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ONCS - 3 near-term catalysts
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Data from its Monotherapy and Combination Therapy Studies with ImmunoPulse® IL-12 at the 9th World Congress of Melanoma - A Joint Meeting with the Society for Melanoma Research
PR NewswireOctober 12, 2017Comment
OncoSec presented at the 2nd Annual Biomarkers & Precision Medicine USA Congress

Oct. 12, 2017 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (ONCS), a company developing DNA-based intratumoral cancer immunotherapies, will present new clinical data on ImmunoPulse® IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation), its lead program focused on oncology, at the upcoming 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research (SMR). In addition, Chris Twitty, Ph.D., Executive Director of Clinical Science, gave an oral presentation at the 2nd Annual Biomarkers & Precision Medicine USA Congress earlier this week.">SAN DIEGO, Oct. 12, 2017 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (ONCS), a company developing DNA-based intratumoral cancer immunotherapies, will present new clinical data on ImmunoPulse® IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation), its lead program focused on oncology, at the upcoming 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research (SMR). In addition, Chris Twitty, Ph.D., Executive Director of Clinical Science, gave an oral presentation at the 2nd Annual Biomarkers & Precision Medicine USA Congress earlier this week.

"We are excited to share updated data from our phase 2 clinical monotherapy trial with ImmunoPulse IL-12 in patients with stage III/IV melanoma," said Punit Dhillon, CEO and President at OncoSec. "These data, along with the emerging clinical data from the phase 2 combination study, further support the rationale for our global, open-label, registration directed phase 2b clinical trial, PISCES/KEYNOTE-695, which we anticipate reporting initial data in mid-2018."

9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research

University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, will give an oral presentation contrasting monotherapy ImmunoPulse IL-12 to its combination with pembrolizumab. The presentation includes an assessment of clinical and immune biomarker data from the company's recently completed monotherapy phase 2 trial. The 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research (SMR) is to be held on October 18-22, 2017, in Brisbane, Australia.">Dr. Alain Algazi, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco(UCSF) Helen Diller Family Comprehensive Cancer Center, will give an oral presentation contrasting monotherapy ImmunoPulse IL-12 to its combination with pembrolizumab. The presentation includes an assessment of clinical and immune biomarker data from the company's recently completed monotherapy phase 2 trial. The 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research (SMR) is to be held on October 18-22, 2017, in Brisbane, Australia.

Details of the presentation are as follows:

Abstract Title: Clinical Immune Monitoring and Biomarker Data of pIL-12 Monotherapy Compared to pIL-12 with Pembrolizumab in Metastatic Melanoma Supports the Rationale for Combination Therapy (Abstract # FC05-3)

Session Title: Biology and Biomarkers

October 19, 2017 at 3:30 PM – 3:40 PM">Date and Time: October 19, 2017 at 3:30 PM – 3:40 PM

Location: Brisbane Convention & Exhibition Centre

Dr. Algazi will present new clinical and immune monitoring data from patients treated with ImmunoPulse IL-12, as a monotherapy (n=51 patients) versus the combination of ImmunoPulse IL-12 and the approved anti-PD-1 therapy pembrolizumab (n=22 patients) to better understand the mechanisms associated with each immunotherapy protocol. In the 51 patients treated with ImmunoPulse IL-12 as monotherapy, an average of 33.5% best overall response rate (BORR) at 180 days by a modified "skin" RECIST was demonstrated, in addition to a favorable safety profile (no life threatening or grade 4 AE). In the combination trial of 22 patients treated to date, a 48% BORR was observed at 24 weeks. Biomarker analyses suggest ImmunoPulse IL-12 drives a cellular response leading to an inflamed tumor with an increased TIL frequency whether as a monotherapy or combined with pembrolizumab, converting "cold" tumors to "hot".

https://worldmelanoma2017.com">Further details on this presentation will be provided in upcoming Company communications. For more information about this conference, please visit: https://worldmelanoma2017.com

USA Congress">2nd Annual Biomarkers & Precision Medicine USA Congress

USA Congress on October 10, 2017 at the Hilton San Diego Mission Valley Hotel in San Diego, CA. For more information, please visit: https://www.biomarkersusa-congress.com/.">Chris Twitty, Ph.D., Executive Director of Clinical Science at OncoSec, gave an oral presentation entitled: "Interrogation of the tumor microenvironment and associated immunity in patients with melanoma" in addition to leading a panel discussion at the 2nd Annual Biomarkers & Precision Medicine USA Congress on October 10, 2017 at the Hilton San Diego Mission Valley Hotel in San Diego, CA. For more information, please visit: https://www.biomarkersusa-congress.com/.

About OncoSec Medical Incorporated:

www.oncosec.com.">OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as plasmid encoded IL-12 (tavokinogene telseplasmid or "tavo"). In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec's lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program's current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.

