BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (“BioVaxys” or “Company“), announced today that it has initiated what could be a scientifically groundbreaking study on the reduced ACE2 binding capabilities of the hapten-modified spike protein that is the foundation of BVX-0320, the Company’s SARS-CoV-2 vaccine.
Many SARS-CoV-2-infected patients develop pneumonia that may lead to acute respiratory distress, with some patients developing cardiac symptoms and cardiovascular injury.
In their peer-reviewed research paper, “SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19,” published in the Journal of Hematological Oncology, S. Zhang et.al.1 conclude 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 pulmonary and cardiovascular issues. Currently available vaccines, whether comprised of 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 spike protein that is modified by the hapten, dinitrophenyl (DNP). Biovaxys believes that the haptenized spike protein has much diminished ability to bind to ACE2, which would result in much diminished vaccine toxicity.
David Berd, MD, Chief Medical Officer of Biovaxys, explained that “Biovaxys will compare the binding of haptenized spike protein with the non-haptenized. The results could provide evidence that our vaccine has lowered potential for some of the observed serious vaccine side effects.”
James Passin, BioVaxys CEO, stated, “Haptenization, as a method to inhibit the ACE2-binding ability of the spike protein, while increasing its immunogenicity, may prove to play a critical role in global COVID-19 vaccine development and deployment strategies, as public health authorities consider options for repeated seasonal vaccine boosters in the context of reported, albeit rare, adverse effects and apparent waning immunity.”
This week BioVaxys entered into an agreement with Millipore-Sigma (“Millipore”) a global Contract Development and Manufacturing Research Organization (“CDMO”), to manufacture a supply of GLP-grade BVX-0320, the Company’s SARS-CoV-2 vaccine candidate for the study. Millipore produced similar yields of BVX-0320 last summer for the Company’s animal immune response studies, but will now be incorporating in manufacturing the recently produced purified recombinant s-protein produced by BioVaxys bioproduction partner, WuXi Biologics. 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$102 billion.
BioVaxys is currently finalizing arrangements with a major US academic research institution who will be collaborating with the Company on the study.
For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.
1J Hematol Oncol 2020 Sep 4;13(1):120