Type: Prophylactic vaccine against COVID-19, consisting of OncoSec’s TAVO™ (interleukin-12 or “IL-12” plasmid), in combination with a DNA-encodable version of the SARS-CoV-2 spike or “S” glycoprotein developed by researchers at the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), and which has been licensed to OncoSec on a non-exclusive basis.
Status: OncoSec on November 9 OncoSec disclosed preclinical data showing that CORVax12 triggered an immune response against SARS-CoV-2, as detailed in “Preliminary evaluation of a novel coronavirus vaccine (CORVax) using electroporation of plasmid DNA encoding a stabilized prefusion SARS-CoV-2 spike protein alone or with transfection of plasmid IL-12,” a poster presentation.
On October 29, OncoSec said the FDA approved its IND application for a first-in-human Phase I trial for CORVax12. Oncosec’s partner in developing CORVax12, Providence Cancer Institute, a part of Providence St. Joseph Health, Providence, will conduct the Phase I, open-label study, which is designed to evaluate the safety and immunogenicity of a plasmid encoding the SARS-CoV-2 spike protein alone or in combination with IL-12 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.
OncoSec reasons that the addition of its proprietary IL-12 delivery system may optimize immune response to several leading COVID-19 vaccines for older adults or immuno-compromised patients. The company also reasons that CORVax12 may also be able to protect those at higher risk for complications from COVID-19, including cancer, transplant and elderly patients who have compromised immune systems, Daniel J. O’Connor, President and CEO, said in a statement.
In April, Providence Cancer Institute, part of Providence St. Joseph Health, submitted to the FDA an IND application and have designed a protocol for a Phase I clinical trial evaluating CORVax12 in healthy adult volunteers, using OncoSec’s next-generation, investigational APOLLO generator technology for the first time clinically.
CORVax12 combines OncoSec’s IL-12 plasmid TAVO 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 non-exclusively to OncoSec.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: