IVVD News & Events

Invivyd announced a peer-reviewed publication by Invivyd that uses data from the recent CANOPY clinical trial of Invivyd's monoclonal antibody pemivibart to predict clinical protection levels from COVID purely from laboratory-determined serum monoclonal antibody activity levels, irrespective of virus variation. This newly published analysis builds on similar, earlier peer-reviewed analyses demonstrating similar findings from pre-Omicron virus variants with a prior Invivyd antibody. "Our perspective at Invivyd from the beginning of the COVID pandemic through today is clear: we believe that once the safety of an Invivyd COVID monoclonal antibody that targets a stable epitope on the virus has been established, one can reliably estimate its ability to prevent COVID disease directly from its laboratory-assessed antiviral activity," said Robert Allen, Ph.D., Chief Scientific Officer at Invivyd. "As we continue to develop this field, our hope is that healthcare professionals, policymakers, and regulators will recognize the demonstrated consistent responsiveness of SARS-CoV-2 to our highly active monoclonal antibodies, irrespective of virus variation, which may enhance the development and use of new monoclonal antibody options for patients in need, if approved."

Invivyd received and is aligned with advice from the U.S. Food and Drug Administration on the LIBERTY Phase 3 clinical trial, which will assess the safety and immunologic profile of VYD2311, the company's vaccine- alternative monoclonal antibody investigational candidate for the prevention of COVID-19, versus commercially available mRNA COVID vaccines. The trial will also explore the safety and immunologic profile of VYD2311 and mRNA COVID vaccine administered simultaneously. The Centers for Disease Control and Prevention surveyed Americans who had not received a COVID booster during the 2023-2024 season, and the main reason, among others, identified was concern about serious or unknown side effects. Citing known risk of myocarditis/pericarditis in young adult Americans who take the mRNA COVID vaccine, the FDA requested Invivyd specifically monitor for these adverse events of special interest in this LIBERTY trial, which includes mRNA vaccination. No such request has been conveyed for DECLARATION or other Invivyd monoclonal antibody clinical trials without an mRNA COVID vaccine arm. Further, myocarditis and pericarditis have not been observed in any Invivyd clinical trial, nor have myocarditis and pericarditis been observed in postmarketing Adverse Event reports for pemivibart. Invivyd previously announced initiation of DECLARATION, the company's Biologics License Application-enabling clinical trial of VYD2311. DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 safety and efficacy in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without underlying risk factors for progression to severe COVID-19, at three months. Participants will receive either a single dose or a monthly dose of VYD2311, each administered via intramuscular injection, compared to placebo. Total enrollment of the trial is expected to be 1770 participants. Top-line data from the trial are expected mid-2026.

Invivyd announced a partnership with ski champion Lindsey Vonn to elevate public understanding of antibodies, one of the most important parts of the immune system, and their role in preventing disease. A national multimedia education campaign is planned to launch in early Spring 2026. "Americans deserve more information and choices about how to stay healthy, especially in light of our ongoing national discussion on prevention of infectious disease. Partnering with Lindsey Vonn will expand awareness of antibody science in a way that is relatable, understandable, and trustworthy," said Marc Elia, Chairman of Invivyd's Board of Directors. "Lindsey's extraordinary work ethic, inspiring comeback, and dedication to personal well-being make her a compelling voice for this effort. We look forward to working together and wish her the very best as she prepares for the upcoming competitions. We are cheering for Lindsey, and we are proud to partner with an awe-inspiring role model."