- BiondVax is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products
- The company primarily targets infectious diseases and autoimmune diseases, with its lead candidate, an inhaled COVID-19 NanoAb therapy, the subject of preclinical studies
- So far, the preclinical studies have shown that the NanoAb results in significantly milder illness and faster recovery, eliminates the SARS-CoV-2 virus from the lungs, and prevents illness when administered prophylactically
- The FDA has revoked the authorization of multiple mAb treatments and one mAb prophylactic drug, creating a significant gap in a market that has shown strong demand for COVID-19 treatments
- BiondVax is uniquely positioned to meet this demand, backed by an extensive library of NanoAbs that allows it to rapidly develop neutralizing treatment as soon as a new variant emerges
The Food and Drug Administration (“FDA”) has, over the last two years, authorized several drugs as treatments for mild-to-moderate COVID-19 or as pre-exposure prophylaxis (“PrEP”) for the prevention of the disease. Most of these drugs were based on human monoclonal antibody (“mAb”) technology and were designed to boost the immune system by mimicking natural neutralizing antibodies. The mAbs would bind with the SARS-CoV-2 virus’ receptor binding domain, a section of the viral spike protein, preventing it from entering the patient’s cells and exacerbating the infection.
However, the virus has continually mutated as it works to correct ‘flaws’ that make it vulnerable to treatment. This has rendered previously authorized mAb treatments ineffective, with the FDA progressively revoking authorizations for these therapies as a result. For example, in November last year, the agency deauthorized bebtelovimab, the last of the COVID-19 treatment antibodies. And in January, a similar fate befell AstraZeneca PLC (NASDAQ: AZN)’s Evusheld, which was designed as a PrEP treatment (https://ibn.fm/OBKpX), and in the first nine months of 2022 generated $1.5 billion in sales, a testament to the huge demand for proactive COVID protection.
Although other non-monoclonal-antibody therapies remain authorized, none can be administered as PrEP for the prevention the COVID-19 disease, according to the FDA’s Emergency Use Authorization webpage (https://ibn.fm/41gyW). Furthermore, Pfizer Inc. (NYSE: PFE)’s Paxlovid, which is still effective against the new subvariants of the Omicron variant, has multiple contraindications for common drugs including blood thinners, heart medications, and prescribed statins. Those patients who were ineligible to receive Paxlovid would have previously received mAb-based drugs. But this is no longer the case.
“Encouragingly,” Amir Reichman, CEO of biotechnology company BiondVax Pharmaceuticals (NASDAQ: BVXV), wrote in his letter to shareholders published December 30, 2022 (https://ibn.fm/b62Lh), “our lead NanoAb candidate, currently being prepared for clinical trials, has demonstrated neutralization of all relevant Omicron subvariants.”
Reichman was highlighting one of the outstanding benefits of the company’s alpaca-derived nanosized antibodies (“NanoAbs”), which exhibit potential superior therapeutic capabilities for a wide range of diseases, including COVID-19. BiondVax, which focuses on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, has so far shown, through an ongoing in vivo preclinical proof-of-concept study, that its lead NanoAb candidate for the treatment of COVID-19 exhibits significant competitive advantages over existing mAbs and oral therapies.
According to statistically significant results released early January, BiondVax established that its inhaled therapy virtually eliminated the SARS-CoV-2 virus and prevented illness when administered prophylactically. The first set of results, announced January 6, showed that a group of COVID-19-infected hamsters that were treated with the company’s inhaled anti-COVID-19 therapy had over 30x lower lung viral titer on average than the placebo group. These results built on previously announced data, which indicated that the NanoAb treatment led to significantly milder illness and faster recovery compared to the placebo group (https://ibn.fm/MGKRe).
The second set of results, announced January 23, evidenced that when the NanoAb was administered by inhalation three hours before infection, it virtually prevented the hamsters from contracting the illness. In particular, the hamsters that received the inhaled NanoAb experienced no significant weight loss over the six-day trial, while the untreated control groups’ weight reduced by 12% on average (https://ibn.fm/WQZSQ). This data shows the prophylactic capabilities of the NanoAb, positioning the company to fill the huge void left by the withdrawal of Evusheld’s authorization.
BiondVax, which aims to replicate in human trials the efficacy demonstrated so far in its animal studies, believes there will continue to be a strong market demand for COVID prophylactics and treatments. This belief is supported by Pfizer’s recent report (https://ibn.fm/ffSCz), suggesting that revenues from COVID products is expected to grow in 2024. Backed by libraries with millions of COVID-19 NanoAb candidates developed by its collaborators at the Max Planck Institute for Multidisciplinary Sciences (“MPI”) and the University Medical Center Göttingen (“UMG”), BiondVax is well positioned to meet the demand.
“Indeed, the emergence of new variants remains a concern, and NanoAb therapeutics have the potential to quickly and effectively address new variants,” Reichman’s letter continues. “Our collaborators at MPI and UMG have generated libraries, each with ~300 million COVID-19 NanoAb candidates, as compared to mAb libraries that contain only thousands of options. Thus, as new variants emerge, we would expect to be in a position to rapidly develop a new neutralizing NanoAb”.
For more information, visit the company’s website at www.BiondVax.com.
NOTE TO INVESTORS: The latest news and updates relating to BVXV are available in the company’s newsroom at https://ibn.fm/BVXV
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