Invivyd Announces Completion of Enrollment in Phase 3 LIBERTY Trial Evaluating VYD2311 Antibody Versus mRNA COVID-19 Vaccine

• Invivyd expects to report topline data from LIBERTY in Q3 2026
• Data from LIBERTY can provide important insight into the VYD2311 clinical profile by direct comparison between COVID antibody prophylaxis and COVID vaccine
• LIBERTY is part of Invivyd’s broader REVOLUTION clinical program, including DECLARATION, designed to generate medical practice-changing data to support VYD2311, a potential new option for prevention of COVID-19

NEW HAVEN, Conn., June 16, 2026 (GLOBE NEWSWIRE) — Invivyd, Inc. (Nasdaq: IVVD) today announced enrollment of participants in its Phase 3 LIBERTY clinical trial is complete. The trial is comparing the safety and tolerability of the company’s investigational COVID-19 monoclonal antibody VYD2311 with an mRNA COVID-19 vaccine. The trial is also evaluating the safety and immune response when both are given together. VYD2311 is being developed as an alternative to vaccines for preventing COVID-19. The LIBERTY study is a randomized, double-blind trial involving healthy adults. A primary endpoint of the trial is to assess the side effects and tolerability of COVID antibody versus vaccine through Day six, for a total of seven days. Invivyd expects to report initial results from the study in the third quarter of 2026. These results may be released alongside data from the company’s pivotal DECLARATION clinical trial.

“We are pleased that enrollment in the LIBERTY trial moved very quickly,” said Marc Elia, Chairman of Invivyd’s Board of Directors. “We believe this reflects strong interest in monoclonal antibodies as a way to protect people from COVID. We now look forward to executing this study, collecting data, and continuing to engage with the FDA as we seek to make VYD2311 available, if approved, to those Americans who can benefit from it as soon as possible.”

Dr. Michael Mina, Chief Medical Officer of Invivyd, continued, “It is rare to get a chance to conduct such a meaningful clinical comparison between two different tools for preventing disease: vaccine and monoclonal antibody. Recent studies have shown that many individuals receiving COVID-19 vaccines experience systemic side effects for an average of 3 days owing to the strong and necessary inflammatory response elicited by existing COVID-19 vaccines. Concerns about these effects have contributed to lower vaccine booster uptake, and, as a result, we at Invivyd are focused on advancing an option that may provide an important effective alternative to prevent COVID-19. If VYD2311 demonstrates an improved side effect profile and tolerability advantage over mRNA COVID vaccination, it would support the potential for VYD2311 to substantially improve public health and offer needed optionality for millions of Americans, if approved.”

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.

About VYD2311

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.

About LIBERTY

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 approximately 210 participants.

About DECLARATION

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.

About Invivyd 

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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Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “plans,” “potential,” “predicts,” “projects,” “future,” and “target,” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, plans related to the company’s research and development activities, and the timing and potential results thereof; expectations regarding the company’s clinical trial designs, enrollment, event accumulation and progress, regulatory pathway, product profile, indication, patient populations, and administration paradigm for VYD2311, including the company’s REVOLUTION clinical program and the timing of results thereof; the potential for data from the LIBERTY clinical trial to be released alongside data from the company’s pivotal DECLARATION clinical trial; the potential of VYD2311 as a novel mAb candidate for the prevention of COVID-19 that may provide an important effective alternative to prevent COVID-19, if approved; the potential advantages of VYD2311 over mRNA COVID vaccination; the potential for the REVOLUTION clinical program to establish VYD2311 as the preferred option for protection from COVID over mRNA-based vaccination; the company’s devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; and other statements that are not historical fact. 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These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress, and results of the company’s discovery, preclinical, and clinical development activities, including with respect to the REVOLUTION clinical program; uncertainties regarding clinical trial event accumulation rates; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of the company’s product candidates based on neutralizing activity in nonclinical studies; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitope that VYD2311 targets remains structurally intact; whether the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory approval process, and available development and regulatory pathways; the company’s ability to generate the data needed to support a potential Biologics License Application submission for VYD2311; how long the EUA granted by the U.S. FDA for a mAb in the company’s pipeline will remain in effect and whether such EUA is revised or revoked by the U.S. FDA; the ability to maintain a continued acceptable safety, tolerability, and efficacy profile of any product candidate following regulatory authorization or approval; the risk that a lack of awareness of mAb therapies and regulatory scrutiny of mAb therapies to prevent or treat COVID-19 or other infectious diseases may adversely impact the development or commercial success of the company’s product candidates; changes in expected or existing competition; the company’s reliance on third parties; complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

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Contacts:

Media Relations
(781) 208-0160
media@invivyd.com 

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