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康方生物-B(09926.HK):Cadonilimab聯合AK119治療晚期實體瘤臨試完成首例患者給藥
格隆匯 01-29 06:16

格隆匯1月29日丨康方生物-B(09926.HK)發佈公吿,公司核心自主研發的、全球首創的新型腫瘤免疫治療雙特異性抗體新藥Cadonilimab (PD-1/CTLA-4雙特異性抗體,研發代號:AK104)及自主研發的新一代CD73單克隆抗體(研發代號:AK119)聯合用於治療晚期實體瘤的I期臨牀試驗完成首例患者給藥。這是一項多中心、劑量遞增和劑量擴展研究,以評價AK104與AK119聯合治療選定晚期實體瘤的安全性、藥代動力學和抗腫瘤活性。

Cadonilimab是公司核心研發管線,主要適應症包括肝癌、宮頸癌、肺癌、胃癌及食管鱗癌等。在宮頸癌、胃癌等多種腫瘤的研究階段性初步資料顯示,Cadonilimab比PD-1和CTLA-4的聯合療法相比,毒性顯著降低,具有明顯的安全性和療效優勢。

AK119亦是公司的重要管線之一,是全球領先進入臨牀試驗階段的CD73抗體藥物。CD73是在腫瘤微環境中產生具有免疫抑制能力的腺苷的重要催化酶。 CD73高表達與包括胰腺癌及結直腸癌在內的多種癌症類型的預後不良相關。通過有效消除CD73介導產生的腺苷,AK119可能提高Cadonilimab免疫療法的療效。2020年,AK119用於治療新型冠狀病毒(COVID-19)的I期臨牀試驗已經開展。此外,2021年1月,AK119也獲得了中國家藥品監督管理局(NMPA)批准,在中國開展治療特發性非纖維化的臨牀試驗。

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