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BioVaxys and MilliporeSigma Enter Vaccine Manufacturing Agreement

Announces bioproduction of BVX-1021 for its pan-sarbecovirus program in collaboration with Ohio State University.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

BioVaxys Technology Corp. has entered into an agreement with MilliporeSigma, a global contract development and manufacturing organization (CDMO), to manufacture a supply of GLP-grade BVX-1021, the company’s newly developed vaccine (BVX-1021) for the strain of coronavirus that causes Severe Acute Respiratory Syndrome (SARS1), the respiratory illness responsible for the deadly 2002–2004 pandemic. There are no vaccines approved for SARS1.

BVX-1021 is the subject of an ongoing research collaboration between Ohio State University and BioVaxys, announced in December 2021, that is evaluating the company’s novel approach for a “universal vaccine” that can treat a broad range of sarbecoviruses (pan-sarbecovirus vaccine). Sarbecoviruses are a family of viruses that include SARS-CoV-2 and all current ‘Variants of Concern’ such as Delta and Omicron (as well as at least ten additional variants that are currently being monitored), SARS1, and a broad range of other potentially dangerous zoonotic viruses.

The collaboration between BioVaxys and Ohio State, which has been underway since early January 2022, is evaluating the combination of 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. (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.

“Scientists have observed that people who survived the 2002-03 SARS pandemic and then were administered a Covid-19 vaccine developed antibodies that cross-reacted with all of the sarbecoviruses that they tested,” said Dr. David Berd, chief medical officer, Biovaxys. “That observation suggested to us that a similar pan-sarbecovirus immune response could be generated by immunizing with haptenized spike protein from SARS1 and SARS-Cov-2, i.e., our BVX-0320 and BVX-1021 products.”

BVX-1021 is a hapten-modified recombinant S-protein from SARS-CoV-1, whereas BVX-0320, BioVaxys’ Covid-19 vaccine, is a hapten-modified recombinant S-spike protein from SARS-CoV-2, the virus which causes Covid-19. A hapten is a small molecule that stimulates an immune response when conjugated with a protein such as a virus surface antigen, but lacks antigenicity of its own. Previous studies conducted by BioVaxys in mice have shown that haptenized SARS-CoV-2 spike protein elicits both, robust T cell and antibody response.

BioVaxys recently announced results of a study that demonstrated that BVX-0320, its haptenized SARS-CoV-2 s-spike protein vaccine, does not bind to the Angiotensin Converting Enzyme-2 (ACE2) receptor. The finding suggests that Company’s haptenized SARS-CoV-2 spike protein vaccine may not lead to the unusual but serious myocarditis observed with mRNA vaccines.

Kenneth Kovan, president and chief operating officer, BioVaxys, said, “The Covid-19 market is shifting to vaccines that will not only protect against emerging variants of SARS-CoV-2, but also for any related coronaviruses that likely may arise in the future. BVX-1021 demonstrates that we can leverage our technology platform to create novel hapten-viral antigen vaccines to target additional markets.”

BioVaxys intends to develop BVX-1021 as a standalone “booster” targeting anyone who has been immunized with a World Health Organization-recognized Covid-19 vaccine or convalesced from a Covid-19 infection. To date, approximately 389 million people worldwide have recovered from Covid-19 (Worldometer, March 11, 2022), and 57% of the global population (Our World in Data, March 2022), or 4.4 billion people, have received a full course of SARS-CoV-2 vaccine.

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