• BiondVax Pharmaceuticals is promoting preclinical results of its lead “biobetter” NanoAb drug candidate for conveniently proactively preventing COVID
• The company’s CEO recently presented the data at the annual BIO CEO & Investor Conference in New York, as well as updates on the company’s pipeline for treating autoimmune diseases such as psoriasis, asthma, psoriatic arthritis and macular degeneration
• Monoclonal antibody-based drug product Evusheld recently lost its EUA authorization as a COVID preventative after FDA findings that it insufficiently protects against the current wOmicron sub-variants, eliminating the only preventative option for vaccine-intolerant patients
• BiondVax nano-sized antibodies may provide superior responses to COVID both for current and potential future subvariants of the virus

Pioneering immunotherapy developer BiondVax Pharmaceuticals (NASDAQ: BVXV) is seeing convincingly positive outcomes for preventing and arresting disease in COVID patients during an ongoing preclinical in vivo study, even as continually evolving variants of the COVID virus are shutting down emergency authorization-approved (“EUA”) avenues of treatment that may no longer be effective.

Last month, drug ineffectiveness led the U.S. Food and Drug Administration (“FDA”) to revise its Emergency Use Authorization (“EUA”) for the monoclonal antibody prophylactic, Evusheld, removing its availability  for people who have a history of severe adverse reactions to vaccines similar to the COVID vaccine or who otherwise may not respond favorably to the COVID vaccine because of an immunocompromised condition (https://ibn.fm/AFJtC).

While Evusheld may return to EUA status in the future if the combined frequency of the extant SARS-CoV-2 variants fall back within the FDA’s standards range for susceptibility to the prophylactic (preventative) drug treatment, for now Evusheld’s sidelining essentially leaves immunocompromised people essentially “on their own against COVID-19,” as Time magazine reported, because Evusheld’s monoclonal antibody product was the only option for pre-exposure prophylaxis (https://ibn.fm/3xfTd).

However, BiondVax’s development of a nano-sized antibody (NanoAb), that to date has shown neutralization of all relevant Omicron subvariants, is generating excitement as a potential superior prophylactic approach to COVID prevention  such as Evusheld’s solution. At-risk groups, such as the elderly and people with comorbidities, may proactively be able to protect themselves through the company’s conveniently self-administered inhaled NanoAb therapy.

BiondVax enjoys exclusive agreements with the Max Planck Institute for Multidisciplinary Sciences (“MPI”) and the University Medical Center Göttingen (“UMG”) to collaborate on the development and commercialization of innovative COVID-fighting NanoAbs, also known as VHH-antibodies. The NanoAbs have neutralized the SARS-COV-2 virus, in-vitro, at drug concentrations about 100 times lower than those required by currently commercially available monoclonal antibodies (“mAbs”), which may lead to increased efficacy, reduced side effects, and allow production at a lower cost, according to the companies (https://ibn.fm/HD6ue).

“NanoAb therapeutics have the potential to quickly and effectively address new variants,” BiondVax CEO Amir Reichman told shareholders in December (https://ibn.fm/NxXuO). “Our collaborators at MPI and UMG have generated libraries each with (about) 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.”

The nanoparticle nature of the company’s leading candidate has made possible administration through an innovative, inhaled treatment that may provide a desirable alternative to available therapies for treating patients after they have become ill with the virus, as well as a preventative prophylactic providing protection prior to exposure. Reichman provided a presentation on BiondVax’s successful preclinical results this month at the annual BIO CEO & Investor Conference in New York, including discussion of the company’s “biobetter” NanoAb R&D pipeline for developing novel treatments for autoimmune diseases such as psoriasis, asthma, psoriatic arthritis and macular degeneration.

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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