Oncolytics Biotech Inc (ONCY)

[Cobra Stock Sleuth]

Looks like we're in the money. Should be a very interesting week. Good luck everyone.

[Cobra Stock Sleuth]

Pancreatic cancer might just be our way into the big leagues !!!!! Awesome sauce!!!!!!

[Paulness]

NEWS -- Oncolytics Biotech® Achieves Success Criteria for Efficacy in the Pancreatic Cancer Cohort of GOBLET

Partial responses achieved in all patients in cohort's 1b portion

Expansion criteria for pancreatic cancer cohort has been met to allow for additional patient enrollment

Data suggest pelareorep synergistically combines with chemotherapy and checkpoint inhibition in a highly challenging indication and are featured in an abstract at the ESMO World Congress on Gastrointestinal Cancer

SAN DIEGO and CALGARY, AB, June 28, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the pancreatic cancer cohort of the multi-indication phase 1/2 GOBLET study has met the efficacy expansion criteria for Stage 1 of the trial. The data from the phase 1b portion of this cohort, which are featured in an abstract accepted for a poster presentation at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2022, show a strong efficacy signal as evidenced by all patients achieving a partial response (n = 3). An independent safety review noted no toxicity concerns in these patients. The trial's metastatic colorectal and advanced anal cancer cohorts are proceeding as planned.



The GOBLET study's pancreatic cancer cohort is evaluating the safety and efficacy of pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel. Per the study's Simon two-stage design, any cohort meeting a pre-specified efficacy threshold in Stage 1 (defined as achieving a minimum number of objective radiologic responses by week 16) may be expanded to enroll additional patients in an optional Stage 2 study expansion. In addition to evaluating the safety and efficacy of pelareorep-atezolizumab combinations, the study seeks to assess the potential of CEACAM6 and T cell clonality to serve as predictive biomarkers that may increase the probability of success in subsequent trials by informing patient selection. The study is being conducted at 14 clinical sites in Germany and is being managed by AIO, a leading academic cooperative medical oncology group.

"With Stage 1's pre-specified efficacy threshold met after just the first three patients, the GOBLET trial's pancreatic cancer cohort is clearly exceeding expectations," said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "Novel therapeutic approaches are urgently needed in pancreatic cancer, as standard-of-care chemotherapy has a limited response rate, and less than 2% of patients are eligible for treatment with checkpoint inhibitors. Prior data in pancreatic cancer patients demonstrated pelareorep's ability to remodel the tumor microenvironment to be less immunosuppressive. These latest results indicate that pelareorep's immunotherapeutic effects may enhance the efficacy of checkpoint inhibitors in pancreatic cancer and increase tumor response rates. This promising finding suggests that pelareorep has the potential to dramatically improve the current therapeutic approach is an indication that is amongst the most difficult to treat."

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "Though early, these data provide a strong and exciting signal of efficacy for the studied combination. Looking forward, we will continue to follow this cohort closely to see if its initial positive results are substantiated as additional patients are evaluated and the data mature. If this impressive signal persists, it may enable us to pursue regulatory paths in pancreatic cancer that include subsequent trials designed to facilitate an expedited approval. We intend to engage regulators to gain insights on pelareorep's optimal path forward in pancreatic cancer later this year and believe this program has the potential to provide a significant source of value that will complement our core efforts in breast cancer."

Additional details related to the upcoming poster and corresponding abstract, entitled, GOBLET: A phase 1/2 multiple indication signal finding and biomarker study in advanced gastrointestinal cancers treated with pelareorep and atezolizumab – safety and preliminary response results, are shown below.

Congress Location: Centre de Convencions Internacional de Barcelona (Barcelona, Spain)
Session Date: Thursday, June 30, 2022
Session Times: 9:30 - 10:00 a.m. CET and 5:15 - 5:45 p.m. CET
Abstract Number: P-49

The poster's corresponding abstract is currently available for viewing on the congress website (LINK). A copy of the poster will be available on the Posters & Publications page of Oncolytics' website (LINK) following the conclusion of the congress.

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 study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/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).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

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 medical 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 estimates indicating that 106,180 new cases of colon cancer and 44,850 new cases of rectal cancer will be diagnosed in the U.S. in 20221. Also, for the 2022 year, the American Cancer Society estimates there will be 62,210 new cases of pancreatic cancer2 and 9,440 new cases of anal cancer3 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 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. "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; Oncolytics' expectations regarding its ability to pursue regulatory paths in pancreatic cancer that include subsequent trials designed to facilitate an expedited approval; Oncolytics' intention to engage regulators to gain insights on pelareorep's optimal path forward in pancreatic cancer later this year; Oncolytics' belief that its pancreatic cancer program has the potential to provide a significant source of value that will complement its core efforts in breast cancer; our plans to advance towards a registration study in metastatic breast cancer; 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.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2022/28/c6684.html

[Cobra Stock Sleuth]

New director has obviously been brought on board to help with Oncolytics Negotiations in a deal with Pfizer.

[Cobra Stock Sleuth]

Buyout by end of August or first two weeks of September for at least $30 US a share that's my call. Just a guess but that's how I see it.

[Paulness]

NEWS -- Oncolytics Biotech® Announces Voting Results from the Annual General Meeting of Shareholders and Appoints James T. Parsons to its Board of Directors

Mr. Parsons served as the Chief Financial Officer of Trillium Therapeutics, which was recently acquired by Pfizer Inc.

SAN DIEGO and CALGARY, AB, June 17, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), today announced the voting results from its Annual General Meeting (AGM) of Shareholders held on Thursday, June 16, 2022. A total of 40.43% of the issued and outstanding common shares of the Corporation were represented either in person or by proxy at the meeting. Additionally, James T. Parsons was elected to the Oncolytics Biotech Board of Directors. Leonard (Leon) Kruimer did not stand for re-election as a director at the AGM.



Mr. Parsons commented, "Oncolytics' clinical data highlight a compelling opportunity ahead, and it is an honor to join the Board at this exciting time. Pelareorep is a unique immunotherapeutic agent with the potential to be a backbone therapy that combines with a variety of oncology drugs to address unmet needs in multiple indications. The company has established collaborations with several of the largest actors in the biopharma world, leaving it well-positioned to efficiently pursue its clinical objectives. I am excited to begin working with the company."

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "Mr. Parsons executive experience, vision, and impressive record of success make him an ideal addition to our Board. I look forward to benefitting from his guidance and expertise as we work to advance pelareorep's development and drive our corporate growth. I would also like to thank Mr. Kruimer for his service and for helping us get to where we are today."

On a vote by ballot, the six 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 April 29, 2022, 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 six 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 https://www.sedar.com. Final voting results on all matters voted on at the annual meeting will also be filed on SEDAR.

James T. Parsons Biography

Mr. Parsons is a life sciences industry veteran with over two decades of executive experience. He served as the Chief Financial Officer (CFO) of Trillium Therapeutics Inc. (TSX: TRIL) (NASDAQ: TRIL) from August 2011 through its acquisition by Pfizer in November 2021 for an aggregate purchase price of approximately $2.2 billion. Prior to his time at Trillium, Mr. Parsons provided financial consulting services as the President of Empar Management. He also previously served as Vice President, Finance, at DiaMedica Therapeutics Inc, CFO of ProMIS Neurosciences (formerly Amorfix Life Sciences Ltd.), and CFO and Vice President, Finance and Administration, at Aptose Biosciences Inc. (formerly Lorus Therapeutics). Mr. Parsons has been a Director and the Chair of the Audit Committees of Sernova Corp. (TSX: SVA) and DiaMedica Therapeutics Inc. (NASDAQ: DMAC) since 2012 and 2015, respectively.

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 and plans to advance towards a registration study in metastatic breast cancer; 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-voting-results-from-the-annual-general-meeting-of-shareholders-and-appoints-james-t-parsons-to-its-board-of-directors-301570185.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/June2022/17/c5770.html

[Cobra Stock Sleuth]

Novartis rumor. They're taking closer look at CAR-T data maybe. They would need to make an up front payment, milestones and
give ONCY a percentage of the CAR-T treatment. Sounds like a big ask on ONCY part. But who knows. ONCY might deal lower to get a deal done? Since share price struggling.

[Paulness]

NEWS -- Oncolytics Biotech® to Participate in a Fireside Chat at the 2022 RBC Capital Markets Global Healthcare Conference

SAN DIEGO, Calif. and CALGARY, AB, May 10, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Dr. Matt Coffey, President and Chief Executive Officer, will participate in a fireside chat at the 2022 RBC Capital Markets Global Healthcare Conference, which is taking place May 17-18, 2022 at the InterContinental New York Barclay in New York, NY. Additional details on the fireside chat can be found below.

Date: Wednesday, May 18, 2022

Time: 11:00 a.m. ET

Location: InterContinental New York Barclay Morgan Suite, Mezzanine Level

Webcast Link: Available by clicking here

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

A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived until August 15, 2022.

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; our plans to advance towards a registration study in metastatic breast cancer; 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-a-fireside-chat-at-the-2022-rbc-capital-markets-global-healthcare-conference-301543480.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/May2022/10/c6727.html

[Paulness]

NEWS -- Oncolytics Biotech® and SOLTI Present New Clinical Biomarker Data Demonstrating Pelareorep's Potential to Improve the Prognosis of Breast Cancer Patients at the ESMO Breast Cancer Meeting

Pelareorep treatment resulted in a favorable Risk of Recurrence Score (ROR-S) in 100% of evaluable patients compared to 55% at baseline in a window-of-opportunity study

Statistically significant increases in markers of tumor cell death and T cell activation observed following treatment with pelareorep-based combinations

SAN DIEGO and CALGARY, AB, May 4, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Cancer Research today announced new clinical biomarker data demonstrating pelareorep's immunotherapeutic effects, synergy with checkpoint inhibition, and potential to improve the outlook for patients with HR+/HER2- breast cancer. The data, which are featured in a poster presentation at the 2022 European Society for Medical Oncology (ESMO) Breast Cancer Meeting, are from cohorts 1 and 2 of the AWARE-1 window-of-opportunity study in early-stage breast cancer patients.

Patients in AWARE-1's first two cohorts were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1), or with (cohort 2), the PD-L1 checkpoint inhibitor atezolizumab approximately 21 days prior to the surgical resection of their tumors. Cohorts 1 and 2 of AWARE-1 exclusively enrolled patients with HR+/HER2- disease, the breast cancer subtype that Oncolytics intends to examine in a future registrational study. Previously reported results showed AWARE-1 met its primary translational endpoint, with cohort 2 achieving the pre-specified success criteria for treatment-induced increases in CelTIL score (link to the PR). CelTIL score is a metric for tumor inflammation and cellularity and is associated with improved clinical outcomes in breast cancer patients.

"The latest data from AWARE-1 further demonstrate pelareorep's potential to improve clinical outcomes in breast cancer patients through its ability to activate T cells and remodel the tumor microenvironment," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "Notably, pelareorep treatment increased markers of tumor cell death and, perhaps even more impressive, 100% of evaluable pelareorep-treated patients had a favorable Risk of Recurrence Score (ROR-S) compared to 55% at baseline. Together, these latest AWARE-1 results further establish pelareorep's ability to attack tumors through multiple mechanisms."

