share_log

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

Moomoo AI 已提取核心信息

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，生命科学公司Invivyd宣布启动VYD2311的一期临床试验，这是一款面向COVID-19的新一代单克隆抗体候选药物。该试验正在澳洲进行，旨在评估VYD2311在健康志愿者中的安全性、耐受性、药动学和免疫原性。VYD2311在体外显示出对Omicron毒株后的COVID-19具有很高的中和力。该试验将探索包括肌肉注射在内的多种给药途径，相对于静脉注射方法，肌肉注射被认为更加适合患者需求。预计2024年第四季度将公布试验的初步数据，并计划在2025年进行进一步的临床评估。Invivyd的主席Marc Elia对VYD2311有着积极的展望，相信它有潜力在特定免疫功能障碍患者的预防性使用方面，建立在PEMGARDA™取得FDA紧急使用授权的成功基础之上。Invivyd致力于开发能够跟上COVID-19不断变化的病毒形势的治疗药物，为对疫苗反应不足的个体提供保护。
2024年9月4日，生命科学公司Invivyd宣布启动VYD2311的一期临床试验，这是一款面向COVID-19的新一代单克隆抗体候选药物。该试验正在澳洲进行，旨在评估VYD2311在健康志愿者中的安全性、耐受性、药动学和免疫原性。VYD2311在体外显示出对Omicron毒株后的COVID-19具有很高的中和力。该试验将探索包括肌肉注射在内的多种给药途径，相对于静脉注射方法，肌肉注射被认为更加适合患者需求。预计2024年第四季度将公布试验的初步数据，并计划在2025年进行进一步的临床评估。Invivyd的主席Marc Elia对VYD2311有着积极的展望，相信它有潜力在特定免疫功能障碍患者的预防性使用方面，建立在PEMGARDA™取得FDA紧急使用授权的成功基础之上。Invivyd致力于开发能够跟上COVID-19不断变化的病毒形势的治疗药物，为对疫苗反应不足的个体提供保护。
有用
没用

该公告为独立文件：

独立文件1  查看翻译

独立文件2  查看翻译

声明：本内容仅用作提供资讯及教育之目的，不构成对任何特定投资或投资策略的推荐或认可。 更多信息
    热议
    美股
    股票代码最新价涨跌幅

    暂无数据

    资讯热榜
    更新时间