Invivyd says PEMGARDA effective against XFG variant of SARS-CoV-2

Invivyd (IVVD) announced positive, continued, clinically meaningful in vitro neutralization data for PEMGARDA against the currently dominant and growing XFG variant of SARS-CoV-2. Notably, and consistent with all dominant variants for the past three years, XFG did not generate any meaningful change to the in vitro neutralization activity of pemivibart or VYD2311, the company’s next generation COVID-19 monoclonal antibody candidate, as the epitopes targeted by pemivibart and VYD2311 remain structurally intact. PEMGARDA is authorized by the U.S. FDA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients. Currently, the level of COVID-19 viral activity detected in wastewater in 12 states is reported as high or very high levels as of early August, and the U.S. Centers for Disease Control and Prevention estimates that COVID-19 infections are growing or likely growing in 34 states and declining in zero states, according to forecasting models. Further, the company estimates that every clinical variant reported in the CDC COVID Data Tracker since the Omicron BA.2 lineage has been susceptible to pemivibart, even if untested, due to the consistent structural integrity of the epitope targeted by pemivibart. Therefore, Invivyd anticipates continued meaningful clinical activity for pemivibart for the foreseeable future if the epitope pemivibart targets remains intact.