/oncolyticsbiotech/db/343/2550/pdf/CAR+TCR+POSTER.pdf)). To access the webcast, please click this link (https://lifesci.rampard.com/WebcastingAppv5/Events/Registration/registration.jsp?Y2lk=MTE2MQ==).

About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

• Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
• Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
• Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
• Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
• Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue is collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day of their mastectomy. Data generated from this study are intended to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.

For more information about the AWARE-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04102618.

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the US in 2020.1

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

References:

1. "Breast Cancer Statistics and Resources." Breast Cancer Research Foundation. https://www.bcrf.org/breast-cancer-statistics-and-resources

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]


Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-and-solti-achieve-primary-endpoint-in-aware-1-study-301266442.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/April2021/12/c2923.html

[Paulness]

NEWS -- Oncolytics Biotech® Presents Preclinical Data on Pelareorep-based Combination Therapies at the AACR Annual Meeting

• Pelareorep enhances anti-tumor efficacy of PARP-1 and CDK 4/6 inhibitors in preclinical models through a novel immunological mechanism not typically associated with PARP-1 and CDK 4/6 inhibitors
• Pelareorep synergizes with a broad array of anti-cancer agents

SAN DIEGO and CALGARY, AB, April 12, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) recently announced preclinical data highlighting pelareorep's ability to synergize with multiple classes of anti-cancer agents. The data are featured in two electronic poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2021.

Experiments presented in the posters evaluate the mechanisms of therapeutic synergy between pelareorep and anti-cancer agents identified via a non-biased high throughput screening assay. The top results identified in the screen were the poly(ADP)-ribose polymerase 1 (PARP-1) inhibitor talazoparib and the Cyclin-dependent kinase (CDK) 4/6 inhibitor palbociclib, which are both FDA approved for the treatment of breast cancer.

"Preclinical data presented at AACR compel the use of pelareorep to broaden the therapeutic applicability of approved anti-cancer agents," said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "Notably, the synergistic interactions between pelareorep and both talazoparib and palbociclib were mediated through immunological effects rather than through the molecular pathways typically associated with PARP-1 and CDK 4/6 inhibition. These findings suggest that pelareorep may expand the mechanisms by which PARP-1 and CDK 4/6 inhibitors exert anti-tumor effects, which may enhance their therapeutic potential."

Key findings from the first poster titled, "Talazoparib interacts with oncolytic reovirus to enhance death-inducing signaling complex (DISC)-mediated apoptosis and immune response" include:

• Pelareorep and talazoparib synergistically increase cancer cell apoptosis in vitro and in vivo
• Pelareorep and talazoparib mechanistically synergize through enhancement of IFN-ß signaling pathways
• Combining pelareorep with talazoparib led to enhanced anti-tumor efficacy and inhibition of recurrent tumor growth in murine tumor models
• The synergistic anti-cancer effects of pelareorep-talazoparib therapy correlated with an increased immune response

Key findings from the second poster titled, "Mechanisms of therapeutic synergy between pattern recognition response agonists and cdk4 inhibitors" include:

• Combining pelareorep with palbociclib increased cancer cell death in vitro and reduced in vivo tumor burden compared to pelareorep or palbociclib monotherapy
• Pelareorep and palbociclib mechanistically synergize through enhancement of endoplasmic reticulum (ER) stress signaling
• Pelareorep-palbociclib enhanced ER stress signaling promoted cancer cell apoptosis by increasing innate immune activation and effector function

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, commented, "Our most recent clinical and preclinical findings support pelareorep's potential to boost the effectiveness of various immunotherapies beyond merely checkpoint inhibitors. Moreover, these findings codify pelareorep's position as a simple and effective enabling technology to enhance the clinical effectiveness of a wide range of immunotherapeutic agents."

The electronic posters are available for on-demand viewing on the AACR Annual Meeting 2021 e-poster website and on the Posters & Publications page of Oncolytics' website (https://www.oncolyticsbiotech.com/technology/posters-publications).

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-presents-preclinical-data-on-pelareorep-based-combination-therapies-at-the-aacr-annual-meeting-301266474.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/April2021/12/c8716.html

[jfordosi]

Looking great here, load up and take the ride !!!

[Paulness]

NEWS -- Oncolytics Biotech® to Participate in a Panel Discussion at the Canaccord Genuity Horizons in Oncology Virtual Conference

SAN DIEGO and CALGARY, Alberta, April 8, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Dr. Matt Coffey, the Company's President and Chief Executive Officer, will be participating in a panel discussion at the Canaccord Genuity Horizons in Oncology Virtual Conference. Details on the panel discussion are provided below.

Title: Off-the-Shelf CAR T - solid tumors, myeloma, lymphoma
Date: Thursday, April 15, 2021
Time: 8:15 am ET

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Canaccord representative or email mailto://[e-mail].

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Contact:
Company Contact
Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-panel-discussion-at-the-canaccord-genuity-horizons-in-oncology-virtual-conference-301264756.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/April2021/08/c9872.html

[Paulness]

NEWS -- Oncolytics Biotech® to Host Key Opinion Leader Webinar to Discuss AWARE-1 Data, the Immunotherapeutic Effects of Pelareorep in Breast Cancer, and its Synergistic Activity with CAR T Cells in Solid Tumors

Webinar will take place Monday April 12, 2021 at 2:00 pm ET

SAN DIEGO and CALGARY, AB, April 5, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a Key Opinion Leader (KOL) webinar discussing AWARE-1 data, the immunotherapeutic effects of pelareorep in breast cancer, and its synergistic activity with CAR T cells in solid tumors. The webinar will take place on Monday, April 12, 2021 at 2:00 pm ET.

The webinar will feature presentations by Key Opinion Leaders Aleix Prat, M.D., Ph.D. (Clínic Barcelona) and Richard Vile, Ph.D., (Mayo Clinic). Dr. Prat's portion of the presentation will focus on data from the AWARE-1 window-of-opportunity clinical trial evaluating pelareorep with and without atezolizumab (Tecentriq®) in early-stage breast cancer, which will be presented at this year's American Association for Cancer Research (AACR) Annual Meeting. Dr. Vile will then discuss the results of a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors (link to PR (https://ir.oncolyticsbiotech.com/press-releases/detail/527/oncolytics-biotech-reports-preclinical-data-demonstrating), link to poster(https://d1io3yog0oux5.cloudfront.net/_49b86442664963185633ed190bda2d58/oncolyticsbiotech/db/343/2550/pdf/CAR+TCR+POSTER.pdf)).

During the event, Oncolytics' management team will also give a corporate update and discuss the company's upcoming milestones. Dr. Prat, Dr. Vile, and company management will be available to answer questions following the formal presentations.

To register for the event, please click here (https://media.rampard.com/20210412/).

