IMP-9064

IMP9064单药治疗晚期实体瘤的积极结果在ESMO 2024大会上发布（西班牙，巴塞罗那）– 在2024年欧洲临床肿瘤学会（ESMO）大会上，一项I/II期首次人体研究结果显示ATR抑制剂IMP9064在晚期实体瘤（AST）患者中的治疗潜力，且具有良好的安全性，相关研究结果以壁报形式展示。 壁报亮点（更多详细信息请参见ESMO2024）： 壁报编号：632P 标题：ATR抑制剂IMP9064单药治疗晚期实体瘤的首次人体研究剂量递增结果 会议主题：开发性治疗 会议日期：2024年9月14日 研究概述 该研究采用剂量递增和扩展设计，评估IMP9064作为单药治疗和与PARP抑制剂塞纳帕利联合使用的效果。IMP9064每日口服一次，采用3天给药/4天停药的方案，剂量范围从7.5 mg到320 mg。 主要结果 ★ 患者入组：截至2024年6月19日，共入组34名患者，肿瘤类型包括结直肠癌、子宫内膜癌和肺癌等。 ★ 安全性和耐受性：76.5%的患者报告治疗相关的不良事件（TRAEs）。在≥2名患者中报告的3级TRAEs包括贫血（14.7%）和腹泻（5.9%），无4级或5级TRAEs，且无患者因TRAEs永久停药。 ★ 初步疗效：在疗效可评估患者中，一名子宫内膜癌患者在第6周的治疗后首次肿瘤评估中显示部分缓解（PR），肿瘤显著缩小31.8%，在第12周评估时缩小45.5%，仍在接受治疗。疾病控制率（DCR）为64.5%。中位无进展生存期（PFS）为4.0个月。 ★ 药代动力学：IMP9064快速吸收，达峰时间约在4.5小时，随着剂量增加，血浆暴露量增高。 其他研究 该研究还探讨了IMP9064血浆浓度与其药效学效应（包括pCHK1表达）之间的关系。分子学应答评估显示，14名患者中有6名显示有利的ctDNA分子学应答，提示在特定基因背景下的潜在疗效。 结论 研究表明IMP9064具有良好的安全性，并在晚期实体瘤患者中显示出积极的早期疗效信号。推荐的II期剂量（RP2D）已确定，研究进入II期阶段，将在特定肿瘤中扩展单药治疗。 “这些结果显示了IMP9064在晚期实体瘤患者中具有成为未来治疗选择的潜力，”英派药业首席医学官兼执行副总裁谢志逸博士表示，“我们期待进一步推进这一研究。” 关于IMP9064 关于英派药业

SHANGHAI and HAYWARD, Calif., June 1, 2023 /PRNewswire/ -- IMPACT Therapeutics ("Impact"), a biopharmaceutical company focusing on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, and Eikon Therapeutics ("Eikon"), a biotechnology company that is advancing breakthrough therapeutics through the purposeful integration of engineering and science today announced that the companies have entered into a global license and collaboration agreement for PARP1 selective inhibitors including IMP1734, which is anticipated to enter into Phase I clinical study in 2023. Under the collaboration agreement, Eikon received an exclusive license from Impact to co-develop, register, manufacture, and commercialize IMP1734 and other PARP1 selective inhibitors globally, excluding Greater China (mainland China, Hong Kong, Macau, and Taiwan). "We are delighted to establish the global partnership with Eikon, whose leadership team has a well-documented track record of developing some of the world's most therapeutically meaningful and commercially successful oncology medicines." said Sui Xiong Cai, Ph.D., Chief Executive Officer of IMPACT Therapeutics. "As a company committed to develop innovative medicines globally, based on our deep understanding of synthetic lethality, we believe this partnership will allow us to accelerate the development of our PARP1 selective inhibitor program combining Impact and Eikon's scientific, clinical, regulatory expertise and financial resources. We look forward to working with Eikon in bringing new cancer medicines to patients in China and across the globe." "Impact has a sophisticated discovery engine that has generated an extensive pipeline of new molecules, including the development of senaparib, a dual PARP1/2 inhibitor that has been recently reported to improve outcomes in patients with advanced ovarian cancer. Eikon is delighted to partner with Impact scientists to help develop IMP1734 and other selective PARP1 inhibitors that exploit DNA damage response aberrations often found in tumors to selectively kill cancer cells," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer and Board Chair of Eikon Therapeutics. "Eikon is confident that we can leverage our expertise, resources and proprietary technology platforms, in partnership with Impact, to bring these important new PARP1 inhibitor therapies to patients who are awaiting new and better treatment options." About IMPACT Therapeutics IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. Impact has assembled one of the most comprehensive DNA damage response ("DDR") global pipeline of novel drug candidates generated by in-house discovery efforts, including PARP1/2 inhibitor senaparib (IMP4297), WEE1 inhibitor IMP7068, ATR inhibitor IMP9064, PARP1 selective inhibitor IMP1734, and is expanding to other novel synthetic lethality targets to broaden its pipeline. IMPACT Therapeutics can be found via the website. About Eikon Therapeutics Eikon Therapeutics is a drug discovery and development company working to advance breakthrough therapeutics through the purposeful integration of engineering and science. Our proprietary platform leverages Nobel Prize-winning super-resolution microscopy, advanced engineering, and high-performance computing to measure the real-time movement of individual proteins and protein populations in living cells, with the goal of bringing important new medicines to people suffering from grievous illness. Eikon is headquartered in California and can be found online via our website or on Twitter or LinkedIn. About IMP1734 IMP1734 is a novel and highly PARP1 selective inhibitor with high potency of inhibiting PARP1 and low activity of inhibiting PARP2. Preclinical in vivo models had demonstrated high anti-tumor activities and a wide therapeutic window. The improved therapeutic index of IMP1734 over currently marketed non-selective PARP1/2 inhibitors supports its development as monotherapy and in combination with other agents. IMPACT Therapeutics Contact: Ke WANG, Senior Manager, Corporate Development ke.wang@impacttherapeutics.com Eikon Therapeutics Contact: Lisa McCormick Lavery, Vice President, Corporate Communications and Investor Relations media@eikontx.com