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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 19:08

牛牛AI助理已提取核心訊息

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,生物製藥公司愛文思控股公司發佈了SARS-CoV-2結構生物學的詳細病毒學數據和分析,預測了其新型單克隆抗體PEMGARDA™ (pemivibart)的抗中和活性。該新聞稿作爲提交給美國證券交易委員會的99.1號附件,重點介紹了PEMGARDA在體外偽病毒中對抗SARS-CoV-2變異株KP.3.1.1和Lb.1的中和效力,與之前測試的變異株相符。 愛文思控股公司持續進行的SARS-CoV-2蛋白刺突分析顯示pemivibart結合位點的結構穩定性一致,這一點在歷史上一直預示其在體內的持續中和活性。公司還指出,潛在的新變異株,如XEC和LP.1,具有與pemivibar...展開全部
2024年9月23日,生物製藥公司愛文思控股公司發佈了SARS-CoV-2結構生物學的詳細病毒學數據和分析,預測了其新型單克隆抗體PEMGARDA™ (pemivibart)的抗中和活性。該新聞稿作爲提交給美國證券交易委員會的99.1號附件,重點介紹了PEMGARDA在體外偽病毒中對抗SARS-CoV-2變異株KP.3.1.1和Lb.1的中和效力,與之前測試的變異株相符。 愛文思控股公司持續進行的SARS-CoV-2蛋白刺突分析顯示pemivibart結合位點的結構穩定性一致,這一點在歷史上一直預示其在體內的持續中和活性。公司還指出,潛在的新變異株,如XEC和LP.1,具有與pemivibart結合位點遠離的突變,表明它們不太可能顯著改變pemivibart的活性。常規中和分析將繼續評估潛在的變化。愛文思控股公司與LabCorp的Monogram Biosciences實驗室簽訂合同,進行獨立的病毒學評估,以監測病毒演變過程中pemivibart的變化潛力。 公司擁有的INVYMAB™平台將病毒監測和預測建模與先進的抗體工程相結合,快速生成新的單克隆抗體以應對不斷演變的病毒威脅。 愛文思控股公司已於2024年3月獲得美國食品藥品監督管理局對於PEMGARDA進行緊急使用授權,以用於特定免疫受損人群的新冠病毒前暴露預防。

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