About the KOLs

Aleix Prat, M.D., Ph.D. is the Head of the Medical Oncology Department of the Hospital Clínic Barcelona (Spain), Associate Professor at the University of Barcelona, Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Lab at IDIBAPS, and President of the governing board of the Spanish Breast Cancer Cooperative Research Group (SOLTI), which performs clinical trials of excellence in oncology. He was also named a member of the Executive Board of The Breast International Group (BIG) in 2018. BIG is an international non-profit organization that is linked to more than 3,000 hospitals and includes more than 10,000 experts and more than 56 cooperative groups from around the world.

Over his career, Dr. Prat obtained worldwide prestige as a research scientist in the field of breast cancer genomics and biomarker development. In 2008, he became a postdoctoral research associate (2008-2012) at the Lineberger Comprehensive Cancer Center (University of North Carolina at Chapel Hill, USA) in the Laboratory of Prof. Charles M. Perou, a world-renowned translational researcher in breast cancer. During this postdoctoral experience, he discovered and characterized a new molecular subtype of breast cancer, known as a Claudin-low (Prat et al. Breast Cancer Research 2010; Citations: 1,518). In addition, he contributed to the breast cancer portion of The Cancer Genome Atlas (Nature 2012; Citations: 4,661), which was a landmark molecular characterization study in the field of cancer research.

Richard Vile, Ph.D. is a world-renowned scientist and member of the Oncolytics Scientific Advisory Board with extensive experience studying pelareorep. As a recognized KOL, his research focuses on several areas of immuno-oncology, including oncolytic viruses, adoptive cell therapies (ACTs) such as chimeric antigen receptor (CAR) T cells, and potential synergistic interactions between oncolytic viruses and ACTs. In addition to his role as a professor at the Mayo Clinic ("Mayo"), Dr. Vile is the Director of Mayo's Immuno-oncology and Gene and Virus Therapy programs and Co-Director of the Cancer Immunology and Immunotherapy program. He also serves on the editorial board of several prestigious scientific journals, including Molecular Therapy, Gene Therapy, The Journal of Gene Medicine, and OncoImmunology. Dr. Vile received his B.A. in Biochemistry from the University of Oxford and his Ph.D. in Viral Vectors from the University of London.

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

• Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
• Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
• Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
• Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
• Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue is collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day of their mastectomy. Data generated from this study are intended to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.

For more information about the AWARE-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04102618.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-key-opinion-leader-webinar-to-discuss-aware-1-data-the-immunotherapeutic-effects-of-pelareorep-in-breast-cancer-and-its-synergistic-activity-with-car-t-cells-in-solid-tumors-301261669.html

View original content: http://www.newswire.ca/en/releases/archive/April2021/05/c0321.html

[ALLEYCATINHEET]

What’s going here

[Paulness]

NEWS -- Oncolytics Biotech® Announces Upcoming Presentations at the AACR Annual Meeting

SAN DIEGO and CALGARY, AB, March 10, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will present updated clinical data from its AWARE-1 window-of-opportunity study in patients with early-stage breast cancer, as well as results from preclinical studies evaluating pelareorep-based combination therapies, in poster presentations during Week 1 of the American Association for Cancer Research (AACR) Annual Meeting 2021, taking place virtually from April 10-15, 2021.

Details on the posters and corresponding abstracts are shown below. All posters will be made available on the conference website on April 10, 2021.

Title: A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (AWARE-1)
Session Type: E-Poster Session
Session Category: Phase II Clinical Trials
Session Title: Phase II Clinical Trials
Abstract Number: CT191 (late-breaking abstract)

Oncolytics will provide details on the results described in this abstract following publication of the abstract and corresponding poster at the AACR Annual Meeting in April, in accordance with conference embargo policies regarding late-breaking abstracts.

Title: Mechanisms of therapeutic synergy between pattern recognition response agonists and cdk4 inhibitors
Session Type: E-Poster Session
Session Category: Molecular and Cellular Biology / Genetics
Session Title: Cell Cycle
Abstract Number: 1960

New preclinical studies identify the mechanisms of therapeutic synergy between pelareorep and the CDK4/6 inhibitor palbociclib. Data show that combining pelareorep with palbociclib augmented pelareorep-induced endoplasmic reticulum (ER) stress signaling and increased innate immune activation and effector function. These results suggest that this combination can be exploited to enhance anti-cancer efficacy with pro-immunogenic consequences and suggest that pelareorep may have the potential to broaden the therapeutic applicability of CDK4/6 inhibitors.

The full text of the corresponding abstract is available on the AACR Annual Meeting 2021 website (https://www.aacr.org/meeting/aacr-annual-meeting-2021/).

Title: Talazoparib interacts with oncolytic reovirus to enhance death-inducing signaling complex (DISC)-mediated apoptosis and immune response
Session Type: E-Poster Session
Session Category: Molecular and Cellular Biology / Genetics
Session Title: Apoptosis
Abstract Number: 1932

New preclinical data show that combining pelareorep with talazoparib, a clinically approved poly(ADP)-ribose polymerase 1 (PARP-1) inhibitor, led to enhanced anti-tumor efficacy that correlated with an increased immune response in murine tumor models. These data provide a scientific rationale for combining pelareorep with PARP-1 inhibitors to exploit immunogenic responses in cancer treatment.

The full text of the corresponding abstract is available on the AACR Annual Meeting 2021 website (https://www.aacr.org/meeting/aacr-annual-meeting-2021/).

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

• Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
• Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
• Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
• Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
• Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep, with or without atezolizumab, and the standard of care therapy according to breast cancer subtype. Patients are biopsied as part of their initial breast cancer evaluation, then again on day three following initial treatment, and a final tissue sample after three weeks, on the day of their mastectomy. Data generated from this study are intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

For more information about the AWARE-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04102618.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: http://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic; the timing and anticipated subject matter of the upcoming presentations of clinical and preclinical study data and the timing thereof; Oncolytics' plans and expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-upcoming-presentations-at-the-aacr-annual-meeting-301244941.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/March2021/10/c4205.html

[Paulness]

NEWS -- Oncolytics Biotech® Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Highlights

• New clinical data highlight pelareorep's potential to boost the effectiveness of checkpoint inhibitors
• Clinical demonstration of pelareorep reversing immunosuppressive tumor microenvironment
• On track to report clinical biomarker and safety data in breast cancer in 2021
• Strong financial foundation with approximately $50 million in cash on hand and cash runway to H2 2022
• Management hosting conference call and webcast today at 8:30 am ET

SAN DIEGO and CALGARY, AB, March 5, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced its financial results and operational highlights for the quarter and year ended December 31, 2020. All dollar amounts are expressed in Canadian currency unless otherwise noted.

"We are beginning 2021 with strong momentum, bolstered by a robust clinical data set that demonstrates the potential of pelareorep to boost the effectiveness of immuno-oncology agents and address major unmet medical needs across multiple indications," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Interim AWARE-1 results highlight pelareorep's ability to train the immune system to target tumors and its potential to synergistically combine with checkpoint blockade therapy in HR+/HER2- breast cancer patients. These findings reinforce the survival benefit observed in our prior phase 2 study and are suggestive of a successful outcome with our phase 2 BRACELET-1 trial, which evaluates pelareorep-checkpoint inhibitor therapy in the same breast cancer subtype. We look forward to reporting additional biomarker and safety data from our lead breast cancer program later this year and to the program's continued advancement towards a registrational study."

