Invivyd Announces Continued Neutralizing Activity of PEMGARDA™ (pemivibart) Against Currently Dominant SARS-CoV-2 Variant LP.8.1

Core Insights - Invivyd, Inc. announced positive in vitro neutralization data for PEMGARDA™ (pemivibart) against the LP.8.1 variant of SARS-CoV-2, indicating no significant change in neutralization activity for this and other dominant variants over the past three years [1][2][4] - The company emphasizes the stability of pemivibart's neutralization activity against various SARS-CoV-2 variants, suggesting that the epitope targeted by the monoclonal antibodies remains structurally intact [2][3][5] - Invivyd's proprietary technology platform allows for the development of monoclonal antibodies that can adapt to evolving virus variants, with VYD2311 being the next-generation candidate showing similar stability [3][11][12] Company Overview - Invivyd, Inc. is focused on developing monoclonal antibodies to provide protection against serious viral infectious diseases, starting with SARS-CoV-2 [13] - The company has received emergency use authorization (EUA) from the U.S. FDA for PEMGARDA for pre-exposure prophylaxis in certain immunocompromised patients [6][10] - PEMGARDA is designed to inhibit virus attachment to the human ACE2 receptor, targeting the spike protein receptor binding domain of SARS-CoV-2 [5][6] Clinical Data and Efficacy - PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC, and LP.8.1, with consistent results since the Omicron BA.2 lineage [2][5][4] - Data provided to the FDA indicates ongoing neutralization activity of PEMGARDA against the LP.8.1 variant, with an update to the PEMGARDA Fact Sheet for Healthcare Providers expected [3][4][10] - The company highlights the increased risks faced by vulnerable patient populations, such as cancer patients and those on immunosuppressive therapies, emphasizing the need for effective prophylactic treatments like PEMGARDA [3][6]