Based in Vancouver, Biovaxys Technology Corp. (CNSX: BIOV) is a British Columbia registered, clinical-stage biotechnology company that is developing viral and oncology vaccine platforms for SARS-CoV-2 and various cancers. The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology and is planning a clinical trial of its haptenized autologous cell therapy used in combination with PD1 and PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and a patent application for its SARS-CoV-2 (Covid-19) technology. BioVaxys common shares trade on the CSE under the stock symbol “BIOV.”
Recently, the company has developed a novel approach to potentially providing durable immunity against SARS-CoV-2 and its novel variants (and all potential variants that may arise) that is based on dual immunization with a SARS-CoV-1 and SARS-CoV-2 vaccine. The company intends to leverage their recombinant protein engineering platform and partnerships with Contract Manufacturing Organizations to quickly produce the novel, haptenized CoV-1 vaccine for testing.
The recent emergence of the Omicron variant has sent the market reeling and public health officials into a tailspin. The virulency and transmissibility of this "variant of concern" are not well-understood yet, and it will take at least one month for scientists to collect enough real-world data to make affirmative claims. In the meantime, we are witnessing another global meltdown as the uninformed public and woefully inept policy makers react to uncertainty. Omicron is not the first, and will certainly not be the last, SARS-CoV-2 variant to wreak havoc before this pandemic is seen for what it is (a seasonal virus that, while deadly in a very small subset of the population, is nothing more worrisome than the seasonal flu). The market's reaction (mRNA up 32% and BIOV up 26% over last 5 days) indicates that the public has placed their faith in vaccine development, which is currently playing catch-up to the novel variants. The medical community is playing behind the ball, when they need to get out in front of it.
The B.1.1.529 SARS variant, named “Omicron,” is the latest coronavirus mutant to be labeled as a “variant of concern” by the World Health Organization (WHO), and cause governments to scramble to prevent another outbreak. Omicron was first reported to the WHO from South Africa on November 24, 2021, from a specimen collected on November 9th. This new variant has accumulated more mutations than the Delta variant, which was likely responsible for half of the 5M total COVID-related deaths since it hit the scene 8 months ago. This does not necessarily mean that it is more transmissible or deadly, but it is simply further proof that coronavirus can adapt to the selective pressures applied to it (via natural evolution and the vaccines) and is here to stay. It will take weeks to months to assess the virulency of Omicron and the efficacy of available vaccines against it. Interestingly, COVID cases follow a 3–4 month cycle that do not seem to be driven solely by the emergence of new variants (Note: the labels in the chart below refer to the first documented cases. As you can see in the chart below, the WHO official designations do not occur in the same order). Omicron has caught us on the upswing.
The efficacy of available vaccines against Omicron has yet to be determined, but it will surely be influenced by the type and number of mutations unique to the South African variant. What we do know is that this variant contains a high number of mutations (over 30) in the spike protein region, the same spike protein that is used by vaccines to prime the immune system and to begin producing spike protein-specific antibodies. Under the direction of Penny Moore, Virologists at the University of Witwatersrand (Johannesburg, South Africa) are scrambling to understand the variant’s capacity for evading detection and rendering available vaccines useless. Many of these mutations were detected in the other variants of concern (Alpha, Beta, Delta, and Gamma), and explain the waning efficacy of the Pfizer, Moderna, and J&J vaccines over time.
“Many mutations we know are problematic, but many more look like they are likely contributing to further evasion. There are even hints from computer modelling that B.1.1.529 could dodge immunity conferred by another component of the immune system called T cells"
Dr. Peter Hotez, an expert in vaccinology and professor at Baylor College of Medicine, is underwhelmed.
“I have not seen strong evidence that it's more transmissible than delta. The UK government says it might be, and it might be."
“We had “beta” out of South Africa. It never really took off. We had “lambda” out of South America. It never took off. This may not take off. The key is knowing its transmissibility. Worst case scenario, studies show it is much more transmissible than delta and has high immune escape potential, then we have to go to Plan B and start designing boosters, but I think we’re a long way away from that yet.”