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OncoSec to Host Fourth Quarter and Year End Financial Results Conference Call on October 25, 2017
PR NewswireOctober 13, 2017Comment
Oct. 13, 2017 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (ONCS), a company developing DNA-based intratumoral cancer immunotherapies, announced today that the Company will host its fiscal fourth quarter and 2017 year-end financial results conference call on Wednesday, October 25th at 1:15 PM PT/4:15 PM ET.">SAN DIEGO, Oct. 13, 2017 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (ONCS), a company developing DNA-based intratumoral cancer immunotherapies, announced today that the Company will host its fiscal fourth quarter and 2017 year-end financial results conference call on Wednesday, October 25th at 1:15 PM PT/4:15 PM ET.

http://ir.oncosec.com/events-presentations.">To access the audio broadcast, please dial (877) 731- 1960 and enter the conference ID number: 86520374. An archived version of the presentation will be available for 90 days on the "Investors" section of OncoSec's website: http://ir.oncosec.com/events-presentations.

www.oncosec.com.">About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as plasmid encoded IL-12 (tavokinogene telseplasmid or "tavo"). In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec's lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program's current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com

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OncoSec Announces Acceptance of Late Breaking Abstract at Upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting 2017
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OCTOBER 11, 2017
Additional abstract highlighting preclinical data from OncoSec's novel multi-gene expression platform
SAN DIEGO, Oct. 11, 2017 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, will present updated clinical data from its phase 2 Investigator Sponsored Trial assessing the combination of OncoSec's investigational therapy, ImmunoPulse® IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation), and the approved anti-PD-1 therapy pembrolizumab, in patients with unresectable metastatic melanoma. The late-breaking poster presentation will occur at the upcoming Society for Immunotherapy of Cancer ("SITC") 32nd Annual Meeting to be held on November 8-12, 2017, in National Harbor, MD. In addition, OncoSec will present preclinical data from its novel multi-gene expression platform termed PIIM (Polycistronic Interleukin-12 Immune Modulator) as a poster presentation at the same meeting.

"We are pleased that the Society for Immunotherapy of Cancer will highlight updated clinical data from our phase 2 study that led us to initiate our global, open-label, registration directed phase 2b clinical trial, PISCES/KEYNOTE-695, which will evaluate the combination of ImmunoPulse IL-12 and pembrolizumab in metastatic melanoma patients who are progressing or have progressed on anti-PD-1," said Punit Dhillon, CEO and President at OncoSec. "We remain committed to excelling in scientific innovation and clinical development and look forward to sharing data from our recently initiated study in mid-2018."

The late-breaking poster presentation details are as follows:

Title: Clinical and biomarker analyses of a phase II study of intratumoral tavokinogene telseplasmid (pIL-12) plus pembrolizumab in stage III/IV melanoma patients predicted to not respond to anti-PD-1

Poster Number: P524

Lead Author: Alain Algazi, MD, Associate Professor, Department of Medicine (Hematology/Oncology), UCSF

Date and Time: Saturday, November 11th, 12:30-2:00 p.m. and 6:30-8:00 p.m.

Location: Gaylord National Resort & Convention Center

For more information about this trial, please visit:
https://clinicaltrials.gov/ct2/show/NCT02493361?term=pIL-12&rank=3

The poster presentation details are as follows:

Title: Intratumoral administration of a multigene construct by electroporation can effectively modulate anti-tumor response in a murine B16.F10 model

Poster Number: P403

Lead Author: Shawna Shirley, Ph.D., Senior Scientist, OncoSec

Session Title: Oncolytic Viruses and Intratumoral Therapies

Date and Time: Friday, November 10th, 12:30-2:00 p.m. and 6:30-8:00 p.m.

Location: Gaylord National Resort & Convention Center

Per SITC guidelines, abstracts are embargoed until 8:00 a.m. EST on November 7, 2017. To view abstracts, please visit the SITC website at https://www.sitcancer.org/2017/abstracts/info.

ImmunoPulse® is a registered trademark of OncoSec Medical Incorporated, San Diego, CA, USA.

About the SITC Annual Meeting
The Society for Immunotherapy of Cancer (SITC) is a non-profit medical professional society of influential scientists, academicians, researchers, clinicians, government representatives, and industry leaders from around the world dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Currently, SITC has nearly 1,600 members representing 17 medical specialties and are engaged in research and treatment of at least a dozen types of cancer. The 32nd SITC Annual Meeting & Associated Programs will take place November 8-12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, MD. For more information, please go to http://www.sitcancer.org/2017.

About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)
PISCES is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).

About OncoSec Medical Incorporated:
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12. In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 (delivering pIL-12 referred to as tavokinogene telseplasmid or "tavo") has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec's lead program with tavo is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program's current focus with PISCES is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.

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