Invivyd's PEMGARDA Shows Neutralizing Activity Against Dominant SARS-CoV-2 Variant XFG

Invivyd announced positive in vitro neutralization data for PEMGARDA, authorized by the FDA for pre-exposure prophylaxis of COVID-19 in immunocompromised patients, against the dominant XFG variant of SARS-CoV-2. PEMGARDA was engineered from adintrevimab, which has a robust safety data package and evidence of clinical efficacy in global Phase 2/3 clinical trials. The emergency use of PEMGARDA is only authorized for the duration of the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act.

Invivyd, Inc. (Nasdaq: IVVD) has announced continued, consistent neutralizing activity of PEMGARDA® (pemivibart) against the currently dominant XFG variant of SARS-CoV-2. This development is significant as the XFG variant is driving a growing wave of COVID-19 infections in the United States, as indicated by Centers for Disease Control and Prevention (CDC) data and wastewater surveillance [1].

PEMGARDA, authorized by the U.S. Food and Drug Administration (FDA) for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients, has demonstrated robust neutralizing activity against various SARS-CoV-2 variants, including the XFG strain. The stability of the epitopes targeted by pemivibart and VYD2311, another investigational monoclonal antibody candidate, underscores the strength of Invivyd's molecular design strategy [1].

The in vitro neutralization data affirm Invivyd’s unique technology and reflect consistently stable target epitopes. The company anticipates continued meaningful clinical activity for pemivibart for the foreseeable future, provided the epitope remains intact [1]. The emergency use of PEMGARDA is authorized under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, and its authorization is subject to the duration of the COVID-19 pandemic [1].

Invivyd's Chief Scientific Officer, Robert Allen, Ph.D., commented on the findings: "The demonstrated stability of the epitopes our monoclonal antibodies target across SARS-CoV-2 evolution underscores the strength of our molecular design strategy and our capability in creating high-barrier-to-resistance medicines" [1]. The company is also advancing VYD2311, a next-generation antibody candidate with similar in vitro neutralization results but at much higher potency [1].

The growing number of COVID-19 infections across the United States highlights the importance of effective preventive measures. Invivyd's ongoing research and development efforts aim to provide scalable and patient-friendly solutions for COVID-19 prophylaxis and treatment.

References:
[1] https://www.morningstar.com/news/globe-newswire/9514390/invivyd-announces-continued-neutralizing-activity-of-pemgarda-pemivibart-and-vyd2311-against-currently-dominant-sars-cov-2-variant-xfg-stratus