徐诺药业公布艾贝司他与Keytruda®联合治疗多种实体瘤临床1b期研究的积极中期数据
09/26/2019 新闻 admin
美国北卡罗利市和中国上海市 2019年8月30日/(GLOBE NEWSWIRE)-

致力于抗肿瘤新药开发的中美跨国制药公司徐诺药业（股票代码: XYNO）今日公布其候选药物艾贝司他联合默沙东肿瘤免疫疗法可瑞达®（”Keytruda®”, 帕博利珠单抗）治疗多种实体瘤的1b期临床试验的积极中期数据。艾贝司他是口服给药的基于异羟肟酸的小分子组蛋白去乙酰化酶抑制剂（“HDAC”），此项联合用药正在于美国加州大学旧金山分校医学中心进行。中期数据将在第三届中国国际免疫&基因治疗论坛上展示，此次论坛于2019年8月30 – 31日在中国北京举行。

该1b期临床试验探讨了艾贝司他与可瑞达®（商品名Keytruda®）联合用于治疗可瑞达®或其他免疫检查点抑制剂治疗的先前进展的患者。共有7名之前接受了抗PD1 / PD-L1治疗的患者参与了剂量爬坡研究。肿瘤类型包括黑素瘤（N = 3），尿路上皮癌（N = 2），神经内分泌癌（N = 1）和食道鳞状细胞癌（N = 1）。受试者前期接受系统治疗方案中位数为3，受试者中位年龄为61岁。在所测试的两个剂量水平（艾贝司他 30 mg / m2和第1-4天45 mg / m2,8-11与可瑞达®联合使用） ，没有发现剂量限制性毒性，试验因达到设计剂量而终止（未达到最大耐受剂量）。该试验阶段未发生任何于药物相关的等级≥3不良事件。最常见的1-2级不良事件是腹泻（N = 3），皮疹（n = 2），血小板减少症（n = 1）和味觉障碍（n = 1）。7名患者中有2名（29％）经历了> 6个月的稳定疾病，其中1名尿路上皮癌患者肿瘤缩小了20％。

该试验的第二阶段正在入组患者，以帮助后续开发适应症的选择。本试验计划在美国招募约42名患者。

“从理论上讲艾贝司他与免疫检查点抑制剂具有潜在的协同作用。我们对加州大学旧金山分校医学中心今天报告的临时数据非常满意，加州大学旧金山分校医学中心是实体肿瘤临床研究的全球领导者。今天报道的数据表明艾贝司他与可瑞达®的组合是安全并且耐受性良好，并且有初步证据证明有效并且可能逆转对免疫检查点阻断的抗性。我们希望在明年初的科学研讨会上公布更多数据。”徐诺药业董事长兼首席执行官徐英霖先生评论道。

关于徐诺药业

徐诺药业是一家专注于肿瘤药物开发的生物制药公司。徐诺药业目前的产品管线主要包括三款候选药物，艾贝司它、 XP-105 和 XP-102。公司拥有这些药物的全球独家开发、生产和商业化权益。其领先的候选药物艾贝司他正在进行治疗肾细胞癌（与培唑帕尼联用）和单药治疗非霍奇金淋巴瘤的全球关键临床试验。徐诺药业另外一款临床阶段候选药物为可进入临床2期的XP-105（BI 860585），这是一个ATP竞争性的mTORC1 / 2抑制剂，对多种实体瘤有效。徐诺药业的临床前候选药物XP-102（BI 882370）是一个泛-RAF抑制剂。

投资者关系、媒体和商务拓展请联系：

angela.feng@xynomicpharma.com

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