Key data and conclusions from the ESMO Breast Cancer poster include:

• Gene expression analyses showed 100% of evaluable patients had a Risk of Recurrence Score (ROR-S) classified as "low" at surgery vs. 55% with a "low" ROR-S at baseline (information pertaining to prognostic testing of gene signature assays in breast cancer can be found by clicking here)
• Treatment with pelareorep with (cohort 2) or without (cohort1) atezolizumab led to the conversion of tumors from the more aggressive luminal B to the luminal A subtype, which is associated with improved clinical outcomes
• Pooled analysis of tumors from cohorts 1 and 2 shows a statistically significant 4-fold post-treatment increase in the average expression of caspase 3, which is a marker of apoptotic cell death
• Pooled analysis across cohorts 1 and 2 shows statistically significant increases in markers of T cell activation and no significant changes in markers of T cell exhaustion from baseline to surgery

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "AWARE-1's results continue to exceed our expectations. With each new dataset, we gain additional clarity on how pelareorep's immunologic mechanism of action synergistically combines with checkpoint inhibition. The study has also identified changes in blood T cell populations as a potential biomarker to predict patient response. We are now working to confirm these promising findings with efficacy data and additional biomarker analyses from our ongoing BRACELET-1 trial. If positive, we expect BRACELET-1's results to inform the design of a registrational study in HR+/HER2- breast cancer and validate our broader strategy of developing pelareorep in combination with leading anti-cancer agents."

BRACELET-1 is a randomized phase 2 trial in HR+/HER2- metastatic breast cancer. The trial includes cohorts evaluating paclitaxel monotherapy, paclitaxel plus pelareorep, and paclitaxel plus pelareorep in combination with a checkpoint inhibitor. Top-line data from the trial are expected in Q4 2022.

The poster, entitled, The oncolytic virus pelareorep primes the tumor microenvironment for checkpoint blockade therapy in early breast cancer patients - Results from AWARE-1 study, is being presented during the "Biomarkers and translational research and precision medicine" session of the ESMO Breast Cancer Meeting. Following the conclusion of the meeting, the poster will be available on the Posters & Publications page of Oncolytics' website (LINK).

About AWARE-1

AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue was 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 their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers.

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; our plans to confirm our findings with efficacy data and additional biomarker analyses from our ongoing BRACELET-1 trial; our expectations that positive results from the BRACELET-1 trial may inform the design of a registrational study in HR+/HER2- breast cancer and validate our broader strategy of developing pelareorep in combination with leading anti-cancer agents; the anticipated timing of receipt of top-line data from the trial are expected in Q4 2022; our plans to advance towards a registration study in metastatic breast cancer; 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-and-solti-present-new-clinical-biomarker-data-demonstrating-pelareoreps-potential-to-improve-the-prognosis-of-breast-cancer-patients-at-the-esmo-breast-cancer-meeting-301539250.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® and SOLTI Announce Upcoming Poster Presentation at the European Society for Medical Oncology Breast Cancer Meeting

SAN DIEGO, Calif. and CALGARY, AB, May 2, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Cancer Research today announced the acceptance of an abstract for a poster presentation at the upcoming European Society for Medical Oncology Breast Cancer Meeting, which is taking place both online and in-person at hub27 – Messe Berlin in Berlin, Germany from May 3-5, 2022.

The accepted abstract (#364) is available on the ESMO Breast Cancer Meeting website. Included in the abstract are new results from cohort 1 and cohort 2 of the AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, each of which enrolled ten HR+/HER2- early-stage breast cancer patients. These patients were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1) or with (cohort 2) the PD-L1 checkpoint inhibitor atezolizumab. Evaluation of these cohorts was the primary focus of AWARE-1 as HR+/HER2- is the breast cancer subtype Oncolytics intends to investigate in a future registrational study.

Results of this exploratory study described in the abstract show pelareorep's potential to induce an inflamed tumor phenotype and its synergy with atezolizumab. They also support pelareorep's immune-based mechanism of action and suggest that the combination of pelareorep and atezolizumab may improve outcomes in breast cancer. Additional details on analyses and results described in the abstract will be provided following the publication of its corresponding poster, in accordance with the ESMO Breast Cancer Meeting's embargo policies.

Details on the abstract and upcoming poster presentation are shown below.

Title: The oncolytic virus pelareorep primes the tumor microenvironment for checkpoint blockade therapy in early breast cancer patients - results from AWARE-1 study

Category: Biomarkers and translational research and precision medicine

Abstract Number: 364

Presentation Date: May 4, 2022

Presentation Time: 12:15 p.m. CET

About AWARE-1

AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue was 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 their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers.

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; the timing and anticipated content of poster presentation at the upcoming European Society for Medical Oncology Breast Cancer Meeting; our plans to advance towards a registration study in metastatic breast cancer; 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-and-solti-announce-upcoming-poster-presentation-at-the-european-society-for-medical-oncology-breast-cancer-meeting-301536730.html

SOURCE Oncolytics Biotech® Inc.

[Cobra Stock Sleuth]

Thought for sure there would be some leaked info or rumors on the Dark Stock Web on Oncolytics Biotech , but it's been strangely quiet. Maybe just bad overall market spooked everyone. Hoping fir a good week next week.

[Cobra Stock Sleuth]

Hopefully something good released. I'm batting zero on my rumor mill so far.

Heard nothing new on DSW this week.

[Paulness]

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

Conference call and webcast to take place on Thursday, May 5, 2022, at 5:00 p.m. ET

SAN DIEGO and CALGARY, AB, April 28, 2022 /PRNewswire/ --Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Thursday, May 5, 2022, at 5:00 p.m. ET to discuss a corporate update and financial results for the first quarter of 2022.

Conference Call & Webcast

• Date: Thursday, May 5, 2022
• Time: 5:00 p.m. ET
• Dial In – North American Toll-Free: [phone]
• Dial In – International: [phone]
• Conference ID (if needed): 6952-6976
• Webcast: please click here

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: 526-976#.

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' plans to advance towards a registration study in metastatic breast cancer; 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-to-host-conference-call-to-discuss-first-quarter-financial-results-and-recent-operational-highlights-301535081.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® to Present at the Bloom Burton & Co. Healthcare Investor Conference

SAN DIEGO, Calif. and CALGARY, AB, April 21, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Dr. Matt Coffey, President and Chief Executive Officer, will be presenting a corporate overview at the Bloom Burton & Co. Healthcare Investor Conference, which is taking place May 2-3, 2022 at the Metro Toronto Convention Centre, North Building in Toronto, Ontario. Additional details on the presentation can be found below.

Date: Tuesday, May 3, 2022
Time: 11:00 a.m. ET
Location: Metro Toronto Convention Centre, North Building Hall B
Webcast Link: Available by clicking here

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

A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.

About the Conference

The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from the premier Canadian publicly traded and private companies through presentations and private meetings.

About Bloom Burton & Co.

Bloom Burton & Co. is a firm dedicated to accelerating returns in the healthcare sector for both investors and companies. Bloom Burton has an experienced team of medical, scientific, pharmaceutical, legal and capital markets professionals who perform a deep level of diligence, which combined with our creative and entrepreneurial approach, assists our clients in achieving the right monetization events. Bloom Burton and its affiliates provide capital raising, M&A advisory, equity research, business strategy and scientific consulting, advisory on direct investing and company creation and incubation services. Bloom Burton Securities Inc. is a member of the Investment Industry Regulatory Organization of Canada (IIROC) and is also a member of the Canadian Investor Protection Fund (CIPF).

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; our plans to advance towards a registration study in metastatic breast cancer; 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-to-present-at-the-bloom-burton--co-healthcare-investor-conference-301529907.html

SOURCE Oncolytics Biotech® Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2022/21/c4776.html

[Paulness]

NEWS -- Oncolytics Biotech® Announces Publication of Preclinical Data Demonstrating the Synergistic Anti-Cancer Activity of Pelareorep Combined with CAR T Cell Therapy in Solid Tumors in Science Translational Medicine

- Pelareorep-CAR T combination may expand the commercial potential of CAR T cells to solid tumors

- Combining CAR T cells with pelareorep prevented antigen escape by creating CAR T cells with dual specificity through a novel mechanism

- Loading CAR T cells with pelareorep led to dramatic improvements in their persistence and anti-cancer activity as well as cures in multiple murine solid tumor models

SAN DIEGO, Calif. and CALGARY, AB, April 14, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the publication of preclinical data demonstrating the synergistic anti-cancer activity of pelareorep combined with chimeric antigen receptor (CAR) T cell therapy in solid tumors. The paper, entitled "Oncolytic virus-mediated expansion of dual-specific CAR T cells improves efficacy against solid tumors in mice," was published in Science Translational Medicine in collaboration with researchers at several prestigious institutions, including the Mayo Clinic and Duke University. A link to the paper can be found by clicking here.

"Having these results published in such a high-impact journal provides important external validation of their significance," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc. "While CAR T cells have generated long-term cures in hematologic malignancies1, the immunosuppressive tumor microenvironments (TMEs) of solid organ cancers have thus far limited their efficacy in these indications. Pelareorep has repeatedly been shown to reverse immunosuppressive TMEs, and in the present publication pelareorep is shown to enable the effectiveness of CAR T cells in multiple murine solid tumor models. This is a powerful finding that, if translated to the clinic, could significantly improve the prognosis of patients with a variety of highly prevalent cancers by providing a novel and potentially durable treatment option. By demonstrating the ability to improve T cell perseverance, reduce antigen escape, and overcome challenging solid tumor TMEs, the inclusion of pelareorep addresses the three most challenging roadblocks to effective CAR T therapy."

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "Despite revolutionizing the treatment of certain cancers and surpassing a billion dollars in sales last year, CAR T therapies currently only serve a small subset of patients suffering from hematologic malignancies. With these latest results, we now have strong preclinical evidence that pelareorep can fully unlock the value of CAR T therapies by expanding their commercial potential to the significantly larger market of cancer patients who are battling solid tumors."

Preclinical studies published in the paper evaluated the persistence and efficacy of pelareorep-loaded CAR T cells ("CAR/Pela therapy") in multiple murine solid tumor models. The effects of combining CAR/Pela therapy with a subsequent intravenous dose of pelareorep ("pelareorep boost") were also investigated. Key data and conclusions from the paper include:

• The persistence and anti-cancer activity of CAR T cells improved drastically when loaded with pelareorep. Compared to either treatment alone, treatment with CAR/Pela therapy led to statistically significant survival benefits in murine skin and brain cancer models.
• CAR/Pela therapy followed by a pelareorep boost led to enhanced efficacy in murine skin and brain cancer models and tumor cures in >80% of treated mice in each model.
• Loading CAR T cells with pelareoep led to improved cancer cell targeting and prevented antigen escape in vivo by generating CAR T cells with dual specificity that target their designed antigen and the native T cell receptor antigen. These results indicate that CAR/Pela therapy may provide longer-lasting therapeutic benefits compared to treatment with CAR T cells alone.

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. and co-author of the paper commented, "These exciting results are an excellent example of how we are leveraging collaborations with key opinion leaders and premier research institutions to broaden pelareorep's potential therapeutic impact. This allows us to remain primarily focused on our lead breast cancer program, which has shown how pelareorep's ability to promote tumor T cell infiltration leads to synergy with checkpoint inhibitors in the clinic. These newly published preclinical findings show pelareorep's synergistic benefits extend even beyond checkpoint inhibitors and highlight an opportunity to increase our addressable patient population. As we pursue this opportunity moving forward, we intend to utilize relationships with academic or industry partners so that we can continue to execute on our clinical and corporate objectives with efficiency."

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.2

About Science Translational Medicine

Science Translational Medicine is the leading weekly online journal publishing translational research at the intersection of science, engineering, and medicine. The goal of Science Translational Medicine is to promote human health by providing a forum for communicating the latest research advances from biomedical, translational, and clinical researchers from all established and emerging disciplines relevant to medicine. In addition to original research, Science Translational Medicine also publishes Reviews, Editorials, Focus articles, and Viewpoints.

