On March 29, 2022 Sumitomo Dainippon Pharma Oncology, Inc., a clinical-stage pharmaceutical company focused on research and development for novel cancer therapeutics, reported that the first patient has been dosed in the Phase 1/2 study of DSP-5336, an inhibitor of menin binding to mixed-lineage leukemia (MLL) protein, in patients with relapsed or refractory acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL) (Press release, Sumitomo Dainippon Pharma, MAR 29, 2022, View Source [SID1234611150]).

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"Patients with refractory or relapsed AML or ALL have an unfavorable prognosis and respond poorly to available treatments.1 Dosing the first patient in our Phase 1/2 study is an important milestone as we evaluate DSP-5336 and its safety and potential benefits for this patient population," said Patricia S. Andrews, Chief Executive Officer, Global Head of Oncology, Sumitomo Dainippon Pharma Oncology, Inc (SDP Oncology). "It is our hope that the data generated by this study furthers our goal of advancing meaningful treatments for patients with blood cancer."

The Phase 1/2 open-label study consists of two parts, dose escalation and dose expansion. The primary objectives of the Phase 1 dose escalation portion of the study are to assess the safety and tolerability of DSP-5336 in relapsed or refractory AML or ALL and to determine the recommended Phase 2 dose (RP2D). Secondary objectives include assessment of preliminary clinical activity of DSP-5336 in adult patients with relapsed or refractory AML or ALL.

Following the completion of the Phase 1 dose escalation portion of the study, the study will move into the Phase 2 dose expansion. The primary objective of the Phase 2 dose expansion portion of the study is to further evaluate the safety and clinical activity of DSP-5336 in adult patients with relapsed or refractory AML who have MLL rearrangement or nucleophosmin 1 (NPM1) mutation.

Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT04988555).

About DSP-5336

DSP-5336 is a small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein. Menin is a scaffold nuclear protein that plays various key roles in biological pathways, including cell growth regulation, cell cycle control, genomic stability, bone development, and hematopoiesis.2, 3 Binding of menin to MLL fusion and wildtype proteins leads to the upregulation of HOXA family and MEIS1 genes that function to stall myeloid cellular differentiation and induce leukemogenic transformation.2,4,5 Preclinical evidence shows that the disruption of fusion and wild-type menin-MLL interactions inhibits leukemic cell proliferation and restores terminal differentiation of MLL-rearranged and nucleophosmin 1 (NPM1)–mutated leukemic cells.1,6 (NCT04988555).