The race to create an effective vaccine against SARS-CoV-2 (the virus that leads to COVID-19) has been dominated by Pfizer and Moderna. Both pharmaceutical giants have developed vaccines targeted against the spike protein of the virus (using mRNA technology), and both vaccines have reported >95% efficacy in preventing patients from contracting the virus. So why are we still so terrified of the pandemic? Why are countries still under lockdown, effectively killing their economies and forcing tax-paying citizens into destitution? Why can’t you simply walk into a CVS and get the vaccine for $10 like you can for the annual flu? The sad truth is that the global supply chain is ill-equipped to handle mass distribution of the vaccine. And the problems don't stop there. Two new SARS-CoV-2 mutant variants have been isolated in the UK and South Africa. These variants may render the current vaccines (should you be able to actually get them) useless. One year and billions of dollars later, it is clear that the global response to eradicating SARS-CoV-2 is woefully inadequate and shortsighted on these two fronts. What we need is a platform technology that is highly scalable and can pivot on a dime. Hope is not lost.
There is a reasonable chance that by the time the vaccines are readily available for the public (not limited to healthcare workers and the elderly), the effectiveness of those vaccines will have dropped off a cliff. Unsurprisingly, two variants of SARS-CoV-2 have emerged in the UK and South Africa, B.1.1.7 and 501Y.V2, respectively. The emergence of these mutated strains of the virus has sent epidemiologists and pharmaceutical research scientists scrambling for a solution. What if the Pfizer and Moderna vaccines stop working? How much time, money, and anxiety-inducing political rhetoric was wasted on this short-sighted strategy? And what if, under strong selective pressure imposed by widespread vaccinations and anti-viral treatments, the virus mutates again? The answer is obvious. Back to the drawing board. A Sisyphean tragedy. A comedy of errors.
Where there is chaos there is opportunity. Many small pharma companies have jumped on the opportunity to apply their novel anti-viral and vaccine development programs to approach the problem from a different, less predictable angle. Biovaxys is one such company that has successfully added a SARS-CoV-2 angle to their anti-cancer vaccine development program, leveraging their core technology (originally designed to address ovarian cancer and melanoma) to efficiently create additional vaccines as new SARS-CoV-2 strains emerge (this is why we love Plug-and-Play platform technologies).
Both of the new SARS-CoV-2 strains are riddled with a number of mutations. The most concerning mutations lie within the spike protein (responsible for breaking open our lung cells and allowing the virus to invade) at position 501 (where the spike protein and human cells rendezvous). Recent research has identified a specific mutation (“501Y”) that could result in quicker transmission of the virus between individuals. So much for flattening the curve. There is major concern that the recent approved vaccines may not be completely effective against these new strains.
The BioVaxys haptenization strategy is a platform technology that can use almost any virus-derived protein to create new vaccines. Haptenization is a chemical process that increases the “visibility” of the viral antigen (the little piece of virus introduced to the immune system, such as a portion of the spike protein). Almost any antigen can be haptenized, which Biovaxys has used to create a 'cassette-type' approach not possible with other vaccines. This “cassette” allows a "swap in" of the target viral antigen(s) for haptenization and the creation of a new vaccine. This scalable, diversifiable approach will lead to faster development compared to other vaccine approaches.
BioVaxys intends to address the new SARS-CoV-2 variants by modifying its original COVID-19 vaccine, BVX-0320. This first-generation vaccine used the “S1 subunit” of the viral spike protein that was identified during the early stages of the pandemic. BioVaxys has a new SARS-CoV-2 vaccine candidate, BVX-0121, under development. The key concept of their approach is creating a “bivalent” or “trivalent” vaccine that contains the original S1 plus the S1 from one or both of the UK and South African strains. The manufacturing process would be similar to that of BVX-0320. BioVaxys plans to collaborate with a pharma partner and jointly seek government funding for the Phase II program.
BioVaxys' Covid-19 diagnostic, Covid-T™, is designed to detect differences in T cells responses (a marker of long-term immunity, conceptually similar to detecting antibody levels) between the original virus and the two new strains. The available T cell diagnostics require a blood draw and time-consuming and expensive analysis of the blood sample at specialized laboratories. There is clearly a need for a low-cost, more efficient, and simpler diagnostic tool to test for T cell immunity against all SARS-CoV-2 variants. Covid-T™ provides this low-cost, easy-to-administer, and accurate tool which can be used to evaluate the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T cell immunity.
If Covid-T™ were to reach mass distribution, individuals could be simultaneously tested for delayed-type hypersensitivity (DTH) – a phenomenon where antibodies are not generated quickly after viral infection and immunity is conferred through immune cells - to all three known S1 variants. BioVaxys has engaged a global regulatory advisory group and is contracting with an FDA-approved Contract Development and Manufacturing Organization (CDMO) for a cell line, expression system and cloning expertise to source GMP-grade S1 protein and is preparing an FDA pre-submission guidance package with delivery to the FDA anticipated shortly. A non-GMP animal toxicity study is scheduled for this March, followed by the proposed Phase I study this summer.
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.
Author owns BioVaxys 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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