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. Melenhorst, J.J., Chen, G.M., Wang, M. et al. Decade-long leukaemia remissions with persistence of CD4+ CAR T cells. Nature (2022). https://doi.org/10.1038/s41586-021-04390-6

2. 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 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; including potentially significantly improving the prognosis of patients with a variety of highly-prevalent cancers by providing them with a novel and potentially durable treatment option and the opportunity to potentially expand our addressable patient population; our intention to utilize relationships with academic or industry partners so that we can continue to execute on our clinical and corporate objectives with efficiency; our leveraging of collaborations with key opinion leaders to broaden pelareorep's potential therapeutic impact; our plans to advance towards a registration study in metastatic breast cancer; 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-publication-of-preclinical-data-demonstrating-the-synergistic-anti-cancer-activity-of-pelareorep-combined-with-car-t-cell-therapy-in-solid-tumors-in-science-translational-medicine-301525571.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

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

SAN DIEGO, Calif. and CALGARY, AB, April 12, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Thomas Heineman, M.D., Ph.D., the Company's Chief Medical Officer, will be participating in a fireside chat at the Canaccord Genuity Horizons in Oncology Virtual Conference. Additional details on the fireside chat are provided below.

Date: Thursday, April 14, 2022
Time: 10:00 a.m. ET
Webcast: Please click here

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 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; our plans to advance towards a registration study in metastatic breast cancer; 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]

SOURCE: Oncolytics Biotech® Inc.




View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-fireside-chat-at-the-canaccord-genuity-horizons-in-oncology-virtual-conference-301523588.html

SOURCE Oncolytics Biotech® Inc.

[Cobra Stock Sleuth]

Something might be happening next week.

No details just chatter on special board for elite stock membership. Don't read much into this but might want to watch the stock closely. I only have this info as third party so take with a grain of salt. It could end up being nothing like last time but with everything that happened last week I might take some profit off if we get a spike.

Sorry if this is just another pain in a** post.

[Paulness]

NEWS -- Oncolytics Biotech® Announces Positive Long-Term Survival Data from Phase 1b Glioblastoma Multiforme Trial at the AACR Annual Meeting

- Results demonstrate meaningful and durable efficacy signal in a highly challenging indication

- A higher dose level of pelareorep led to 50% 24-month median overall survival (mOS) and a patient still alive at 42 months compared to 16.7% mOS at the lower dose

- Investigator-sponsored trial confirms pelareorep's favorable safety profile

SAN DIEGO and CALGARY, AB, April 8, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced positive long-term survival 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 glioblastoma multiforme (GBM). The results, which are the subject of a presentation at the American Association for Cancer Research (AACR) Annual Meeting, show a substantial and durable efficacy signal in newly diagnosed GBM patients and demonstrate the safety and tolerability of the studied treatment combination in this indication.

"These results provide further evidence suggesting that the long-term survival benefits pelareorep delivers to breast cancer patients may be extended to a variety of indications," said Susan Short, M.R.C.P., Ph.D., Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds. "I am highly encouraged by the two-year survival rate and median overall survival observed in ReoGlio and view the relative increases these metrics show in the high dose cohort as a promising sign of this therapy combination's dose-dependent activity in GBM. ReoGlio's long-term results are also consistent with the positive progression-free survival data that were previously reported and confirm pelareorep's favorable safety profile in this new indication. Collectively, these findings highlight pelareorep's potential to drive clinical benefit in GBM patients, who are historically very challenging to treat and in urgent need of novel therapies."

Key data and conclusions from the AACR poster and corresponding abstract include:

• Evaluable patients treated with pelareorep at dose level-2 (3x1010 TCID50) had a median overall survival (mOS) of 16.1 months and a 24-month survival rate of 50% (n=6)
• Evaluable patients treated with pelareorep at dose level-1 (1x1010 TCID50) had a mOS of 12.6 months and a 24-month survival rate of 16.7% (n=6)
• Across both dose levels, mOS was 13.1 months and the 24-month survival rate was 33% (n=12)
• One patient treated at dose level-2 remains alive at 42 months
• The studied treatment combination was deemed safe and well-tolerated at both dose levels by a Safety Review Committee that included two independent physicians

The long-term follow-up data from the ReoGlio study being presented at AACR are an extension of prior data that were featured in a podium presentation at the 2020 Society of Neuro-Oncology Annual Meeting (https://www.oncolyticsbiotech.com/press-releases/detail/525/oncolytics-biotech-announces-positive-clinical-results). These data demonstrated an estimated median progression-free survival (mPFS) of 7.8 months across all evaluable patients in the study (n=12), with those treated at dose level-2 showing an estimated mPFS of 9.4 months (n=6) and those treated at dose level-1 showing an estimated mPFS of 6.1 months (n=6).

Matt Coffey, Ph.D., MBA, President and Chief Executive Officer of Oncolytics Biotech Inc. added, "ReoGlio's results strengthen the broad clinical dataset demonstrating pelareorep's potential to address unmet needs across a range of cancers. We believe they warrant additional clinical study, and plan to discuss them with thought leaders and potential partners to identify the best and most efficient potential path forward in GBM. This strategy will allow us to opportunistically expand pelareorep's commercial potential while staying focused on the advancement of our lead breast cancer program to a registrational study. We would like to sincerely thank the University of Leeds, Cancer Research UK, and The Brain Tumor Charity for designing and funding the ReoGlio trial, as well as all of the patients who participated."

An electronic copy of the presentation and the corresponding abstract, entitled, Combination of reovirus (pelareorep) and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant chemotherapy (temozolomide) for patients with glioblastoma multiforme (GBM): long term follow up results of the ReoGlio phase Ib trial, is available to registered attendees of the AACR annual meeting on the meeting website. A copy of the presentation will also be posted to the Posters & Publications page of Oncolytics' website (https://www.oncolyticsbiotech.com/technology/posters-publications) following the conclusion of the meeting.

Details for the online presentation are shown below.

Abstract Number: CT569

Session Title: OPO.CT01.01 - Phase I Clinical Trials

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 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; the timing and results of the presentation to be made at the American Association for Cancer Research Annual Meeting; our plans to discuss the results of the ReoGlio study with thought leaders and potential partners to identify the best and most efficient potential path forward in GBM and the anticipated results of this strategy; our plans to advance towards a registration study in metastatic breast cancer; 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.

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[Paulness]

NEWS -- Oncolytics Biotech® Presents New Data Demonstrating Durable Clinical Benefit in Relapsed/Refractory Multiple Myeloma Patients at the AACR Annual Meeting

- Pelareorep's immunotherapeutic effects produced progression-free survival of >3 years in a subset of multiple myeloma patients who had failed prior therapy

- Results strengthen the clinical dataset demonstrating pelareorep's ability to remodel the tumor microenvironment

SAN DIEGO and CALGARY, AB , April 8, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the publication of an electronic poster at the American Association for Cancer Research (AACR) Annual Meeting featuring new clinical biomarker data from a completed investigator-sponsored phase 1b trial of pelareorep and the proteasome inhibitor bortezomib in relapsed/refractory multiple myeloma patients.

"The results from this trial provide a powerful example of how pelareorep's immunologic effects trigger a durable clinical benefit in an extremely challenging patient population," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc. "All patients enrolled into the study had failed prior therapies, yet despite this, treatment with pelareorep-based therapy prevented disease progression for over three years in a subset of the patients. In addition, this study shows that pelareorep's ability to recruit high concentrations of anti-cancer immune cells into the tumor microenvironment (TME) can yield strong clinical outcomes. This impressive finding has implications for cancers beyond multiple myeloma as it builds on existing data that support pelareorep's potential to enhance the effectiveness of a wide array of therapies through its ability to stimulate a pro-inflammatory TME."

Previously reported data highlighted in the poster's corresponding abstract demonstrated the efficacy of the studied combination and showed a subset of trial participants achieving prolonged progression-free survival (PFS) of greater than three years (https://www.oncolyticsbiotech.com/press-releases/press-releases/detail/562/oncolytics-biotech-announces-phase-1b-data-demonstrating). These data also demonstrate a clinical response correlating with changes in T cell clonality and post-treatment increases in innate and adaptive immune cells within the TME. New biomarker analyses featured in the poster show these anti-cancer immune cells clustering more closely around cancer cells containing pelareorep compared to those that did not. Collectively, these results indicate that the sustained clinical benefits observed were driven by pelareorep's recruitment of anti-cancer immune cells into the TME.

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "This trial generated important proof-of-concept data that reaffirm pelareorep's favorable safety profile, increase our understanding of its mechanism of action, and further support the use of T cell clonality as a biomarker. These important learnings strengthen the systemic effect observed in other datasets supporting each of our clinical programs and can be applied to accelerate their advancement. Moving forward, we plan to use our findings in multiple myeloma to drive conversations with potential partners and collaborators interested in leveraging pelareorep's immunotherapeutic effects to address unmet needs in this and other indications. Internally, we remain primarily focused on our lead breast cancer program and look forward to its expected randomized phase 2 data readout in the fourth quarter of the year."

The electronic AACR poster, entitled, Single Cell Analysis Shows That Reovirus Immune Priming Changes the Tumor Immune Micro Environment in Multiple Myeloma, is available to registered attendees of the AACR annual meeting on the meeting website (Abstract #6354). A copy of the poster will also be posted to the Posters & Publications page of Oncolytics' website (LINK) following the conclusion of the meeting.

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; our plan to use our findings in multiple myeloma to drive conversations with potential partners and collaborators; our primary focus on our lead breast cancer program and our expectations regarding its randomized phase 2 data readout in the fourth quarter of the year; our plans to advance towards a registration study in metastatic breast cancer; 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-new-data-demonstrating-durable-clinical-benefit-in-relapsedrefractory-multiple-myeloma-patients-at-the-aacr-annual-meeting-301520747.html

SOURCE Oncolytics Biotech® Inc.

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[Paulness]

NEWS -- Oncolytics Biotech® Letter to Shareholders - Update on Recent Progress

SAN DIEGO, Calif. and CALGARY, AB, April 6, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) is providing a letter to shareholders, included below.

To Oncolytics' Shareholders,

During the first quarter of 2022, we continued to make important progress across our development pipeline. Our 2021 year-end letter to shareholders detailed our accomplishments last year and set the stage for the catalysts we expect to see in 2022. I am excited to update you on our progress this past quarter and highlight how it has driven the momentum behind our clinical and preclinical programs.

HR+/HER2- Breast Cancer Program: Randomized Phase 2 Data Readout Expected in Q4 2022

I am happy to report that our BRACELET-1 trial is about to complete enrollment. We remain on track to announce top-line data from the study in Q4 2022. Together with our AWARE-1 window-of-opportunity study in early-stage breast cancer, BRACELET-1 was designed to confirm and expand upon the promising efficacy data generated from earlier trials evaluating pelareorep in HR+/HER2- breast cancer patients.

The first of these prior trials was our phase 1 study, which established pelareorep's single agent anti-cancer activity. The second was IND-213, a randomized phase 2 trial that showed a statistically significant near doubling of median overall survival in metastatic HR+/HER2- breast cancer patients when pelareorep was combined with the chemotherapy paclitaxel. The results of these trials formed a strong foundational dataset that supported our successful requests for Fast Track Designation and a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA). These provide important regulatory benefits and indicate that IND-213 can be considered one of the two pivotal trials that are typically needed to support regulatory approval.

