Type: Vaccine against COVID-19 based on Vaxine’s Advax™ non-inflammatory Advax-CpG55.2 adjuvant platform, designed to strongly stimulate both T cell and antibody responses when combined with a recombinant SARS-CoV-2 spike protein.
Status: Vaxine said July 1 that its COVAX-19 became the first COVID-19 vaccine developed in the Southern Hemisphere to enter human trials. The Phase I trial is designed to provide initial safety and immune response data, and is being conducted by the PARC clinical trial unit at Australia’s Royal Adelaide Hospital, and will involve 40 healthy participants aged between ages 18-65 who have already been pre-screened. Participants with receive two doses, three weeks apart, of COVAX-19 vaccine or a placebo injection and will then have blood tests to measure protective antibody and T cell responses induced by the vaccine.
On June 15, Vaxine said June 15 that it completed the immunization phase of ferret challenge studies being conducted at the University of Georgia to test the ability of the company’s COVAX-19 vaccine to protect against COVID-19. No adverse reactions were reported. UGA has one of the largest high-security ferret challenge facilities in North America. Over the next four weeks, Vaxine said, the immunized ferrets will be challenged with COVID-19 virus to assess their protection.
“We have already seen that COVAX-19 vaccine induces potent antibody and T cell responses against COVID-19 spike protein in mice and have seeen antibody responses in monkeys that exceeded levels in recovering human patients post-COVID-19 infection”, said Prof. Nikolai Petrovsky, MBBS, FRACP, PhD, Chairman and Research Director of Vaxine.
In May, Vaxcine entered into a formal collaboration with Medytox to accelerate development and commercialization of COVAX-19, through a Memorandum of Understanding formally signed on May 12. The companies agreed to work together to conduct product development, process development, clinical trial program and commercial scale-up for the Australian and Asian markets, including South Korea. Medytox is headquartered in Seocho-gu, Seoul, and Vaxine in Adelaide, South Australia.
According to Vaxine, Phase I human clinical trials of COVAX-19 are set to start “soon,” with early results by September and Phase II/III clinical trials planned for Q4 2020. Vaccine launch is expected for early in 2021.
Advax is designed to avoid the high fevers, fatigue and muscle aches seen with vaccines based on adenovirus vectors or mRNA or formulated with traditional inflammatory adjuvants.
Support for Advax has come from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), Development and discovery of the Advax-CpG55.2 adjuvant platform was funded in whole or in part with Federal funds under NIAID Contracts HHSN272200800039C, HHSN272201400053C, and HHSN27221800024C.
COVID-19: 200 Candidates and Counting
To navigate through the >200 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: