CINCINNATI--(BUSINESS WIRE)--Kurome Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the IND for KME-0584, allowing the company to proceed with a Ph1 clinical trial in relapsed/refractory (R/R) AML and high-risk (HR) MDS patients. Kurome plans to initiate the clinical trial in the latter half of 2024..

辛辛那提--（商业新闻短讯）--Kurome Therapeutics Inc.很高兴地宣布，美国食品和药物管理局（FDA）已经批准了KME-0584的IND，允许该公司在复发/难治（R/R）AML和高危（HR）MDS患者中进行Ph1临床试验。库罗姆计划在2024年下半年启动临床试验。。

“This is a major milestone for the Kurome team and our collaborators and validates our unique approach to AML and MDS as well as the suitability of KME-0584 for initial clinical testing,” said Jan Rosenbaum, Ph.D., CEO and CSO at Kurome. “We look forward to getting our clinical trial underway and testing our approach of targeting dysregulated immune signalling in the setting of AML and HR-MDS by targeting both IRAK1 and IRAK4 together to improve efficacy in this difficult to treat R/R patient population.”.

Kurome的首席执行官兼首席信息官Jan Rosenbaum博士说：“这是Kurome团队和合作伙伴的一个重要里程碑，验证了我们对AML和MDS的独特方法，以及KME-0584在初始临床测试中的适用性。”。“我们期待着进行我们的临床试验，并通过同时靶向IRAK1和IRAK4来测试我们在AML和HR-MDS中靶向失调的免疫信号传导的方法，以提高这种难以治疗的R/R患者群体的疗效。”。

About KME-0584

关于KME-0584

KME-0584 is a potent and highly selective small molecule inhibitor of interleukin 1 receptor associated kinases (IRAK)1, IRAK4, and all mutations of FMS-like receptor tyrosine kinase-3 (FLT3), for the treatment of R/R AML or HR-MDS. KME-0584 is intended for oral administration as a monotherapy, and as combination therapy with azacitidine or venetoclax..

KME-0584是白细胞介素1受体相关激酶（IRAK）1，IRAK4和FMS样受体酪氨酸激酶-3（FLT3）的所有突变的有效且高度选择性的小分子抑制剂，用于治疗R/R AML或HR-MDS。KME-0584用于口服单药治疗，以及与阿扎胞苷或venetoclax的联合治疗。。

About the Phase 1 Clinical Trial

关于1期临床试验

The Phase I study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of KME-0584 alone or in combination with venetoclax or azacitidine in patients with AML and HR MDS. The study will include a dose escalation and an expansion phase with up to 100 total participants. Kurome Therapeutics is planning to start the study in 2024 across multiple investigative sites in the US..

I期研究将评估KME-0584单独或联合venetoclax或阿扎胞苷治疗AML和HR MDS患者的安全性，耐受性，药代动力学和抗肿瘤活性。该研究将包括剂量递增和扩展阶段，共有100名参与者。Kurome Therapeutics计划于2024年在美国多个调查地点开始这项研究。。

About Kurome Therapeutics

关于Kurome Therapeutics

Kurome® Therapeutics is a privately held clinical stage biotechnology company developing novel therapies that target dysregulated immune signalling in cancer. Founded on research and intellectual property developed at Cincinnati Children’s in collaboration with the National Center for Advancing Translational Sciences (NCATS), Kurome is developing a series of combined IRAK1/4 inhibitors to target cancer cells that have co-opted IRAK1/4-mediated immune signalling pathways to survive and maintain a more primitive cancer cell phenotype..

Kurome®Therapeutics是一家私营临床阶段生物技术公司，开发针对癌症免疫信号失调的新型疗法。Kurome基于辛辛那提儿童研究所与国家转化科学促进中心（NCATS）合作开发的研究和知识产权，正在开发一系列IRAK1/4联合抑制剂，以靶向选择IRAK1/4介导的免疫信号通路的癌细胞，以生存和维持更原始的癌细胞表型。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements as defined in the private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Jan Rosenbaum, Ph.D. in this press release, statements regarding the development, plans and expectations for our KME-0584 development program, our plans to initiate a Phase 1 clinical trial in patients with R/R AML and HR-MDS, and anticipated benefits of KME-0584.

本新闻稿包含1995年《私人证券诉讼改革法案》中定义的前瞻性声明，包括但不限于Jan Rosenbaum博士在本新闻稿中的声明，关于我们KME-0584开发计划的发展、计划和期望的声明，我们计划在R/R AML和HR-MDS患者中启动一期临床试验，以及KME-0584的预期收益。

While Kurome Therapeutics believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are several risks and uncertainties that could cause actual events or results to differ materially from those expressed in forward-looking statements.

虽然Kurome Therapeutics认为本新闻稿中包含的前瞻性陈述是准确的，但这些前瞻性陈述仅代表了截至本新闻稿发布之日的公司信念，并且存在一些风险和不确定性，可能导致实际事件或结果与前瞻性陈述中表达的结果存在重大差异。

These include but are not limited to Kurome’s need for, and the availability of, substantial capital in the future to fund its operations and research and development program, that data from an initial limited number of patients may not be indicative of final clinical results, that Kurome’s compounds may not successfully complete clinical trials or be granted regulatory approval to be sold and marketed in the United States and elsewhere.

这些因素包括但不限于Kurome对未来大量资金的需求和可用性，以资助其运营和研发计划，最初有限数量患者的数据可能无法表明最终的临床结果，Kurome的化合物可能无法成功完成临床试验或获得监管部门批准在美国和其他地方销售和销售。

You should not place undue reliance on these statements. Kurome Therapeutics undertakes no obligation to update the information contained in this press release as new information becomes available..

你不应该过分依赖这些陈述。Kurome Therapeutics没有义务在新信息可用时更新本新闻稿中包含的信息。。