I hope Dr. Hotez is right. What is more likely is that we will need to rapidly design boosters against the new variants as they continue to emerge. Pfizer believes that they can create 4 billion doses within 12 months and promise to effectively counter the new variant within 100 days from genome sequencing (the clock is ticking…) . This time frame is ambitious and doesn’t account for the logistical nightmare of actually getting the vaccines into human bodies (especially in African countries). By the time that the Omicron booster is widely available we will be on to the next, deadlier variant. Our approach is reactive, and is by definition Sisyphean. Clearly, there is a gaping need for a proactive approach to get ahead of the ever-evolving pandemic.
A vaccine with broad-spectrum efficacy against all the known sarbecovirus strains (including SARS-CoV-1 and SARS-CoV-2), and high likelihood of protection against theoretical (“pre-emergent”) mutations, is the Holy Grail. Recently, scientists discovered that people who survived infection by the 2003 SARS-CoV-1 virus and also received the Pfizer SARS-CoV-2 vaccine (BTN162b2) were better protected against the variants of concern than healthy patients who received the Pfizer vaccine. Importantly, the serum from these “dual-clade” patients contained high levels of neutralizing antibodies against all 10 SARS viruses tested, including several that only occur in animals but may be capable of zoonotic transmission. The researchers concluded that these high levels of neutralizing antibodies against a broad range of SARS viruses found in the convalescent plasma of SARS-CoV-1 survivors suggest that a combination of CoV-1 and CoV-2 vaccines may be able to elicit broad immunity against the entire group of sarbecoviruses .
Perhaps the key to durable immunity is to administer a SARS-CoV-1 booster in patients who already received their Pfizer/Moderna/J&J vaccines?
BioVaxys certainly thinks so. The company intends to leverage its haptenized viral protein vaccine platform to induce immunity against all or most sarbecoviruses by immunizing people who have convalesced (i.e., recovered) from a documented Covid-19 infection, or received a full course of any Covid-19 vaccine recognized by the World Health Organization, with a novel vaccine composed of the dinitrophenyl ("DNP")-modified S-spike protein of SARS-CoV-1. [Read press release here]
"Scientists dream of a pan-Coronavirus vaccine that would protect the population against any SARS-like respiratory virus that might mutate and emerge from a wild animal in the future. Our approach could constitute a pan-sarbecovirus vaccine that would protect humans against a very dangerous subgroup of Coronavirus that could emerge from the wild and cause as much devastation as Covid-19."
"There have been over 217 million recoveries following confirmed cases of Covid-19 (www.statista.com) and 6.6B doses have been given of Covid-19 vaccine (Bloomberg Oct 15 2021); this total target population of almost 4 billion people represents a massive commercial opportunity for proposed our pan-sarbecovirus booster vaccine, which has the potential to confer cross-reactive neutralizing antibodies, not only against all Covid-19 variants, but future emerging dangerous zoonotic sarbecoviruses."
The biotech sector has been one of the worst performing sectors of 2021 with a 17.05% year-to-date loss as of the market close on Friday November 26. However, vaccine stocks like Pfizer (NYSE:PFE), Moderna (Nasdaq:MRNA), and BioNTech (Nasdaq:BNTX) have seen impressive gains in recent weeks as case numbers have surged across the northern hemisphere. Omicron variant concerns fueled additional upside in vaccine manufacturer shares on Friday.
BioVaxys shares gained 16.7% on above average trading volume during Friday’s trading session.
BIOV shares appear to have endured the worst of the tax-loss selling season and now appear poised for additional upside; a bullish MACD crossover is imminent and the daily-RSI(14) is also on the verge of moving above the median line into bullish territory. The $.22-$.25 zone offers strong support with the $.40 offering the next area of resistance. The current setup BIOV is one of those rare situations in which the fundamentals and technicals are lining up simultaneously.
 Heavily mutated Omicron variant puts scientists on alert [Link]
 'No reason to panic' about new omicron COVID-19 variant yet, Houston expert says [Link]
 Omicron: Keep Calm and Carry on Vaccinating [Link]
 Pan-Sarbecovirus Neutralizing Antibodies in BNT162b2-Immunized SARS-CoV-1 Survivors [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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