Invivyd Announces New England Journal of Medicine Publishes Letter to the Editor Highlighting Immunobridging Pathway Leading to PEMGARDA™ (pemivibart) Emergency Use Authorization; Comments on Adjacent Third-Party Letter to the Editor

Core Insights - The New England Journal of Medicine (NEJM) published a Letter to the Editor detailing the immunobridging emergency use authorization (EUA) pathway for PEMGARDA (pemivibart) and an updated correlate of protection (CoP) curve for monoclonal antibody protection against symptomatic COVID-19 [1][2] - The immunobridging approach, designed by the FDA, allows for rapid development of novel monoclonal antibodies to protect vulnerable populations from symptomatic COVID-19 amidst evolving variants [2] - Invivyd expressed disappointment regarding a separate NEJM publication from a third-party lab that presented outdated and inaccurate virology data on "research-grade" pemivibart [1][4] Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [8] - The company utilizes its proprietary INVYMAB platform to facilitate rapid generation of new monoclonal antibodies to address evolving viral threats [8] - PEMGARDA is an investigational monoclonal antibody engineered from adintrevimab, demonstrating in vitro neutralizing activity against major SARS-CoV-2 variants [9] Clinical Data and Efficacy - The updated CoP curve published in NEJM provides a continuous relationship between serum virus neutralizing antibody (sVNA) titers and clinical protection from symptomatic COVID-19, which is more representative of human immunobiology than previous binary analyses [3] - The CANOPY Phase 3 clinical trial is ongoing to evaluate the safety and efficacy of pemivibart, with the latest analysis including 365-day data [15] - The FDA has indicated that PEMGARDA likely retains adequate neutralization activity against circulating SARS-CoV-2 variants, including KP.3.1.1, which comprise over 75% of currently circulating variants [6][7] Regulatory and Market Context - The EUA for PEMGARDA is authorized for individuals with moderate-to-severe immune compromise who are unlikely to mount an adequate immune response to COVID-19 vaccination [10] - The immunobridging approach used for PEMGARDA's EUA is based on established relationships from other neutralizing monoclonal antibodies against SARS-CoV-2 [13] - The company aims to leverage the updated CoP data in the development of next-generation monoclonal antibodies, such as VYD2311, targeting a low dose and patient-friendly profile [3][6]