Invivyd, Inc. has commenced a Phase 1 clinical trial for VYD2311, a novel monoclonal antibody (mAb) candidate designed to combat COVID-19. The trial, which began with the dosing of the first participants, aims to assess the safety, tolerability, and pharmacokinetics of VYD2311 in healthy volunteers.
The Phase 1 trial (NCT06523153) is a randomized, blinded, placebo-controlled study being conducted in Australia. It will evaluate escalating doses of VYD2311 administered through various routes, including intramuscular (IM) injection, which is intended to be more patient-friendly than intravenous administration. The company anticipates preliminary data readouts from the Phase 1 trial in the fourth quarter of 2024 and expects additional clinical readouts from the VYD2311 program throughout 2025.
Marc Elia, Chairman of the Board, stated, "We are excited that VYD2311 has potential to build on the success of PEMGARDA™ (pemivibart), which was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for pre-exposure prophylaxis (PrEP) for COVID-19 for certain immunocompromised patients."
About VYD2311
VYD2311 is engineered from adintrevimab, Invivyd’s investigational mAb, and is designed to offer improved protection against emerging SARS-CoV-2 variants. It is specifically targeted at addressing the ongoing need for effective therapeutic options for vulnerable populations, including the estimated 8 million immunocompromised individuals in the U.S. who may not respond adequately to COVID-19 vaccination.
The pharmacokinetic profile of VYD2311 may allow for clinically meaningful titer levels to be achieved through intramuscular administration.
PEMGARDA EUA
PEMGARDA™ (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.
