Invivyd announced that the U.S. Food and Drug Administration, FDA, has cleared its Investigational New Drug, IND, application for VYD222, a monoclonal antibody candidate. Invivyd is developing VYD222 for the prevention of COVID-19 in vulnerable populations, such as immunocompromised people. "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."
Published first on TheFly
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- Invivyd to Participate at H.C. Wainwright’s BioConnect Investor Conference
- 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
- Invivyd Appoints Robert Allen as Chief Scientific Officer and Stacy Price as Chief Technology and Manufacturing Officer
- Invivyd appoints Allen as CSO, Price as CTMO
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