Dr. Coffey continued, "Beyond our lead program, we continue to leverage our compelling data and collaborations with industry leaders to expand pelareorep's commercial and business development potential. Pelareorep promotes tumor inflammation and upregulates PD-L1 expression in the clinic, positioning it to address unmet needs in triple-negative breast cancer (TNBC) and gastrointestinal (GI) cancers. In each of these indications, checkpoint inhibitors have had commercial success, but immunosuppressive tumor microenvironments (TMEs) and low PD-L1 expression severely limit their efficacy and the number of patients who can be successfully treated. Through our IRENE and GOBLET trials, we are collaborating with industry leaders to show that we can increase the percentage of TNBC and GI cancer patients responding to checkpoint blockade by taking advantage of pelareorep's immunotherapeutic effects. Excitingly, pelareorep's synergistic benefits appear to extend to immunomodulatory agents beyond checkpoint inhibitors, as recent preclinical results show that pelareorep may broaden the applicability of CAR T cells to solid tumors by improving their persistence and efficacy. Looking ahead, we will explore a partnership strategy to develop pelareorep as an enabling technology for CAR T cells and other immunotherapies while keeping our primary focus on our lead breast cancer program. We believe this strategy will drive and expand our sustained growth by allowing for the efficient development of pelareorep in a variety of difficult-to-treat indications. Finally, with our strengthened financial position, we look forward to accelerating these activities and delivering on our catalysts."

Select highlights from 2020 and early 2021

Breast Cancer Program

Reported AWARE-1 Data Demonstrating Pelareorep's Ability to Reverse Immunosuppressive TMEs and Potential to Boost the Effectiveness of Checkpoint Inhibitors

AWARE-1 data presented at the 2020 San Antonio Breast Cancer Symposium (SABCS) showed that systemic pelareorep treatment increased tumor PD-L1 expression by an average of 105-fold in early-stage breast cancer patients, thereby making tumors more amenable to checkpoint inhibitor therapy. Data also showed that 72% of patients saw an increase in CelTIL (the study's primary endpoint), a measure of tumor-associated cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical response. These data add to prior AWARE-1 results showing that systemic pelareorep treatment led to the generation of new anti-viral and anti-tumor T cell clones and an average 14-fold increase in intratumoral CD8+ T cells. Together, these data support the results of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment by demonstrating pelareorep's ability to induce robust and potentially long-lasting anti-tumor immune responses in HR+/HER2- breast cancer patients (link to PR, link to poster).

Initiated Dosing in Phase 2 BRACELET-1 Study and Successfully Completed Safety Run-in

Oncolytics advanced its lead breast cancer program with the initiation of dosing in BRACELET-1, a randomized phase 2 study being conducted under a co-development agreement with Merck KGaA (Darmstadt, Germany) and Pfizer. BRACELET-1 is designed to generate mechanistic data supporting the results of IND-213 and to evaluate pelareorep's ability to synergistically combine with anti-PD-L1 therapy. The study also seeks to validate peripheral T cell clonality as a biomarker of pelareorep response in HR+/HER2- metastatic breast cancer, which may improve the patient selection process in future registration studies and increase their likelihood of success. The trial's safety run-in has been successfully completed, with the Data and Safety Monitoring Board verifying pelareorep's outstanding safety profile.

Initiated Dosing in Phase 2 IRENE Study

Oncolytics expanded its lead breast cancer program into a new disease subtype through the initiation of dosing in IRENE, a phase 2 investigator-sponsored study investigating the use of pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC. In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study also evaluates changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality.

Gastrointestinal Cancer Program

Announced Phase 1/2 GOBLET Study in Collaboration with Roche and AIO

GOBLET is a phase 1/2 multi-center trial designed to investigate the use of pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers. The trial is being managed by AIO, a leading academic cooperative medical oncology group based in Germany. GOBLET builds on previously reported early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS mutated colorectal cancer patients (link to PR, link to study), as well as a greater than 80% increase in progression-free survival (PFS) in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to validate CEACAM6 and T cell clonality as predictive biomarkers, which may improve the patient selection process in future registration studies and increase their likelihood of success.

Hematologic Malignancies Program

Announced Clinical Proof-of-Concept Data at the ASCO Virtual Meeting

Phase 1b data presented at the American Society of Clinical Oncology (ASCO) meeting showed that pelareorep, when combined with carfilzomib, activated a profound inflammatory response accompanied by a 50% overall response rate and an 83% clinical benefit rate in patients with challenging-to-treat carfilzomib-refractory multiple myeloma (link to the PR, link to the poster). The data also showed the first reported incidence of cytokine stimulation associated with tumor response in multiple myeloma, highlighting the ability of pelareorep to induce robust immune cell activation and tumor lysis. Together with earlier trial data showing pelareorep-induced upregulation of PD-L1 expression, these data highlight the potential of pelareorep to synergistically combine with checkpoint inhibitors in hematologic cancers.

Opportunities to Further Expand the Clinical Benefits of Pelareorep to Additional Indications

Reported Positive Clinical Results Against Glioblastoma Multiforme

Oncolytics announced positive results from ReoGlio, an investigator-sponsored phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of glioblastoma multiforme (GBM) at the 2020 Society of Neuro-Oncology Annual Meeting (link to the PR). The results showed a compelling signal of efficacy and demonstrated the safety and tolerability of the pelareorep-based combination therapy in newly diagnosed GBM patients. Notably, observed improvements in median PFS correlated with the dose of pelareorep administered. Oncolytics thanks the University of Leeds, Cancer Research UK, and The Brain Tumor Charity for designing, managing, and funding the ReoGlio trial.

Demonstrated the Potential of Pelareorep to Broaden the Applicability of CAR T Cells to Solid Tumors

A recent preclinical study from the Mayo Clinic showed that loading chimeric antigen receptor (CAR) T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells (link to the PR, link to the poster). The efficacy of pelareorep-loaded CAR T cell ("CAR/Pela") therapy was further enhanced by boosting mice 8 days later with a single intravenous dose of pelareorep, which led to the generation of highly persistent CAR T cells, the inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Together, these data demonstrate the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors, an area where CAR T cell efficacy is currently limited due to immunosuppressive TMEs that promote T cell exhaustion and exclusion.

Corporate Highlights

Appointed Richard Vile, Ph.D., to Scientific Advisory Board

Dr. Vile, a Professor of Immunology at the Mayo Clinic, is a world-renowned scientist and long-time collaborator of Oncolytics with extensive experience studying pelareorep, and led the Mayo Clinic CAR T preclinical study mentioned above. Dr. Vile is a recognized key opinion leader whose research focuses on several areas of immuno-oncology, including oncolytic viruses, adoptive cell therapies (ACTs) such as CAR T cells, and potential synergistic interactions between oncolytic viruses and ACTs. In addition to his role as a professor at the Mayo Clinic ("Mayo"), Dr. Vile is the Director of Mayo's Immuno-oncology and Gene and Virus Therapy programs and Co-Director of the Cancer Immunology and Immunotherapy program. He also serves on the editorial board of several prestigious scientific journals, including Molecular Therapy, Gene Therapy, The Journal of Gene Medicine, and OncoImmunology.

Financial Highlights

• As at December 31, 2020, the Company reported $31.2 million in cash and cash equivalents. The Company raised gross proceeds of $40.0 million during 2020 through the issuing of common stock through our ATM facility.
• Operating expense was $4.0 million for the fourth quarter of 2020 and $12.5 million for the full year 2020, compared to $4.1 million in the fourth quarter of 2019 and $9.6 million for the full year 2019.
• R&D expense was $4.1 million for the fourth quarter of 2020 and $12.9 million for the full year 2020, compared to $2.7 million in the fourth quarter of 2019 and $10.8 million for the full year 2019.
• Net cash used in operating activities was $5.7 million for the fourth quarter of 2020 and $22.1 million for the full year 2020, compared to $7.3 million in the fourth quarter of 2019 and $19.9 million for the full year 2019.
• The net loss for the fourth quarter of 2020 was $9.3 million, compared to a net loss of $19.4 million in the fourth quarter of 2019. The basic and diluted loss per share was $0.21 in the fourth quarter of 2020, compared to a basic and diluted loss per share of $0.71 in the fourth quarter of 2019. The net loss for the full year 2020 was $22.5 million, compared to a net loss of $33.1 million for the full year 2019. The basic and diluted loss per share was $0.56 for the full year 2020, compared to a basic and diluted loss per share of $1.50 for the full year 2019.
• As at March 4, 2021, the Company had approximately $50 million in cash and cash equivalents, an unlimited number of authorized common shares with 52,083,924 common shares issued and outstanding, 16,443,500 warrants (exercisable into 1,730,894 common shares) issued in 2017 with a $9.025 strike price, 110,572 warrants issued in 2020 with a US$0.90 strike price and 3,878,852 options and share units.

Anticipated Milestones & Catalysts

• Announcement of final data from phase 2 NU 18I01 second-line pancreatic cancer study*: H1 2021
• Dosing of the first patient in GOBLET study in gastrointestinal cancer: H1 2021
• Interim data for AWARE-1 breast cancer study: H1 2021
• Final biomarker data for AWARE-1 breast cancer study in the intended target population for a registrational study: H2 2021
• Interim safety update from Phase 2 BRACELET-1 metastatic breast cancer study: H2 2021
• Completion of enrollment in BRACELET-1 metastatic breast cancer study: Q4 2021
• Interim safety update from IRENE study in TNBC: Q4 2021
• Interim safety data from phase 1 WINSHIP 4398-18 multiple myeloma study: Q4 2021

*Guidance provided by clinical investigators

Oncolytics expects to provide updates on the timing of the following milestones over the coming months:

• Phase 2 BRACELET-1 metastatic breast cancer study: final data

Update on COVID-19

Oncolytics continues to collaborate with its investigators to ensure the safety of patients and employees, as well as the productivity of its clinical programs. We expect these measures will allow us to build on the positive momentum of the past year, despite any COVID-19-related challenges that may arise. Moving forward, we plan to remain in contact with relevant stakeholders and keep the market apprised of any new information that may impact clinical timelines.

Webcast and Conference Call

Management will host a conference call for analysts and institutional investors at 8:30 am ET today, March 5, 2021. To access the call, please dial [phone] (North America) or [phone] (International) and, if needed, provide confirmation number 569-6653. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing [phone] (North America) or [phone] (International) and using reference code 569-6653.



About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

• Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
• Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
• Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
• Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
• Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep, with or without atezolizumab, and the standard of care according to breast cancer subtype. Patients are biopsied as part of their initial breast cancer evaluation, then again on day three following initial treatment, and a final tissue sample after three weeks, on the day of their mastectomy. Data generated from this study are intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.

For more information about the AWARE-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04102618.

About BRACELET-1

The BRACELET-1(BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer. PrECOG LLC, a leading cancer research network, is managing the study. The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts. A three patient safety run-in will be conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts will be treated as follows:

Cohort 1 (n=15): paclitaxel

Cohort 2 (n=15): paclitaxel + pelareorep

Cohort 3 (n=18): paclitaxel + pelareorep + avelumab (Bavencio®)Patients in cohort 1 will receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 will receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 will receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

For more information about the BRACELET-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04215146

About IRENE

The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression-free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

For more information on the IRENE study, refer to https://clinicaltrials.gov/ct2/show/NCT04445844.

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic GI tumors. The study will be conducted at 25 centers in Germany. The primary endpoint of the study is safety, with overall response rate and blood-based biomarkers (T cell clonality and CEACAM6) as exploratory endpoints. Approximately 55 patients are planned for enrollment across four separate cohorts:

• Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic Pancreatic cancer patients (n=12);
• Pelareorep in combination with atezolizumab in 2nd and 3rd line metastatic colorectal cancer patients that are diagnosed as MSI (microsatellite instability) high (n=19);
• Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
• Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).

About ReoGlio

The ReoGlio trial was an investigator-sponsored phase 1b, open-label trial evaluating the combination of pelareorep and GM-CSF, alongside standard chemoradiotherapy and adjuvant temozolomide, for the treatment of newly diagnosed GBM. Fifteen patients were treated in the trial, twelve of which were evaluable for efficacy analyses. The primary objective of the study was to determine the maximum tolerated dose of pelareorep and GM-CSF with standard chemoradiotherapy. Secondary objectives were to gain a preliminary assessment of the activity of the pelareorep-GM-CSF combination and to assess treatment compliance. The trial was designed and managed by the University of Leeds and funded through grants provided by Cancer Research UK and The Brain Tumor Charity.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the US in 2020.1

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Gastrointestinal Cancer

Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,610 new cases of colon cancer and 43,340 new cases of rectal cancer diagnosed in the U.S. in 20202. Also, for the 2020 year, the American Cancer Society estimates there will be 57,600 new cases of pancreatic cancer3 and 8,590 new cases of anal cancer 4 in the U.S.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

References:

1. "Breast Cancer Statistics And Resources." Breast Cancer Research Foundation. https://www.bcrf.org/breast-cancer-statistics-and-resources
2. "Key Statistics for Colorectal Cancer." The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html
3. "Key Statistics for Pancreatic Cancer." The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html
4. "Key Statistics for Anal Cancer." The American Cancer Society, American Cancer Society, Inc., https://www.cancer.org/cancer/anal-cancer/about/what-is-key-statistics.html

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; plans respecting the delivery of additional clinical data and the timing thereof; the potential commercial opportunity of pelareorep; Oncolytics' expectations for its various partnerships and collaborations and its strategies for further partnerships and collaborations; Oncolytics' anticipated milestones and catalysts; Oncolytics' objectives, including registration opportunities; Oncolytics' measures to manage the impact of the COVID-19 pandemic on its operations; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-reports-fourth-quarter-and-full-year-2020-financial-results-and-operational-highlights-301241184.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/March2021/05/c0303.html

[Paulness]

NEWS -- Oncolytics Biotech® Establishes New At-The-Market Facility

SAN DIEGO, Calif. and CALGARY, AB, March 5, 2021 /CNW/ ---- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it has entered into an at-the-market (ATM) equity offering sales agreement with Canaccord Genuity LLC. The ATM allows the Company, at its sole discretion, to issue common shares from treasury, at prevailing market prices, with an aggregate gross sales amount of up to US$80 million. The company has no obligation to sell any shares pursuant to the ATM. The ATM provides Oncolytics the option to efficiently tap into the financial markets as needed to support ongoing business development activities and clinical trials, while bolstering management's ability to negotiate potential business development agreements from a position of financial strength.

