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Invivyd Doses First Participants in Phase 1 Clinical Trial of VYD2311, a Next Generation Monoclonal Antibody Candidate for COVID-19, Building on the Success of PEMGARDA™
WALTHAM, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious
About this update from Invivyd, Inc.
[{"type":"text","content":"WALTHAM, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced dosing of the first participants in the Phase 1 healthy volunteer clinical trial of VYD2311, a next generation monoclonal antibody (mAb) candidate for COVID-19. VYD2311 is a mAb with high in vitro neutralization potency shown against post-Omicron COVID-19 variants tested to date. The Phase 1 randomized, blinded, placebo-controlled clinical trial will evaluate escalating dosing as well as safety, tolerability, pharmacokinetics and immunogenicity of VYD2311 in healthy trial participants (NCT06523153). The Phase 1 trial is being conducted in Australia and will evaluate multiple dose levels of VYD2311 through various routes of administration, including exploration of intramuscular (IM) administration, which is designed to be more system- and patient-friendly than intravenous administration. In addition, consistent with the company’s overall strategy, VYD2311 was discovered via affinity maturation against more recent variants of SARS-CoV-2. The company expects preliminary data readouts from the Phase 1 trial in the fourth quarter of 2024 and anticipates additional clinical readouts from the VYD2311 program throughout 2025. “We are excited that VYD2311 has potential to build on the success of PEMGARDA™ (pemivibart), which was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for pre-exposure prophylaxis (PrEP) for COVID-19 for certain immunocompromised patients,” said Marc Elia, Chairman of the Board. “COVID-19 and its long-term health impact continue to be a global threat to every individual. Therefore, at Invivyd we are focused on developing novel therapeutics that keep pace with the viral evolution of this disease, with the mission to help protect all individuals who may benefit from greater protection than that available from vaccine boosts.” About VYD2311VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new therapeutic options for vulnerable populations, including immunocompromised people. Globally, there are millions of immunocompromised people, with an estimated 8 million in the U.S. alone, who may not adequately respon...