Biotechnology company OncoSec Medical Incorporated (NASDAQ:ONCS) reported on Thursday the receipt of the US Food and Drug Administration's (FDA) Investigational New Drug (IND) application for the first-in-human Phase 1 trial for its CORVax12, a novel DNA-encodable vaccine against SARS-CoV-2, in partnership with Providence Cancer Institute, a part of Providence St Joseph Health.

The 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 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.

Under the terms of the agreement, Providence will begin 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.

In conjunction with the agreement, CORVax12 will be given as a prime and booster dose four weeks apart. The subjects will be subdivided in parallel age cohorts of 18-55 years old versus > 55 years old, added the company.

According to the companies, 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 or S glycoprotein to enhance immunogenicity of the component developed at NIAID Vaccine Research Center.