Invivyd Receives FDA Guidance on Rapid Path to Potential BLA Approval for COVID-19 Antibody

Invivyd has received FDA guidance on a rapid path to potential BLA approval for its COVID-19 antibody. The FDA has advised Invivyd on the necessary steps to take for approval, which could lead to a BLA (Biologics License Application) being filed. Invivyd's COVID-19 antibody is currently in late-stage clinical trials, with results expected soon. The FDA's guidance is seen as a positive step for Invivyd and its potential COVID-19 treatment.

Invivyd, Inc. (Nasdaq: IVVD) has received constructive guidance from the U.S. Food and Drug Administration (FDA) regarding a potential rapid pathway to Biologics License Application (BLA) approval for its COVID-19 monoclonal antibody (mAb) candidate, VYD2311. The FDA's advice, following a recent Type C meeting, outlines a streamlined trial design for VYD2311, which aims to prevent COVID-19 in a broad population, including adults and adolescents (12 years and older, weighing at least 40 kg).

The FDA has recommended a single, Phase 2/3 randomized, double-blind, placebo-controlled trial with a primary endpoint of reduction in symptomatic COVID-19. The trial will evaluate the efficacy of VYD2311 in a compact, 12-week format, with the potential for a longer duration analysis at 24 weeks. This compact trial design is aimed at enabling rapid enrollment and timely results.

The guidance aligns with Invivyd’s previous clinical trial success, such as the CANOPY Cohort B trial, and recognizes the potential of VYD2311’s long-lasting protection and robust safety profile. The FDA’s advice is seen as a positive step for Invivyd, potentially expediting the development of a new prophylactic option for COVID-19.

Invivyd plans to study two doses of VYD2311 to assess any differences in resulting levels of protection or safety, aiming to offer Americans more choices for COVID-19 protection. The company anticipates sharing its plans for a U.S. Investigational New Drug (IND) application and pivotal clinical trial design with the FDA as soon as possible.

Invivyd’s VYD2311 is a novel mAb candidate engineered using its proprietary integrated technology platform. It leverages the same antibody backbone as pemivibart, an investigational mAb granted emergency use authorization (EUA) for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients.

The FDA’s guidance is a significant milestone for Invivyd, potentially bringing forward a medically attractive and patient-friendly alternative to COVID-19 vaccination. If approved, VYD2311 could provide protective monoclonal antibodies to Americans who wish for non-vaccine protection, whether immune compromised, at high risk for severe disease, or simply interested in avoiding illness.

References:
[1] https://www.morningstar.com/news/globe-newswire/9512989/invivyd-aligns-with-us-fda-on-rapid-pathway-to-full-approval-bla-of-vaccine-alternative-monoclonal-antibody-vyd2311-to-protect-american-adults-and-adolescents-from-covid-19