Invivyd, Inc. announced interim exploratory COVID-19 clinical event data for VYD222, an investigational, monoclonal antibody (mAb) in development for the pre-exposure prophylaxis of COVID-19. The data announced from the ongoing Phase 3 CANOPY clinical trial reflect and add further to the initial potential signal of clinical protection from symptomatic COVID-19 shared in December 2023, and may be useful in updating prior published work that analyzed the relationships between serum virus neutralizing antibody (sVNA) titers and protection in patients who had no prior exposure to vaccine or natural infection. The ongoing CANOPY Phase 3 clinical trial is designed to evaluate the safety and tolerability of VYD222 and to assess immunobridging from VYD222 to certain historical data from the company's previous Phase 2/3 clinical trial of adintrevimab (ADG20) for the prevention of symptomatic COVID-19 (EVADE).

Symptomatic COVID-19 event collection in the CANOPY clinical trial is a secondary exploratory endpoint designed to allow Invivyd to encompass further discovery and development work only. The CANOPY clinical trial enrolled participants in two cohorts. Cohort A is a single-arm, open-label trial in adults who have moderate-to-severe immune compromise including complex underlying medical conditions (n=306).

Cohort B is a randomized, placebo-controlled cohort that enrolled adults without moderate-to-severe immune compromise who are at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings. All CANOPY Cohort A participants received VYD222 administered via intravenous (IV) infusion. Cohort B participants were randomized 2:1 to receive VYD222 or placebo administered via IV infusion.