亚盛医药-B(06855.HK)：APG-115单药或联合APG-2575 IIa期临床研究获中美两国临试许可
格隆汇 12 月 2日丨亚盛医药-B(06855.HK)发布公告，公司在研1类新药MDM2-p53抑制剂APG-115作为单药及联合公司另一1类新药Bcl-2抑制剂APG2575获得国家药品监督管理局药物审评中心(CDE)的临床试验许可，将开展治疗复发/难治T-幼淋巴细胞白血病(R/RT-PLL)的IIa期临床研究。此前该研究方案已获美国食品及药物管理局(FDA)临床许可。
该研究是一项全球多中心、开放的IIa期临床研究，旨在评价APG-115单药或联合APG-2575治疗复发/难治T-PLL患者的安全性、药代动力学及初步疗效。
T-PLL为侵袭性T淋巴细胞白血病。高达80%-90%的T-PLL患者存在共济失调毛细血管扩张突变(ATM)位点11q23缺失或错义突变。亚盛医药临床前研究发现，在多个携带ATM突变的患者来源的小鼠异种移植瘤动物模型(PDX)中，APG115展现高度抗肿瘤活性；在多个人类血液恶性肿瘤或实体瘤细胞系(CDX)及PDX模型中，APG-115和APG-2575联用展现高度协同作用，并显著增强抗肿瘤活性。值得一提的是该联合用药在携带AML(MV-4-11)和MCL(Z138)异种移植瘤动物模型中达到100％的缓解率。
APG-115是亚盛医药自主研发的口服生物可利用的、高选择性的小分子MDM2蛋白抑制剂。APG-115对MDM2具有高度结合亲和力，通过阻断MDM2-p53相互作用从而恢复p53肿瘤抑制活性。APG-115是首个在中国进入临床阶段的MDM2-p53抑制剂，正在中国和美国展开多项治疗实体瘤及血液肿瘤的临床研究。
公司深信APG-115与APG-2575的联合能在多种癌症中激发“合成致死”机制，即同时阻断肿瘤细胞藉以逃避细胞凋亡的MDM2-TP53及BCL-2两条关键通路，从而导致肿瘤细胞死亡，具有极大的临床意义。此外，APG-115及APG-2575均为口服靶向药物，使T-PLL患者可实现chemo-free的治疗方案,临床应用价值很高。更重要的是，该联合为全球治疗复发╱难治T幼淋巴细胞白血病(R/RT-PLL)的首创。公司希望我们的相关研究能为T-PLL患者提供临床突破，并更早、更快让更多患者受益。
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