- BiondVax is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products
- The company is developing nanosized antibodies (“NanoAbs”) addressing large market diseases underserved by current treatments, with its lead candidate targeting COVID-19
- The FDA recently revoked the sole authorization of a COVID prophylactic, Evusheld, citing the inability of the monoclonal antibody cocktail to neutralize emerging subvariants of the Omicron variant
- BiondVax’s lead NanoAb candidate shows superior advantages to monoclonal antibodies, with the data gathered strengthening the value proposition of the COVID-19 NanoAb as a safe, efficacious, and convenient therapeutic and prophylactic drug
The Food and Drug Administration (“FDA”) recently withdrew the authorization of AstraZeneca PLC (NASDAQ: AZN)’s Evusheld, a combination of two monoclonal antibodies (“mAbs”), which was being marketed as a pre-exposure prophylaxis to prevent COVID-19 infection among people with moderate to severe immune compromise (https://ibn.fm/zmmHn). The agency revoked the authorization citing the expectation that Evusheld may not neutralize the XBB.1.5 sub-variant of the Omicron variant. In fact, according to the FDA, sublineages not neutralized by the antibody therapy are presently causing at least 90% of infections.
Evusheld’s cancellation is the latest in a series of withdrawals, with the FDA having previously revoked the authorization for emergency use of bebtelovimab, another monoclonal antibody therapy, because it was not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1 (https://ibn.fm/IhUqw).
“Beyond Evusheld, the virus’s evolution has also left the country without any antibody therapies for patients once they are infected,” reads an article in Stat News (https://ibn.fm/Vm5sL). However, BiondVax Pharmaceuticals (NASDAQ: BVXV), a Jerusalem-based biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products, is working on changing this grim reality. In fact, the company’s leading inhaled nanosized antibody (“NanoAb”) candidate, which is currently being prepared for clinical trials, has shown neutralization of all relevant Omicron subvariants.
“Indeed, the emergence of new variants remains a concern, and NanoAb therapeutics have the potential to quickly and effectively address new variants,” wrote CEO Amir Reichman in his 2022 letter to shareholders (https://ibn.fm/uOpcQ). “Our collaborators at the Max Planck Institute for Multidisciplinary Sciences (“MPI”) and the University Medical Center Göttingen (“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.”
With the cancellation of these monoclonal antibody therapies, originally authorized to help protect high-risk populations from the ever-evolving SARS-COV-2 virus, the value of BiondVax’s NanoAb-based COVID-19 therapeutic currently under development has never been clearer.
Developed in collaboration with Germany-based MPI and UMG, the alpaca-derived NanoAbs have demonstrated unique characteristics such as greater formulation advantages, stability at high temperatures, and binding affinity than mAbs. Moreover, NanoAbs have shown strong potential for superior clinical outcomes, safety, and patient convenience at lower costs than mAbs, which have generated billions in annual commercial sales.
In fact, BiondVax’s ongoing preclinical in vivo study is convincingly demonstrating the unique capabilities of its inhaled COVID-19 therapy. As reported by the company in November 2022, animal models treated with BiondVax’s inhaled NanoAbs experienced a milder and shorter illness (https://ibn.fm/FTm6x). The company also announced early January 2023 that the inhaled therapy virtually eliminated the SARS-CoV-2 virus from the animal models’ lungs (https://ibn.fm/2GKAy). In the most recent announcement, BiondVax reported its inhaled therapeutic virtually prevented illness when administered prophylactically. Obviously, this data strengthens the value proposition of the COVID-19 NanoAb as both a therapeutic and prophylactic drug.
“COVID vaccine uptake is declining, effectiveness wanes over a short period of time, and vaccination campaigns demand vast health care system resources. We believe the additional ‘biobetter’ value provided by our NanoAb potentially positions it to capture significant market share both for treatment and prevention of COVID-19 illness,” commented Reichman in a January 23 news release reporting the prophylactic properties of the NanoAbs (https://ibn.fm/YpEYG).
BiondVax aims to fill the existing void in COVID prophylactics and treatments, which, as sales figures indicate, is strong. AstraZeneca, for instance, reported that Evusheld had generated $1.451 billion in revenue from Q1 through Q3 2022 (https://ibn.fm/UPZ8M); and even with its limitations, Paxlovid, an antiviral medication developed by Pfizer Inc. (NYSE: PFE), generated $18.9 billion in sales in 2022 (https://ibn.fm/6sOdX).
BiondVax’s NanoAbs may be the key to an effective, economical, and easy to use solution for COVID therapeutics and prophylactics. With human clinical trials scheduled for later this year it certainly makes sense to keep BVXV on the radar.
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