Invivyd, Inc. 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 candidate, for the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents. The EUA submission was based on positive initial results from the CANOPY Phase 3 pivotal clinical trial of VYD222, as well as ongoing in vitro neutralization activity against relevant variants such as JN.1. On December 18, 2023, Invivyd announced positive initial results from the ongoing CANOPY pivotal clinical trial. VYD222 produced high serum virus neutralizing antibody (sVNA) titer levels against XBB.1.5 in the immunocompromised cohort.

The company observed an encouraging, potential early signal of strong clinical protection from symptomatic COVID-19 in CANOPY, which would be expected based on the high sVNA titer levels and dose selected. In addition, the company believes that the initial results from CANOPY support an immunobridging approach which utilizes in vitro VYD222 potency data to calculate and efficiently determine the sVNA titer levels against new SARS-CoV-2 variants as they emerge. Initial results showed that the safety and tolerability profile of VYD222 remained favorable with no study drug related serious adverse events reported; adverse events attributed to VYD222 were Grade 1 or 2 (mild or moderate) in severity.

In vitro pseudovirus testing shows that VYD222 has potency against various SARS-CoV-2 variants currently circulating, including JN.1, which is currently the fastest growing variant in the U.S., as well as HV.1, BA.2.86, XBB.1.5.10 EG.5, and HK.3. If authorized, Invivyd aims to have VYD222 commercially available rapidly thereafter.