Sumitomo Pharma America has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI).

住友制药美国公司与美国国家癌症研究所 (NCI) 签订了一项合作研究与开发协议 (CRADA)。

Enzomenib is designed to block the interaction between menin and KMT2A (also known as MLL), a key driver in the development and growth of certain acute leukaemias. This interaction has been identified as a target for therapeutic intervention, particularly in cancers associated with KMT2A rearrangements or NPM1 mutations, which are known for their poor outcomes and limited treatment options..

恩佐美尼布旨在阻断menin与KMT2A（也称为MLL）之间的相互作用，这是某些急性白血病发展和生长的关键驱动因素。这种相互作用已被确定为治疗干预的靶点，特别是在与KMT2A重排或NPM1突变相关的癌症中，这些癌症以其预后差和治疗选择有限而著称。

Enzomenib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukaemia, along with Fast Track Designation for use in patients with relapsed or refractory AML with MLL rearrangements or NPM1 mutations. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) has also awarded Orphan Drug Designation for the same indication..

恩佐美尼布已被美国食品药品监督管理局（FDA）授予用于治疗急性髓系白血病的孤儿药资格，并且还获得了用于治疗伴有MLL重排或NPM1突变的复发或难治性AML患者的快速通道资格。在日本，药品和医疗器械管理局（PMDA）也针对相同适应症授予了孤儿药资格。

The collaboration will support further clinical research into enzomenib, an investigational oral small molecule, to better understand its potential in treating cancers that are currently difficult to manage.

该合作将支持对恩佐美尼（一种在研口服小分子药物）进行进一步的临床研究，以更好地了解其在治疗目前难以控制的癌症方面的潜力。

Currently, enzomenib is being tested by SMPA in an ongoing Phase 1/2 clinical trial for patients with relapsed or refractory acute leukaemia. Preclinical data have shown that enzomenib can selectively inhibit the growth of human acute leukaemia cell lines with KMT2A rearrangements or NPM1 mutations.

目前，SMPA 正在一项正在进行的 1/2 期临床试验中测试 enzomenib 对复发或难治性急性白血病患者的效果。临床前数据显示，enzomenib 可以选择性抑制具有 KMT2A 重排或 NPM1 突变的人急性白血病细胞系的生长。

The molecule has also been found to influence gene expression by lowering levels of HOXA9 and MEIS1, while increasing CD11b, a marker linked to cell differentiation..

该分子还被发现通过降低HOXA9和MEIS1的水平来影响基因表达，同时增加与细胞分化相关的标记CD11b。

Through the CRADA, enzomenib will be studied further as part of the NCI's MyeloMATCH initiative, a precision medicine clinical trial aimed at improving treatments for acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). The collaboration may also extend to other NCI programmes, expanding the investigation into additional cancer types..

通过合作研发协议（CRADA），恩佐美尼将进一步作为美国国家癌症研究所（NCI）MyeloMATCH计划的一部分进行研究。该计划是一项精准医疗临床试验，旨在改善急性髓系白血病（AML）和骨髓增生异常综合征（MDS）的治疗方法。这项合作还可能扩展到NCI的其他项目，进一步扩大对其他癌症类型的研究。

This partnership brings together SMPA’s research efforts and the NCI’s scientific expertise, aiming to accelerate the development of new treatment options for patients facing urgent and unmet medical needs.

这一合作汇集了SMPA的研究力量和NCI的科学专长，旨在加速为面临紧急且未满足医疗需求的患者开发新的治疗方案。