Invivyd (IVVD) said Thursday its phase 1/2 clinical data for VYD2311, a monoclonal antibody candidate to prevent and treat COVID-19, was well tolerated with all adverse events deemed unrelated or classified as mild to moderate in severity.
After six months at the end of the study, serum concentrations of VYD2311 remained high and were observed to be substantially greater than that of Invivyd's first-generation monoclonal antibody, pemivibart, the company said.
Half-life estimates for VYD2311 ranged from 61 days to 76 days as compared with pemivibart estimated half-life of 49 days, potentially providing longer protection and making it more durable, Invivyd said.
The company further said it plans to discuss approval pathways for VYD2311 and follow-on COVID-19 monoclonal antibodies with the US Food and Drug Administration early in Q3.
Invivyd's shares were up more than 3% in recent premarket activity.
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