ASC40联合贝伐珠单抗治疗复发性胶质母细胞瘤患者的临床试验申请获国家药监局受理
2021年5月25日，歌礼制药有限公司(香港联交所代码：1672)宣布经与中国国家药品监督管理局(NMPA)沟通交流，ASC40联合贝伐珠单抗治疗复发性胶质母细胞瘤(rGBM)患者的临床试验申请已获得受理。
有报告指出脂质代谢在多种肿瘤中起着关键作用。脂肪酸合成酶(FASN)是调节脂质代谢的最重要的蛋白质之一。许多实体瘤和血液肿瘤都过度表达脂肪酸合成酶，包括复发性胶质母细胞瘤、非小细胞肺癌、乳腺癌、卵巢癌、前列腺癌、结肠癌、胰腺癌和非霍奇金淋巴瘤。
ASC40(国外代号为TVB-2640)是一种强效安全的选择性脂肪酸合成酶口服小分子抑制剂。由研究者发起、在美国完成的ASC40(TVB-2640)联合贝伐珠单抗治疗高级别星形细胞瘤首次复发患者即复发性胶质母细胞瘤患者的II期临床试验取得积极结果(临床试验注册编号：NCT03032484)。II期临床试验数据显示，ASC40(TVB-2640)加贝伐珠单抗的总应答率(ORR)为65%，包括20%的完全应答(CR)和45%的部分应答(PR)。此外，数据显示，ASC40(TVB-2640)联合贝伐珠单抗观察到的6个月无进展生存期(PFS6)为47%，相比较过往贝伐珠单抗单药治疗的历史数据(BELOB16%)，6个月无进展生存期(PFS6)在统计学上有显著改善(P=0.01)。ASC40(TVB-2640)联合贝伐珠单抗在此类患者人群中安全性和耐受性良好。
歌礼创始人、董事长兼首席执行官吴劲梓博士表示：“这是自今年3月30日宣布肿瘤脂质代谢与口服检查点抑制剂研发投资升级以来，公司在肿瘤管线领域迈出的关键一步。”
关于歌礼
歌礼是一家在香港证券交易所上市(1672.HK)的创新研发驱动型生物科技公司。歌礼致力于脂肪性肝炎、肿瘤(脂质代谢与口服检查点抑制剂)、病毒性肝炎和艾滋病四大疾病领域创新药的研发和商业化，满足国内外患者临床需求。在具备深厚专业知识及优秀过往成就的管理团队带领下，歌礼已发展成为一体化平台型公司，涵盖了从新药发现和开发直到生产和商业化的完整价值链。
歌礼目前拥有三个商业化产品和十七个在研产品(其中十一个为完全自主研发)。1、非酒精性脂肪性肝炎：歌礼制药有限公司旗下全资子公司甘莱制药专注于非酒精性脂肪性肝炎领域创新药的开发和商业化。甘莱制药有三款分别针对脂肪酸合成酶(FASN)、甲状腺激素受体ß(THR-ß)及法尼醇X受体(FXR)的处于临床阶段的候选药物及三种联合用药疗法。2、肿瘤(脂质代谢与口服检查点抑制剂)：专注于在肿瘤脂质代谢中起关键作用的脂肪酸合成酶口服抑制剂管线以及新一代检查点抑制剂-口服PD-L1小分子抑制剂管线。3、病毒性肝炎：(i)乙肝：歌礼专注于乙肝临床治愈创新药物的研发。探索以皮下注射PD-L1抗体ASC22及派罗欣®为基石药物，与其他靶点药物联合的治疗方案，有望为临床治愈乙肝带来重大突破。(ii)丙肝：歌礼成功研发上市两个1类新药戈诺卫®和新力莱®，组成全口服丙肝治疗方案；ASC18固定剂量复方制剂是升级版的丙肝治疗方案，已完成桥接试验。4、艾滋病：ASC09F是一种用于治疗HIV的蛋白酶固定剂量复方抑制剂，ASC09F的临床试验申请已获得批准。欲了解更多信息，请登录网站：www.ascletis.com。
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