Pre-exposure Prevention Monoclonal Antibody for Immunocompromised Seeks COVID-19 Authorization

Invivyd, Inc. today announced that it has requested Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for VYD222, a broadly neutralizing, half-life extended monoclonal antibody (mAb) candidate, for the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents.

This is essential news since about 9 million people in the U.S. may not adequately respond to current COVID-19 vaccines.

Initially authorized in late 2020, there are no mAbs currently authorized by the FDA targeting COVID-19. mAb treatments are effective when they block the SARS-CoV-2 beta coronavirus that causes COVID-19 from entering cells in the human body.

"We are tremendously pleased by the fact that VYD222 continues to demonstrate in vitro neutralization activity against the latest dominant variant, JN.1, as well as other prevalent SARS-CoV-2 strains," said Dave Hering, Chief Executive Officer of Invivyd, in a press release on January 3, 2023.

"We believe that the demonstrated durability of VYD222 is reflective of our strategy to select antibody candidates that target conserved epitopes to achieve our stated goal of keeping pace with viral evolution." 

The EUA submission was based on positive initial results from the CANOPY Phase 3 pivotal clinical trial of VYD222 and ongoing in vitro neutralization activity against relevant variants such as JN.1.

Previous COVID-19 mAb news is posted by Precision Vaccinations.