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基石藥業-B(02616.HK)重磅產品CS2009(PD-1/VEGF/CTLA-4三特異性抗體)在澳大利亞遞交臨牀試驗申請
格隆匯 12-23 08:06

格隆匯12月23日丨基石藥業-B(02616.HK)發佈公吿,公司用於治療多種實體瘤的管線2.0重磅產品CS2009(PD-1/VEGF/CTLA-4三特異性抗體)已在澳大利亞遞交臨牀試驗申請。

CS2009是一款具有創新結構設計的、同時靶向PD-1、VEGFA及CTLA-4的三特異性抗體。CS2009擁有平衡的抗PD-1和抗CTLA-4親和力,能夠傾向性地靶向並阻斷雙陽性腫瘤浸潤淋巴細胞(TILs)上的PD-1和CTLA-4,同時不會阻斷單陽性細胞上的CTLA-4,從而在保證藥效的前提下降低潛在的系統毒性。CS2009還可以誘導高效內化,從而減少雙陽性TILs細胞表面免疫抑制性分子PD-1和CTLA-4的表達。此外,CS2009保留了完整的抗VEGF功能,並且臨牀前數據顯示,CS2009的抗VEGF功能與免疫檢查點抑制功能有明顯的協同效應——與VEGFA的 “交聯”,可以顯著增強抗PD-1和抗CTLA-4的活性。

基石藥業已在2024年第39屆癌症免疫治療學會(SITC)年會上公佈了CS2009的臨牀前數據。臨牀前數據顯示,CS2009具有明顯優於潛在競品的抗腫瘤活性,有望覆蓋廣泛瘤種,包括非小細胞肺癌,卵巢癌,腎細胞癌,宮頸癌,肝癌,胃癌等,成為同類首創/同類最優的下一代腫瘤免疫骨架產品。

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:“很高興看到CS2009如期遞交I期臨牀試驗申請,這是基石藥業管線2.0又一重大里程碑進展。CS2009是我們2022年自立項,從分子設計開始自主研發的一款新型三特異性抗體,擁有充分的臨牀前數據支撐,有望替代現有 PD-1(L1)療法。通過各部門之間密切配合和努力,CS2009非常順利地邁入了臨牀開發階段,近期我們將在澳大利亞啟動其首次人體研究,期待早日看到CS2009能讓癌症患者獲益、尤其是那些PD-(L)1療法響應不佳的PD-L1低表達或PD-L1陰性的羣體。” 

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