- 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…
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