宜明昂科-B(01541.HK):自國家藥監局獲得IMM47治療實體瘤臨牀研究用新藥(IND)批件
格隆匯10月16日丨宜明昂科-B(01541.HK)宣佈,集團自中華人民共和國國家藥品監督管理局(國家藥監局)獲得IMM47治療實體瘤臨牀研究用新藥(IND)批件。
IMM47是一款有潛力成為全球同類首創的靶向CD24人源化單克隆抗體,用於癌症治療。IMM47於腫瘤細胞上表達的CD24具有高親和力,能夠阻斷從CD24/Siglec-10通路傳遞至巨噬細胞、自然殺傷(NK)細胞及T細胞的免疫抑制信號。IMM47具有抗體依賴的細胞毒性作用(ADCC)增強的IgG1 Fc,能夠通過強抗體依賴的細胞吞噬作用(ADCP)及ADCC有效激活巨噬細胞及NK細胞的免疫反應。公司的體內概念驗證試驗表明,IMM47能夠顯著增加腫瘤組織中M1巨噬細胞的數量,具有良好的療效,並與其他免疫療法產生強大的協同潛力,如程序性細胞死亡蛋白1 (PD-1)/PD-1配體1 (PD-L1)抑制劑。
2023年9月26日,集團於澳大利亞完成IMM47 I期臨牀試驗的首例患者給藥。於2023年9月9日,IMM47的臨牀前結果於同行評審期刊《Antibody Therapeutics》上發表,該期刊為全球科學界發表治療性抗體的發現、研究、開發、製造及方法論的最新進展及挑戰提供討論平台。
截至公吿日期,就IMM47而言,集團擁有一項在中國的已授權的專利、一項在日本的已批准專利申請、一項在美國及一項在歐盟的待批專利申請,以及一項可能於未來進入多個締約國的待批專利合作條約(PCT)專利申請。此外,IMM47治療實體瘤的IND申請預計將於不久後向美國食品藥品監督管理局(FDA)提交。
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