Policy & Regulation
First Subjects Dosed in Phase 1 Trial of CORVax12, OncoSec's COVID-19 Vaccine Candidate Combining Interleukin-12 (IL-12) with an Enhanced SARS-CoV-2 Spike Protein
27 January 2021 - - US-based biotechnology company OncoSec Medical Inc. (NASDAQ: ONCS) 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, the company said.

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 '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.

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 US.

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 and long-lasting anti-viral response.

OncoSec Medical Inc. 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, to target deep visceral lesions, such as liver, lung or pancreatic lesions.