Waltham, Mass.-based biopharmaceutical company, Inviyd, announced today that new data showed continued neutralizing activity of pemivibart (Pemgarda) and pipeline candidate VYD2311 against the dominant COVID-19 variant, XEC.
The company said it has demonstrated positive pemivibart neutralization activity against over 75% of currently circulating US variants, and all prior variants, tested to date. Additionally, Invivyd estimates that every clinical variant reported in the CDC COVID Tracker since the Omicron BA1 lineage has been susceptible to pemivibart even if untested due to the consistent structural integrity of the pemivibart epitope. Therefore, Invivyd does not anticipate any meaningful change to pemivibart neutralization activity, aside from expected normal quantitative variation in assay output, for the foreseeable future if the epitope pemivibart targets remains structurally intact, as it has since Omicron BA1.
“We designed pemivibart and our pipeline molecules to resist the effects of evolution,” Invivyd Chief Scientific Officer Robert Allen, PhD, said in a statement. “Pemivibart has now demonstrated antiviral activity in neutralization assays representing thirty-nine distinct SARS-CoV-2 variants across almost three years of rapid virus evolution. The ongoing pemivibart activity, with minimal quantitative change in neutralization activity, especially as compared to predecessor medicines such as tixagavimab/cilgavimab (Evusheld), is incredibly reassuring and validating of our fundamental R&D engine and potentiates our ability to successfully drug this target for long periods of time despite evolutionary pressure.”
What You Need to Know
Invivyd's investigational monoclonal antibody, pemivibart (Pemgarda), has demonstrated neutralizing activity against over 75% of currently circulating US COVID-19 variants and all prior tested variants.
Pemivibart's design prioritizes resistance to viral evolution. With demonstrated neutralizing activity across 39 SARS-CoV-2 variants over three years.
Pemivibart had been granted emergency use authorization (EUA) by the FDA for pre-exposure prophylaxis (PrEP) of COVID-19 in immunocompromised adults and adolescents (12+ years, ≥40 kg).
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.
VYD2311 is a novel monoclonal antibody (mAb) candidate, and was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global phase 3 clinical trials for both the prevention and treatment of COVID-19.
Read More:A Monoclonal Antibodies' Prospective Place in the COVID-19 PrEP Market
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.
This particular population has been challenged in fending off COVID-19, and vaccination alone has offered limited efficacy. One concept is to complement vaccination with an mAb, with the idea that it may offer additional protection for the immunocompromised.
“For those of whom vaccination is recommended, we would recommend that they take the vaccine, and then, in combination with that, should [pemivibart] be prescribed by their physician, then they would administer the antibody for PrEP,” Allen said in an interview with Contagion late last year.
References
1. Invivyd Announces Continued Neutralizing Activity of PEMGARDA™ (pemivibart) Against Dominant SARS-CoV-2 Variant XEC. Invivyd press release. January 10, 2025. Accessed January 10, 2025.
https://www.globenewswire.com/news-release/2025/01/10/3007561/0/en/Invivyd-Announces-Continued-Neutralizing-Activity-of-PEMGARDA-pemivibart-Against-Dominant-SARS-CoV-2-Variant-XEC.html
2. Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19. Invivyd press release. March 22, 2024. Accessed January 10, 2025.
