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Invivyd Announces Positive Initial Results from Ongoing CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of COVID-19
VYD222 produced high serum virus neutralizing antibody titer levels in immunocompromised participantsData supportive of an immunobridging approach to the
About this update from Invivyd, Inc.
[{"type":"text","content":"VYD222 produced high serum virus neutralizing antibody titer levels in immunocompromised participantsData supportive of an immunobridging approach to the EVADE study of adintrevimab Overall favorable safety and tolerability profile of VYD222 including no study drug-related serious adverse events (SAEs) to dateVYD222 demonstrates continued in-vitro neutralization activity against major SARS-CoV-2 variants, including against HV.1, the currently dominant variant in the U.S. WALTHAM, Mass., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial of VYD222, a broadly neutralizing, half-life extended monoclonal antibody candidate, for the prevention of 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. “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 (EUA) as soon as practicable.” Pete Schmidt, M.D., M.Sc., Chief Medical Officer at Invivyd added, “The CANOPY clinical trial utilizes an innovative immunobridging design in which pharmacokinetic (PK) data from participants and potency data (IC50 values) are used to calculate sVNA titer levels. As characterized in our Science Translational Medicine paper, we believe calculated sVNA titer levels can be bridged back to the titer levels and corresponding clinical efficacy observed in EVADE, our pivotal clinical trial of ADG20 for prevention of COVID-19. We are encouraged by the initia...