OncoSec Collaborates With Providence Cancer Institute to Conduct First-in-Human Trial of Investigational Vaccine to Prevent COVID-19

OncoSec Medical Incorporated recently announced that Providence Cancer Institute, a part of Providence St. Joseph Health, is pursuing a first-in-human Phase 1 clinical trial of OncoSec’s novel DNA‑encodable, investigational vaccine, CORVax12, which is designed to act as a prophylactic vaccine to prevent COVID-19.  CORVax12 consists of OncoSec’s existing product candidate, TAVO (interleukin-12 or IL-12 plasmid), in combination with an immunogenic component of the SARS-CoV-2 virus recently developed by researchers at NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and licensed to OncoSec on a non-exclusive basis.

Specifically, OncoSec’s 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 NIAID Vaccine Research Center.  CORVax12 is designed to drive a coordinated vaccine response, capable of drawing upon the innate, adaptive humoral, and adaptive cellular arms.  We believe this multi-pronged innate, adaptive and cellular immune response is likely to be important in generating a robust anti-viral response.

“Previous vaccine efforts against coronaviruses, including the SARS coronavirus, have focused on the S glycoprotein, which facilitates interaction with the host cell through binding to the ACE2 receptor,” said Rom Leidner, MD, Co-Medical Director, Head and Neck Cancer Program at Providence Cancer Institute, and Assistant Member, Earle A. Chiles Research Institute and the Principle Investigator on the planned study. “Given the structural similarities between ACE2-receptor binding domain of the SARS-CoV-2 and SARS-CoV viruses, we would like to explore whether a similar strategy with OncoSec’s CORVax12 may hold potential as an effective vaccine. Importantly, we believe the delivery of CORVax12 using OncoSec’s electroporation system may allow for highly effective DNA transfer to drive this investigational vaccine.”

Dr. Leidner continued, “Providence is among the US’s largest, not-for-profit network of hospitals and includes 51 hospitals in Alaska, Washington, Oregon, Montana, and California.  We are positioned to rapidly initiate studies following FDA clearance of our IND and are hopeful that CORVax12, driven by OncoSec’s IL-12 and NIH’s spike DNA sequence, could have a meaningful impact on COVID-19 prevention and guide the development of a new generation of vaccines.”

Providence investigators have filed an Investigator-Initiated Investigational New Drug (IND) Application with the US FDA and have designed a clinical trial protocol that will evaluate the vaccination of healthy adult volunteers utilizing OncoSec’s next-generation, investigational APOLLO generator technology for the first time clinically if FDA clears the APOLLO to enter the clinic.  The trial will also include extensive immune monitoring.

“Teams of scientists at the Earle A. Chiles Research Institute, a division of Providence Cancer Institute, have moved quickly, using philanthropic support and experience from cancer vaccine manufacture to construct and manufacture the viral component of the CORVax12 vaccine that is licensed to OncoSec,” said Bernard A. Fox, PhD, Harder Family Chair and Member of the Earle A. Chiles Research Institute.

OncoSec will supply CORVax12 and its investigational APOLLO electroporation device to Providence as part of this effort and does not anticipate any additional capital commitment at this time.  Additionally, OncoSec will contribute manufacturing, preclinical, and prior clinical information and data for TAVO, along with manufacturing data for its APOLLO technology, to support FDA’s allowance of the Providence IND.  Providence will hold the IND, if cleared by FDA, and perform the preclinical and clinical development work.

“During a pandemic such as COVID-19, any opportunity to find a medical solution should be fully investigated,” said Christopher Twitty, Chief Scientific Officer of OncoSec. “We are excited to extend our deep expertise in IL-12 based immunotherapies along with an innovative vaccine candidate in support of the clinicians at Providence and their exploration of our CORVax12 vaccine to address this crisis. We hope to make a meaningful impact on COVID-19 as well as gaining a deeper understanding of its associated immunobiology.”

“While it is incumbent on OncoSec to assist Providence in the face of this pandemic, I want to take this opportunity to reiterate our primary focus is on advancing our ongoing pivotal KEYNOTE-695 study of TAVO and KEYTRUDA (pembrolizumab) combination therapy in late-stage checkpoint refractory metastatic melanoma, which remains open and actively recruiting patients at participating clinical sites,” said Daniel J. O’Connor, President and Chief Executive Officer of OncoSec, “However, when word of COVID-19 was emerging from China, we realized that our experience with IL-12 and electroporation and knowledge of cancer immunotherapy could be important in addressing this health issue.  We are pleased to support the research and medical teams at Providence in their desire to investigate CORVax12 with our Apollo generator and to understand its potential for COVID-19.”

OncoSec Medical Incorporated 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, visit www.oncosec.com.