中國生物製藥(01177.HK):LM-24C5"CEACAM5/4-1BB雙抗"II期臨牀試驗申請獲NMPA批準
格隆匯8月7日丨中國生物製藥(01177.HK)公告,集團全資附屬公司禮新醫藥科技(上海)有限公司("禮新醫藥")自主研發的創新藥LM-24C5"CEACAM5/4-1BB雙抗"已獲得中國國家藥品監督管理局(NMPA)的臨牀試驗批準,同意其在CEACAM5陽性的晚期實體瘤患者中開展一項聯合其他抗腫瘤藥物的II期臨牀試驗。
CEACAM5(癌胚抗原相關細胞黏附分子5)在多種實體瘤中高表達,包括非小細胞肺癌、結直腸癌和胃癌等,使其成爲一個極具前景的腫瘤治療靶點。LM-24C5是禮新醫藥基於條件激活型4-1BB平臺開發的雙特異性抗體,通過特異性結合腫瘤細胞表面的CEACAM5和免疫細胞表面的4-1BB,將免疫細胞特異性定向至腫瘤微環境,激活並增強其抗腫瘤活性。LM-24C5的獨特結構可以CEACAM5依賴性方式選擇性激活4-1BB信號通路,避免非特異性外周免疫系統激活帶來的毒性風險。
臨牀前研究表明,LM-24C5可誘導持久的抗腫瘤免疫記憶,並與其他免疫治療藥物具有協同效應,具有成爲同類首創(First-in-Class)免疫療法的潛力。目前,LM-24C5正在美國開展I/II期臨牀試驗。
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