Sumitomo Pharma America, Inc. has announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the US National Institutes of Health (NIH), to evaluate enzomenib, an investigational, oral, small molecule designed to inhibit the menin and KMT2A protein interaction present in certain difficult to treat cancers.

This unique partnership aims to harness the combined expertise of SMPA and the NCI to further expand the scientific evaluation of enzomenib as a potential therapeutic and explore additional cancers to address unmet patient needs.

Enzomenib is an investigational, oral, small-molecule currently being clinically evaluated by SMPA in Phase 1/2 clinical trials for relapsed or refractory acute leukemia. Enzomenib is designed to target the menin and mixed-lineage leukemia protein interaction, a key interaction for acute leukemia and other cancer cell growth. In preclinical studies, enzomenib demonstrated selective growth inhibition in human acute leukemia cell lines with KMT2A (MLL) rearrangements or NPM1 mutations – cancers with particularly high mortality rates and limited treatment options.

"We are highly encouraged by the preliminary data showing promising clinical activity of enzomenib in patients with relapsed/refractory acute leukemia, and with the support and partnership of the National Cancer Institute, we are poised to continue this positive momentum by expanding exploration of its application across additional cancers," said Jatin Shah, M.D., Chief Medical Officer, Oncology, SMPA. 

"We're honored to partner with the National Cancer Institute whose scientific expertise, resources and commitment to advancing oncological research will enable an even broader pursuit of scientific innovation on behalf of patients with urgent and unmet needs," added Shah. 

As part of the collaboration, enzomenib will be explored in MyeloMATCH (Myeloid Malignancies Molecular Analysis for Therapy Choice), an NCI precision medicine clinical trial designed to improve treatment outcomes for individuals diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). Enzomenib will also be explored with other important NCI programs.