OncoSec Hosting an Investor and Analyst Day Webinar Showcasing Positive KEYNOTE-695 Data in Anti-PD-1 Checkpoint Refractory Metastatic Melanoma

PENNINGTON, N.J. and SAN DIEGO, Nov. 5, 2020 /PRNewswire/ -- OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") today announced that it will host an Investor and Analyst webinar on Wednesday, November 11, 2020 from 8:30 am ET – 10:00 am ET showcasing interim data from its KEYNOTE-695 registration-enabled Phase 2b clinical trial investigating TAVO™ (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), in combination with KEYTRUDA® (pembrolizumab) in patients with anti-PD-1 checkpoint refractory metastatic melanoma.

Additional topics will include an update on its KEYNOTE-890 Phase 2 clinical trial investigating TAVO™ in patients with metastatic triple negative breast cancer (mTNBC) as well as a discussion on CORVax12, the Company's novel DNA-encodable vaccine for COVID-19. CORVax12 combines TAVO™ with the National Institute of Health's DNA-encodable stabilized trimeric SARS-CoV-2 spike glycoprotein and is expected to enter a Phase 1 clinical trial in the immediate future given recent IND acceptance.

Experts will also share insights about OncoSec's new neoadjuvant melanoma clinical trial and opinions on the visceral lesion applicator program, which will look to the future of gene electrotransfer in both lung and liver tumors.  A live question and answer session will follow the formal presentations.

This webcast is intended for institutional investors, sell-side analysts, and business development professionals. 

To register for the investor and analyst day, please click here. For those who cannot participate, the event will be recorded and available on the company website.

The event will feature presentations by the following Key Opinion Leaders (KOLs):

  • Tara Mitchell, MD, Associate Professor of Medicine, will describe the challenges of treating patients with checkpoint refractory metastatic melanoma. Dr. Mitchell will also give her initial review of the KEYNOTE-695 data.
  • Alain Algazi, MD, Associate Professor, Department of Medicine and Adil Daud, MD, Professor of Clinical Medicine, UCSF Helen Diller Family Comprehensive Cancer Center, will present and evaluate the KEYNOTE-695 clinical data and how it compares to other current treatments. 
  • Matteo Carlino, MD, Medical Oncologist and Clinical Senior Lecturer, Westmead and Blacktown Hospitals and University of Sydney, will provide his interpretation of the KEYNOTE-695 data and comment on how it will impact the way he treats patients.  
  • Ahmad Tarhini, MD, PhD, Director, Cutaneous Clinical and Translational Research, Moffitt Cancer Center, will provide an update on the ongoing neoadjuvant study combining TAVO and OPDIVO®.
  • Bernard Fox, PhD, Harder Family Chair for Cancer Research, Member and Chief of the Laboratory of Molecular and Tumor Immunology, Earle A. Chiles Research Institute, will provide an overview of the trial design for CORVax12, a COVID-19 vaccine.  He will also comment on the strategy behind this vaccine.
  • Rohit Joshi, MBBS, MD, FRACP, FACP, Medical Oncologist, Adelaide Medical School and Calvary Central Districts Hospital, will provide an overview of the KEYNOTE-890 study in triple negative breast cancer (TNBC). 
  • Dan Simon, MD, Interventional Radiologist Chief, Maryland Cardiology Associates, will provide an overview of the Visceral Lesion Applicator program.  He will share his experience with the technology and provide insight as to what this means for the future of gene electrotransfer.

About KEYNOTE-695

KEYNOTE-695 is OncoSec's registration-directed Phase 2b trial (NCT#03132675) evaluating TAVO™ (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12) + KEYTRUDA® (pembrolizumab) in patients with rigorously confirmed anti-PD-1 checkpoint resistant metastatic melanoma. The trial aims to enroll up to 100 patients with refractory, locally advanced or metastatic disease defined as unresectable Stage III/IV metastatic melanoma that had definitively progressed on a full-course of anti-PD-1 treatment with KEYTRUDA® (pembrolizumab) or OPDIVO® (nivolumab). TAVO™ has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of metastatic melanoma following progression on KEYTRUDA® or OPDIVO®.

