COVID-19 Monoclonal Antibody for Immunocompromised People Posts Positive Results

Invivyd, Inc. today announced positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial of VYD222, a broadly neutralizing, half-life extended monoclonal antibody (mAb) candidate for the prevention of symptomatic COVID-19.

Results showed that the safety and tolerability profile of VYD222 remains favorable, with no study drug-related serious adverse events reported to date.

The company also reported on December 14, 2023, that in vitro pseudovirus testing shows VYD222 has potency against various SARS-CoV-2 coronavirus variants currently circulating, such as HV.1, BA.2.86, XBB.1.5.10/EG.5, and HK.3.

Importantly, VYD222 continues to show neutralizing activity against variants with the F456L mutation found in most variants in the U.S.

Currently, no mAb is authorized or approved in the U.S. to prevent symptomatic COVID-19.

"We are pleased to share positive initial topline results from CANOPY, which bolster our belief that VYD222 holds the potential to provide vulnerable people, particularly the immunocompromised (IC), with meaningful protection from COVID-19," said Dave Hering, Chief Executive Officer of Invivyd, in a press release.

"VYD222 produced high serum virus neutralizing antibody (sVNA) titer levels against XBB.1.5 in the IC cohort, essentially replicating the titer levels observed in our Phase 1 clinical trial of VYD222 in healthy volunteers."

"We are also encouraged by the potential early signal of strong clinical protection from symptomatic COVID-19 in the CANOPY clinical trial to date, which would be expected given the high VYD222 sVNA titer levels and dose selected."

"We look forward to continued engagement with the FDA on these promising results, and we intend to submit a request for Emergency Use Authorization as soon as practicable."

Globally, there are millions of immunocompromised people, with more than 9 million in the U.S. alone who may not adequately respond to COVID-19 vaccination.