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(RTTNews) - Invivyd, Inc. (IVVD) announced on Tuesday that the first participant in its Phase 3 LIBERTY trial has been dosed with VYD2311, the company's investigational monoclonal antibody candidate for COVID-19. Company Profile

Invivyd is a commercial-stage biopharmaceutical company engaged in the development and commercialization of antibody therapies against viral infections. Invivyd's lead commercial product is Pemvidart, marketed as PEMGARDA, which is FDA-authorized under Emergency Use Authorization (EUA) for COVID-19.

VYD2311

VYD2311 is an investigational mAb candidate designed to neutralize contemporary virus lineages, especially SARS-CoV-2 (COVID-19).

This candidate has completed a Phase 1/2 trial and is currently in Phase 3, dubbed the DECLARATION trial, which assesses efficacy and safety in a broad population of participants to prevent symptomatic COVID. The U.S. FDA granted fast-track designation for VYD2311.

LIBERTY Trial

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-administration of VYD2311 with an mRNA COVID vaccine.

Additionally, it will explore the safety and immunology of co-administration of VYD2311 and the mRNA COVID-19 vaccine.

Total enrollment in the trial is expected to be approximately 210 participants aged between 18 and 49 years.

Patients will have randomized administration across three treatment arms:

- Intramuscular (IM) administration of a mRNA COVID-19 vaccine against placebo administered by IM injection - VYD2311 (250 mg) administered by IM injection and placebo administered by IM injection - VYD2311 (250 mg) administered by IM injection and an mRNA COVID-19 vaccine administered by IM injections.

The primary endpoint of the trial is safety based on treatment-emergent adverse events, injection site reactions, hypersensitivity reactions, and post-injection participants reporting more than 1 systemic symptom.

Further, the company added that, based on the study recruitment rate, it expects to report topline data from the LIBERTY trial in the third quarter of 2026.

Invivyd has traded between $0.4830 and $3.070 over the last year.

Invivyd shares closed Tuesday at $0.99, down 2.94%. In the pre-market, the shares are currently trading at $0.98, down 0.39%.

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