Invivyd Announces Interim Exploratory Data on VYD222 from Ongoing CANOPY Clinical Trial - Seite 2

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 contemplate 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. 

Updated Findings

As previously disclosed by the company in December 2023, a potential early signal of clinical protection from symptomatic COVID-19 confirmed by RT-PCR was observed. Invivyd is now providing an update on the clinical cases of confirmed symptomatic COVID-19 through Day 90. Beyond today’s update, additional cases of COVID-19 have occurred in Cohorts A and B post Day 90. These data are planned to be analyzed at Day 180 and presented when available.

Cohort B (Randomized, placebo-controlled cohort without moderate-to-severe immune compromise at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions) — Proportion of participants with RT-PCR-confirmed symptomatic COVID-19 (exploratory data):

	As of December 1, 2023 (median 67 days follow-up)	Through Day 90
VYD222	0% (0/322)	0.3% (1/314)
Placebo	3% (5/162)	5% (8/159)

Cohort A (Open-label cohort with moderate-to-severe immune compromise) — Proportion of participants with RT-PCR-confirmed symptomatic COVID-19 (exploratory data):

	As of December 1, 2023 (median 35 days follow-up)	Through Day 90
VYD222	0% (0/306)	1% (3/298)

Additional COVID-19 events have occurred in Cohort A (unblinded) and Cohort B (randomized, not yet analyzed) post Day 90, but the company has not yet analyzed the data. Invivyd plans to provide a Day 180 update and a more complete analysis of the observed relationships between sVNA titers, both calculated and measured, and events of confirmed symptomatic COVID-19 when these data are available.