When discussing our data with potential biopharma partners, it became clear that we could de-risk a future registrational study and bolster our business development prospects by conducting two well-defined trials designed to supplement IND-213's results. This was the rationale behind AWARE-1 and BRACELET-1, which we designed in collaboration with Roche, Pfizer and Merck Serono, respectively. Together, these trials aim to: (1) explore pelareorep's mechanism of action, (2) evaluate pelareorep's potential synergy with checkpoint inhibitors, and (3) identify a biomarker that can predict patient response.

Data from AWARE-1 presented at AACR 2021 (link to the PR) showed that the trial was a success. It met its primary endpoint by showing treatment-induced increases in CelTIL scores in patients with HR+/HER2- breast cancer. CelTIL score is a pro-inflammatory metric correlated with improved clinical outcomes. Information explaining how CelTIL is scored and its importance in predicting clinical outcomes can be found by clicking here and clicking here. AWARE-1 also showed that pelareorep upregulates PD-L1 on tumor targets; promotes tumor infiltration of CD8+ T cells; and induces the generation and expansion of anti-tumor T cell clones. All of these effects drive the immune-based killing of tumor cells. Moreover, these immunotherapeutic effects were enhanced when a checkpoint inhibitor was added to the treatment regimen. BRACELET-1 is expected to confirm these exciting findings in metastatic HR+/HER2- breast cancer, our targeted phase 3 patient population.

We view the potential synergy between pelareorep and checkpoint inhibitors as a key selling point for new partnering opportunities with our breast cancer program and broader pipeline. There are multiple PD-L1/PD-1 therapies on the market. Most of these are produced by large biopharma companies. The potential to increase the efficacy of PD-L1/PD-1 therapies, and the number of patients eligible for treatment, would create a substantial new commercial opportunity. The BRACELET-1 study includes different cohorts to evaluate: (1) paclitaxel monotherapy, (2) paclitaxel plus pelareorep, and (3) paclitaxel plus pelareorep in combination with the PD-L1 inhibitor avelumab. By doing so, we aim to generate a randomized dataset that will confirm the benefit of adding pelareorep to chemotherapy and explore the potential synergies of adding checkpoint blockade to this combination. This may provide avenues toward superior clinical benefits for patients. Together with our phase 1 and IND-213 results, we expect these data to propel our lead program to a registrational study and fuel our business development efforts.

While breast cancer remains our focus and priority, we believe pelareorep has the potential to ultimately play an important role in the future treatment of a wide variety of major cancers. To further explore this potential, we are working toward a number of other initiatives designed to:

• Pursue the promising clinical signal previously seen in gastrointestinal cancers
• Expand our global presence through our international partnership with Adlai Nortye
• Enhance our understanding of pelareorep's mechanism of action through collaboration with academic thought leaders
• Leverage pelareorep's favorable safety profile to further explore synergies with different drug classes

Gastrointestinal Cancers: GOBLET Trial Rapidly Progressing

Our collaboration with Roche to evaluate pelareorep-checkpoint inhibitor combination therapies in gastrointestinal (GI) cancers is advancing as planned. In January, we announced enrollment in the safety run-ins for the GOBLET trial had been completed (link to the PR). In February, we announced that the Data Safety Monitoring Board (DSMB) had completed its evaluation of the trial's pancreatic cancer cohort with a positive outcome (link to the PR). In March, we announced that the colorectal cancer safety run-in completed its DSMB review with a positive outcome. In addition, the pancreatic cancer cohort received approval from the Paul Ehrlich Institute (PEI; Germany's medical regulatory body) to pursue full enrollment (link to the PR). We are thrilled with this rapid progress, given that we announced the dosing of the first patient only this past November (link to the PR). We are now planning to submit an abstract providing additional updates on the pancreatic cancer cohort to ESMO GI in late June. We are also pleased to see pelareorep continue its favorable safety and tolerability track record. This is discussed in more detail below.

Adlai Nortye Partnership: Enabling Expansion into New Territories

We, together with our partner Adlai Nortye, have seen considerable progress in the bridging clinical trial in China. This trial evaluates the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. The objective of this trial is to accelerate pelareorep's clinical development by permitting the inclusion of data from IND-213 and BRACELET-1 in regulatory submissions in territories where Adlai plans to commercialize pelareorep. These include China, Hong Kong, Macau, Singapore, South Korea and Taiwan. After advancing to the second dose-escalation cohort in January (link to the PR), the trial quickly proceeded to the third and final dose-escalation cohort in March (link to the PR). For some background, the dosing regimen for the second cohort is equivalent to what was administered in IND-213, where we saw a statistically significant near doubling of median overall survival in metastatic HR+/HER2- breast cancer patients. The study's third dosing cohort is receiving the same dose of pelareorep as patients in the ongoing BRACELET-1 study. The results of the Adlai Nortye study are expected to support the safety of pelareorep in an Asian population and set the stage for future development efforts in this region.

Pelareorep Activates Natural Killer (NK) Cells – New Insights into its Immunological Mechanism of Action

In March, a peer-reviewed paper was published in Immunology that discussed pelareorep's effects on NK cells, which, similar to T cells, are a critical component of the body's anti-cancer immune response (link to the PR, link to the publication). NK cells both kill cancer cells directly and stimulate adaptive anti-tumor immunity. Data featured in the paper showed pelareorep activating NK cells in vitro and in the blood of participants from a previously completed window-of-opportunity study in patients with colorectal liver metastases. Analyses showed pelareorep's effects on NK cells to be mediated by type 1 interferon (IFN-1) signaling, a key modulator of immunoregulation and tumor cell recognition. Together with data from AWARE-1 and other studies highlighting pelareorep's effects on T cells, these results demonstrate how pelareorep drives a robust anti-cancer response that harnesses the power of both innate and adaptive immune systems.

AACR Preview: Clinical Findings in Multiple Myeloma and Glioblastoma Multiforme (ReoGlio)

We are excited about the posters our collaborators will present at the American Association for Cancer Research (AACR) Annual Meeting later this week. One poster will feature new long-term follow-up results from ReoGlio. This was an investigator-sponsored, phase 1b trial in glioblastoma multiforme (GBM) we first discussed in November 2020 at the Society for Neuro-Oncology Annual Meeting (link to the PR). Details on the second poster can be found in its abstract, which has already been published on the AACR website (link to the PR, link to the abstract). This abstract highlights proof-of-concept clinical data showing progression-free survival of over three years in a subset of relapsed/refractory multiple myeloma patients treated with pelareorep and a proteasome inhibitor. We look forward to providing additional comments on these findings and to announcing ReoGlio's follow-up data during the AACR meeting, in accordance with the conference's embargo policy.

Business Development Benefits of Pelareorep's Favorable Safety Profile

A common refrain you have likely heard from us is the strength of pelareorep's safety profile. There is a good reason for this: the strong safety profile is a highly valuable selling point for our partnering strategy. Many promising new agents have been stymied by unacceptable single agent or combination toxicities. Pelareorep's safety profile alone or in combination with other therapies has enabled us to explore a wide range of anti-cancer therapy combinations. This helps to establish the potential appeal of pelareorep as an important backbone to a variety of immunotherapies and, in turn, provides opportunities to maximize value for our stakeholders. Our primary focus and most advanced clinical data are in breast cancer; however, there are emerging opportunities in additional indications. Our strategy of leveraging partnerships with thought leaders from industry and academia to pursue these opportunities remains unchanged.

Looking Ahead

We are looking forward to BRACELET-1's anticipated top-line data announcement in Q4 2022 and expect to have several clinical presentations at AACR and the upcoming ESMO Breast Cancer Congress. Since the start of the year, we have been encouraged by the rapid enrollment seen in our clinical programs, including GOBLET and Adlai Nortye's breast cancer study. Moreover, we are pleased to have more preclinical evidence highlighting pelareorep's potential as an immunologic backbone therapy published in prestigious journals. We believe these advances, along with our impressive safety record, will help us expand our business development opportunities.

As always, I would like to thank you all for your continued interest and support.

Dr. Matt Coffey

President & CEO

Oncolytics Biotech

This letter to shareholders 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 letter to shareholders include statements regarding Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep, including the potential to lead to a registrational study and fuel our business development efforts; our expectations as to the completion of enrollment in our BRACELET-1 study; our belief that the potential synergy between pelareorep and checkpoint inhibitors could facilitate partnering opportunities; our belief that the potential to increase the efficacy of PD-L1/PD-1 therapies, and the number of patients eligible for treatment, would create a substantial new commercial opportunity; our belief that pelareorep has the potential to ultimately play an important role in the future treatment of a wide variety of major cancers; our plans to work towards a number of other initiatives and the purpose thereof; the advancement of our collaboration with Roche; our expectations regarding the results of the Adlai Nortye study; upcoming presentations and the timing and content thereof; our primary focus and other opportunities; our plans and expectations regarding a potential registrational study in breast cancer, including the anticipated timing and impact of the announcement of our top-line data announcement for BRACELET-1, 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® Provides Positive Safety Update on the Third-Line Metastatic Colorectal Cancer Cohort of its Multi-Indication Phase 1/2 Gastrointestinal Cancer Trial

Independent review identified, no safety concerns in trial's final safety run-in

Cohort supported by prior clinical data showing a pelareorep-based combination driving a 90% clinical benefit rate in KRAS-mutated colorectal cancer patients

Multi-indication trial being conducted in collaboration with Roche and AIO also includes pancreatic and advanced anal cancer cohorts

SAN DIEGO, Calif. and CALGARY, AB, March 31, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the successful completion of the three-patient safety run-in for the third-line metastatic colorectal cancer (mCRC) cohort of the phase 1/2 GOBLET study, following an independent review by the study's Data Safety Monitoring Board (DSMB). The DSMB noted no safety concerns in these patients and has recommended that the study proceed to full enrollment pending clearance by the Paul Ehrlich Institute (PEI; Germany's medical regulatory body). The PEI recently cleared the study's pancreatic cancer cohort for full enrollment following a similar recommendation by the DSMB. The trial's anal cancer and first-line mCRC cohorts do not include safety run-ins and are proceeding as planned.

The GOBLET study is designed to evaluate the safety and efficacy of pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study includes 14 clinical trial sites across Germany and is being managed by AIO, a leading academic cooperative medical oncology group.

"The successful completion of GOBLET's final safety run-in underscores the trial's strong momentum and supports the ability of pelareorep to be safely combined with checkpoint inhibitors," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "This achievement positions us to continue building on prior clinical data that demonstrate the potential of pelareorep to provide a clinical benefit in colorectal and other gastrointestinal (GI) cancers. Existing data suggest this clinical benefit likely results from the stimulation of protective immune responses that may be enhanced by the addition of checkpoint inhibition. Given the high prevalence of GI malignancies, including colorectal and pancreatic cancer, and the fact that most cases do not respond to checkpoint inhibition, we view GOBLET as an important opportunity to evaluate a novel therapeutic approach that may address a pressing unmet medical need."

The GOBLET study's metastatic colorectal cancer cohorts are supported by prior clinical data demonstrating adaptive anti-tumor immune responses and a 90% clinical benefit rate in KRAS-mutated mCRC patients treated with a pelareorep-based combination (link to PR, link to study). In addition to primary endpoints evaluating safety and efficacy, GOBLET also includes exploratory endpoints designed to explore the potential of CEACAM6 and T cell clonality to serve as predictive biomarkers. This may increase the likelihood of success of future registrational studies by allowing for the selection of the most appropriate patients.

