科濟藥業-B(02171.HK)達成一項合作 評估AB011與PD-L1免疫檢查點抑制劑聯合治療胃癌的效果
格隆匯1月31日丨科濟藥業-B(02171.HK)發佈公吿,科濟藥業與F. Hoffmann-La Roche Ltd (“羅氏”)達成一項臨牀合作協定,就科濟藥業全球首個獲批IND的人源化Claudin18.2(CLDN18.2)單克隆抗體產品AB011與羅氏PD-L1免疫檢查點抑制劑阿替利珠單抗(atezolizumab)及標準治療化療,開展聯合用藥治療胃癌患者或者胃食管結合處癌患者的臨牀試驗。根據協定,羅氏將負責臨牀試驗的運營管理和推進,科濟藥業與羅氏將共同承擔AB011用藥組在臨牀試驗中的費用。在本次臨牀合作中,科濟藥業自主研發的高特異性和高靈敏度CLDN18.2免疫組化(IHC)檢測試劑盒將用於評估CLDN18.2在胃癌患者中的表達。
雙方共同開展的AB011聯合Atezolizumab的試驗將作為羅氏腫瘤免疫治療開發平台Morpheus項目的一部分。Morpheus項目是Ib/II期臨牀試驗平台,針對包括消化道腫瘤在內的多種具有高度未滿足臨牀需求的癌症,旨在評估藥物的安全性和早期療效,從而更快速、更有效地開發新型的聯合治療方案。
胃癌是全球最常見的癌症類型之一,而胃癌患者的治療選擇非常有限。CLDN18.2 是治療胃癌、胰腺癌等實體瘤的頗具前景的治療靶點。自2014年以來,科濟團隊圍繞CLDN18.2靶點進行全面的管線佈局,開發了多個針對CLDN18.2的強大管線產品,包括CAR-T細胞療法和AB011單抗。AB011是科濟藥業CLDN18.2管線組合的重要部分,是中國自主研發首個獲批IND的CLDN18.2單抗。科濟藥業期待通過這項合作來評估AB011和阿替利珠單抗的聯合治療效果,也希望這能為胃癌患者帶來更大的臨牀獲益。
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