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Invivyd | 8-K: Current report

Invivyd | 8-K: Current report

Invivyd | 8-K:重大事件
美股SEC公告 ·  09/04 07:15

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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.
2024年9月4日,生物製藥公司Invivyd宣佈啓動COVID-19下一代單克隆抗體候選藥物VYD2311的1期臨床試驗。該試驗正在澳洲進行,旨在評估VYD2311在健康志願者中的安全性、耐受性、藥代動力學和免疫原性。VYD2311對奧米克戎COVID-19變異株表現出很高的體外中和效力。該試驗將探索不同的給藥途徑,包括肌肉注射,這種方法被認爲比靜脈注射更適合患者。預計將於2024年第四季度公佈試驗的初步數據,並預計在2025年進行其他臨床觀測。Invivyd的董事長Marc Elia對VYD2311有望在某些免疫受損患者中提供預暴露預防措施的藥物PEMGARDA™的成功表示樂觀。Invivyd專注於開發與COVID-19不斷變化的病毒景觀保持同步的治療方法,爲對疫苗反應不足的個體提供保護。
2024年9月4日,生物製藥公司Invivyd宣佈啓動COVID-19下一代單克隆抗體候選藥物VYD2311的1期臨床試驗。該試驗正在澳洲進行,旨在評估VYD2311在健康志願者中的安全性、耐受性、藥代動力學和免疫原性。VYD2311對奧米克戎COVID-19變異株表現出很高的體外中和效力。該試驗將探索不同的給藥途徑,包括肌肉注射,這種方法被認爲比靜脈注射更適合患者。預計將於2024年第四季度公佈試驗的初步數據,並預計在2025年進行其他臨床觀測。Invivyd的董事長Marc Elia對VYD2311有望在某些免疫受損患者中提供預暴露預防措施的藥物PEMGARDA™的成功表示樂觀。Invivyd專注於開發與COVID-19不斷變化的病毒景觀保持同步的治療方法,爲對疫苗反應不足的個體提供保護。
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