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 study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

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).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

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 estimates indicating that 106,180 new cases of colon cancer and 44,850 new cases of rectal cancer will be diagnosed in the U.S. in 20221. Also, for the 2022 year, the American Cancer Society estimates there will be 62,210 new cases of pancreatic cancer2 and 9,440 new cases of anal cancer3 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 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. "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

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; management's expectations as to enrollment in the company's GOBLET study, our beliefs regarding the potential of CEACAM6 and T cell clonality to predict patient responses to therapy and improvements to our ability to select patients most likely to respond to pelareorep-based therapies in future trials across multiple indications; our plans to advance towards a registration study in metastatic breast cancer; 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-provides-positive-safety-update-on-the-third-line-metastatic-colorectal-cancer-cohort-of-its-multi-indication-phase-12-gastrointestinal-cancer-trial-301514611.html

SOURCE Oncolytics Biotech® Inc.

[Cobra Stock Sleuth]

https://pharmaboardroom.com/interviews/carsten-lu-ceo-adlai-nortye-china/


2019 interview with CEO. You have to register to get full interview but there's some good info there. He says in interview that they aren't going into breast cancer because space is " Too crowded"

That's pretty interesting because there deep into that now and it might be a big win for them? and for us in USA and Europe.
Phase III study by end of year In USA Europe and Asia should move the stock big time if it happens.

[Paulness]

NEWS -- Oncolytics Biotech® Partner Adlai Nortye Advances Chinese Bridging Trial of Pelareorep-Paclitaxel Combination Treatment in Breast Cancer to Final Dosing Cohort

• First two cohorts indicate pelareorep in combination with paclitaxel was well-tolerated with no new safety signals observed to date
• Trial is designed to satisfy regulatory requirements and accelerate pelareorep's development in large and rapidly growing pharmaceutical markets, including China, Hong Kong, Macau, Taiwan, Singapore, and South Korea
• Final cohort's dosing regimen is equivalent to Oncolytics' North American phase 2 trial in metastatic breast cancer (BRACELET-1)

SAN DIEGO, Calif. and CALGARY, AB, March 24, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that its partner Adlai Nortye has advanced to the third and final dose escalation cohort of the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. The trial's first two cohorts have completed their dose escalation evaluation periods and indicated pelareorep in combination with paclitaxel was well-tolerated with no new safety signals observed to date.

The dosing regimens for the bridging trial's second and third cohorts are equivalent to those administered in Oncolytics' randomized North American breast cancer trials, IND-213 and BRACELET-1, respectively. In IND-213, HR+/HER2- breast cancer patients treated with pelareorep and paclitaxel showed a statistically significant, near doubling of overall survival compared to those treated with paclitaxel alone. BRACELET-1, an ongoing phase 2 study evaluating pelareorep-paclitaxel combination therapy with and without a checkpoint inhibitor, is on track for a top-line data readout in Q4 2022 that will inform the design of a registrational study in the United States. Final results from the Chinese bridging trial are expected to accelerate pelareorep's development in territories such as China, Hong Kong, and Macau, by allowing Adlai Nortye to include data from IND-213 and BRACELET-1 in future submissions to regulators in these jurisdictions.

"The territories covered by our partnership with Adlai Nortye represent an important component of our business development strategy, as China and the other areas in which Adlai Nortye anticipates commercializing pelareorep are among the largest in the world and growing rapidly," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "With the bridging trial entering its final cohort less than six months after dosing began, Adlai is making major strides towards satisfying the regulatory criteria needed to accelerate pelareorep's development in China. The trial also continues to generate positive safety data, which will serve us well as we collaborate with Adlai Nortye to advance pelareorep towards approval in key 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 20201. 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 20202.

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 clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, with its R&D centers in both China and the U.S. 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, four of them are being investigated in multiple clinical trials, including (i) Buparlisib(AN2025) which received the FDA Fast-Track designation and was in a global Phase III clinical trial; (ii) Pelareorep (AN1004), an intravenously delivered oncolytic virus which received the FDA Fast-Track designation and have completed a phase II clinical trial; (iii) Palupiprant (AN0025), an oral EP4 antagonist which has completed Phase Ib trial in a neoadjuvant setting in localized advanced rectal cancer and is undergoing Phase Ib trial in combination with Keytruda® in patients with multiple solid tumors; and (iv) AN4005, an orally available, small molecule PD-L1 inhibitor which was currently in Phase Ia trial that was shown to functionally overcome the inhibition derived from PD-1/L1 interaction in reporter- and human PBMC (hPBMC)-based cellular assays. In addition, Adlai Nortye also completed the first patient dosing for its Phase I clinical trial in collaboration with Roche to evaluate the triple combination of AN2025, AN0025 and Tecentriq® (PD-L1 inhibitor) for a variety of PIK3CA mutant solid tumors in September 2021 in the U.S.

Adlai Nortye has assembled an experienced management team, built its proprietary 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 mission of the Company is to transform deadly cancer into a chronic and eventually a curable disease. 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 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; including management's belief that the BRACELET-1 study is on track for a top-line data readout in Q4 2022 that will inform the design of a registrational study in the United States; management's expectation that final results from the Chinese bridging trial are expected to accelerate pelareorep's development in territories such as China, Hong Kong, and Macau, by allowing Adlai as China and the areas in which Adlai Nortye anticipates commercializing pelareorep to include data from IND-213 and BRACELET-1 in future submissions to regulators in these jurisdictions; management's beliefs as to the rapid growth in the areas in which Adlai Nortye anticipates commercializing pelareorep; management's belief that the Company is making major strides towards satisfying the regulatory criteria needed to accelerate pelareorep's development in China and the other areas in which Adlai anticipates commercializing pelareorep; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics' business and technologies; our plans to advance towards a registration study in metastatic breast cancer; 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-partner-adlai-nortye-advances-chinese-bridging-trial-of-pelareorep-paclitaxel-combination-treatment-in-breast-cancer-to-final-dosing-cohort-301509468.html

SOURCE Oncolytics Biotech® Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/March2022/24/c6310.html

[Paulness]

NEWS -- Oncolytics Biotech® Announces Publication of Preclinical and Patient Data Demonstrating Pelareorep's Stimulation of Natural Killer Cell Anti-Cancer Activity

New insights into pelareorep's immune-related mechanism of action demonstrate it stimulates an innate immune response that in turn triggers adaptive anti-tumor immunity

Specificity for tumor cells compared to normal cells likely results from the impairment of viral detection/interferon responses in malignant cells

SAN DIEGO and CALGARY, AB, March 17, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the publication of preclinical and patient data on pelareorep in the peer-reviewed journal Immunology. The paper, entitled "Oncolytic virus treatment differentially affects the CD56dim and CD56bright NK cell subsets in vivo and regulates a spectrum of human NK cell activity," was published in collaboration with researchers at several prestigious institutions, including the University of Leeds School of Medicine and the Institute of Cancer Research, London. A link to the paper can be found by clicking here (https://onlinelibrary.wiley.com/doi/10.1111/imm.13453).

Described in the paper are in vitro studies evaluating pelareorep's effects on Natural Killer (NK) cells as well as analyses of blood samples from patients with colorectal liver metastases taken prior to and after treatment with pelareorep. Results showed pelareorep treatment led to the activation of NK cells, which are known to directly kill cancer cells while stimulating adaptive anti-tumor immunity. The beneficial effects of pelareorep were observed both in patient samples and in vitro and were mediated by type 1 interferon (IFN-1) signaling, a key pathway involved in immunoregulation and tumor cell recognition.

"These important results further demonstrate both pelareorep's innate and adaptive immunologic mechanism of action, and we are pleased to have them published in such a prestigious, peer-reviewed journal," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech and co-author of the paper. "When viewing these findings, alongside prior clinical data demonstrating pelareorep's ability to activate T cells while promoting their infiltration into tumors, we see pelareorep delivering a robust, coordinated anti-cancer immune response driven by both the innate and adaptive immune systems. Looking forward, we will continue to leverage the immunotherapeutic effects of pelareorep as we further its development as an enabling technology for a wide cross-section of immunotherapeutic agents in breast cancer and other oncologic indications with high unmet needs."

Patient samples evaluated in the publication were from a completed window-of-opportunity clinical study evaluating pelareorep in colorectal cancer patients with liver metastases. Patients received between one and five doses of pelareorep prior to planned surgery to resect metastases. Blood samples were taken both prior to and at multiple time points after pelareorep treatment. Additional details of the trial, as well as previously reported results, are available in prior peer-reviewed publications1,2.

References:

1. Adair RA, Roulstone V, Scott KJ, et al. Sci Transl Med. 2012;4(138):138ra77. doi:10.1126/scitranslmed.3003578

2. El-Sherbiny YM, Holmes TD, Wetherill LF, et al. Clin Exp Immunol. 2015;180(1):98-107. doi:10.1111/cei.12562

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' plans to advance towards a registration study in metastatic breast cancer; 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-publication-of-preclinical-and-patient-data-demonstrating-pelareoreps-stimulation-of-natural-killer-cell-anti-cancer-activity-301504761.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/March2022/17/c5251.html

[Paulness]

NEWS -- Oncolytics Biotech® Announces Phase 1b Data Demonstrating Clinical Proof-of-Concept for Pelareorep-Proteasome Inhibitor Combination in Multiple Myeloma in an Abstract at the AACR Annual Meeting

• Prolonged progression-free survival of >3 years achieved in a subset of relapsed/refractory patients
• Treatment-induced increases in tumor-infiltrating anti-cancer immune cells correlated with clinical response

SAN DIEGO, Calif. and CALGARY, AB, March 9, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced phase 1b data demonstrating clinical proof-of-concept for pelareorep-proteasome inhibitor combination therapy in multiple myeloma. The data are featured in an abstract accepted for a poster presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting, which is taking place both virtually and in-person April 8-13, 2022, at the Ernest N. Morial Convention Center in New Orleans, Louisiana. The abstract is also posted on the AACR meeting website.

The AACR data are from a completed phase 1b trial evaluating the combination of pelareorep and the proteasome inhibitor bortezomib in relapsed/refractory multiple myeloma patients. Results from the trial showed that the combination was well-tolerated and led to prolonged progression-free survival (PFS) of over three years in a subset of patients. Additionally, biomarker data demonstrated increased infiltration of T and NK cells in the tumor immune microenvironment post-treatment. These post-treatment increases in anti-cancer immune cells correlated with both clinical response and changes in T cell clonality, which has previously been identified as a potential predictive biomarker that could increase the likelihood of success in future trials of pelareorep by informing patient selection.

"To see patients resistant to prior therapies achieve multi-year PFS is a remarkable finding that speaks to pelareorep's potential to synergistically combine with anti-cancer agents and provide sustained clinical benefit," said Kevin Kelly, M.D., Ph.D., Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and Principal Investigator of the trial. "The observed correlation between clinical response and increases in anti-cancer immune cells in the tumor immune microenvironment is also an important result, as it suggests the studied combination's activity is being driven by pelareorep's immunologic mechanism of action. I look forward to discussing these findings with the clinical community and presenting additional data from the trial at the upcoming AACR meeting."

Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc., added, "These are exciting results that we believe bode well for successful outcomes in our two ongoing multiple myeloma studies that are evaluating pelareorep in combination with a next-generation proteasome inhibitor. We are also very pleased that this study further supports the potential of T cell clonality to predict patient responses to therapy, and we look forward to continuing the development of this biomarker as a potential tool to improve our ability to select patients most likely to respond to pelareorep-based therapies in future trials across multiple indications."

Oncolytics continues to build on data from the completed multiple myeloma trial through the advancement of two ongoing phase 1 trials of pelareorep in this indication. The first of these trials, NCI-9603, is being conducted in collaboration with the United States National Cancer Institute and is evaluating pelareorep in combination with the proteasome inhibitor carfilzomib (Kyprolis®). The second, WINSHIP 4398-18, is a collaboration with Bristol Myers Squibb and is evaluating the combination of pelareorep, carfilzomib, and the checkpoint inhibitor nivolumab (Opdivo®). For more information on these trials, see https://Clinicaltrials.gov identifiers NCT02101944 (NCI-9603) and NCT03605719 (WINSHIP 4398-18).

