The Company previously demonstrated that BVX-0320 stimulated a strong antibody and T cell response in a murine model, and believes that administering BVX-1021 and BVX-0320 is a valid approach for inducing immunity to sarbecoviruses.  The results from the Ohio State animal study showed an excellent emerging tolerability profile for BVX-1021, with no observed side effects or noteworthy clinical observations.  

"We planned this experiment over a year ago in response to market pressure to aggressively evaluate new approaches to the pandemic.  The study was designed to test a hypothesis that expanded on what was shown to work in the mouse model," stated BioVaxys President & Chief Operating Officer Kenneth Kovan.  "In discussion with the research team at Ohio State, the consensus is that Company's technical approach for its sarbecovirus vaccine is sound, but that factors related to the study design and the chosen animal model need to be addressed, such as rethinking the experimental controls, species-specific dose ranging, and use of a different adjuvant.  Emerging SARS-CoV-2 variants are not going away.  We believe the approach is valid, and having gained valuable scientific information, plan a redesign of the study while we continue to focus on our core cancer immunotherapy platform and emerging women's healthcare portfolio."