In connection with the ATM, Oncolytics has filed a Prospectus Supplement with the Alberta Securities Commission and with the United States Securities and Exchange Commission, which supplements Oncolytics' Canadian short form base shelf prospectus dated June 12, 2020, and Oncolytics' shelf registration statement on Form F-10 declared effective on June 15, 2020 by the United States Securities and Exchange Commission. Sales of the ATM offering will only be conducted in the United States through NASDAQ or another exchange at market prices. No sales will be conducted in Canada or through the Toronto Stock Exchange.

A copy of the Prospectus Supplement is available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov or may be obtained upon request to Oncolytics' Investor Relations Department using the contact information set out below. Before you invest, you should read the Prospectus Supplement and accompanying base shelf prospectus and the other documents the Company has filed with the SEC for more complete information about the Company and the ATM offering. Alternatively, a copy of the Prospectus Supplement and accompanying base shelf prospectus are available upon request by contacting Canaccord Genuity LLC Attention: Syndicate Department, 99 High Street, Suite 1200, Boston, MA 02110, Attn: Equity Syndicate Department, by telephone at [phone] or by e-mail at mailto://[e-mail].

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the anticipated benefits of the ATM to Oncolytics; Oncolytics' plans for additional studies; Oncolytics' preparation for a phase 3 registration study in metastatic breast cancer; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Kirk Look
Chief Financial Officer
403.670.7658
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
917.679.9282
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-establishes-new-at-the-market-facility-301241334.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/March2021/05/c8817.html

[Paulness]

NEWS -- Oncolytics Biotech, Inc. to Host Earnings Call

NEW YORK, NY / ACCESSWIRE / March 5, 2021 / Oncolytics Biotech, Inc. (NASDAQ:ONCY) will be discussing their earnings results in their 2020 Fourth Quarter Earnings call to be held on March 5, 2021 at 8:30 AM Eastern Time.

To listen to the event live or access a replay of the call - visit
https://www.investornetwork.com/event/presentation/75207

To receive updates for this company you can register by emailing mailto://[e-mail] or by clicking get investment info from the company's profile.

About Investor Network

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SOURCE: Investor Network

View source version on accesswire.com:
https://www.accesswire.com/633485/Oncolytics-Biotech-Inc-to-Host-Earnings-Call

[Paulness]

NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Fourth Quarter and Full-Year Financial Results and Operational Highlights

Conference call and webcast to take place on Friday, March 5, 2021 at 8:30 am ET

SAN DIEGO, Calif. and CALGARY, AB, Feb. 26, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Friday, March 5, 2021, at 8:30 am ET to discuss a corporate update and financial results for the fourth quarter and full year 2020.

Conference Call & Webcast

Date: Friday, March 5, 2021
Time: 8:30 am ET
Dial In – North American Toll-Free: [phone]
Dial In – International: [phone]
Conference ID (if needed): 569-6653
Webcast: https://produceredition.webcasts.com/starthere.jsp?ei=1432035&tp_key=48e3f6e8b0

A live webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking https://ir.oncolyticsbiotech.com/events-presentations and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing [phone] (North America) or [phone] (International) and using reference code: 569-6653.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: http://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the company's intentions regarding a potential phase 3 study involving pelareorep; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-fourth-quarter-and-full-year-financial-results-and-operational-highlights-301236150.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

Seeking Alpha -- Oncolytics surges on encouraging pelareorep + CAR T data in solid tumors

Feb. 23, 2021 7:52 AM ET Oncolytics Biotech Inc. (ONCY)
By: Dulan Lokuwithana, SA News Editor

Oncolytics Biotech (NASDAQ:ONCY) has gained 13.6% in the premarket after announcing preclinical data from a study evaluating the treatment combination of pelareorep and chimeric antigen receptor (“CAR”) T cell in solid tumors.

The data reported with the publication of an electronic poster at the CAR-TCR Summit Europe 2021has indicated that loading CAR T cells with pelareorep significantly improved their persistence and efficacy in a murine solid tumor model (survival rate at end of the study: 57% [4/7]).

The performance of pelareorep, an intravenously delivered immuno-oncolytic virus, contrasts with the preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells, the company said.

A pelareorep boost introduced 8 days later with a single intravenous dose of pelareorep further enhanced the efficacy of pelareorep-loaded CAR T cell (survival rate at end of the study: 100% [7/7]) generating highly persistent CAR T cells, inhibition of recurrent tumor growth, and ultimately tumor cures.

The intravenous boosting with VSV did not augment the efficacy of CAR/Pela therapy or prevent the growth of recurrent tumors (survival rate at end of the study: 42% [3/7]).

"These very exciting data demonstrate pelareorep's ability to overcome major shortcomings of CAR T cells," commented Matt Coffey CEO of Oncolytics.

“This would be a major advancement, as it would substantially broaden the applicability of CAR T cells to a variety of highly prevalent and difficult-to-treat indications."

In October, Oncolytics announced a Phase 1/2 trial to investigate the effect of pelareorep, in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq), in patients with metastatic pancreatic, colorectal, and advanced anal cancers.

[Paulness]

NEWS -- Oncolytics Biotech® Reports Preclinical Data Demonstrating the Synergistic Anti-cancer Activity of Pelareorep Combined with CAR T Cell Therapy in Solid Tumors

Mayo Clinic shows pelareorep vastly improved persistence and efficacy of CAR T cell therapy leading to cures in this model

Pelareorep's synergistic effects with CAR T therapy appear to be specific and were not observed with the oncolytic virus VSV

Results demonstrate the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors

SAN DIEGO, Calif. and CALGARY, AB, Feb. 23, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) announced publication of an electronic poster at the CAR-TCR Summit Europe 2021 with data from a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors.

