- 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…
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