Pharma Focus Asia

Invivyd Announces VYD222's Effectiveness Against New SARS-CoV-2 KP.1.1 FLiRT and KP.3 Variants

Saturday, June 15, 2024

Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company focused on combating serious viral infectious diseases, announced today that its investigational monoclonal antibody (mAb) VYD222 (pemivibart) maintains in vitro neutralization activity in pseudovirus assays representing the predominant emerging SARS-CoV-2 variants, including KP.1.1 FLiRT and KP.3. Over half of the circulating SARS-CoV-2 variant sequences for the two-week period ending June 8, 2024, are FLiRT variants, with KP.3's prevalence increasing. The Centers for Disease Control and Prevention (CDC) predicts KP.3 will soon become the dominant SARS-CoV-2 lineage in the U.S. Notably, VYD222 has also shown in vitro neutralization activity against ancestral XBB lineage viruses with FLip and FLiRT mutations.

Invivyd, stated, "The VYD222 epitope has shown remarkable stability, with 99.8% of sequences submitted to the Global Initiative on Sharing All Influenza Data (GISAID) in 2024 displaying strict conservation at positions within five angstroms of the VYD222 binding interface. There have been no changes to residues within this binding interface for the spike proteins of the KP.1.1 FLiRT and KP.3 variants. We are encouraged by the consistent in vitro neutralization activity of VYD222 and VYD2311 and will continue our monitoring and assessments."

Invivyd uses its proprietary software, VivydTools, to continually monitor the SARS-CoV-2 variant landscape. This software tracks virus variation across SARS-CoV-2, enabling early detection and characterization of neutralization activity against emerging variants, including FLiRT variants.

VYD222 is an investigational monoclonal antibody (mAb) candidate with an extended half-life, being studied for the prevention (pre-exposure prophylaxis) of COVID-19 and the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised adults and adolescents. VYD222 has demonstrated in vitro neutralizing activity in pseudotyped virus-like particle and authentic virus neutralization assays against various pre-Omicron and Omicron variants, including JN.1. VYD222 is derived from adintrevimab, Invivyd’s investigational mAb, which has a robust safety profile and has shown clinical efficacy in global Phase 2/3 trials for both prevention and treatment of COVID-19. VYD222 has not been approved by the U.S. FDA or any other regulatory authority.



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