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OncoSec Medical Incorporated (NASDAQ: ONCS) today announced that it has dosed several subjects in its Phase 1 clinical trial of CORVax12, the only vaccine candidate to include an immunostimulatory cytokine to address COVID-19. This trial, entitled, CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2)(NCT04627675), will address safety and anti-viral immunological responses with the combination of a DNA-encodable stabilized SARS-CoV-2 spike glycoprotein and OnocSec's cancer immunotherapy candidate, TAVO™ (tavokinogene telseplasmid), a potent and well-characterized plasmid-based IL-12 cytokine.
Similar to other current vaccines, CORVax12 expresses a stabilized SARS-CoV-2 spike protein which trains the immune system to recognize the virus that causes COVID-19. However, the addition of IL-12 may augment the depth and type of immune response, which may enhance long-term anti-viral immunity. This coordinated cellular and humoral immunity is a hallmark of IL-12 and may not only provide for a better vaccine, but could significantly benefit patients with cancer who may not mount an effective immune response via a traditional vaccine approach.
Recent preclinical data on CORVax12 presented at the Society for Immunotherapy of Cancer (SITC)'s 35th Anniversary Annual Meeting demonstrated that CORVax12 induced a strong immune response in mouse models by leading to the production of anti-spike IgG antibodies capable of disrupting the receptor-binding domain of the spike protein.
Additionally, preliminary preclinical data has demonstrated that CORVax12 administered into tumor tissue not only yields a productive anti-viral response, but also a strong anti-tumor response. If these preclinical observations are supported with positive clinical data, this vaccine strategy may be developed to directly treat patients with tumors. Thus, CORVax12 has the potential to effectively combine OncoSec's powerful oncology platform with a strong vaccination.
"Patients' cancer, whether due to their immune status or anti-tumor therapy, may be unable to mount an effective immune response against COVID-19 via traditional vaccine approaches. As such, there remains a need to develop vaccine candidates (or combinations), such as CORVax12, so that patients do not lose precious time off therapy for an opportunity to be protected from COVID-19," said Christopher Twitty, Ph.D., Chief Scientific Officer of OncoSec. "We are encouraged by the potential of CORVax12 as a next-generation vaccine to facilitate a long-lasting immune response. Immune compromised patients, such as those with cancer, may benefit from a vaccine option that not only drives an anti-tumor response, but also creates lasting immunity to SARS-CoV2 by boosting their immune systems to mount a defense against COVID-19. We joined the COVID-19 arena because we believe our IL-12 cancer immunotherapy and the spike protein vaccine approach may make a real impact for these patients."
The Phase 1, open-label study aims to evaluate the safety and immunogenicity of a DNA plasmid encoding the SARS-CoV-2 spike protein alone or in combination with TAVO (CORVax12) in up to 36 healthy volunteers. CORVax12 will be given as a prime dose and a booster dose four weeks apart. Subjects will be sub-divided into two parallel age cohorts of 18-55 years old and >55 years old. CORVax12 will be administered using the Cliniporator® low-voltage gene electro-transfer platform, which OncoSec recently licensed exclusively in the U.S.