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

• Analysis of secondary endpoint of symptomatic COVID-19 events in CANOPY is unrelated to regulatory filing or review, but may be hypothesis generating for future Invivyd discovery and development work
  
• Today’s update on Day 67 and Day 90 event rates is the first of two planned public updates on symptomatic COVID-19 events in CANOPY; Invivyd plans to analyze all future events at Day 180
• Further defining the relationship between serum virus neutralizing antibody titers and clinical protection that prospectively builds on published data is an anticipated goal of future clinical trials
  

WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today 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 today 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 vaccination or natural infection.¹

“While these interim clinical efficacy data are exploratory and not part of the primary immunobridging endpoint of the CANOPY clinical trial, we believe they further our efforts to understand the relationship between sVNA titers and clinical efficacy in individuals who have some level of vaccine- or infection-induced immunity,” said Dave Hering, Chief Executive Officer. “As we continue to build out our company and advance the science describing monoclonal antibody pre-exposure prophylaxis (PrEP), we believe we can incorporate these findings into future prospectively designed clinical studies that seek to establish formal relationships between neutralizing titers and protection. Exploratory data such as provided in today’s update are important for broad reflection as they represent some of the first data from a clinical trial conducted with a monoclonal antibody in a population that has acquired prior immune exposure from either vaccination or natural infection. By contrast, studies of prior authorized COVID-19 PrEP mAbs largely relied on participants required by protocol to be naïve to vaccination or prior infection². As such, these people would presumably have no baseline titers. We continue to explore how measured titers compare with calculated titers and look to assess if higher levels of protection in future studies may be possible with lower levels of additional titers conferred from mAbs.”