U.S. FDA Cleared COVID-19 Monoclonal Antibody Candidate's Application

Invivyd, Inc. today announced that the U.S. Food and Drug Administration (FDA) had cleared its Investigational New Drug (IND) application for VYD222, a monoclonal antibody (mAb) candidate.

Invivyd is developing VYD222 to prevent 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," commented Dave Hering, CEO of Invivyd, in a press release on April 25, 2023.

"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 and 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."

The ongoing Phase 1 trial is a randomized, blinded, placebo-controlled, dose-ranging trial that will evaluate the safety, pharmacokinetics, tolerability, and serum virus-neutralizing activity of VYD222 in healthy adult volunteers.

As of April 25, 2023, the FDA has discontinued authorizing mAbs to prevent COVID-19 in the U.S. However, mAbs are available in Europe and other countries.