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SDP Oncology Begins Phase I/II Trial of Leukemia Drug

The headline has been changed to reflect the correct abbreviation for Sumitomo Dainippon Pharma Oncology at the time this article was published. The company as of April 1 has changed its name to Sumitomo Pharma Oncology.

NEW YORK – Sumitomo Dainippon Pharma Oncology dosed the first patient in a Phase I/II study of its investigational drug for acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL).

Following a Phase I dose escalation study, the Phase II portion of this trial will evaluate safety and clinical activity of DSP-5336 in patients with relapsed or refractory AML who have an MLL rearrangement or a NPM1 mutation.

DSP-5336 is a small molecule that blocks the cellular scaffold protein menin from binding to the mixed lineage leukemia (MLL) protein. The interaction of these two proteins drives leukemia, and preclinical evidence shows that blocking their binding can inhibit proliferation of leukemia cells and restore terminal differentiation of MLL-rearranged and NPM1-mutated cells. Between 5 percent and 10 percent of leukemia cases involve a translocation of the MLL1 gene, leading to expression of MLL fusion proteins.

Other companies targeting menin-MLL interactions include Biomea Fusion and Daiichi Sankyo. Biomea Fusion received clearance from the US Food and Drug Administration to launch a Phase I trial for its menin inhibitor BMF-219. And Daiichi Sankyo began dosing patients in a Phase I/II of its menin inhibitor DS-1594 in AML.

Leukemia patients with MLL rearrangements have a poor prognosis with a five-year survival rate of about 35 percent. In addition to leukemia, MLL dysregulations play a significant role in other cancers including Ewing sarcoma, hepatocellular carcinoma, and pediatric gliomas.