About TAVO™

OncoSec's gene therapy technology combines TAVOTM (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO™ has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-895 Phase 2 trial in triple negative breast cancer (TNBC). TAVO™ has received Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration (FDA) for the treatment of metastatic melanoma following progression on KEYTRUDA® or OPDIVO®.

About Advanced Metastatic Melanoma

Metastatic melanoma refers to stage IV melanoma, which has typically spread through the lymph nodes to distant sites in the body such as the liver, lungs, bones and brain. Every year, approximately 100,000 adults in the United States are diagnosed with metastatic melanoma. Due to this metastatic tumor burden, stage IV melanoma is often very difficult to treat. Available treatment options frequently combine surgery with immunotherapy or targeted therapy. The 5-year survival rate for metastatic melanoma is approximately 25%.

About Metastatic Triple Negative Breast Cancer (TNBC)

Metastatic triple negative breast cancer (mTNBC) is an aggressive type of breast cancer with a high recurrence rate within the first five years following diagnosis, which accounts for 10-20% of all breast cancers. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is difficult to treat and there are very few FDA approved treatment options for these patients, which mostly rely on surgery, radiation, and chemotherapy. The 5-year survival rate for these patients is approximately 11%.

About CORVax12

CORVax12 is the only DNA vaccine that uses an immune stimulant to promote an immune response against the SARS-CoV-2 virus. The CORVax12 vaccine approach combines the co-administration of TAVO™ (plasmid IL-12) with a DNA-encodable version of the SARS-CoV-2 spike or "S" glycoprotein to enhance immunogenicity of the component developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. CORVax12 is designed to drive a coordinated vaccine response, capable of drawing upon the innate and adaptive humoral and cellular arms. This multi-pronged innate, adaptive and cellular immune response has the potential to generate a robust anti-viral response.

About OncoSec Medical Incorporated

OncoSec Medical Incorporated (the "Company," "OncoSec," "we" or "our") is a late-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec's lead immunotherapy investigational product candidate – TAVO™ (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVO™ as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from recently completed clinical studies of TAVO™ have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach along with an acceptable safety profile, warranting further development. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visit www.oncosec.com. TAVO™ is a trademark of OncoSec Medical Incorporated.

TAVO™ is a trademark of OncoSec Medical Incorporated.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

OPDIVO® is a registered trademark of Bristol-Myers Squibb Company.

Risk Factors and Forward-Looking Statements

This release, as well as other information provided from time to time by the Company or its employees, may contain forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Forward-looking statements provide the Company's current beliefs, expectations and intentions regarding future events and involve risks, uncertainties (some of which are beyond the Company's control) and assumptions. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "should," "will" and "would" and similar expressions (including the negative of these terms). Although we believe that expectations reflected in the forward- looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. The Company intends these forward-looking statements to speak only at the time they are published on or as otherwise specified, and does not undertake to update or revise these statements as more information becomes available, except as required under federal securities laws and the rules and regulations of the Securities Exchange Commission ("SEC"). In particular, you should be aware that the success and timing of our clinical trials, including safety and efficacy of our product candidates, patient accrual, unexpected or expected safety events, the impact of COVID-19 on the supply of our candidates or the initiation or completion of clinical trials and the usability of data generated from our trials may differ and may not meet our estimated timelines. Please refer to the risk factors and other cautionary statements provided in the Company's Annual Report on Form 10-K for the fiscal year ended July 31, 2020 and subsequent periodic and current reports filed with the SEC (each of which can be found at the SEC's website www.sec.gov), as well as other factors described from time to time in the Company's filings with the SEC.

Company Contact
Keir Loiacono
General Counsel, Vice President of Corporate Development, Chief Compliance Officer

Media Contact
Monica Rouco Molina, Ph.D.
LifeSci Communications

OncoSec Medical Incorporated logo (PRNewsfoto/OncoSec Medical Incorporated)



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