Invivyd Secures U.S. FDA IND Clearance And Greenlight To Advance Pivotal Clinical Program For VYD2311, Its Vaccine-Alternative Antibody To Prevent COVID-19

Invivyd, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application and provided feedback to advance the company’s REVOLUTION clinical program. This program focuses on VYD2311, a monoclonal antibody being developed as a vaccine alternative for the prevention of COVID-19. The clearance from the FDA marks a major milestone for Invivyd as it moves closer to initiating late-stage clinical studies for this potential new form of protection against the virus.

The REVOLUTION program includes two major studies, named DECLARATION and LIBERTY. Both trials are designed to generate comprehensive clinical data that can guide regulators, healthcare professionals, and policy makers in evaluating VYD2311 as a safe and effective antibody-based approach to preventing COVID-19. Invivyd plans to begin these trials by the end of 2025, with top-line results expected by mid-2026.

The DECLARATION trial will serve as the company’s Phase 3 pivotal study to support a future Biologics License Application (BLA) for VYD2311. This study will evaluate how well VYD2311 prevents symptomatic COVID-19 compared with a placebo. Participants will receive either a single intramuscular (IM) injection or monthly IM doses of the antibody. The single-dose regimen is expected to offer strong protection for at least three months, and possibly longer, while the monthly dosing arm could offer added flexibility for people who wish to maintain higher levels of protection during specific periods of risk. This design allows for both long-term coverage—such as annual or semi-annual dosing—and short-term reinforcement during times like travel, family gatherings, or seasonal COVID surges.

The LIBERTY trial will compare the safety and tolerability of VYD2311 with that of mRNA-based COVID-19 vaccines. It will also explore whether VYD2311 can be safely given alongside existing vaccines, depending on final FDA alignment. Invivyd expects that antibody-based protection could provide a meaningful safety advantage over traditional vaccine-induced immune responses, which are driven by inflammatory mechanisms. By generating robust safety and immunologic data, this study aims to position VYD2311 as a viable alternative or complementary option for COVID-19 prevention.

Beyond these two pivotal studies, Invivyd’s broader REVOLUTION clinical program may include pediatric and post-approval Phase 4 trials. These studies would further establish the role of VYD2311 and potential future Invivyd antibodies as preferred choices for COVID-19 protection. The company has already produced commercial launch quantities of VYD2311 and secured sufficient capital to support the execution of these clinical trials through to the pivotal data readouts.

Marc Elia, Chairman of Invivyd’s Board of Directors, stated that the company’s goal is to bring people a new, safe, and convenient choice for COVID-19 protection. He emphasized that Invivyd’s antibody-based approach aims to reduce the need for repeated vaccine doses and give individuals greater freedom to decide how and when they want protection. He added that antibody medicines like VYD2311 build on the natural immune mechanisms humans acquire from birth, offering a scientifically advanced and flexible way to safeguard against COVID-19.

Invivyd plans to share more details about the REVOLUTION program, including its scientific foundation, dose selection, trial design, and potential commercial implications, during a public investor event later this month.