vaccine. Strains upticking globally as original vaccines wear off.
VANCOUVER, BC, June 3, 2022 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") announced today that The Ohio State University ("Ohio State"), its research collaborator that is jointly evaluating the Company's novel approach for a "universal vaccine" that can treat a broad range of sarbecoviruses ("pan-sarbecovirus vaccine"), has completed preparation of the surrogate virus neutralization assays for the SARS-CoV-2 variants, as well as Pangolin-Cov-GD1 and Bat-CoV-RaTG13 sarbecoviruses. The next step will be immunizing the test animals with BVX-1021, BioVaxys' "booster" vaccine to be administered with current SARS-CoV-2 vaccines, to target sarbecoviruses.
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. These are a family of viruses that include SARS-CoV-2 and current 'Variants of Concern' such as Delta and Omicron (as well as at least ten additional variants that are currently being globally monitored), 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.
Recent yields of recombinant SARS-1 protein obtained from an external 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. Kenneth Kovan, BioVaxys President and Chief Operating Officer stated, "Although this likely would not have impacted the neutralizing antibody assays of the study, our team felt it prudent for scientific reproducibility to re-synthesize a new yield of recombinant SARS-1 protein specifically screening out the extraneous protein aggregate, even though it would incur some delay in obtaining study results; the Covid-19 lockdown situation in Shanghai further impacted the lead time for production of the SARS-1 protein by our Shanghai-based supplier. MilliporeSigma, our contract manufacturer, is now able to begin the bioproduction of new yields of BVX-1021 vaccine for the study. We now anticipate data from the neutralizing antibody study by late August 2022."
BioVaxys and Ohio State were recently invited by The Coalition for Epidemic Preparedness Innovations ("CEPI") to present their strategy for a pan-sarbecovirus vaccine to a panel of CEPI vaccine experts. Following this presentation, the Company and Ohio State were invited to return and deliver an update following completion of the animal studies. Based in Oslo, London, and Washington, DC, CEPI is a global foundation that directs public, private, and philanthropic funding towards vaccines targeting major unmet needs (
https://cepi.net/).
In January 2022, the World Health Organization ("WHO") Covid Vaccines Research Expert Group presented a report on the critical need for a pan-sarbecovirus vaccine ("
Why do we need a pan-sarbecovirus?" January 28, 2022, World Health Organization). This report stated that there is a "very high urgency for pan-sarbecovirus vaccines: Current vaccines are becoming less effective against evolving variants, and waning even of booster vaccine response indicates that we don't have a practical vaccine for the future. Although severe disease is critical, a pan-sarbecovirus vaccine may have a better chance of blocking transmission and facilitating herd immunity, and are expected to be more durable."