COVID-19 Monoclonal Antibodies Plan Innovative Authorization Pathway

Invivyd, Inc. today announced that it has reached general alignment with the U.S. Food and Drug Administration (FDA) on a pathway to potential emergency use authorization (EUA) for VYD222 and anticipated follow-on monoclonal antibody (mAb) candidates designed to prevent symptomatic COVID-19.

The company plans to leverage the pathway, which includes the use of serum-neutralizing titers as a correlate of protection in an immunobridging approach to a pivotal clinical trial of VYD222, to rapidly generate data to support a potential VYD222 EUA for the prevention of symptomatic COVID-19.

Based on FDA feedback, the use of a correlate of protection in an immunobridging approach to a pivotal EUA-directed clinical trial may be a reasonable approach for a new mAb candidate when clinical trial data from a "prototype" mAb is available, provided that the new mAb candidate:

1. Is similar to the prototype mAb such that it leverages a consistent manufacturing platform and has limited structural and functional differences, and,
2. Has supportive nonclinical data, such as favorable in vitro neutralization data against currently circulating SARS-CoV-2 variants.

"We are very encouraged by the recent feedback from the FDA and appreciate their commitment to exploring alternative strategies to expedite the development of mAbs for the prevention of symptomatic COVID-19, such as the use of a correlate of protection as the primary endpoint in a pivotal clinical trial, a strategy that we are pleased to see further advance following the joint EMA-FDA workshop last December where the approach was discussed," said Dave Hering, chief executive officer of Invivyd, in a press release on June 26, 2023.

"Given our previous work developing adintrevimab and our platform-based approach to rapid mAb discovery, we believe we are one of few companies positioned to rapidly and serially generate data for potential EUA submission for next-generation mAb candidates for the prevention of symptomatic COVID-19."

"This potential pathway supports the company's vision and strategy of establishing a platform and stream of optimized anti-SARS-CoV-2 mAb candidates that can be deployed to keep pace with viral evolution and protect the vulnerable."

COVID-19 antibody and antiviral news was updated on June 26, 2023.