Invivyd announces IND clearance, alignment with FDA on VYD2311 program

Invivyd (IVVD) announced that the FDA has cleared the company’s Investigational New Drug application and provided feedback to advance the company’s REVOLUTION clinical program, Invivyd’s development program for VYD2311, a vaccine alternative monoclonal antibody candidate for the prevention of COVID. The DECLARATION clinical trial is the company’s Biologics License Application-enabling, Phase 3 pivotal clinical trial evaluating VYD2311 safety and prevention of COVID versus placebo. The LIBERTY clinical trial will assess the safety and tolerability of VYD2311 in a head-to-head clinical trial against mRNA-based COVID vaccine, as well as evaluate co-administration of VYD2311 with vaccination, subject to final alignment with the FDA. Together, these two clinical trials are designed to provide robust, medical practice-changing information to regulators, populations at risk for COVID, and policy makers seeking high-quality, safe, non-vaccine protection from COVID. Invivyd intends to initiate these clinical trials as soon as practicable, with the goal of year-end 2025 trial start and top-line data mid-2026. Additional studies in the REVOLUTION program may be contemplated for conduct post-approval of VYD2311, if a BLA is granted by the FDA, to further elaborate the profile of antibody prevention of COVID. The DECLARATION Phase 3 clinical trial will evaluate prevention of symptomatic COVID at three months, with either a single dose or monthly doses of VYD2311, each administered via intramuscular injection, compared to placebo. A single IM dose of VYD2311 is expected to confer strong protection from COVID across the three-month measured dosing interval and beyond, with further clinical demonstration of long-term protection possible post-approval. By including a monthly dosing arm, the DECLARATION trial could also provide safety and efficacy data that support a VYD2311 indication and administration paradigm that enables individual choice and flexibility for extra periodic protection from COVID if desired, as opposed to a single centrally defined or mandated protection regimen. If approved, access to baseline and periodic extra protection via VYD2311 could, for example, support long interval protection such as annual or semi-annual dosing, as well as provide a mechanism for increased protection through additional doses for at-risk populations seeking extra protection or for individuals facing periods of enhanced risk of COVID. The LIBERTY clinical trial is anticipated to demonstrate the meaningful safety and tolerability advantage expected for antibody-based prophylaxis versus mRNA-based vaccine-induced inflammatory mechanisms, and to provide safety and immunologic data regarding any interaction between the mRNA-based vaccine and VYD2311 for people who may receive both, if approved. Invivyd expects that its broader REVOLUTION clinical program may also include pediatric and other post-approval Phase 4 studies designed to establish VYD2311 and potential future Invivyd antibodies as the preferred option for protection from COVID over mRNA-based vaccination going forward. Invivyd has produced commercial launch quantities of VYD2311 and has secured capital to support clinical trial execution through pivotal data readouts. More details about the REVOLUTION clinical program for VYD2311, including the scientific basis for trial design, dose selection, endpoints, populations, and potential commercial implications will be shared in a public investor event later this month.