Invivyd’s Monoclonal Antibody Neutralizes Against Dominant COVID-19 Strain
Pemivibart (Pemgarda) demonstrated activity against the LP81 variant.
Invivyd’s Chief Scientific Officer Robert Allen, PhD
Image credit: Invivyd
Today, Waltham, Mass.-based biopharmaceutical company,Invivyd, announced its monoclonal antibody, pemivibart (Pemgarda), continued to demonstrate neutralizing activity against the dominant strain of COVID-19, LP81. The variant did not generate any meaningful change to the neutralization activity of pemivibart or VYD2311, the company’s next generation COVID-19 monoclonal antibody (mAb) candidate, as the epitope these mAbs target remains structurally intact.1
"Pemivibart neutralization activity has been remarkably stable in the face of constant SARS-CoV-2 evolution,” Invivyd Chief Scientific Officer Robert Allen, PhD, said in a statement. “Scientifically, the ongoing in vitro neutralization activity as reported for pemivibart is a demonstration of our foundational hypothesis: that virus variants with the structural properties required for fitness and broad infectivity among humans will also likely be susceptible to pemivibart due to our intended accommodation of ACE2 binding and immune evasion in our molecular design and selection criteria."1
The company said it has provided this data to FDA, with an update to pemivibart fact sheet for providers anticipated.1
Read more: Invivyd Tracks SARS-CoV-2 Evolution, Prepares for Future Variants
Pemivibart is a half-life extended investigational monoclonal antibody (mAb). Pemivibart was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in a global Phase 2/3 clinical trial for the prevention and treatment of COVID-19. It is administered as an intravenous (IV) infusion with a dosage of 4500mg. Previously, the mAb has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN1, KP311, and XEC.
The Immunocompetent Population and Limited COVID-19 Vaccine Efficacy
Last year, the FDA granted an emergency use authorization (EUA) to pemivibart for the pre-exposure prophylaxis (PrEP) of COVID-19 for both adults and adolescents at least 12 years of age, and weighing at least 40 kg (88.1 lbs) who are immunocompromised.2
This population has been challenged in fending off COVID-19, and vaccination alone has offered limited efficacy. One prophylaxis strategy is to complement vaccination with an mAb, and that it may offer additional protection for the immunocompromised.
In just last week’s Centers for Disease Control’s (CDC) Morbidity and Mortality Weekly Report, investigators published the efficacy of this year’s COVID-19 vaccine confirming its limited benefit.3
“Vaccine effectiveness (VE) of 2024–2025 COVID-19 vaccine was 33% against COVID-19–associated emergency department (ED) or urgent care (UC) visits among adults aged ≥18 years and 45%–46% against hospitalizations among immunocompetent adults aged ≥65 years, compared with not receiving a 2024–2025 vaccine dose. VE against hospitalizations in immunocompromised adults aged ≥65 years was 40%,” they wrote.3
