亞盛醫藥-B(06855.HK)：APG-115單藥或聯合APG-2575 IIa期臨牀研究獲中美兩國臨試許可
格隆匯 12 月 2日丨亞盛醫藥-B(06855.HK)發佈公告，公司在研1類新藥MDM2-p53抑制劑APG-115作為單藥及聯合公司另一1類新藥Bcl-2抑制劑APG2575獲得國家藥品監督管理局藥物審評中心(CDE)的臨牀試驗許可，將開展治療復發/難治T-幼淋巴細胞白血病(R/RT-PLL)的IIa期臨牀研究。此前該研究方案已獲美國食品及藥物管理局(FDA)臨牀許可。
該研究是一項全球多中心、開放的IIa期臨牀研究，旨在評價APG-115單藥或聯合APG-2575治療復發/難治T-PLL患者的安全性、藥代動力學及初步療效。
T-PLL為侵襲性T淋巴細胞白血病。高達80%-90%的T-PLL患者存在共濟失調毛細血管擴張突變(ATM)位點11q23缺失或錯義突變。亞盛醫藥臨牀前研究發現，在多個攜帶ATM突變的患者來源的小鼠異種移植瘤動物模型(PDX)中，APG115展現高度抗腫瘤活性；在多個人類血液惡性腫瘤或實體瘤細胞系(CDX)及PDX模型中，APG-115和APG-2575聯用展現高度協同作用，並顯著增強抗腫瘤活性。值得一提的是該聯合用藥在攜帶AML(MV-4-11)和MCL(Z138)異種移植瘤動物模型中達到100％的緩解率。
APG-115是亞盛醫藥自主研發的口服生物可利用的、高選擇性的小分子MDM2蛋白抑制劑。APG-115對MDM2具有高度結合親和力，通過阻斷MDM2-p53相互作用從而恢復p53腫瘤抑制活性。APG-115是首個在中國進入臨牀階段的MDM2-p53抑制劑，正在中國和美國展開多項治療實體瘤及血液腫瘤的臨牀研究。
公司深信APG-115與APG-2575的聯合能在多種癌症中激發“合成致死”機制，即同時阻斷腫瘤細胞藉以逃避細胞凋亡的MDM2-TP53及BCL-2兩條關鍵通路，從而導致腫瘤細胞死亡，具有極大的臨牀意義。此外，APG-115及APG-2575均為口服靶向藥物，使T-PLL患者可實現chemo-free的治療方案,臨牀應用價值很高。更重要的是，該聯合為全球治療復發╱難治T幼淋巴細胞白血病(R/RT-PLL)的首創。公司希望我們的相關研究能為T-PLL患者提供臨牀突破，並更早、更快讓更多患者受益。
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