Eilean Therapeutics LLC, a biopharmaceutical company dedicated to discovering and developing best-in-class and first-in-class small molecule inhibitors to target escape mutations in hematologic and solid malignancies, today announced that Eilean Therapeutics Australia Pty, Ltd, received clearance from the Human Research Ethics Committee in Australia to begin a Phase 1 trial of balamenib (ZE63-0302) under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutics Goods Administration (TGA).

Eilean Therapeutics LLC是一家生物制药公司，致力于发现和开发一流的小分子抑制剂，以靶向血液学和实体恶性肿瘤的逃逸突变，今天宣布Eilean Therapeutics Australia Pty，Ltd，根据澳大利亚治疗商品管理局（TGA）的临床试验通知（CTN）计划，获得澳大利亚人类研究伦理委员会的批准，开始balamenib（ZE63-0302）的1期试验。

The Phase 1 program includes a single ascending dose trial in healthy volunteers to evaluate the safety, pharmacokinetics and target engagement profile of balamenib, a highly selective inhibitor of the menin–KMT2A binding interaction.

第一阶段计划包括在健康志愿者中进行单次递增剂量试验，以评估巴拉美尼（一种高选择性的menin-KMT2A结合相互作用抑制剂）的安全性，药代动力学和目标参与情况。

'The first-in-human study of balamenib in Australia represents another important milestone for Eilean Therapeutics, as we progress, with an accelerated development of our portfolio of best-in-class agents targeting hematological malignancies,' stated Iain Dukes, Chief Executive Officer of Eilean Therapeutics.

艾琳治疗公司首席执行官伊恩·杜克斯（IainDukes）表示：“随着我们的进步，澳大利亚首次对巴拉美尼进行人体研究代表了艾琳治疗的另一个重要里程碑，我们加速了针对血液系统恶性肿瘤的一流药物组合的发展。”

'The highly differentiated pre-clinical profile of balamenib emphasizes important advantages over molecules in the same class in safety, tolerability and feasibility of outpatient treatment, enabling our drug to safely treat AML patients alone and in combination with our other targeted therapies.'

“balamenib的高度分化的临床前特征强调了在门诊治疗的安全性，耐受性和可行性方面优于同类分子的重要优势，使我们的药物能够安全地单独治疗AML患者，并与我们的其他靶向治疗相结合。”

About Balamenib

关于Balamenib

Balamenib (ZE63-0302) is an oral small molecule inhibitor of the menin-KMT2A interaction. In vitro studies with KMT2Ar specific cell lines and in vivo studies using xenograft models demonstrated that balamenib is a potent menin inhibitor when administered both as a stand-alone agent or in combination with other compounds used for the treatment of r/rAML, in particular with eiletoclax (ZE50-0134), and lomonitinib (ZE46-0134), Eilean Therapeutics' BCL-2 selective inhibitor and pan FLT3/IRAK4 inhibitor, respectively.

Balamenib（ZE63-0302）是menin-KMT2A相互作用的口服小分子抑制剂。用KMT2Ar特异性细胞系进行的体外研究和使用异种移植模型进行的体内研究表明，巴拉美尼是一种有效的脑膜抑制剂，无论是作为独立药物还是与用于治疗r/rAML的其他化合物联合使用，尤其是与艾来托克司（ZE50-0134）和洛莫替尼（ZE46-0134），Eilean Therapeutics的BCL-2选择性抑制剂和pan FLT3/IRAK4抑制剂。

Balamenib demonstrates improved safety compared to other molecules in the same class, with an absence of QTc prolongation and is neither a substrate nor inducer of cytochrome P450 3A4 metabolism. Furthermore, balamenib shows significantly reduced susceptibility to 'hot spot' menin mutations currently being encountered in the clinic with other menin inhibitors.

与同类其他分子相比，Balamenib表现出更好的安全性，没有QTc延长，既不是细胞色素P450 3A4代谢的底物也不是诱导剂。此外，balamenib显示出对目前临床上与其他menin抑制剂一起遇到的“热点”menin突变的敏感性显着降低。

About Eilean Therapeutics

关于Eilean Therapeutics

Eilean Therapeutics LLC is a pharmaceutical company co-founded by Orbimed, Torrey Pines Investment and Dr John C. Byrd, focused on the discovery and development of best-in-class and first-in-class small molecule inhibitors that target escape mutations in hematologic and solid cancers. The company is utilizing a proprietary hybrid AI/ML platform (Expert Systems Inc.), leveraging its key partners proprietary data, chem-bio platforms, knowledge and expertise to choose highly valuable molecular mechanisms of pathology; to precisely design and accelerate the execution of discovery and development of best-in-class and first-in-class therapies.

Eilean Therapeutics LLC是由Orbimed，Torrey Pines Investment和John C.Byrd博士共同创立的一家制药公司，专注于发现和开发针对血液和实体癌逃逸突变的一流和一流小分子抑制剂。该公司正在利用专有的混合AI/ML平台（Expert Systems Inc.），利用其关键合作伙伴专有数据，化学生物平台，知识和专业知识来选择极具价值的病理分子机制；精确设计并加速发现和开发一流和一流疗法的执行。

Eilean Therapeutics' goal is to utilize its capabilities and platform to become a leader in developing novel breakthrough medicines to maximize the clinical benefit when treating hematologic and solid malignancies.

Eilean Therapeutics的目标是利用其能力和平台成为开发新型突破性药物的领导者，以最大限度地提高治疗血液和实体恶性肿瘤的临床效益。