Additional details on the AACR abstract titled, Using imaging mass cytometry to visualize the multiple myeloma tumor microenvironment post immune priming, and its corresponding poster are shown below.

Session Category: Tumor Biology
Session Title: Models and Technical Approaches to Analyze and Examine the Tumor Microenvironment
Session Date and Time: Wednesday April 13, 2022, 9:00 AM – 12:30 PM Central Daylight Time
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 14
Poster Board Number: 25
Abstract Number: 3880

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; including our two ongoing multiple myeloma studies that are evaluating pelareorep in combination with a next-generation proteasome inhibitor, our beliefs regarding the potential of T cell clonality to predict patient responses to therapy and improvements to our ability to select patients most likely to respond to pelareorep-based therapies in future trials across multiple indications; our plans to advance towards a registration study in metastatic breast cancer; 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-announces-phase-1b-data-demonstrating-clinical-proof-of-concept-for-pelareorep-proteasome-inhibitor-combination-in-multiple-myeloma-in-an-abstract-at-the-aacr-annual-meeting-301499008.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

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

SAN DIEGO, Calif. and CALGARY, AB, March 9, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced an upcoming poster presentation that will feature long-term follow-up 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). The poster will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2022, which is taking place both virtually and in-person at the Ernest N. Morial Convention Center in New Orleans from April 8-13, 2022.

Details on the poster and corresponding abstract are shown below.

Poster Title: Combination of reovirus (pelareorep) and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant chemotherapy (temozolomide) for patients with glioblastoma multiforme (GBM): Long term follow up results of the ReoGlio phase Ib trial

Session Title: Phase I Clinical Trials 2

Abstract Number: CT194

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 clinical trials abstracts.

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, 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; our plans to advance towards a registration study in metastatic 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
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-announces-upcoming-poster-presentation-at-the-aacr-annual-meeting-301498760.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

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

Conference call and webcast to take place on Thursday, March 3, 2022, at 5:00 p.m. ET

SAN DIEGO, Calif. and CALGARY, AB, Feb. 22, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Thursday, March 3, 2022, at 5:00 p.m. ET to discuss a corporate update and financial results for the fourth quarter and full year 2021.

Conference Call & Webcast

Date: Thursday, March 3, 2022
Time: 5:00 p.m. Eastern Standard Time
Dial In – North American Toll-Free: [phone]
Dial In – International: [phone]
Conference ID (if needed): 4650-7590
Webcast: please click here

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: 507-590#.

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' plans to advance towards a registration study in metastatic breast cancer; 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]

Logo - https://mma.prnewswire.com/media/1064079/Oncolytics_Logo.jpg

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-fourth-quarter-and-full-year-financial-results-and-recent-operational-highlights-301486117.html

SOURCE Oncolytics Biotech® Inc.

[tknuncle]

Omygoodness I could not agree more with you on your post. Great post and very well written Cobra.

[Cobra Stock Sleuth]

I think a buyout may happen this year as well. The thing that confuses me about this stock is that so many different big Pharmas have trials going on with it. That's kind of unusual. Maybe giving virus to people is too complicated for investors to understand.
I'm still trying to wrap my head around it too actually. We are just coming through a virus pandemic that brought the whole world to a standstill. If we could somehow harness that power and direct it against cancer it could be groundbreaking.

[Cobra Stock Sleuth]

Ya my friend bought a bunch at 4 something and then bunch more at almost 6 CDN. He's not too happy but feeling better with latest news.

I know some people in Healthcare and they have never heard of it. They work on Cancer ward too and are barely making it through some days. They said something like this if it works would be pretty close to miraculous if it can be given IV and no special biohazard precautions required.

I bought a bit too much portfolio % wise broke my 10% rule on this one. We'll see what happens.

[tknuncle]

I hear you, thank you for your response. One of my best friends tells me ONCY is going to be bought out is his suspicion. We were going over the financials the other day and he was explaining what is leading him to this conclusion. But he also feels that the price will need to get to $3.50 a share for one more dump. I'm sorry "offering" is the word he used. Because of his enthusiasm I purchased my first block in the high $4 range and have been averaging down ever since but not doing too good at it. I've managed to avg down to $3.27 because I bought the bulk at the high 4's. I did add a bunch more at $2.20 but again the PPS kept dropping. Now looking back, I wish I would have waited till the low of $1.20, but I am not really good at reading charts and what not. So, I have these bags tied around my neck lmao. Don't mean to complain I do believe in the product and the fact it can help improve so many lives dealing with this horrible disease of cancer! I trust my buddy and believe in his theories so I will have to wait and see if he is correct. He was positive the buyout was last year but now he feels like things have changed and it will happen this year or early next year. In the whole sachem of things that's not too long IMO. Take care and have a great weekend Cobra ;).

[Cobra Stock Sleuth]

Ya hate to repeat it because I think it's garbage. He did tell me to look at trades on Canadian side for Thursday. I don't have access to a trade workstation to see all the trades for the day. Trading was up on the Canadian side though for Thursday. Not sure this helps anyone sorry man.

[tknuncle]

I wish you would share your rumor with us bag holders lol. Especially if it could be good news. Have a good weekend everyone

[Cobra Stock Sleuth]

RUMOR OF ANNOUNCEMENT COMING NEXT WEEK. APPARENTLY THAT'S WHAT CAUSED THURSDAY SPIKE. NOT GOING TO POST WHAT I HEARD CAN'T CONFIRM ANYTHING. JUST A HEADS UP.

[justthefactsmam]

FDA taking a critical look at drugs developed and tested in China. Even though ONCY has partnered with Adlai Nortye and Adlai is conducting trials in China, it is with a product already approved here in the U.S. which was developed in North America. If the FDA rules against or slows down Chinese developed and tested drugs, this may be another reason for some big pharma to partner or buy out oncy. FDA has already worked with ONCY to develop registration parameters so that leg up may tempt a partnership/buyout sooner rather than later.

FDA Raises Concerns About China-Developed Drugs.

Agency could slow the plans of big Western drugmakers to sell Chinese-tested medicines in U.S.

“We have nothing against drugs being developed in China,” said Richard Pazdur, director of the FDA’s cancer-drugs division. “Our issue is, are those results generalizable to the U.S. population?”

Drug-industry executives and analysts say the apparent shift in tone could lead to delays or outright FDA rejections of efforts to bring a growing pipeline of the treatments to American patients.

The shift threatens to halt the plans of Western drugmakers, including Eli Lilly & Co. and Novartis AG NVS, who were eyeing billions of dollars in sales from bringing the Chinese medicines to the U.S. It could also raise a new source of tension between the two countries.

[Paulness]

NEWS -- Oncolytics Biotech® Provides Positive Safety Update on the Pancreatic Cancer Cohort of its Multi-Indication Phase 1/2 Gastrointestinal Cancer Trial

Independent safety review completed with no toxicity concerns

Cohort builds on prior proof-of-concept data demonstrating clinical benefit of pelareorep-checkpoint inhibitor combination in pancreatic cancer

Multi-indication trial being conducted in collaboration with Roche and AIO also includes cohorts in metastatic colorectal and advanced anal cancers

SAN DIEGO and CALGARY, AB, Feb. 2, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the successful completion of the three-patient safety run-in for the pancreatic cancer cohort of the phase 1/2 GOBLET study following evaluation by the study's Data Safety Monitoring Board (DSMB). The DSMB noted no safety concerns in these patients and recommended the study proceed as planned. The safety run-in for the trial's third-line metastatic colorectal cancer cohort remains ongoing.

The GOBLET study is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany.

"This positive safety evaluation adds to a robust body of evidence demonstrating the favorable safety profile of pelareorep-checkpoint inhibitor combinations across multiple indications," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "It also represents an important step in the development of these combinations for the treatment of pancreatic cancer and builds on prior clinical proof-of-concept data in this indication. These data highlight the potential of pelareorep to benefit patients with pancreatic and other gastrointestinal cancers by reversing immunosuppressive tumor microenvironments that limit the effectiveness of checkpoint inhibitors. We believe adding pelareorep to treatment regimens will improve clinical response rates in these patients, and we look forward to evaluating this hypothesis through successfully advancing the GOBLET study."

The GOBLET study's pancreatic cancer cohort extends previously reported clinical data demonstrating the synergy and anti-cancer activity of pelareorep combined with checkpoint inhibition in pancreatic cancer patients who progressed after first-line treatment (link to PR (https://www.oncolyticsbiotech.com/press-releases/press-releases/detail/541/oncolytics-biotech-announces-clinical-and-biomarker-data), link to poster (https://d1io3yog0oux5.cloudfront.net/_6fbc2aab61c569b67df26fcb0b81d15b/oncolyticsbiotech/db/343/2562/pdf/ASCO+2021_final.pdf)). It also builds on prior early clinical data that showed a greater than 80% increase in median progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression who received pelareorep in combination with chemotherapy (link to PR (https://ir.oncolyticsbiotech.com/press-releases/detail/494/oncolytics-biotech-announces-statistically-significant), link to poster (https://d1io3yog0oux5.cloudfront.net/_6b48a135651525a703eef6c0b666cf11/oncolyticsbiotech/db/343/2513/pdf/2020+-+ASCO+GI+-+Noonan+-+CEACAM6+is+a+candidate+biomarker+for+Reolysin%C2%AE+(pelareorep)+sensitivity+in+pancreatic+adenocarcinoma+(PDAC).pdf)). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, GOBLET also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may increase the likelihood of success of future registrational studies by allowing selection of the most appropriate patients.

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 study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

• Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic pancreatic cancer patients (n=12);
• Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (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).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group (https://www.aio-portal.de/) 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 20211. Also, for the 2021 year, the American Cancer Society estimates there will be 60,430 new cases of pancreatic cancer2 and 9,090 new cases of anal cancer3 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 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. "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; management's expectations as to enrollment in the Company's GOBLET 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: https://www.prnewswire.com/news-releases/oncolytics-biotech-provides-positive-safety-update-on-the-pancreatic-cancer-cohort-of-its-multi-indication-phase-12-gastrointestinal-cancer-trial-301473357.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/February2022/02/c8233.html

[Cobra Stock Sleuth]

Gilead C47 drug trial halted FDA by. Positive news on Pelareorep with same combo!!!!!!!!@



- 15 Dec 2021--- Treatment with intravenous pelareorep plus azacitidine reduced tumor burden ------------------------------------------------------

26 Jan 2022--- Gilead Announces Partial Clinical Hold for Studies Evaluating Magrolimab in Combination With Azacitidine.

[Paulness]

NEWS -- Oncolytics Biotech® Partner Adlai Nortye Advances to the Second Dose Escalation Cohort of the Chinese Bridging Trial Evaluating Pelareorep-Paclitaxel Combination Treatment in Breast Cancer

Enrollment in the first dose escalation is complete with no safety issues reported to date

Trial is designed to accelerate pelareorep's development in Asian territories such as China, the world's second-largest pharmaceutical market

SAN DIEGO, Calif. and CALGARY, AB, Jan. 27, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that its partner Adlai Nortye has advanced to the second of three dose escalation cohorts in the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Dosing in the trial's first dose escalation cohort is complete and no safety issues have been reported. The second dose escalation cohort is the equivalent dose that was administered in the IND-213 study, which reported a near doubling of survival in HR+/HER2- metastatic breast cancer patients.

