徐诺药业完成其治疗结直肠癌和肺癌的泛-RAF抑制剂XP-102的PRE-IND会议
06/14/2019 新闻 admin
2019年6月12日  10:00 ET |

来源: Xynomic Pharmaceuticals Holdings, Inc.

美国北卡罗利市和中国上海市,2019年6月12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(纳斯达克:XYN)今日宣布与美国食品药品监督管理局(FDA)完成了其治疗结直肠癌和肺癌的泛-RAF抑制剂XP-102 (BI 882370)的PRE-IND会议。FDA解答了徐诺药业关于CMC、非临床和临床研究方案的问题,并就此候选药物的整体临床开发计划提供了宝贵建议。徐诺药业计划在2019年下半年提交此项新药研究申请(IND)。

XP-102是一款强效和高选择性的第二代泛-RAF抑制剂,具有独特的DFG-out构象结合模式,不同于已批准上市BRAF抑制剂的DFG-in构象结合。在包括Colo-205V600V/E  和HT-29V600V/E的结直肠癌(CRC)动物模型中,XP-102的抗肿瘤活性显著优于已上市的BRAF抑制剂维莫非尼。在低敏感性HT-29模型中XP-102与西妥昔单抗联用可诱导肿瘤消退。

“我们与FDA的会议是向前迈出的重要一步,FDA的反馈对我们的临床开发和监管策略非常有价值,这些策略将支持我们推进XP-102的临床开发,达到获批的目标,”徐诺药业董事长兼首席执行官徐英霖先生评论说, “我们相信XP-102作为一种治疗B-RAF V600突变实体瘤的创新疗法,对于治疗结直肠癌、非小细胞肺癌和毛细胞白血病具有巨大的潜力。

新闻原文链接:

http://www.globenewswire.com/news-release/2019/06/12/1867687/0/en/Xynomic-Completes-Pre-IND-Meeting-with-US-FDA-for-XP-102-a-Novel-Pan-RAF-Inhibitor-against-Colorectal-Cancer-and-Lung-Cancer.html

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。

Use of Forward-Looking Statements

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