ASC40聯合貝伐珠單抗治療複發性膠質母細胞瘤患者的臨牀試驗申請獲國家藥監局受理
2021年5月25日,歌禮制藥有限公司(香港聯交所代碼:1672)宣佈經與中國國家藥品監督管理局(NMPA)溝通交流,ASC40聯合貝伐珠單抗治療複發性膠質母細胞瘤(rGBM)患者的臨牀試驗申請已獲得受理。
有報吿指出脂質代謝在多種腫瘤中起着關鍵作用。脂肪酸合成酶(FASN)是調節脂質代謝的最重要的蛋白質之一。許多實體瘤和血液腫瘤都過度表達脂肪酸合成酶,包括複發性膠質母細胞瘤、非小細胞肺癌、乳腺癌、卵巢癌、前列腺癌、結腸癌、胰腺癌和非霍奇金淋巴瘤。
ASC40(國外代號為TVB-2640)是一種強效安全的選擇性脂肪酸合成酶口服小分子抑制劑。由研究者發起、在美國完成的ASC40(TVB-2640)聯合貝伐珠單抗治療高級別星形細胞瘤首次復發患者即複發性膠質母細胞瘤患者的II期臨牀試驗取得積極結果(臨牀試驗註冊編號:NCT03032484)。II期臨牀試驗數據顯示,ASC40(TVB-2640)加貝伐珠單抗的總應答率(ORR)為65%,包括20%的完全應答(CR)和45%的部分應答(PR)。此外,數據顯示,ASC40(TVB-2640)聯合貝伐珠單抗觀察到的6個月無進展生存期(PFS6)為47%,相比較過往貝伐珠單抗單藥治療的歷史數據(BELOB16%),6個月無進展生存期(PFS6)在統計學上有顯著改善(P=0.01)。ASC40(TVB-2640)聯合貝伐珠單抗在此類患者人羣中安全性和耐受性良好。
歌禮創始人、董事長兼首席執行官吳勁梓博士表示:“這是自今年3月30日宣佈腫瘤脂質代謝與口服檢查點抑制劑研發投資升級以來,公司在腫瘤管線領域邁出的關鍵一步。”
關於歌禮
歌禮是一家在香港證券交易所上市(1672.HK)的創新研發驅動型生物科技公司。歌禮致力於脂肪性肝炎、腫瘤(脂質代謝與口服檢查點抑制劑)、病毒性肝炎和艾滋病四大疾病領域創新藥的研發和商業化,滿足國內外患者臨牀需求。在具備深厚專業知識及優秀過往成就的管理團隊帶領下,歌禮已發展成為一體化平台型公司,涵蓋了從新藥發現和開發直到生產和商業化的完整價值鏈。
歌禮目前擁有三個商業化產品和十七個在研產品(其中十一個為完全自主研發)。1、非酒精性脂肪性肝炎:歌禮制藥有限公司旗下全資子公司甘萊製藥專注於非酒精性脂肪性肝炎領域創新藥的開發和商業化。甘萊製藥有三款分別針對脂肪酸合成酶(FASN)、甲狀腺激素受體ß(THR-ß)及法尼醇X受體(FXR)的處於臨牀階段的候選藥物及三種聯合用藥療法。2、腫瘤(脂質代謝與口服檢查點抑制劑):專注於在腫瘤脂質代謝中起關鍵作用的脂肪酸合成酶口服抑制劑管線以及新一代檢查點抑制劑-口服PD-L1小分子抑制劑管線。3、病毒性肝炎:(i)乙肝:歌禮專注於乙肝臨牀治癒創新藥物的研發。探索以皮下注射PD-L1抗體ASC22及派羅欣®為基石藥物,與其他靶點藥物聯合的治療方案,有望為臨牀治癒乙肝帶來重大突破。(ii)丙肝:歌禮成功研發上市兩個1類新藥戈諾衞®和新力萊®,組成全口服丙肝治療方案;ASC18固定劑量複方製劑是升級版的丙肝治療方案,已完成橋接試驗。4、艾滋病:ASC09F是一種用於治療HIV的蛋白酶固定劑量複方抑制劑,ASC09F的臨牀試驗申請已獲得批准。欲瞭解更多信息,請登錄網站:www.ascletis.com。
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