和譽-B(02256.HK):創新PRMT5*MTA抑制劑ABSK131 IND申請獲美國FDA批准
格隆匯12月3日丨和譽-B(02256.HK)宣佈,高選擇性小分子PRMT5*MTA抑制劑ABSK131獲得FDA的 IND批准。此次獲批的是在晚期實體瘤患者中開展I期臨牀試驗,試驗題為「一項評估ABSK131在晚期╱轉移性實體瘤患者中的安全性、耐受性、藥代動力學和初步有效性的1期、首次人體、多中心、開放性研究」。研究人羣主要為抑癌基因MTAP缺失的患者。
約15%的人類實體腫瘤缺乏抑癌基因MTAP的表達。MTAP缺失發生率較高的實體瘤包括非小細胞肺癌(「NSCLC」)(15.7%)、胰腺癌(21.7%)、食管癌(28.4%)、間皮瘤(32.2%)和胃腸癌(10.4%的胃癌和1%的結直腸癌)等。其中,間皮瘤及胰腺癌尚無已獲批靶向治療藥物。
MTAP參與編碼多胺和嘌呤代謝中的關鍵限速酶,在嘌呤和甲硫氨酸合成補救途徑中起重要作用。MTAP缺失會導致其底物甲硫代腺苷(「MTA」)積累,進而抑制PRMT5的活性。PRMT5作為一種酶,可催化兩個甲基從S-腺苷蛋氨酸(「SAM」)對稱轉移到蛋白質上的精氨酸殘基,影響着多種生理過程,包括轉錄、RNA剪接、核糖體生物合成和細胞週期調控。PRMT5與MTAP缺失表現出「合成致死」效應。近期研究表明,選擇性靶向抑制PRMT5*MTA有望成為MTAP缺失型癌症的治療策略。ABSK131獲得FDA的IND批准。
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