Monoclonal Antibody Shows Promise Against Dominant COVID-19 Variant

Inviyd, a biopharmaceutical company based in Waltham, Mass., has announced that its monoclonal antibody, pemivibart (Pemgarda), along with pipeline candidate VYD2311, has shown continued neutralizing activity against the dominant COVID-19 variant, XEC. The company reports that pemivibart has demonstrated positive neutralization activity against more than 75% of currently circulating US variants and all prior variants tested to date.

Invivyd's Chief Scientific Officer, Robert Allen, PhD, emphasized the design of pemivibart and pipeline molecules to resist the effects of evolution, highlighting the antibody's antiviral activity across 39 distinct SARS-CoV-2 variants over nearly three years. This ongoing activity, with minimal quantitative change in neutralization activity, is seen as a validation of the company's R&D efforts and its ability to target the virus effectively over time.

Pemivibart, which has been granted emergency use authorization (EUA) by the FDA for pre-exposure prophylaxis (PrEP) of COVID-19 in immunocompromised adults and adolescents, is a half-life extended investigational monoclonal antibody. It was engineered from adintrevimab, which has a robust safety data package and demonstrated clinical efficacy in global Phase 2/3 clinical trials. Pemivibart is administered as an intravenous (IV) infusion with a dosage of 4500mg and has shown in vitro neutralizing activity against major SARS-CoV-2 variants, including JN1, KP311, and XEC.

VYD2311, another novel monoclonal antibody candidate from Invivyd, was also engineered from adintrevimab and has shown clinically meaningful results in global phase 3 clinical trials for both the prevention and treatment of COVID-19. The FDA's EUA for pemivibart last year marked a significant step in providing additional protection for the immunocompromised population, complementing vaccination efforts where efficacy alone may be limited.