BioVaxys Technology announced that Millipore-Sigma, the contract manufacturer for its preclinical viral vaccine program, has completed the bioproduction and batch release endotoxin screening of BVX-1021, the company's vaccine for SARS-CoV, which is being used in the collaboration with The Ohio State University ("OSU") to develop a pan-sarbecovirus vaccine.
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he next step is measuring neutralizing antibody development to sarbecoviruses following immunization of study animals with BVX-1021, followed by administration of a SARS-CoV-2 vaccine - in this case with BVX-0320, the Company's Covid-19 vaccine candidate.
In June, the Company disclosed that yields of recombinant SARS-1 protein obtained from a Chinese supplier for the bioproduction of BVX-1021 were determined to contain the presence of a natural protein aggregate byproduct in addition to the SARS-1 protein.
Although not likely to have impacted the neutralizing antibody studies, the Company felt it prudent to synthesize BVX-1021 using a new batch of recombinant SARS-1 protein from the supplier that screened out the extraneous protein aggregate.
A Covid-19 outbreak in August at a supplier of the reagents needed for the final QC/QA led to a short delay in final release of BVX-1021.
BVX-1021 is the subject of an ongoing research collaboration between OSU and BioVaxys that is evaluating the Company's novel approach for a "universal vaccine" that can treat a broad range of sarbecoviruses.
These are a family of viruses that include SARS-CoV-2 and emerging variants, SARS-CoV-1, and a broad range of other potentially dangerous zoonotic viruses.
The collaboration, which began earlier this year, is evaluating the combination of BioVaxys' BVX-0320 and BVX-1021 in a guinea pig model. The major endpoints of the study are the development of virus-neutralizing antibodies to live virus SARS-CoV-2 and other sarbecoviruses, including bat and pangolin SARS-related coronaviruses.
Bats are a major reservoir of many strains of SARS, with several strains have been identified in palm civets, which were likely ancestors of SARS-CoV-1 ("SARS-1") (Journal of Virology. 84 (6): 2808–19, 2010).
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 says, "Now that BVX-1021 has been synthesized using the purified SARS1 protein, OSU is now able to complete the neutralizing antibody studies. Barring any unforeseen circumstances, we anticipate data from the study in September." ■