Source: Pharmaceutical Technology
VYD222 is being developed to prevent Covid-19 in vulnerable people, including immunocompromised individuals. Credit: Fusion Medical Animation on Unsplash. VYD222 is a new monoclonal antibody (mAb) candidate and is being developed to prevent Covid-19 in vulnerable people, including immunocompromised individuals. Source: Pharmaceutical Technology
Source: Pharmaceutical Technology
Engineered from adintrevimab (ADG20), the antibody showed in vitro neutralising activity against dominant variants of concern, including XBB.1.5. It is being assessed in an ongoing Phase I healthy volunteer clinical trial in Australia.
The company commenced dosing participants in March 2023.
Invivyd chief medical officer Pete Schmidt said: “For the millions of immunocompromised people around the world who may not generate adequate protection from SARS-CoV-2 vaccines, there is an urgent need for new therapeutics that provide the rapid, passive immunity that results from the direct delivery of mAbs.
“With the previously authorised anti-SARS-CoV-2 mAbs losing activity against current variants of concern, we look forward to continuing to work with the FDA and global regulators to advance VYD222 and our platform-based approach to development.” The dose-ranging, blinded, placebo-controlled, randomised Phase I trial has been designed for assessing the pharmacokinetics, tolerability, safety and serum virus-neutralising activity of VYD222 in healthy adult volunteers. The trial will assess three different doses of VYD222, each administered as a single IV infusion. The company stated that all dose levels will provide durability in the face of viral evolution and flexibility during the regulatory submission.