BioVaxys Technology Corp. (CSE:BIOV, OTCQB:BVAXF) has revealed that studies on BVX-0320, its haptenized SARS-CoV-2 s-spike protein vaccine candidate, demonstrated that the vaccine does not bind to the Angiotensin Converting Enzyme-2 (ACE2) receptor.
The Vancouver-based biotechnology company said this suggests superior cardiac safety compared to standard coronavirus (COVID-19) mRNA and Adenovirus Vector vaccines. The findings show that the company’s vaccine candidate BVX-0320 may not lead to the “unusual but serious myocarditis observed with mRNA vaccines,” said BioVaxys.
Previous studies in mice have also shown that BVX-0320 stimulates a robust antibody and T cell response and was safe and well tolerated.
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There have been several adverse events associated with mRNA COVID-19 vaccines, resulting in cardiac complications related to the vaccines, according to a review of case reports.
A study published in the Journal of Hematological Oncology 2 concluded that the Receptor Binding Domain (RBD) of the SARS-CoV-2 spike protein binds to the ACE2 receptor and that this binding of SARS-CoV-2 to the ACE2 prevents the enzyme from converting angiotensin II, potentiating cardiac issues. The ACE2 receptor is present in many cell types and tissues including the lungs, heart, blood vessels, kidneys, liver, gastrointestinal tract, and epithelial cells.
Currently available vaccines, whether comprised of either recombinant full-length or partial spike protein can result in rare, but life-threatening side effects, such as abnormal blood clotting or myocarditis. These toxicities may be caused by unwanted binding of the vaccine spike protein to ACE2 receptors in the heart.
The Biovaxys vaccine for Covid-19, BVX-0320, comprises a portion of the SARS-CoV-2 spike protein that is modified by the hapten, dinitrophenyl (DNP). The company explained that the hapten modification prevents ACE2 binding while retaining immunogenicity.
The study on ACE2 binding inhibition, conducted by contract manufacturing firm Millipore-Sigma was part of a BVX-0320 bioproduction run locked-in by BioVaxys in September last year. The work with Millipore-Sigma also resulted in major improvements in the manufacturing process. Millipore is a subsidiary of pharma giant Merck KGaA.
The company said the new batch of BVX-0320 is being used for its ongoing pan-sarbecovirus vaccine collaboration with the Ohio State University.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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