Invivyd, FDA agree on steps to emergency approval for COVID monoclonal antibody

Invivyd and the FDA have agreed on a path toward potential emergency use authorization of the biotech’s lead monoclonal antibody (mAb) and possible follow-on candidates designed to prevent symptomatic COVID-19. Currently, there aren’t any approved mAb treatments in the U.S. for the indication.    

Invivyd, which launched early in the pandemic under the name Adagio, recently shed its former focus— a mAb targeting COVID-19 and known as NVD200—in hopes that its third mAB will do the trick. Dubbed VYD222, the new pipeline star is made up of a component of the older treatment and was also engineered from the biotech’s original mAb adintrevimab.

Now, the company says it has reached a “general alignment” with the FDA on a path to potential EUA for VYD222, which is currently being assessed in a phase 1 clinical trial.

Part of the pathway, which Invivyd says it plans to follow, includes using serum-neutralizing titers as a correlate of protection, which is the immune response level that needs to be triggered to protect someone from the disease. The agreed-upon steps forward also include an immunobridging approach to a pivotal clinical trial, which means the trial is made to show the asset has similar activity to a comparable existing therapy.  

Invivyd plans to use the path to push forward clinical development of VYD222 and potential follow-on mAb candidates, with adintrevimab or new future mAbs used as the prototype. The company thinks the investigational adintrevimab would be a good control based on safety and clinical data from a global phase 2/3 trial 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,” Invivyd CEO Dave Hering said in a June 26 release.   

Invivyd is prepping for a VYD222 pivotal clinical trial to support a potential EUA submission. The asset is currently being studied among 30 healthy volunteers in a phase 1 trial and is designed for broad activity against circulating COVID-19 variants.