Invivyd Reports Sustained Neutralizing Effect of PEMGARDA™ Against Leading SARS-CoV-2 Variant XEC

In recent developments, Invivyd, Inc., a biopharmaceutical company listed on Nasdaq as IVVD, has announced significant findings regarding its monoclonal antibody product, PEMGARDA™ (pemivibart), demonstrating its efficacy against the prevailing SARS-CoV-2 variant XEC. This news comes as the Centers for Disease Control (CDC) identified that XEC, alongside KP.3.1.1, comprises a majority of the current SARS-CoV-2 variants circulating across the United States as of late December 2024.

Invivyd has undertaken rigorous virology research using a sophisticated pseudoviral system to test its antibodies, including PEMGARDA and a pipeline candidate named VYD2311. The results indicate that PEMGARDA exhibits robust neutralizing activity against 75% of currently circulating U.S. variants. This is a continuation of its demonstrated efficacy against all previously tested variants since the emergence of the Omicron BA.1 lineage.

Dr. Robert Allen, the Chief Scientific Officer at Invivyd, highlighted the resilience of pemivibart in maintaining its antiviral capabilities amidst the rapid evolution of the virus. The structural integrity of the targeted epitope by pemivibart has remained unchanged since Omicron BA.1, suggesting that the neutralization activity is expected to remain consistent moving forward.

Pemivibart's performance is being compared to earlier treatments like Evusheld™. The persistent efficacy of PEMGARDA is considered a validation of Invivyd's research and development framework. Invivyd’s Chairman, Marc Elia, echoed sentiments of confidence in their virology platform’s capacity to deliver advanced antibodies designed to combat evolving viral challenges.

The ongoing mutation of SARS-CoV-2 emphasizes the necessity for continuous monitoring and testing of PEMGARDA against emerging variants. Dr. Amesh Adalja from Johns Hopkins Center for Health Security remarked on the importance of such proactive measures. He noted that PEMGARDA remains a vital option for moderately to severely immunocompromised patients, especially as COVID-19 cases rise during respiratory seasons.

Data confirming PEMGARDA’s neutralizing activity against the XEC variant have been submitted to the U.S. Food and Drug Administration (FDA). An update to the PEMGARDA Fact Sheet for Healthcare Providers is expected soon.

PEMGARDA, an investigational monoclonal antibody, is authorized for emergency use by the U.S. FDA for pre-exposure prevention of COVID-19 in specific immunocompromised individuals. However, it is not approved for treatment or post-exposure prophylaxis. It's crucial that individuals suitable for vaccination continue with their COVID-19 vaccinations, and PEMGARDA should only be administered two weeks post-vaccination if needed.

Adverse reactions such as anaphylaxis have been noted with PEMGARDA, leading to a boxed warning in its Fact Sheet. Common side effects include infusion-related reactions and symptoms like fatigue and headache.

To secure its emergency use authorization (EUA), PEMGARDA’s effectiveness was assessed through an immunobridging approach, correlating serum virus neutralizing titers with efficacy observed in other monoclonal antibodies. However, there are constraints related to data variability and the emergence of variants that may reduce PEMGARDA’s efficacy. The EUA remains valid as long as the prevalence of variants significantly resistant to PEMGARDA is below 90%.

The investigational candidate VYD2311, also derived from adintrevimab, aims to address the therapeutic needs of vulnerable groups, potentially offering easier administration routes like intramuscular injections.

Invivyd is committed to advancing protection against viral diseases, with a platform designed to generate new antibodies rapidly to meet evolving viral threats. This mission is underscored by their ongoing efforts to combat SARS-CoV-2, beginning with PEMGARDA and extending to future developments.