"Initiation of the bridging trial's second dose escalation cohort is an important advancement that reflects the positive safety findings observed in the trial to date," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "Completion of the bridging trial will allow future Chinese regulatory submissions that will include previously reported clinical data demonstrating pelareorep's potential to substantially benefit metastatic breast cancer patients. This may accelerate pelareorep's development in rapidly growing pharmaceutical markets such as China, which is the second largest in the world after the United States. Looking ahead, we will continue to collaborate closely with Adlai Nortye to advance pelareorep towards registration in these jurisdictions and maximize its potential therapeutic impact."

The bridging clinical trial is designed to satisfy Chinese regulatory requirements and thereby accelerate pelareorep's development in territories that include China, Hong Kong, and Macau. Results from the trial are expected to allow Adlai Nortye to include data from Oncolytics' randomized North American metastatic breast cancer trials in future submissions to regulators in China and its territories.

The first of Oncolytics' randomized North American trials, IND-213, showed a statistically significant near doubling of overall survival in patients treated with pelareorep and paclitaxel compared to those treated with paclitaxel alone. Oncolytics' second randomized North American trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor. Oncolytics expects to complete enrollment in BRACELET-1 later this quarter and to report top-line data from the trial in Q4. Oncolytics believes completion of BRACELET-1 represents the last major clinical step on pelareorep's path to a registrational study in metastatic breast cancer in the United States.

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 20201. 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 20202.

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, four of them are being investigated in multiple 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; an oral EP4 antagonist (AN0025, Palupiprant) has completed Phase 1b trial in a neoadjuvant setting in locally advanced rectal cancer and is undergoing Phase 1b trial in combination with Keytruda® in patients with multiple solid tumors; an oral small molecule PD-L1 drug (AN4005) currently in Phase 1 trial that was shown to functionally overcome the inhibition derived from PD-1/L1 interaction in reporter- and human PBMC (hPBMC)-based cellular assays. In addition, the Company also completed the first patient dosing for its Phase I clinical trial in collaboration with Roche to evaluate the triple combination of AN2025, AN0025 and atezolizumab (PD-L1 inhibitor) for a variety of PIK3CA mutant solid tumors in September 2021 in the U.S.

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 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; pelareorep's potential to substantially benefit metastatic breast cancer patients; the potential acceleration of pelareorep's development in rapidly growing pharmaceutical markets such as China; Oncolytics' plans to continue to collaborate closely with Adlai Nortye to advance pelareorep towards registration in certain jurisdictions and maximize its potential therapeutic impact; 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-partner-adlai-nortye-advances-to-the-second-dose-escalation-cohort-of-the-chinese-bridging-trial-evaluating-pelareorep-paclitaxel-combination-treatment-in-breast-cancer-301469132.html

SOURCE Oncolytics Biotech® Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/January2022/27/c5674.html

[Cobra Stock Sleuth]

Other posts that may be responsible for uptick recently.
https://www.entrepreneur.com/article/413987

https://chicagotoday.news/world-nation/this-under-the-radar-biotech-stocks-latest-move-could-be-2022s-best-play-usa-news-group/

https://www.fiercebiotech.com/research/stop-sugarcoating-cancer-cells-to-empower-car-t-therapy-solid-tumors

Strong speculation that there may be follow up to their CAR-T/ Pelareorep that cured 7 out of 7 cancers in mice last Feb 17.

Good luck to all I've been loading up big time on yhis since end of Dec.

[Paulness]

NEWS -- Oncolytics Biotech® Provides Enrollment Update on Multi-Indication Phase 1/2 Gastrointestinal Cancer Trial at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium

• Successfully enrolled first-line metastatic pancreatic and third-line metastatic colorectal safety run-ins
• Company moving to full enrollment pending independent safety review
• Multi-center trial being conducted in collaboration with Roche and AIO builds on prior promising data from pancreatic and colorectal cancer trials

SAN DIEGO, Calif. and CALGARY, Canada, Jan. 20, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) provided an enrollment update on the phase 1/2 GOBLET study in a poster presentation at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI).

The GOBLET study is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study includes three-patient safety run-ins for two of its four cohorts (first-line metastatic pancreatic and third-line metastatic colorectal cancer). Enrollment in these safety run-ins is complete. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany.

"There is a pressing unmet need for agents that can synergize with immune checkpoint inhibitors (ICI) in gastrointestinal (GI) cancers, as fewer than half of these patients respond to ICI monotherapy," said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "These low response rates are driven by immunosuppressive tumor microenvironments, which pelareorep has been shown to reverse in prior clinical studies in GI, breast, and hematological cancers. We thus believe pelareorep can increase the proportion of GI cancer patients responding to checkpoint inhibitors and are seeking to validate this hypothesis in the GOBLET study. We are very pleased with the trial's progress to date and look forward to its continued advancement."

The GOBLET study builds on previously reported clinical proof-of-concept data 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 study 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.

A copy of the ASCO-GI poster titled, "GOBLET: A phase 1 / 2 multiple-indication biomarker, safety, and efficacy study in advanced or metastatic gastrointestinal cancers exploring treatment combinations with pelareorep and atezolizumab," will be available on the Posters & Publications page of Oncolytics' website (LINK) following the conclusion of the symposium.

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 study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

• Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic pancreatic cancer patients (n=12);
• Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (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).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

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 20211. Also, for the 2021 year, the American Cancer Society estimates there will be 60,430 new cases of pancreatic cancer2 and 9,090 new cases of anal cancer3 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 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: 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; management's expectations as to enrollment in the Company's GOBLET 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]

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SOURCE Oncolytics Biotech® Inc.

[micham2012]

Other than this letter, are you aware of anything else that might explain recent improvement in share price?

[Paulness]

NEWS -- Oncolytics Biotech® Releases a Letter to Shareholders - 2021 Review and 2022 Outlook

SAN DIEGO, Calif. and CALGARY, AB, Jan. 11, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) is providing a letter to shareholders, included below.

To the Shareholders of Oncolytics Biotech,

2021 generated ground-breaking data that creates the foundation for continued success in 2022 as we build our clinical opportunities and the data required to embark on our registrational study in metastatic breast cancer. This critical data encompasses data requested by the FDA and our global pharma collaborators, data that de-risks both our registrational program and clinical studies going forward. I would like to provide a summary of our 2021 accomplishments, an update on the final pieces of our metastatic HR+/HER2- breast cancer program, and provide some commentary on several of our promising programs in other indications.

Most importantly, the AWARE-1 study results presented this past year exceeded our expectations and provided us with additional confidence in our overall clinical development program. We are well on our way to completing enrollment in BRACELET-1, expected to occur in early 2022. The combination of clinical data from BRACELET-1 along with data from AWARE-1 will provide the final elements necessary to develop and launch a registrational study in metastatic breast cancer.

HR+/HER2- Breast Cancer Program: Our Primary Focus

If you have been following the Company, you're likely aware that we saw a near doubling of overall survival (OS) in metastatic HR+/HER2- breast cancer patients treated with pelareorep in IND-213, a randomized phase 2 study (https://www.oncolyticsbiotech.com/press-releases/detail/33/oncolytics-biotech-inc-s-reolysin-more-than-doubles). After analyzing these data, we focused on achieving three key objectives set forth by regulators and our pharma partners, which represent important steps on the path to a registrational study. These objectives are to:

• Confirm that pelareorep works through an immunotherapeutic mechanism of action. Our enhanced understanding demonstrates pelareorep acts as an immunotherapeutic agent, part of an emerging drug class that provides much longer-lasting anti-cancer effects. This understanding allows us to better design clinical studies that are more likely to be successful;
• Determine whether pelareorep synergizes with immune checkpoint inhibitors (ICIs). Enhancing ICI activity exposes the Company to an oncology market expected to exceed $55 billion by 2025;
• Identify a biomarker to select patients who are likely to have better clinical outcomes. Biomarkers allow us to identify patients who are likely to respond to treatment, streamlining our registration program.

I am pleased to report that we are well on our way to achieving these three objectives. In April, at AACR (https://ir.oncolyticsbiotech.com/press-releases/detail/535/oncolytics-biotech-and-solti-achieve-primary-endpoint-in), we presented data from cohort 1 and cohort 2 (both cohorts exclusively enrolled HR+/HER2- breast cancer patients) of our AWARE-1 study, which is being conducted in collaboration with Roche. Importantly, these data showed we had achieved the first two objectives referenced above. Specifically, we demonstrated that pelareorep treatment reverses immunosuppressive tumor microenvironments, generates and expands T cell clones, upregulates PD-L1 expression, promotes tumor infiltration of CD8+ T cells, and increases CelTIL score, a metric known to correlate with improved clinical outcomes. These effects were even more notable when pelareorep was combined with Roche's ICI atezolizumab, which demonstrates synergy between the two agents. This finding could be a significant advance, not only in breast cancer but in multiple other indications. Finally, in Q4 2021, after completing further analyses of samples from AWARE-1, we reported that changes in peripheral blood T cell populations acts as a putative predictive biomarker. This robust engagement of anti-tumor activity in AWARE-1 supports the hypothesis that the near doubling of overall survival seen in IND-213 was the result of the engagement of innate and adaptive immunity.

Based on the findings from IND-213 and AWARE-1, we continue to have confidence in the expected results from BRACELET-1, a randomized phase 2 study in metastatic HR+/HER2- breast cancer patients being conducted in collaboration with Pfizer and Merck Serono. To better understand and potentially optimize the overall clinical benefit observed in IND-213, BRACELET-1 was designed almost identically, but with an additional cohort to evaluate pelareorep in combination with the checkpoint inhibitor avelumab. Our principal objective for BRACELET-1 is to study our target patient population to inform the design of a registrational study, determine the number of patients required, and confirm what was seen in AWARE-1: the synergistic clinical benefits of pelareorep-ICI combination therapy in addition to using changes in peripheral blood T cell populations as a biomarker to select patients likely to have better outcomes.

We consider BRACELET-1 to be the last major step on our path to a registrational study, and we are on track to reach full enrollment in the trial in the first quarter of 2022. From there, we will need 16 weeks to conclude the patient scans required for a complete dataset for the primary endpoint, as well as additional time to compile and analyze the data. Considering all of this, we anticipate announcing BRACELET-1's top-line data in the fourth quarter of 2022. These timelines assume no or limited adverse impact from COVID-19. In the meantime, we plan to begin discussing our plans for a registrational study with the FDA and additional regulators while we are completing enrollment and performing data analysis.

Triple-Negative Breast Cancer: Expanding Pelareorep into an Additional Subtype

In December, we provided a positive safety update for the first five patients enrolled in IRENE (https://ir.oncolyticsbiotech.com/press-releases/detail/552/oncolytics-biotech-presents-positive-interim-safety), our study investigating pelareorep and an ICI in second- or third-line metastatic triple-negative breast cancer (TNBC). The absence of additional toxicity with this treatment combination in the TNBC subtype, in addition to the more established safety profile of pelareorep-ICI combinations in the HR+/HER2- subtype, means we could potentially expand into large ICI indication opportunities. We are excited about pelareorep's potential in TNBC and look forward to further results from IRENE.

