Invivyd Announces First Participants Dosed in LIBERTY, a Phase 3 Clinical Trial to Evaluate the Safety and Tolerability of VYD2311 Antibody Versus mRNA COVID Vaccine and to Characterize the Safety and Immunology of Antibody and mRNA Vaccine Co-Administration

• LIBERTY clinical trial will evaluate the comparative safety and tolerability of VYD2311 versus mRNA COVID-19 vaccine, as well as explore the safety and immunology of co-administered VYD2311 and mRNA COVID-19 vaccine

• Depending on study recruitment rate, Invivyd expects to report topline data from LIBERTY in Q3 2026, to accompany anticipated data from the pivotal DECLARATION clinical trial

• Prior exploration of monoclonal antibody (mAb) interaction with vaccine publishedheresuggests a minimal clinical consequence to a similar interaction today, but could provide data to aid in potential product labelling language, if approved. This earlier work demonstrated an expected, modest reduction in vaccine-induced neutralizing antibody titers from co-administration of mAb and vaccine, in seronegative populations, with T Cell and other vaccine-induced metrics minimally changed

• LIBERTY is part of Invivyd’s broader REVOLUTION clinical program, including DECLARATION, designed to characterize the profile of mAb-mediated prophylaxis from COVID-19 and the potential medical benefits to vulnerable Americans

NEW HAVEN, Conn., June 09, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the first participants have been dosed in the LIBERTY Phase 3 clinical trial, a randomized, double-blind study that is evaluating the safety and tolerability and immunology of VYD2311 alone, an mRNA COVID-19 vaccine alone, and VYD2311 co-administered with a COVID-19 vaccine in healthy adults. VYD2311 is Invivyd’s vaccine-alternative monoclonal antibody (mAb) investigational candidate for the prevention of COVID-19. Depending on study recruitment rate, Invivyd expects to report topline data from the LIBERTY trial in Q3 2026, to accompany anticipated data from the pivotal DECLARATION clinical trial.

“We are pleased to have dosed the first participants in LIBERTY, a trial we believe can better characterize the favorable tolerability profile of a mAb and highlight the benefits of our expected new standard of care in COVID-19 prevention if VYD2311 is approved,” said Marc Elia, Chairman of Invivyd’s Board of Directors. “In light of Sanofi’s recent findings in the COMPARE study that greater than 80% of patients who received a COVID-19 vaccine experienced at least one systemic side effect, we are moving with urgency to provide Americans with a COVID prevention option that does not require the repeated inflammation of COVID-19 vaccination. CDC data have shown that concern about serious or unknown side effects have been leading reasons adults have elected not to receive a COVID-19 vaccine booster, which is why Invivyd is focused on developing a potential prevention option that is more tolerable.”

LIBERTY is an innovative head-to-head clinical trial to evaluate the comparative safety and tolerability of a mAb and an mRNA COVID-19 vaccine. Prior data from Invivyd’s EVADE study and Sanofi’s COMPARE study provided exploratory evidence that mAbs may offer a more tolerable prevention profile than traditional vaccines.

LIBERTY is expected to enroll approximately 210 adult participants aged 18 to 49 years. Patients will be randomized 1:1:1 across three treatment arms:

1)   An mRNA COVID-19 vaccine administered by intramuscular (IM) injection and placebo administered by IM injection2)   VYD2311 (250 mg) administered by IM injection and placebo administered by IM injection3)   VYD2311 (250 mg) administered by IM injection and an mRNA COVID-19 vaccine administered by IM injections

The primary endpoints of the trial are safety, based on treatment-emergent adverse events, injection site reactions, and hypersensitivity reactions through Day 6, and the number of participants reporting ≥1 systemic symptoms post-injection through Day 6, in participants administered VYD2311 alone, COVID-19 mRNA vaccine alone, or VYD2311 and a COVID-19 mRNA vaccine concurrently.

LIBERTY is part of Invivyd’s broader REVOLUTION clinical program, which is designed to establish VYD2311 as the preferred option for protection from COVID over mRNA-based vaccination, if approved. Data from the LIBERTY clinical trial are expected to be included in anticipated VYD2311 regulatory filings.

VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration.

VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19.

LIBERTY is a Phase 3, randomized, double-blind study to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of VYD2311, an mRNA COVID vaccine, and co-administered VYD2311 with an mRNA COVID vaccine. Total enrollment of the trial is expected to be approximately 210 participants.

DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without risk factors for progression to severe COVID-19 at three months. Participants will receive either a single dose or monthly doses of VYD2311, each administered via intramuscular (IM) injection, compared to placebo. Total enrollment of the trial is approximately 2,400 participants.

Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more.

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