Invivyd, Inc. has announced promising data regarding its monoclonal antibody (mAb) candidate, VYD222 (pemivibart), which continues to show effective neutralization against emerging SARS-CoV-2 variants. These findings were derived from pseudovirus assays targeting the KP.1.1 FLiRT and KP.3 variants. Notably, these variants represent the dominant strains currently circulating, reflecting significant recent changes in the virus's genetic landscape.
KP.3 is particularly noteworthy, as its prevalence is rising, with the Centers for Disease Control and Prevention (CDC) predicting it will soon become the most dominant SARS-CoV-2 lineage in the United States. The continued efficacy of VYD222 against these new strains is significant, given that it had already shown neutralizing activity against earlier variants, including those in the ancestral XBB lineage.
Dr. Robert Allen, Chief Scientific Officer of Invivyd, highlighted the stability of the VYD222 epitope, noting that there have been no significant changes to the residues within the VYD222 binding interface in the spike proteins of KP.1.1 FLiRT and KP.3 variants. This stability underpins the continued neutralizing activity of VYD222, a crucial factor as the virus evolves.
Additionally, Invivyd's next anticipated SARS-CoV-2 monoclonal antibody candidate, VYD2311, has shown similar promising in vitro neutralization activity in pseudovirus assays against these predominant strains. This consistency supports Invivyd's strategy of using its proprietary software, VivydTools, to monitor and analyze the evolving SARS-CoV-2 variant landscape. This tool aids in the early detection and characterization of new variants' neutralizing activity, ensuring the company stays ahead in the fight against COVID-19.
VYD222 is being investigated for both the prevention of COVID-19 in immunocompromised individuals and the treatment of mild to moderate symptomatic COVID-19. It has demonstrated in vitro neutralizing activity in assays against various SARS-CoV-2 variants, bolstering its potential as a versatile therapeutic option. Engineered from adintrevimab, another mAb from Invivyd with substantial safety and efficacy data from global Phase 2/3 clinical trials, VYD222 represents an evolution of Invivyd's ongoing efforts to combat the pandemic.
It's important to note that while VYD222 has shown promising results in laboratory settings, it has not yet received approval from the U.S. Food and Drug Administration (FDA) or other regulatory bodies. This underscores the need for continued research and regulatory review to confirm its efficacy and safety in broader clinical settings.
Invivyd, a biopharmaceutical company listed on Nasdaq under the ticker IVVD, focuses on developing protections against serious viral infectious diseases, starting with SARS-CoV-2. The company's INVYMAB™ platform leverages cutting-edge viral surveillance, predictive modeling, and advanced antibody engineering to rapidly generate new monoclonal antibodies. This approach is designed to keep pace with the fast-evolving viral threats.
In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for its first monoclonal antibody in a planned series of candidates. This milestone highlights the company's commitment to delivering novel antibody-based therapies to address urgent public health needs.
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