Newly published results show that loading CAR T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells. Efficacy of pelareorep-loaded CAR T cell ("CAR/Pela") therapy was further enhanced by boosting mice 8 days later with a single intravenous dose of pelareorep ("pelareorep boost"), generating highly persistent CAR T cells, inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Survival data from the preclinical study are shown below:



"These very exciting data demonstrate pelareorep's ability to overcome major shortcomings of CAR T cells," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Despite commercial success in hematological cancers, CAR T therapies have limited efficacy against solid tumors due to immunosuppressive tumor microenvironments (TMEs) that promote T cell exhaustion and exclusion. Pelareorep's ability to reverse immunosuppressive TMEs has been well documented in the clinic, and combining CAR T cells with pelareorep may enable their success against solid cancers. This would be a major advancement, as it would substantially broaden the applicability of CAR T cells to a variety of highly prevalent and difficult-to-treat indications."

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "While our primary focus is on advancing our lead breast cancer program to a registrational trial, we continue to evaluate additional opportunities to expand pelareorep's business development and partnership potential. In clinical studies, pelareorep recruited high concentrations of T cells to solid tumors, positioning it to synergistically interact with checkpoint inhibitors. In this newly published study, we show the synergistic benefits of pelareorep can be extended to additional cutting-edge immunotherapeutic agents. Based on these findings, we are specifically exploring a partnership strategy to further the development of pelareorep as an enabling technology for CAR T cells and additional immunotherapies that require immune effector cell infiltration in solid tumors."

The electronic poster titled "Combination Therapy with Oncolytic Viruses and CAR T Cells," was developed in collaboration with researchers from the Mayo Clinic, Duke University, and Oncolytics. It is available on the Posters & Publications page of Oncolytics' website (https://www.oncolyticsbiotech.com/technology/posters-publications).

About CAR T cells and CAR T therapy

The CAR T process begins when blood is drawn from a patient and their T cells are separated so they can be genetically engineered to produce chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein or antigen on tumor cells. Once the engineering process is complete, a laboratory can increase the number of CAR T cells into the hundreds of millions. Finally, the CAR T cells will be infused back into the patient where, ideally, the engineered cells further multiply, and recognize and kill cancer cells. Historically, solid tumors have been considered beyond the reach of CAR T therapy due to their tumor microenvironment, which is detrimental to CAR T cell entry and activity, amongst other challenges.1

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: http://www.oncolyticsbiotech.com.

References:

1. National Cancer Institute. CAR T Cells: Engineering Patients' Immune Cells to Treat Their Cancers. Updated July 31, 2019. Accessed February 18, 2021. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, potential commercial opportunities for pelareorep; the Company's primary focus on advancing its lead breast cancer program to a registrational trial; the Company's evaluation and pursuit of business development and partnership potential opportunities; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-reports-preclinical-data-demonstrating-the-synergistic-anti-cancer-activity-of-pelareorep-combined-with-car-t-cell-therapy-in-solid-tumors-301232827.html

SOURCE Oncolytics Biotech® Inc.

[INFINITI]

$15 target

[jfordosi]

Thanks i missed that. Go ONCY !!!

[INFINITI]

Wow looking good here got in $$$

[Atlanta1]

06:49
ONCY
Oncolytics Biotech initiation details -- Buy at H.C. Wainwright; tgt $15 (3.01)
H.C. Wainwright initiates ONCY with a Buy and price target of $15. Analyst Patrick Trucchio added, "Oncolytics Biotech, founded in 1998 and based in San Diego, California and Calgary, Alberta, is a biotechnology company focused on developing oncolytic viruses (OVs) for cancer treatment. Oncolytics' lead compound, pelareorep (pela), an unmodified reovirus and first-in-class systemically administered immuno-oncology (I-O) viral agent for solid tumors and hematological malignancies, is on the cusp of demonstrating potential to upend the treatment paradigms of several cancers, in our view. OVs are a group of viruses that infect and kill cancer cells preferentially to normal tissues; although the OV concept is not new, the field is gaining momentum only recently as advancements in technology have made it feasible to thoroughly study viruses and analyze the safety and antitumor efficacy. Oncolytics is evaluating pela in various combination trials in co-development or combination collaborations with Roche, Merck, Pfizer, Incyte, and Bristol-Myers Squibb. We believe it is the studies being conducted in breast cancer (BrCa) that could generate substantial value for shareholders in 2021 and beyond. Hence, we initiate coverage of Oncolytics with a Buy and $15 price target."

[jfordosi]

BUYOUT OR BIG NEWS FOR SURE. GO ONCY

[jfordosi]

Anyone know whats is happening?

[willlbone]

Will ONCY bouncy?

[Paulness]

NEWS -- Oncolytics and SOLTI Report Clinical Synergy of Pelareorep with Checkpoint Inhibitors at the 2020 San Antonio Breast Cancer Symposium

• Pelareorep strongly increases CelTIL score, the primary endpoint and a measure of tumor cellularity and inflammation associated with favorable clinical outcomes
• Pelareorep increased tumor PD-L1 expression 105-fold, thereby making the tumors more amenable to immuno-checkpoint inhibitor treatment

SAN DIEGO and CALGARY, AB, Dec. 9, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Breast Cancer Research today published an electronic poster at the 2020 San Antonio Breast Cancer Symposium (SABCS) with data from the AWARE-1 window-of-opportunity study in patients with early-stage breast cancer showing pelareorep delivers a significant boost known to increase the effectiveness of checkpoint inhibitors.

In the AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, early-stage breast cancer patients are treated with pelareorep, with or without atezolizumab (Tecentriq®), plus an appropriate therapy for each patient's breast cancer subtype, followed by surgery. The SABCS poster includes 17 out of the 20 HR+/HER2- breast cancer patients comprising the study's first two cohorts, the targeted patient population for our intended phase 3 study. Treatment with pelareorep increased the CelTIL score in tumor biopsies, which has been associated with improved clinical outcomes. In addition, pelareorep treatment dramatically upregulated PD-L1 expression in the tumor microenvironment (TME). These findings highlight the potential of pelareorep to act synergistically with checkpoint inhibitors and also provides a basis for the near doubling of overall survival observed in a prior phase 2 trial when pelareorep was added to chemotherapy in HR+/HER2- breast cancer patients (link to PR, link to poster).

"AWARE-1 data demonstrate pelareorep's consistent remodeling of the tumor immune environment," said Dr. Aleix Prat, M.D., Ph.D., Translational Investigator of AWARE-1, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona. "Pelareorep seems to train the immune system to target cancer cells while simultaneously promoting tumor inflammation and priming a response to immune checkpoint blockade. This demonstrates pelareorep's potential to overcome the immunosuppressive nature of the tumor microenvironment which could limit checkpoint inhibitor efficacy."

Key data and conclusions from the SABCS poster include:

• 72% of evaluated patients (n=18) saw an increase in CelTIL, the study's primary endpoint that is associated with favorable clinical outcomes.
• The maximum percentage increase in CelTIL (~300%) was achieved in a cohort 2 patient receiving pelareorep in combination with checkpoint blockade therapy.
• On average, there was a 105-fold increase in TME PD-L1 expression (n=13) from baseline (pre-pelareorep administration) to surgery (21-days post-administration).
• Tumor microenvironment PD-L1 expression increased in all evaluated patients (n=13).
• Preliminary imaging mass cytometry analysis showed pelareorep treatment promoted broad anti-tumor changes in the TME, including enhanced CD8+ T cell activation and the recruitment of memory T cells.

Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, commented, "In the AWARE-1 study, pelareorep delivered consistent increases in tumor PD-L1 expression and recruitment of anti-cancer immune cells into tumors, as well as increases in CelTIL score for over 70% of the patients. This is highly encouraging given the association between CelTIL and clinical outcomes, and we hope to observe the same success from our phase 2 BRACELET-1 trial, which is exclusively enrolling HR+/HER2- breast cancer patients."

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "Immune deserts or immunosuppressive tumor microenvironments limit tumor PD-L1 expression levels and thereby limit regulatory approval and commercial success of checkpoint inhibitors in certain breast and other malignancies. AWARE-1 data show that pelareorep can alter the tumor microenvironment and induce robust PD-L1 expression, highlighting the potential of pelareorep to boost the efficacy of checkpoint inhibitors and increase the proportion of patients eligible for these therapies. We expect this synergistic potential to enable the continued execution of our strategy to develop pelareorep-based therapies in collaboration with industry leaders."

The electronic poster, titled "A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (REO-027, AWARE-1)" is available in the SABCS virtual poster hall and on the Posters & Publications page of Oncolytics' website (https://www.oncolyticsbiotech.com/technology/posters-publications).

Ongoing 'trial-in-progress' posters giving an overview of Oncolytics' IRENE and BRACELET-1 study designs were also presented at SABCS and are available at the same locations.

About AWARE-1

AWARE-1 is an open-label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

• Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
• Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
• Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
• Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
• Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep, with or without atezolizumab, and the standard of care therapy according to breast cancer subtype. Patients are biopsied as part of their initial breast cancer evaluation, then again on day three following initial treatment, and a final tissue sample after three weeks, on the day of their mastectomy. Data generated from this study are intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.

For more information about the AWARE-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04102618.

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About SOLTI

SOLTI is a leading cooperative group in the field of clinical cancer research. With its academic and translational core, the group is committed to designing and executing clinical trials based on the molecular biology of tumors. Its focus is on breast cancer, but it also explores other kinds of tumors. The main goal of SOLTI is to promote through disruptive means the development of innovative research that will improve the well-being and future outcomes of cancer patients. Since its creation in 1995, SOLTI's purpose has been to bring about a paradigm shift in clinical and translational cancer research from within academia. With 77 clinical trials under their belt and more than 30 ongoing investigations, SOLTI counts on the work of more than 400 researchers from a network comprising more than 100 hospitals in Spain and Portugal, all coordinated by the team of 50 workers from the head office. SOLTI is a member of the Spanish Society of Medical Oncology (SEOM).

To find out more about SOLTI, visit HTTP://www.gruposolti.org / Twitter: @SOLTI / LinkedIn / Youtube

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: HTTP://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the Company's intentions regarding a potential phase 3 study involving pelareorep; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

Company Contact

Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-and-solti-report-clinical-synergy-of-pelareorep-with-checkpoint-inhibitors-at-the-2020-san-antonio-breast-cancer-symposium-301189190.html

SOURCE Oncolytics Biotech® Inc.

[nferna]

Anyone know how/where to access the SABCS 2020 posters?

[Paulness]

NEWS -- Oncolytics Biotech® to Present AWARE-1 Data and Provide Updates on Phase 2 BRACELET-1 and IRENE Trials at the 2020 San Antonio Breast Cancer Symposium

SAN DIEGO, Calif. and CALGARY, Alberta, Nov. 17, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the publication of three abstracts for electronic poster presentations to be given as part of the 2020 San Antonio Breast Cancer Symposium, which is being held virtually from December 8-11, 2020.

Details on the abstracts and corresponding electronic posters are shown below. All posters will be available in a virtual poster hall beginning Wednesday, December 9, 2020 at 9:00 AM ET.

Poster Number: PS12-08
Title: A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (REO-027, AWARE-1)
Session Name: Poster Session 12
Presenter: Dr. Luis Manso

Poster Number: OT-13-02
Title: Bracelet-1 (pre0113): a study to assess overall response rate by inducing an inflammatory phenotype in metastatic breast cancer with the oncolytic reovirus pelareorep in combination with anti-PD-L1 avelumab and paclitaxel
Session Name: Ongoing Trials Posters
Presenter: Dr. Kathy Miller

Poster Number: OT-32-02
Title: Irene study: phase 2 study of incmga00012 (retifanlimab) and the oncolytic virus pelareorep in metastatic triple negative breast cancer
Session Name: Ongoing Trials Posters
Presenter: Dr. Mridula George

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: HTTP://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic; the timing of the presentations to be given as part of the 2020 San Antonio Breast Cancer Symposium; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

Company Contact

Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-to-present-aware-1-data-and-provide-updates-on-phase-2-bracelet-1-and-irene-trials-at-the-2020-san-antonio-breast-cancer-symposium-301174275.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech, Inc. to Host Earnings Call

NEW YORK, NY / ACCESSWIRE / November 11, 2020 / Oncolytics Biotech, Inc. (NASDAQ:ONCY) will be discussing their earnings results in their 2020 Third Quarter Earnings call to be held on November 11, 2020 at 5:00 PM Eastern Time.

To listen to the event live or access a replay of the call - visit
https://www.investornetwork.com/event/presentation/71533

To receive updates for this company you can register by emailing mailto://[e-mail] or by clicking get investment info from the company's profile.

About Investor Network

Investor Network (IN) is a financial content community, serving millions of unique investors market information, earnings, commentary and news on what's trending. Dedicated to both the professional and the average traders, IN offers timely, trusted and relevant financial information for virtually every investor. IN is an Issuer Direct brand, to learn more or for the latest financial news and market information, visit http://www.investornetwork.com. Follow us on Twitter @investornetwork.

SOURCE: Investor Network

View source version on accesswire.com:
https://www.accesswire.com/616057/Oncolytics-Biotech-Inc-to-Host-Earnings-Call

[Paulness]

NEWS -- Oncolytics Biotech® and SOLTI Present Clinical Breast Cancer Data Highlighting Pelareorep-Induced Anti-Tumor T Cell Responses at The Society for Immunotherapy of Cancer Annual Meeting

• AWARE-1 data support the results of a prior phase 2 trial that showed a near doubling of overall survival with pelareorep treatment in HR+/HER2- breast cancer patients
• Data show pelareorep-induced generation and expansion of anti-tumor T cell clones that may contribute to a durable anti-cancer immune memory effect and improve outcomes in breast cancer
• 70% of cohort-1 patients saw an increase in CelTIL, the study's primary endpoint and a measure of tumor inflammation that is associated with favorable clinical outcomes

SAN DIEGO, CA and CALGARY, AB, Nov. 9, 2020 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Breast Cancer Research today announced the publication of an electronic poster with clinical data from the AWARE-1 window-of-opportunity breast cancer study at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting.

The AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, combines the appropriate intervention for each patient's breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq®), followed by surgery in early-stage breast cancer patients. Data presented in the electronic poster were from the ten HR+/HER2- breast cancer patients that make up the study's first cohort. These data demonstrate the ability of pelareorep to promote a pro-inflammatory tumor microenvironment (TME) and provide a basis for the findings of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment in HR+/HER2- breast cancer patients (link to PR, link to poster).

"AWARE-1's elegant paired-biopsy design allows us to assess the impact of pelareorep on each patient's tumor immune environment, and the results to date have been very promising," said Dr. Aleix Prat, M.D., PhD., Translational Investigator of the Study, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona. "These data continue to support pelareorep's ability to train the immune system to target cancer and highlight its potential to address a critical unmet need by increasing the number of patients responding to checkpoint inhibitor therapies. Data presented at SITC showing pelareorep-induced generation and expansion of anti-tumor and anti-viral T cell clones are also noteworthy, as they suggest the induction of a durable anti-cancer immune memory effect. These data, together with previously reported AWARE-1 results, provide strong support for the observed survival benefit in a prior randomized phase 2 study evaluating pelareorep in metastatic breast cancer patients."

Key data and conclusions from the electronic poster include:

• Tumor-cell specific pelareorep replication was observed in all cohort-1 patients following systemic pelareorep administration
• 70% of cohort 1 patients saw an increase in CelTIL, the study's primary endpoint and a measure of tumor-associated cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes
• On average, there was a 14-fold increase in intratumoral CD8+ T cells from baseline (pre-pelareorep administration) to surgery (21-days post-administration), with increases observed in all cohort-1 patients
• Pelareorep administration led to the generation and expansion of new T cell clones in the tumor and periphery, which included both anti-tumor and anti-viral clones

Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, commented, "These newly announced AWARE-1 results add to the promising clinical dataset supporting pelareorep's immunotherapeutic mechanism of action and to the proposed registration pathway in our lead metastatic breast cancer program. The observed 70% CelTIL response rate in cohort-1 patients is highly encouraging, as CelTIL is associated with favorable patient outcomes, and this response rate was achieved despite the absence of checkpoint blockade therapy. Further, previously announced data have shown that CelTIL scores correlate with high peripheral T cell clonality, underscoring T cell clonality's potential as a predictive biomarker that may facilitate the design of future registrational trials and improve their chances of success. We look forward to presenting additional AWARE-1 data later this year and to the continued progress of the trial, which will be key as we move our lead breast cancer program towards a registrational study."

The electronic poster, titled, "Changes in T cell clonality in AWARE-1 study, a window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer" is being presented at SITC by Dr. Prat. As of the SITC data cut-off, AWARE-1 has enrolled 23 out of 38 patients, including all patients in the study's first two cohorts.

Details on the AWARE-1 electronic poster, which are available on the SITC 2020 website and on the Posters & Publications page of Oncolytics' website (LINK), are shown below.

Poster Number: 806

Title: Changes in T cell clonality in AWARE-1 study, a window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer

Presentation Date and Time: Thursday, November 12 from 4:50-5:20 p.m. EST and Saturday, November 14 from 1:00-1:30 p.m. EST

Presenter: Dr. Aleix Prat

About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

• Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
• Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
• Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
• Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
• Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

For more information about the AWARE-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04102618.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About SOLTI

SOLTI is a leading cooperative group in the field of clinical cancer research. With its academic and translational core, the group is committed to designing and executing clinical trials based on the molecular biology of tumors. Its focus is on breast cancer, but it also explores other kinds of tumors. The main goal of SOLTI is to promote through disruptive means the development of innovative research that will improve the well-being and future outcomes of cancer patients. Since its creation in 1995, SOLTI's purpose has been to bring about a paradigm shift in clinical and translational cancer research from within academia. With 77 clinical trials under their belt and more than 30 ongoing investigations, SOLTI counts on the work of more than 400 researchers from a network comprising more than 100 hospitals in Spain and Portugal, all coordinated by the team of 50 workers from the head office. SOLTI is a member of the Spanish Society of Medical Oncology (SEOM).

To find out more about SOLTI, visit http://www.gruposolti.org / Twitter: @SOLTI / LinkedIn / Youtube

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: http://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action and benefits of pelareorep as a cancer therapeutic; the Company's expectations respecting the delivery of additional clinical data and the timing thereof; the Company's expectations respecting potential future registrational trials and the likelihood of success thereof; the timing of the presentation of the clinical data from the Company's AWARE-1 study at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

Company Contact
Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

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SOURCE Oncolytics Biotech® Inc.

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[Paulness]

NEWS -- Oncolytics Biotech® Announces Abstract Publication and Upcoming Oral Presentation at the 2020 Society of Neuro-Oncology Annual Meeting

SAN DIEGO, CA and CALGARY, AB, Nov. 9, 2020 /CNW/ -- Oncolytics Biotech® Inc. [NASDAQ: ONCY] [TSX: ONC] today announced the publication of an abstract for an oral presentation to be given as part of the virtual 2020 Society of Neuro-Oncology (SNO) Annual Meeting. The abstract highlights clinical data from ReoGlio, an investigator-sponsored phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of patients with newly diagnosed glioblastoma multiforme (GBM). For more details on the abstract and the oral presentation, see below.

Abstract ID: CTIM-14

Title: Pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) with standard chemoradiotherapy/adjuvant temozolomide for glioblastoma multiforme (GBM) patients: ReoGlio phase I trial results.

Session Name: Clinical Trials Session II

Presentation Date and Time: On-demand (link to the presentation)

Speaker: Susan Short, M.R.C.P., Ph.D., Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds

The published abstract is available on the SNO website at https://academic.oup.com/neuro-oncology.

About ReoGlio

The ReoGlio trial was an investigator-sponsored, phase 1b, open-label trial evaluating the combination of pelareorep and GM-CSF, alongside standard chemoradiotherapy and adjuvant temozolomide, for the treatment of newly diagnosed GBM. Fifteen patients were treated in the trial. The primary objective of the study was to determine the maximum tolerated dose of pelareorep and GM-CSF with standard chemoradiotherapy. Secondary objectives were to assess the activity of the pelareorep-GM-CSF combination and treatment compliance. The trial was designed and managed by the University of Leeds and funded through grants provided by Cancer Research UK and The Brain Tumor Charity.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: http://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential of pelareorep as a cancer therapeutic; the Company's expectations respecting the delivery of additional clinical data and the timing thereof; the Company's expectations respecting potential future registrational trials and the likelihood of success thereof; the timing of the presentation of the clinical data from the Company's ReoGlio study at The Society of Neuro-Oncology (SNO) Annual Meeting; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

Kirk Look
Chief Financial Officer
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-abstract-publication-and-upcoming-oral-presentation-at-the-2020-society-of-neuro-oncology-annual-meeting-301168496.html

View original content: http://www.newswire.ca/en/releases/archive/November2020/09/c3835.html

SOURCE Oncolytics Biotech® Inc.