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基石藥業-B(02616.HK):CS2009(PD-1/VEGF/CTLA-4三特異性抗體)最新臨牀進展
格隆匯 07-07 08:07

格隆匯7月7日丨基石藥業-B(02616.HK)公佈CS2009(PD-1/VEGF/CTLA-4三特異性抗體)最新臨牀進展,CS2009是一款由基石藥業自主研發的潛在同類首創/同類最佳的PD-1/VEGF/CTLA-4三特異性抗體。其具有均衡的單價PD-1和CTLA-4結合臂以及雙價VEGFA結合臂,可產生強效多靶點協同效應以及優先靶向腫瘤組織以降低系統性毒性。

CS2009通過親和力驅動的靶點結合,優先阻斷PD-1/CTLA-4雙陽性腫瘤浸潤T細胞上的PD-1和 CTLA-4,同時最大程度弱化對外周T細胞CTLA-4信號通路的干擾,從而有望實現在提升療效的同時降低系統性毒性。在腫瘤微環境(TME)中,與TME內表達上調的VEGFA二聚體交聯可顯著增強CS2009的抗PD-1及抗CTLA-4活性。

關鍵亮點:CS2009的全球多中心I/II期臨牀研究正在澳大利亞和中國積極招募患者,並計劃擴展至美國進行II期入組。在研究者及患者強烈興趣的加持下,試驗入組非常迅速,預計年底前患者數將突破100例。

Ia期劑量遞增研究已在多綫經治的晚期實體瘤患者中完成了四個劑量水平的評估。第四劑量水平(20毫克/千克,每三週給藥一次)經安全性監測委員會(SMC)評估未發生劑量限制性毒性(DLT)。研究當前正在第五劑量水平(30毫克/千克,每三週給藥一次)入組患者,主要目的為觀測CS2009在潛在II期推薦劑量(RP2D)之上的安全性以及拓寬其安全性邊界;同步持續回填前期劑量組(1至20毫克/千克,每三週給藥一次)。Ib期/II期劑量擴展研究/關鍵延展研究預計將於2025年下半年啟動。

截至目前,CS2009在所有已評估的劑量水平上展現出良好的耐受性,優異的藥代動力學(PK)特徵支持每三週給藥一次的治療方案,藥效學(PD)數據亦證實CS2009觸發的PD1/CTLA-4阻斷啟動T細胞及對VEGFA的中和作用,並且已在低劑量組的“冷腫瘤”及PD-(L)1經治患者中觀察到抗腫瘤活性。

Ia期臨牀數據(包括安全性、PK,PD和抗腫瘤活性)預計將於2025年第四季度國際學術會議上公佈。

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