基石藥業-B(02616.HK)：PD-1/VEGF/CTLA-4三抗CS2009全球多中心I期臨牀試驗完成首例患者給藥
格隆匯3月4日丨基石藥業-B(02616.HK)發佈公吿，公司自主研發的PD-1/VEGF/CTLA-4三特異性抗體CS2009的全球多中心I期臨牀試驗順利完成首例患者給藥，未發生輸液反應或其他不良事件。該試驗將深入評估CS2009在多種晚期實體瘤中的臨牀應用價值，包括非小細胞肺癌、肝癌、胃癌、子宮內膜癌、卵巢癌、腎細胞癌及宮頸癌等，旨在推動創新腫瘤免疫療法的發展。
基石藥業首席執行官、研發總裁及執行董事楊建新博士表示：“CS2009首次人體研究的順利啟動，標誌着這一創新療法正式邁入臨牀驗證階段。我們現有的臨牀前數據已證明其在各種實體瘤適應症中的潛力。體外試驗中，CS2009展現出其有效的特異性激活腫瘤浸潤T細胞能力，並且與VEGF拮抗功能高效協同；在免疫功能完全的小鼠模型中，CS2009的腫瘤殺傷作用優於PD-1/CTLA-4雙抗和PD-1/VEGF雙抗；毒理研究顯示，CS2009的安全劑量水平明顯高於PD1/CTLA-4雙抗，且與PD-1/VEGF雙抗相當。基於此，我們對CS2009的臨牀潛力充滿信心，期待能公佈更多的臨牀數據，進一步證明其優異的安全性與抗腫瘤活性，為下一代腫瘤免疫治療開創新局面。”
基石藥業首席醫學官史青梅博士表示：“我們很高興看到CS2009順利達成首例患者給藥的里程碑。作為一款創新型三特異性抗體，CS2009不僅能平衡療效與安全性，還有望突破PD-L1低表達或PD-L1陰性患者的治療瓶頸。我們期待該研究取得快速和積極的進展，早日為全球實體瘤患者提供更優的治療選擇。同時，我們非常感謝基石藥業臨牀團隊在橫跨國內外多個假期的的情況下，僅用兩個多月的時間就完成了從澳大利亞臨牀試驗申請遞交到首例患者給藥的全過程，這再次充分展示了基石藥業卓越的臨牀開發效率和對服務患者的堅定承諾。”
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