BIOVAXYS ANNOUNCES complete inhibition of ACE-2 binding activity of hapten-modified SARS-CoV-2 protein
VANCOUVER, BC, Feb. 16, 2022 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAX) ("BioVaxys" or "Company") announced today that studies on BVX-0320, its haptenized SARS-CoV-2 s-spike protein vaccine, demonstrate that the vaccine does not bind to the Angiotensin Converting Enzyme-2 (ACE2) receptor. The finding suggests that the Company's haptenized SARS-CoV-2 spike protein vaccine may not lead to the unusual but serious myocarditis observed with mRNA vaccines. Previous studies in mice have shown that BVX-0320 stimulates a robust antibody and T cell response and was safe and well tolerated.
There have been several local and systemic adverse events associated with mRNA COVID-19 vaccines, with pericarditis, myocarditis and myocardial infarction as examples of cardiac complications related to these vaccines.[1] A study published in the Journal of Hematological Oncology [2] concludes 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 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 or platelet factor 4. 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); hapten modification prevents ACE2 binding while retaining immunogenicity.
The recently completed study on ACE2 binding inhibition by CDMO Millipore-Sigma was part of a bioproduction run of BVX-0320 contracted by BioVaxys last September; the new batch is being used for the Company's ongoing pan-sarbecovirus vaccine collaboration with The Ohio State University. The work with Millipore-Sigma also resulted in major improvements in the manufacturing process and analytic methods. Millipore is a subsidiary of Merck KGaA (Deutsche Bourse: MRCG), one of the largest pharmaceutical companies in the world, with a market capitalization of US$95 billion.
For greater certainty, BioVaxys is not making any express or implied claims that the Company can currently treat COVID-19.
[1] Cardiac complications following mRNA COVID-19 vaccines: A systematic review of case reports and case series, Rev Med Virol 2021 Dec 17
[2] SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19, J Hematol Oncol 2020 Sep 4;13(1):120
About BioVaxys Technology Corp.
Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, clinical stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology and is planning a European clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for Stage III/Stage IV ovarian cancer. Also in development is CoviDTH®, a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and multiple US, PCT and National Phase applications related to its vaccine and diagnostic portfolio products. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).
ON BEHALF OF THE BOARD
Signed "James Passin"
James Passin, CEO
+1 646 452 7054
jpassin@biovaxys.com