Earlier this year, BioVaxys (CSE: BIOV, FRA:5LB, OTCQB:BVAXF) announced that it completed a pivotal, in vitro study on its experimental COVID vaccine, BVX-0320, that supports the vaccine’s improved safety profile compared to the available mRNA vaccines (Pfizer, Moderna). In this experiment, it was determined that BVX-0320, a haptenized version of the SARS-CoV-2 spike protein, does not bind to the Angiotensin Converting Enzyme-2 (ACE2) receptor found on many types of human cells (including lung, heart, and blood cell types). The relationship between the SARS spike protein (s-protein) and ACE2 receptor interaction is well-established as the cause of COVID-related effects such as myocarditis and deep vein thrombosis. Ironically, these conditions have also presented themselves as side effects of mRNA vaccination (although not unsurprisingly, since those mRNA vaccines encode for the s-protein themselves). This key finding adds to the growing set of data that suggests that BioVaxys’ BVX-0320 could be a potent inhibitor of SARS-CoV-2 infection that delivers efficacy without the safety concerns that plague currently available vaccines.
Researchers recently observed that people who survived the 2002-2003 SARS pandemic who were later administered a COVID-19 vaccine developed an immune response – in a sense a “super immune response” – which cross-reacted with all sarbecoviruses for which they were tested. Sarbecoviruses are a family of viruses that include SARS-CoV-2 and all current ‘Variants of Concern’ such as Delta and Omicron (as well as at least ten additional variants that are currently being monitored by the World Health Organization), SARS1, and a broad range of other potentially dangerous zoonotic viruses. In theory, this means those who contracted SARS in the early 2000s and who were vaccinated against COVID-19 are now immune to all sarbecoviruses. BioVaxys concluded that a similar immune response could be generated by immunizing people who have never been vaccinated, or do not have natural immunity, with a haptenized spike protein vaccine for both SARS1 and SARS-Cov-2. Likewise, a similar response would be generated by a haptenized SARS-CoV-1 spike protein “booster” vaccine in people who have been vaccinated for COVID-19, or who have natural immunity. Recently, BioVaxys announced dosing of the first animals with their SARS-CoV-1 vaccine, BVX-1021. Their theory is that administration of their SARS-CoV-2 vaccine (BVX-0320) followed by injection of their SARS-CoV-1 vaccine (BVX-1021) could provide universal immunity to all SARS variants.
The ongoing emergence of new variants is unlikely to end any time soon, forcing vaccine developers to play a game in which they are always a day late and a dollar short. A significant portion of the global population is wary of taking experimental drugs that have been accelerated through the regulatory process, and the idea of a never-ending cycle of “boosters” is abhorrent to those who are skeptical about government and Big Pharma’s motives. But what if a universal, “pan-sarbecovirus” vaccine was developed that eliminated the life-threatening adverse conditions (such as heart inflammation and abnormal blood clotting) and provided a robust, durable immunity against all future SRS-CoV-2 variants? This is the Holy Grail of vaccine development, and BioVaxys just might hold the map.
As the pandemic continues to develop, the SARS variants are developing ever increasing numbers of mutations in key regions of their genetic code that allow them to evade immune detection and render available vaccines impotent. The number of mutations and diversity of mutation sites makes it increasingly more difficult to predict what the next novel variant will look like and develop a vaccine against it. A more robust approach is needed that is agnostic to future variant designs. BioVaxys believes that they hold the key to developing a universal, “pan-sarbecovirus” vaccine, and have entered into a partnership with The Ohio State University to pursue this endeavor. Their theory is that previous infection with the SARS-CoV-1 variant predicts a stronger neutralizing antibody response to subsequent vaccination with a SARS-CoV-2 vaccine. The goal of the partnership is to “stimulate virus cross-reactivity and induce immunity against all or most SARS viruses by immunizing people who have convalesced from a documented SARS-CoV-2 infection or received a full course of any SARS-CoV-2 vaccine, leading to a pan-sarbecovirus vaccine that encompasses current and emerging SARS-CoV-2 variants.”
On October 17th, The Ohio State University began dosing animals with BVX-1021, with the goal of protecting against all COVID variants when administered in combination with BVX-0320. The major endpoints of the study are the development of virus-neutralizing antibodies to live virus SARS-CoV-2 and other sarbecoviruses, including bat and pangolin SARS-related coronaviruses. Bats are a major reservoir of many strains of SARS, with several strains have been identified in palm civets, which were likely ancestors of SARS-CoV-1. (Journal of Virology. 84 (6): 2808–19, 2010). The presence of neutralizing antibodies in the animal model would strongly suggest that BVX-1021 would confer an additional immune response across all sarbecoviruses in those people fully vaccinated for Covid-19 as well as those with natural immunity. The study will complete in 40 days.
BIOV shares have seen a substantial volume expansion in recent weeks as price lifted higher from a double-bottom at $.09. After surging as high as $.26 on October 6th, BIOV pulled back to test important support near $.14. The stock now appears poised to embark on its next leg higher as the company advances toward multiple potential catalysts (Ohio State pan-sarbecovirus vaccine animal study, Papilocare definitive agreement, ovarian cancer vaccine phase 1 trial, etc.).
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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