Invivyd aligns with FDA on pathway to approval of COVID-19 vaccine VYD2311

Invivyd (IVVD) has received and is aligned with advice from the FDA on a compact and, therefore, rapid pathway to potential Biologics License Application – BLA – approval for Invivyd’s novel monoclonal antibody candidate VYD2311, for the prevention of COVID-19. As part of a recent Type C meeting, FDA advised that a single, Phase 2/3 randomized, double-blind, placebo-controlled trial evaluating mAb efficacy from a relatively modest number of RT-PCR -confirmed symptomatic COVID-19 disease events could support a BLA submission for VYD2311 for the prevention of COVID-19 in a broad population of Americans, including immunocompromised people, subject to agreement on safety database size and pending full protocol review. In agreement with FDA advice, Invivyd plans to study two doses of VYD2311 to assess any differences in resulting levels of protection or differences in safety. Invivyd’s analysis of CANOPY clinical trial data and Cox Proportional Hazards modeling, combined with biophysical properties of VYD2311, suggest likely robust, long-term protection from symptomatic COVID-19 due to high potency and observed long half-life of ~76 days, following a relatively low dose of VYD2311 via intramuscular route of administration. Invivyd’s most recent analysis aligns well with multiple similar analyses spanning the majority of SARS-CoV-2 virus variation since emerging as a global human disease in 2020. Invivyd has quantities of VYD2311 clinical supply and potential commercial launch product available.