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

26 Jun 2023
www.fiercebiotech.com
Phase 1Emergency Use AuthorizationIND
Invivyd, FDA agree on steps to emergency approval for COVID monoclonal antibody
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Source: FierceBiotech
Currently, there aren't any FDA-approved mAbs for preventing symptomatic COVID-19.
Invivyd and the FDA have agreed on a path toward potential emergency use authorization (EUA) of the biotech’s lead monoclonal antibody 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 monoclonal antibody (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.
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