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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 ·  09/23 04:08

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On September 23, 2024, Invivyd, Inc., a biopharmaceutical company, released detailed virology data and analysis of SARS-CoV-2 structural biology, predicting anticipated neutralization activity for its investigational monoclonal antibody, PEMGARDA™ (pemivibart). The press release, filed as Exhibit 99.1 with the SEC, highlighted the in vitro pseudovirus neutralization potency of PEMGARDA against SARS-CoV-2 variants KP.3.1.1 and LB.1, which aligns with previous variants tested. Invivyd's ongoing SARS-CoV-2 spike analyses have shown consistent structural stability of the pemivibart binding site, which has historically predicted sustained in vitro neutralization activity. The company also noted that potential emerging variants, such as XEC and LP.1, have mutations distal from the pemivibart binding site, suggesting they would not significantly alter pemivibart activity. Routine neutralization analysis will continue...Show More
On September 23, 2024, Invivyd, Inc., a biopharmaceutical company, released detailed virology data and analysis of SARS-CoV-2 structural biology, predicting anticipated neutralization activity for its investigational monoclonal antibody, PEMGARDA™ (pemivibart). The press release, filed as Exhibit 99.1 with the SEC, highlighted the in vitro pseudovirus neutralization potency of PEMGARDA against SARS-CoV-2 variants KP.3.1.1 and LB.1, which aligns with previous variants tested. Invivyd's ongoing SARS-CoV-2 spike analyses have shown consistent structural stability of the pemivibart binding site, which has historically predicted sustained in vitro neutralization activity. The company also noted that potential emerging variants, such as XEC and LP.1, have mutations distal from the pemivibart binding site, suggesting they would not significantly alter pemivibart activity. Routine neutralization analysis will continue to assess potential changes. Invivyd contracts with LabCorp’s Monogram Biosciences lab for independent virology assessments to monitor the changing potency of pemivibart as the virus evolves. The company's proprietary INVYMAB™ platform combines viral surveillance and predictive modeling with advanced antibody engineering to rapidly generate new monoclonal antibodies to address evolving viral threats. Invivyd received emergency use authorization (EUA) from the U.S. FDA for PEMGARDA in March 2024 for pre-exposure prophylaxis of COVID-19 in certain immunocompromised individuals.
2024年9月23日,生物制药公司Invivyd, Inc.发布了关于SARS-CoV-2结构生物学的详细病毒学数据和分析,预测了其实验性单克隆抗体PEMGARDA™(pemivibart)的预期中和活性。这篇新闻稿作为第99.1展览文件提交给了美国证券交易委员会,重点突出了PEMGARDA对SARS-CoV-2变体KP.3.1.1和Lb.1的体外拟病毒中和效力,这与之前测试的变体一致。Invivyd持续进行的SARS-CoV-2尖峰分析显示了pemivibart结合位点的稳定结构,这在历史上预测了其在体外中和活性的持续性。公司还指出,潜在的新变体,如XEC和LP.1,具有远离pemiviba...展开全部
2024年9月23日,生物制药公司Invivyd, Inc.发布了关于SARS-CoV-2结构生物学的详细病毒学数据和分析,预测了其实验性单克隆抗体PEMGARDA™(pemivibart)的预期中和活性。这篇新闻稿作为第99.1展览文件提交给了美国证券交易委员会,重点突出了PEMGARDA对SARS-CoV-2变体KP.3.1.1和Lb.1的体外拟病毒中和效力,这与之前测试的变体一致。Invivyd持续进行的SARS-CoV-2尖峰分析显示了pemivibart结合位点的稳定结构,这在历史上预测了其在体外中和活性的持续性。公司还指出,潜在的新变体,如XEC和LP.1,具有远离pemivibart结合位点的突变,表明它们不会显著改变pemivibart的活性。常规中和分析将继续评估潜在的变化。Invivyd与LabCorp的Monogram Biosciences实验室签订合同,进行独立病毒学评估,以监测随着病毒演变pemivibart的变化潜力。该公司专有的INVYMAB™平台结合了病毒监测和预测建模与先进的抗体工程技术,快速生成新的单克隆抗体以应对不断变化的病毒威胁。Invivyd于2024年3月获得了美国FDA对于PEMGARDA的紧急使用授权(EUA),用于在某些免疫受损个体中预防COVID-19的暴露前预防。
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