This morning, BioVaxys (CSE:BIOV, OTCQB:BVAXF) announced a manufacturing and development agreement with Millipore to develop their “haptenized” Spike-protein (s-protein) vaccine and conduct pivotal preclinical studies to support its enhanced efficacy and reduced toxicity. Preliminary animal studies conducted by the company support the immune efficacy of the company’s novel approach to COVID resistance, but the study will be repeated in vitro to examine the proposed mechanism of action:
According to the US Centers for Disease Control and Prevention, myocarditis occurs in approximately 12.6 cases per million doses of second-dose mRNA vaccines (Pfizer, Moderna) in patients 12 to 39 years of age (79% were in males, with the majority in individuals <30 years of age with a median age of 24), usually 2 to 3 days after a second dose of mRNA vaccination (67%). Clinicians have noted elevated cardiac troponin, a protein biomarker that correlated with damaged heart muscle .
It is well-understood that the presence of SARS-CoV-2 viral RNA (which is found in the Pfizer and Moderna vaccines)) elicits the activation of cell growth pathways (MAPK), elevation of immune pathways, and dysregulated cytokine expression. These effects lead to dysregulated blood clotting and cardiac cell inflammation. Some researchers have proposed direct virus invasion as the most likely mechanism, while others have focused on inflammatory cell responses via platelet activation. Researchers who examined the hearts of patients who died from COVID-19 revealed a greater number of CD68+ cells compared with controls indicating that cells of monocyte/macrophage lineage (platelets, for example) rather than lymphocytes (immune cells) may be the causative factor in this disease. BioVaxys presents evidence suggesting that the MAPK pathway, downstream of the ACE2 receptor, mediates the increase of virus-related platelet activation and the release of coagulation factors and the secretion of inflammatory proteins .
The core of BioVaxy’s innovation is the attachment of a “hapten” protein to their s-protein vaccine. Haptens are molecules that induce an immune response only when attached to a large carrier protein, such as BioVaxy’s engineered s-protein, and have the ability to increase the targeted immune response. Once the haptenized s-protein is recognized by the immune system, antibodies are generated against the hapten-s-protein conjugate.
This strategy accomplishes two things:
"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."
BioVaxy’s recent partnership with Millipore will accelerate the development of the haptenized s-protein and provide key resources to conduct the pivotal studies  that will prove its potential to induce a stronger immune response against the virus while simultaneously reducing blood clotting and heart inflammation. Combined with the recent positive results for the company’s COVID diagnostic “CoviDTH,” which measures durable immunity via T cell response , the company is poised to completely change the SARS-CoV-2 vaccine and diagnostic game. This is a completely novel approach that is clearly superior to the current vaccines and antibody diagnostics.
BioVaxys shares have climbed to the highest levels since February as the company methodically advances its broad clinical stage viral and oncology vaccine platforms. Some resistance is to be expected near the $.60 level, followed by the February 2021 high at $.78. The $.45 level now becomes near term support.
MedicalGold will be publishing an interview with BioVaxys management early next week. Stay tuned for continued coverage of this rapidly emerging biotech story.
 Bozkurt, B., Kamat, I., & Hotez, P. J. (2021). Myocarditis With COVID-19 mRNA Vaccines. Circulation, 144(6), 471–484. https://doi.org/10.1161/CIRCULATIONAHA.121.056135 [Link]
 Zhang, S., Liu, Y., Wang, X., Yang, L., Li, H., Wang, Y., Liu, M., Zhao, X., Xie, Y., Yang, Y., Zhang, S., Fan, Z., Dong, J., Yuan, Z., Ding, Z., Zhang, Y., & Hu, L. (2020). SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19. Journal of hematology & oncology, 13(1), 120. https://doi.org/10.1186/s13045-020-00954-7 [Link]
 BioVaxys Prepares for Groundbreaking Study on reduced ACE2 binding capabilities of Hapten-modified SARS-CoV-2 proteins [Link]
 BioVaxys Expanding Technology Platform To Address Emerging SARS-CoV-2 Variants [Link]
 Further Study in humans shows that the DTH response, the basis for CoviDTH, is highly durable and persists for at least one year after COVID-19 exposure or vaccine administration [Link]
Author owns BIOV.CA shares at the time of publishing and may choose to buy or sell at any time without notice. Author has been compensated for marketing services by BioVaxys Technology Corp.
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