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康方生物-B(09926.HK):Cadonilimab聯合VEGFR-2單抗治療晚期實體瘤Ib/II期臨牀研究獲批開展
格隆匯 08-04 06:35

格隆匯8月4日丨康方生物-B(09926.HK)發佈公吿,公司已經獲得中國國家藥品監督管理局批准,開展其自主研發的全球首創新型腫瘤免疫治療新藥Cadonilimab(PD-1/CTLA-4雙特異性抗體,研發代號:AK104)聯合VEGFR-2單克隆抗體(研發代號:AK109)治療晚期實體瘤的開放性、多中心的Ib/II期臨牀研究。

近年來,以PD-1為代表的免疫療法在多種晚期實體腫瘤中均改善了患者的預後,但免疫治療對於晚期實體瘤患者的生存獲益仍有限。研究發現,免疫細胞和腫瘤血管生成之間存在相互調節作用,這為抗血管生成藥物與免疫檢查點抑制劑聯合治療惡性腫瘤提供了理論依據。

AK109可高親和力地與人VEGFR-2蛋白結合,進而有效抑制由VEGF/VEGFR-2結合所誘導的血管內皮細胞增殖。Cadonilimab是靶向PD-1和CTLA-4的雙特異性抗體,在獲得性免疫通路的不同週期解除免疫抑制,動員和啟動T細胞殺傷腫瘤細胞。本項PD-1/CTLA-4雙抗聯合VEGFR-2單抗的臨牀研究,重點針對標準治療失敗的晚期實體瘤患者以及部分初治患者。公司期待能為晚期實體腫瘤患者帶來新希望。公司此前已經在中國啟動AK109治療晚期實體瘤的I期臨牀研究及AK109聯合Cadonilimab治療胃癌的Ib/II期臨牀研究。

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