BioVaxys Technology announced that interim results from its ongoing preclinical of BVX-1021, the company's vaccine for SARS-CoV-1 (SARS1) which is being evaluated in a collaboration with the Ohio State University to develop a pan-sarbecovirus vaccine, show an excellent emerging tolerability profile with no observed side effects or noteworthy clinical observations.
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BVX-1021 is the subject of an ongoing research collaboration between Ohio State and BioVaxys that is evaluating the company's novel approach for a "universal vaccine" that can treat a broad range of sarbecoviruses.
Sarbecoviruses are a family of viruses that include all Covid-19 variants, the SARS-CoV-1 virus responsible for the 2003 global SARS pandemic, and a broad range of other potentially dangerous zoonotic viruses.
The collaboration is evaluating the combination of BioVaxys' BVX-0320 and BVX-1021 in a guinea pig model; BVX-1021 is a hapten-modified recombinant S1 subunit of the spike protein from the SARS1 virus, whereas BVX-0320, is a hapten-modified recombinant S1 subunit of the spike protein from SARS-CoV-2 (SARS2), the virus which causes Covid-19.
Three weeks post-administration of BVX-1021 in the guinea pig animal model, no toxicities or body weight changes have been observed, nor any injection site reactions.
Dr. David Berd, Chief Medical Officer of BioVaxys, stated, "Although preclinical results in animal models do not always duplicate in humans, the emerging tolerability and clean toxicity profile are very promising for clinical evaluation."
The next step of the study is the follow-on immunization of the test animals with BVX-0320, the Company's Covid-19 vaccine candidate, currently underway at Ohio State.
The major endpoints of the study are the development of virus-neutralizing antibodies to live virus SARS2 and other sarbecoviruses, including bat and pangolin SARS-related coronaviruses.
The presence of neutralizing antibodies in the animal model would strongly suggest that BVX-1021 would confer an additional immune response across all sarbecoviruses in those people fully vaccinated for Covid-19, as well as those with natural immunity.
BioVaxys President and Chief Operating Officer Kenneth Kovan stated, "These interim data further support our efforts to develop a safe and well-tolerated solution for sarbecoviruses such as SARS-1, SARS-CoV-2, and its continuously emerging variants.
"The emerging in vivo safety and tolerability profile of BVX-1021 mirrors that shown by our SARS-CoV-2 vaccine, BVX-0320, and is further evidence of the viability of our haptenized antigen vaccine platform across different viruses." ■