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Invivyd Announces the FDA Has Cleared Its IND Application for VYD222, a Monoclonal Antibody Candidate for Prevention of COVID-19, and Provides Phase 1 VYD222 Clinical Trial Update
On track for initial readouts in Q2 2023 from ongoing Phase 1 VYD222 clinical trial being conducted in Australia, with cohort 1 dosing completeDiscussions are
About this update from Invivyd, Inc.
[{"type":"text","content":"On track for initial readouts in Q2 2023 from ongoing Phase 1 VYD222 clinical trial being conducted in Australia, with cohort 1 dosing completeDiscussions are underway with the FDA and global regulators regarding the company’s proposed VYD222 pivotal clinical trial design WALTHAM, Mass., April 25, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for VYD222, a monoclonal antibody (mAb) candidate. Invivyd is developing VYD222 for the prevention of COVID-19 in vulnerable populations, such as immunocompromised people. As previously announced, VYD222 is currently being evaluated in an ongoing Phase 1 healthy volunteer clinical trial being conducted in Australia. “We are pleased that the FDA has cleared our IND for VYD222 and we are excited by the progress we’ve made in our ongoing Phase 1 VYD222 clinical trial,” said Dave Hering, chief executive officer of Invivyd. “We have completed dosing of the first cohort and have moved to the second dosing cohort, with initial readouts from the Phase 1 clinical trial on track for the second quarter. The swift progress of our Phase 1 VYD222 clinical trial, along with the FDA’s recent clearance of the VYD222 IND, are important steps in our plan to rapidly advance a stream of mAb candidates designed to keep pace with SARS-CoV-2 viral evolution.” “For the millions of immunocompromised people around the world who may not generate adequate protection from SARS-CoV-2 vaccines, there is an urgent need for new therapeutics that provide the rapid, passive immunity that results from the direct delivery of mAbs,\" said Pete Schmidt, M.D., M.Sc., chief medical officer of Invivyd. “With the previously authorized anti-SARS-CoV-2 mAbs losing activity against current variants of concern, we look forward to continuing to work with the FDA and global regulators to advance VYD222 and our platform-based approach to development.” In March 2023, Invivyd announced the election of VYD222 for clinical development and subsequently announced dosing of the first participants in a Phase 1 VYD222 clinical trial. The ongoing Phase 1 trial is a randomized, blinded, placebo-contro...