BioVaxys Technology Corp. (CSE:BIOV, OTCQB:BVAXF) said it has initiated a study on the reduced ACE2 binding capabilities of the hapten-modified spike protein that is the very foundation of its coronavirus (COVID-19) vaccine candidate, BVX-0320.
The Vancouver-based biotechnology company is leveraging its haptenized antigen technology platforms to develop vaccines to potentially treat viral infections such as SARS-CoV-2.
BioVaxys noted that many SARS-CoV-2-infected patients develop pneumonia that may lead to “acute respiratory distress, with some patients developing cardiac symptoms.”
READ: BioVaxys says partner completed synthesis of recombinant SARS-CoV-2 s-protein for its BVX-0320 and CoviDTH programs
In a research paper titled “SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19,” published in the Journal of Hematological Oncology, researchers found that the receptor binding domain (RBD) of the SARS-CoV-2 spike protein binds to the ACE2 receptor. This binding of the SARS-CoV-2 to ACE2 prevents the enzyme from "converting angiotensin II, increasing pulmonary and cardiovascular issues," according to the research paper.
Currently, vaccines, whether they comprise “recombinant full-length or partial Spike protein can result in rare, but life-threatening side effects” such as abnormal blood clotting. “These toxicities may be caused by unwanted binding of the vaccine spike protein to ACE2 receptors in the heart or platelet factor 4,” the research found.
On the other hand, BioVaxys says its COVID-19 vaccine, BVX-0320, comprises a portion of the spike protein that is “modified by the hapten, dinitrophenyl (DNP).” As a result, the haptenized spike protein has a much more diminished ability to bind to ACE2, which would result in “diminished vaccine toxicity,” noted the company.
Fewer side effects
In a statement, BioVaxys Chief Medical Officer David Berd said: “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.”
BioVaxys CEO James Passin noted that haptenization, as a method to inhibit the ACE2-binding ability of the s-spike protein, while increasing its immunogenicity, may prove to play a “critical role in global Covid-19 vaccine development and deployment strategies,” as health authorities consider options for repeated seasonal vaccine boosters in the context of reported rare, adverse effects and “apparent waning immunity.”
BioVaxys struck an agreement this week with Millipore-Sigma, a global contract development and manufacturing research organization (CDMO), to manufacture GLP-grade BVX-0320 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 the manufacturing the recently produced purified recombinant s-protein produced by BioVaxys bioproduction partner, WuXi Biologics.
Millipore is a subsidiary of Merck KGaA, one of the largest pharmaceutical companies in the world, with a market capitalization of $102 billion.
BioVaxys said it is currently finalizing arrangements with a major US academic research institution that will be collaborating with it on the study.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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