US FDA Approves OncoSecs IND Application To Initiate Phase 1 Trial Of CORVax12 To Treat COVID-19

OncoSec Medical announced that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for a first-in-human phase 1 trial for CORVax12, a novel DNA-encodable vaccine against SARS-CoV-2 that the company is developing with Providence Cancer Institute, a part of Providence St. Joseph Health (Providence).CORVax combines OncoSec's immuno-stimulant IL-12 expression platform, Tavo (tavokinogene telseplasmid), with a DNA-encodable stabilized trimeric SARS-CoV-2 spike glycoprotein developed by researchers at the National Institute of Health's National Institute of Allergy and Infectious Diseases (NIAID), and which has been licensed to OncoSec on a non-exclusive basis.“CORVax12 leverages Tavo, our clinically established IL-12 platform, and is designed as a next-generation vaccine to evaluate whether Tavo can optimize immune responses of existing vaccines and vaccine candidates to address COVID-19,” said Daniel J. O'Connor, president and chief executive officer of OncoSec. “Specifically, should the addition of IL-12 to the SARS-CoV-2 spike glycoprotein facilitate a coordinated immune response more effectively than the SARS-CoV-2 spike glycoprotein alone, this could support the premise that Tavo has the ability to enhance other vaccines currently in development. Additionally, we believe that CORVax12 may also be able to protect those at higher risk for complications from the coronavirus, including cancer, transplant and elderly patients who have compromised immune systems.”Chris Twitty, Ph.D., chief scientific officer of OncoSec added, “Dysfunctional immune responses and exhausted T-cells have been associated with increased morbidity and mortality in patients with COVID-19. Since IL-12 can support T-cell responses while limiting T-cell exhaustion, patients receiving CORVax12 may develop a more robust anti-viral response, supporting higher titers of neutralizing antibodies. Neutralizing antibodies have been associated with protection from reinfection, meaning that CORVax12 may provide superior protection from exposure to SARS-CoV-2.”Rom Leidner, M.D., co-medical director of the Head and Neck Cancer Program at Providence Cancer Institute, Assistant Member of the Earle A. Chiles Research Institute and the Principle Investigator on the planned study added, “By combining the spike protein with OncoSec's immune-stimulating protein IL-12, we hope to drive robust cellular and humoral immunity against SARS-CoV-2. We are thankful to be able to work with OncoSec to advance this novel vaccine approach into the clinic.”Providence will conduct a phase 1, open-label study to evaluate the safety and immunogenicity of a plasmid encoding the SARS-CoV-2 spike protein alone or in combination with IL-12 (CORVax12, SARS-CoV-2 S glycoprotein plasmid DNA in combination with IL-12 plasmid) in up to 36 healthy volunteers. CORVax12 will be given as a prime and booster dose four weeks apart. Subjects will be subdivided in parallel age cohorts of 18-55 years old versus > 55 years old.CORVax12 is the only DNA vaccine that uses an immune stimulant to promote an immune response against the SARS-CoV-2 virus. The CORVax vaccine approach combines the co-administration of Tavo (plasmid IL-12) with a DNA-encodable version of the SARS-CoV-2 spike glycoprotein to enhance immunogenicity of the component developed by scientists at 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.

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