Invivyd Announces Continued Neutralizing Activity of PEMGARDA™ (pemivibart) Against Dominant SARS-CoV-2 Variant XEC

Core Findings - New in vitro neutralization data show continued neutralizing activity of PEMGARDA™ (pemivibart) and pipeline candidate VYD2311 against dominant SARS-CoV-2 variant XEC, consistent with previous data for KP 3 1 1 [1][2] - XEC and KP 3 1 1 accounted for 69% of U S circulating SARS-CoV-2 variants for the two weeks ended December 21, 2024 [1] - PEMGARDA has demonstrated neutralizing activity against over 75% of currently circulating U S variants and all prior variants tested to date [6] - Data submitted to FDA, with timely update to PEMGARDA™ Fact Sheet for Healthcare Providers anticipated [2][7] Product Details - PEMGARDA (pemivibart) is an investigational monoclonal antibody (mAb) authorized for emergency use by the U S FDA for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise [3][11] - PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), inhibiting virus attachment to the human ACE2 receptor on host cells [11] - VYD2311, a novel mAb candidate, is being developed for COVID-19 to address the urgent need for new therapeutic options for vulnerable populations, including immunocompromised individuals [15][16] Research and Development - Invivyd leverages a consistent, high-quality, independent, third-party pseudoviral system for testing pemivibart, supported by extensive structure-based and proprietary analytics [1][9] - The company's INVYMAB™ platform combines viral surveillance, predictive modeling, and advanced antibody engineering to facilitate the rapid, serial generation of new mAbs to address evolving viral threats [17] - Pemivibart has demonstrated antiviral activity in neutralization assays representing 39 distinct SARS-CoV-2 variants across almost three years of rapid virus evolution [10] Market and Industry Context - The emergency use of PEMGARDA is authorized only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is ≤90% [14] - Invivyd received emergency use authorization (EUA) from the U S FDA for PEMGARDA in March 2024, marking its first mAb in a planned series of innovative antibody candidates [17]