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Invivyd | 8-K: Current report

SEC ·  Sep 4 19:15

Summary by Futu AI

On September 4, 2024, Invivyd, Inc., a biopharmaceutical company, announced the initiation of a Phase 1 clinical trial for VYD2311, a next-generation monoclonal antibody candidate for COVID-19. The trial, which is being conducted in Australia, aims to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of VYD2311 in healthy volunteers. VYD2311 has shown high in vitro neutralization potency against post-Omicron COVID-19 variants. The trial will explore various routes of administration, including intramuscular injections, which are considered more patient-friendly than intravenous methods. Preliminary data from the trial is expected in the fourth quarter of 2024, with additional clinical readouts anticipated throughout 2025. Invivyd's Chairman, Marc Elia, expressed optimism about VYD2311's potential to build on the success of PEMGARDA™, which received Emergency Use Authorization from the FDA for pre-exposure prophylaxis in certain immunocompromised patients. Invivyd is focused on developing therapeutics that keep pace with the evolving viral landscape of COVID-19 to provide protection for individuals who may not respond adequately to vaccines.
On September 4, 2024, Invivyd, Inc., a biopharmaceutical company, announced the initiation of a Phase 1 clinical trial for VYD2311, a next-generation monoclonal antibody candidate for COVID-19. The trial, which is being conducted in Australia, aims to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of VYD2311 in healthy volunteers. VYD2311 has shown high in vitro neutralization potency against post-Omicron COVID-19 variants. The trial will explore various routes of administration, including intramuscular injections, which are considered more patient-friendly than intravenous methods. Preliminary data from the trial is expected in the fourth quarter of 2024, with additional clinical readouts anticipated throughout 2025. Invivyd's Chairman, Marc Elia, expressed optimism about VYD2311's potential to build on the success of PEMGARDA™, which received Emergency Use Authorization from the FDA for pre-exposure prophylaxis in certain immunocompromised patients. Invivyd is focused on developing therapeutics that keep pace with the evolving viral landscape of COVID-19 to provide protection for individuals who may not respond adequately to vaccines.

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