COVID-19 Monoclonal Antibody Therapy Advances Into the Clinic
Invivyd, Inc. recently announced the election of VYD222 to advance into the clinic as a novel monoclonal antibody (mAb) therapeutic option for COVID-19.
The company confirmed on March 6, 2023, it aims to leverage evolving COVID-19 regulatory paradigms and maximize efficiency to deliver this much-needed product for immunocompromised individuals and other vulnerable populations.
As of January 2023, no monoclonal antibodies (mAbs) are authorized or approved in the U.S. for the prevention or treatment of COVID-19.
mAbs are well suited to meet the need of immunocompromised individuals because they provide a prompt onset of protection, have a well-characterized safety profile, and do not rely on the individual’s immune response.
“The lack of commercially available mAbs in the U.S. is an unacceptable situation for the estimated 8 million people with impaired immune systems who don’t respond to vaccination and means a return to the isolation many of us experienced early in the pandemic,” stated Pete Schmidt, M.D., M.Sc., Chief Medical Officer of Invivyd, in a press release.
“This urgent need was recently acknowledged by the FDA and EMA at a joint workshop in December where various options such as the use of surrogate endpoints and immunologic bridging studies were discussed.”
The company plans for a Phase 1 clinical trial starting in Q1 2023. Once aligned with regulatory authorities, pivotal studies are designed to follow swiftly.