GOBLET Trial: An Expansion of our Roche Collaboration into a New Indication

This past November, the first patient was dosed in GOBLET (https://ir.oncolyticsbiotech.com/press-releases/detail/549/oncolytics-biotech-doses-first-patient-in-phase-12), our phase 1/2 trial to evaluate pelareorep in combination with atezolizumab for the treatment of colorectal, pancreatic, and anal cancer. This study is being conducted in collaboration with AIO and Roche and is exciting because it is an expansion of our relationship with Roche, our collaborator in AWARE-1, and represents an additional opportunity beyond breast cancer. GOBLET is supported by the encouraging AWARE-1 data and by data previously reported in pancreatic and colorectal cancer, which showed 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 (https://ir.oncolyticsbiotech.com/press-releases/detail/498/oncolytics-biotech-announces-publication-of-pelareoreps), and
• a greater than 80% increase in progression-free survival (PFS) in pancreatic cancer patients with low levels of CEACAM6 expression (https://ir.oncolyticsbiotech.com/press-releases/detail/494/oncolytics-biotech-announces-statistically-significant).

We are planning to provide a safety and enrollment update for this study in Q1 2022 and will provide more data as they become available.

Pelareorep and CAR T Cell Therapy in Solid Tumors: Potentially Opening a New Market

One development I found particularly exciting this past year was the announcement of data from preclinical studies of pelareorep and CAR T cell therapy in solid tumors (https://ir.oncolyticsbiotech.com/press-releases/detail/527/oncolytics-biotech-reports-preclinical-data-demonstrating). While CAR T cell therapy has historically been ineffective in solid tumors, combining CAR T cells with pelareorep in mice improved CAR T cell persistence and efficacy. This was further enhanced by an intravenous boost of pelareorep, which ultimately led to tumor cures. In that same study, boosting with a different oncolytic virus did not prevent recurrent tumor growth. If these results in solid tumors can be translated to the clinic, it would open a very significant new potential market that is currently unavailable, as CAR T therapy is now only used in hematological malignancies. As we've previously mentioned, this is largely a business development opportunity for Oncolytics, and 2021 involved working with our academic and industry collaborators to further evaluate and confirm the earlier results. We look forward to sharing additional updates as our work matures.

Partnership with Adlai: International Expansion and Opportunities

Pelareorep's development in China is positively progressing, with partner Adlai Nortye dosing the first patient 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 (https://ir.oncolyticsbiotech.com/press-releases/detail/547/oncolytics-biotechpartner-adlai-nortye-doses-first). This study, a Chinese FDA requirement, is very similar to our metastatic HR+/HER2- studies and is intended to accelerate pelareorep's clinical development in territories that include China, Hong Kong, Macau, Singapore, South Korea, and Taiwan. These are valuable and rapidly growing pharmaceutical markets, with China alone being the second-largest in the world after the United States.

Additional Opportunities: Leveraging Pelareorep's Immunotherapeutic Effects

Pelareorep's ability to recruit T cells into tumors, as demonstrated in AWARE-1, positions it as a potentially enabling technology for a wide cross-section of therapeutic agents. The findings highlighted below are from preclinical studies run by investigators at various institutions who have seen the value of pelareorep as an immunotherapeutic agent and have allocated their research budgets to evaluate combination therapies in their laboratories.

• Data from AACR highlighted pelareorep's ability to synergize with 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 (https://ir.oncolyticsbiotech.com/press-releases/detail/534/oncolytics-biotech-presents-preclinical-data-on).
• Combining pelareorep and radiotherapy led to an increase in the number of infiltrating anti-cancer CD8+ T cells and prolonged survival in a basal-like breast cancer model. This effect was seen in the primary tumor that received treatment and in a secondary tumor that was on the other side of the body, which is indicative of an immunotherapeutic effect. 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 (https://ir.oncolyticsbiotech.com/press-releases/detail/546/oncolytics-biotech-announces-preclinical-data).
• Data presented at ASH 2021 demonstrated the synergistic anti-leukemic effects of pelareorep combined with the chemotherapeutic agent azacitidine in acute myeloid leukemia (AML) cells. Along with reducing tumor burden in vivo and showing increased anti-leukemic activity against AML cells in vitro, this combination therapy dramatically upregulated multiple genes known to drive anti-cancer immune responses such as IFNß1, BATF2, IL-12ß, CCL2, TLR3, and PD-L1 (https://ir.oncolyticsbiotech.com/press-releases/detail/553/oncolytics-biotech-announces-the-presentation-of).

Looking Ahead to an Exciting 2022

Over the last year, the data we generated and reported on have been invaluable, showing us that pelareorep generates a profound immunological response and synergizes with multiple oncology treatments. This leads us to an expanding list of potential combination partners and target indications. While breast cancer, specifically the HR+/HER2- subtype, a multi-billion-dollar opportunity, remains our primary focus, investigators continue to evaluate pelareorep as a potential immunotherapy backbone, and we continue to consider additional areas of study going forward. We believe we are on track to achieve several important milestones this year, the most significant of which will be our top-line data announcement for BRACELET-1, which is the last major step on our path to a registrational study. Based on our current timing expectations, we expect to report top-line data in Q4 2022. In lockstep with this, we will be furthering our regulatory plan with the FDA and potentially with other regulators to refine our phase 3 study design, an essential step before beginning a registrational study. Additionally, we expect to provide a GOBLET enrollment update, a multiple myeloma study update, disclose new data from our glioblastoma study, and provide more updates from other studies later this year.

Wishing everyone a happy new year and offering my thanks for your continued support,

Dr. Matt Coffey, President & CEO of Oncolytics Biotech

This letter to shareholders 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 letter to shareholders include statements regarding Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; our plans and expectations regarding a potential registrational study in breast cancer, including the anticipated timing and impact of the announcement of our top-line data announcement for BRACELET-1, the other steps necessary to position us for the registrational study and various timing matters related thereto; our plans and timelines for interactions with the FDA and potentially with additional regulators to refine our potential phase 3 study design; our plans to investigate changes in peripheral blood T cell populations in BRACELET-1 patients; our expectations regarding enrollment in our various studies and the planned timing of further announcements in respect thereto; the potential for expansion into large ICI drug franchise opportunities; our expectations regarding pelareorep's potential in TNBC; the potential for new addressable markets not currently available; our plans expectations regarding the continued evaluation of pelareorep CAR T cell combinations by our academic and industry collaborators; Pelareorep's potential as enabling technology for a wide cross-section of therapeutic agents; the expansion of the list of potential combination partners and target indications. our primary focus and our ongoing consideration of additional areas of study; our upcoming milestones and catalysts and the anticipated timing of release of updates in respect thereof; 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]
[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-releases-a-letter-to-shareholders--2021-review-and-2022-outlook-301457925.html

SOURCE Oncolytics Biotech® Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/January2022/11/c6745.html

[Paulness]

NEWS -- Oncolytics Biotech® Promotes Thomas C. Heineman, M.D., Ph.D., to Chief Medical Officer

• Dr. Heineman has over two decades of experience successfully leading clinical development programs and previously served as Oncolytics' Global Head of Clinical Development and Operations

SAN DIEGO and CALGARY, AB, Dec. 21, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Thomas (Tom) C. Heineman, M.D., Ph.D., has been promoted to the role of Chief Medical Officer (CMO). Dr. Heineman has over two decades of experience leading clinical development programs and previously served as Oncolytics' Global Head of Clinical Development and Operations.

"Tom's clinical expertise, deep understanding of oncology drug development, and impressive track record make him an ideal fit as our CMO," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Since joining Oncolytics in August 2020, Tom has provided crucial insights that have enabled the efficient advancement of our lead breast cancer program and facilitated our pipeline's expansion into additional indications. Looking forward, Tom's strategic guidance will continue to be an invaluable asset as we move towards a registration study in metastatic breast cancer and advance our broader pipeline."
- ADVERTISEMENT -

Dr. Heineman added, "The opportunity to serve as Oncolytics' CMO is exciting. Pelareorep's ability to recruit anti-cancer immune cells into tumors and promote an inflamed microenvironment positions it as a potential immunotherapeutic backbone that can enable the success of a wide range of immuno-oncology agents. We have demonstrated clinical proof-of-concept in several high unmet need indications and are now building on these results in ongoing trials. As CMO, I look forward to leading the clinical development of pelareorep through these and future trials, and to my continued work alongside my highly talented colleagues at Oncolytics."

Prior to joining Oncolytics, Dr. Heineman was Senior Vice President and Head of Clinical Development at Denovo Biopharma. Prior to his time at Denovo, he served as Vice President and Head of Clinical Development at both Genocea Biosciences and Halozyme Therapeutics. At Halozyme, Dr. Heineman was also Head of Translational Medicine and oversaw clinical trials in indications such as breast and pancreatic cancer. Dr. Heineman's experience further extends to big pharma and academia, as he previously worked as Senior Director, Global Clinical Research and Development at GlaxoSmithKline and as an Associate Professor at the Saint Louis University School of Medicine.

Dr. Heineman has co-authored over 60 peer-reviewed publications and is board certified in Internal Medicine and Infectious Diseases. He completed his fellowship in Infectious Diseases at the National Institutes of Health and his internship and residency at the University of Maryland. Dr. Heineman earned his M.D. and Ph.D. in Virology at the University of Chicago.

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; 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-promotes-thomas-c-heineman-md-phd-to-chief-medical-officer-301448727.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Announces the Presentation of Preclinical Data Demonstrating the Synergistic Anti-Leukemic Effects of Pelareorep Combined with Azacitidine at the 2021 American Society of Hematology Annual Meeting

• Treatment with intravenous pelareorep plus azacitidine reduced tumor burden
• Treatment with pelareorep and azacitidine dramatically upregulated multiple genes known to drive anti-cancer immune responses

SAN DIEGO and CALGARY, AB, Dec. 15, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) announced preclinical data demonstrating the synergistic anti-leukemic effects of pelareorep combined with the chemotherapeutic agent azacitidine. The data were featured in a poster presentation at the 2021 American Society of Hematology (ASH) Annual Meeting (https://www.hematology.org/meetings/annual-meeting), which took place from December 11-14, 2021, in Atlanta, Georgia.

Preclinical studies featured in the poster evaluated pelareorep in combination with azacitidine in acute myeloid leukemia (AML) cells in vitro and in a leukemia xenograft mouse model. Key data and conclusions from the poster include:

• Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant reduction (p<0.01) in tumor burden in a leukemia xenograft mouse model
• Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant (p<0.001) synergistic enhancement of anti-leukemic activity against AML cell lines, a benefit that was confirmed in AML patient samples in vitro
• The combination of pelareorep and azacitidine dramatically upregulated multiple genes known to drive anti-cancer immune responses such as IFNß1, BATF2, IL-12ß, CCL2, TLR3, and PD-L1

"These compelling preclinical findings, together with previously reported data demonstrating clinical proof-of-concept in multiple myeloma, indicate that pelareorep's immunotherapeutic effects extend across multiple hematological malignancies. They also further highlight pelareorep's potential to enhance the efficacy of a wide range of cancer therapeutics and have stimulated interest in investigator-sponsored clinical studies of pelareorep in leukemia," said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "Given its ability to be administered intravenously without special handling procedures, pelareorep exerts a systemic effect that is uniquely suited to address liquid tumors compared to other oncolytic viruses. We look forward to leveraging collaborative relationships to continue evaluating pelareorep in hematological malignancies, which will allow us to potentially broaden its therapeutic impact while maintaining our primary focus on our lead breast cancer program."

A copy of the ASH poster titled, "The Clinical Oncolytic Reovirus Formulation Reolysin Synergistically Augments the Anti-Leukemic Activity of Azacitidine," is available 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 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; the potential to leverage collaborative relationships to continue evaluating pelareorep and potentially broaden its therapeutic impact; 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-the-presentation-of-preclinical-data-demonstrating-the-synergistic-anti-leukemic-effects-of-pelareorep-combined-with-azacitidine-at-the-2021-american-society-of-hematology-annual-meeting-301445082.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/December2021/15/c6863.html

[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