By IDSE News Staff
Recent in vitro neutralization data demonstrated the continued neutralizing activity of pemivibart (Pemgarda, Invivyd) against circulating strains of SARS-CoV-2.
Pemivibart and a pipeline candidate called VYD2311 are effective against the XEC and KP.3.1.1 strains, which the CDC estimates accounted for an aggregate 69% of U.S. circulating variants of SARS-CoV-2 for the two weeks ending on Dec. 21, 2024. The company said pemivibart has neutralization activity against more than 75% of currently circulating U.S. variants, and all prior variants, tested to date.
“The company estimates that every clinical variant reported in the CDC COVID Tracker since the Omicron BA.1 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 BA.1,” the company said in a statement.
“We designed pemivibart and our pipeline molecules to resist the effects of evolution,” said Robert Allen, PhD, the chief scientific officer. “Pemivibart has now demonstrated antiviral activity in neutralization assays representing 39 distinct SARS-CoV-2 variants across almost three years of rapid virus evolution.”
Dr. Allen called these findings reassuring, particularly when one compares the efficacy with previous monoclonal antibodies (mAbs) against COVID-19, such as tixagevimab-cilgavimab (Evusheld, AstraZeneca); the FDA rescinded the emergency use authorization (EUA) for tixagevimab-cilgavimab in early 2023 because of its lack of efficacy.
Pemivibart is a half-life extended investigational mAb engineered from adintrevimab, which targets the SARS-CoV-2 spike protein receptor-binding domain, thereby inhibiting virus attachment to the human ACE2 receptor on host cells. In March 2024, the FDA granted pemivibart an EUA as pre-exposure prophylaxis against COVID-19.
Invivyd generated these new data as part of its ongoing effort, which leverages a consistent, high-quality, independent, third-party pseudoviral system that routinely tests authentic pemivibart and is supported by extensive structure-based and proprietary analytics, the company said.
“Amidst the continual mutations that characterize SARS-CoV-2, proactively monitoring viral evolution as Invivyd is doing is a necessity in order to continuously test Pemgarda against emerging variants of SARS-CoV- 2,” noted Amesh Adalja, MD, FIDSA, FACP, FACEP, a senior scholar, Johns Hopkins Center for Health Security, in Baltimore. “It is reassuring that Pemgarda continues to show neutralizing activity against XEC, the current dominant circulating variant in the U.S. As we see COVID-19 numbers continue to rise through the respiratory season, Pemgarda offers a valuable tool for certain moderately to severely immunocompromised patients who need options.”
