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Aptose Biosciences Collaborates with NCI to Advance Tuspetinib in Precision Medicine Trials for AML and MDS

NextEdge Admin

04 Dec 2024

2 min 43 sec

Aptose Biosciences , a clinical-stage precision oncology company, announced a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to advance its lead clinical-stage compound, tuspetinib (TUS). This inhibitor of key signaling kinases involved in myeloid malignancies will be studied within the NCI’s myeloMATCH precision medicine trials (NCT05564390). Funded by the NCI and launched in May 2024, myeloMATCH aims to accelerate the development of personalized combination therapies for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). These trials, conducted by the NCI’s National Clinical Trials Network (NCTN) and Community Oncology Research Program (NCORP), focus on tailoring treatment across the disease continuum for AML/MDS patients.

The collaboration allows tuspetinib to be evaluated in early Phase II trials, exploring novel drug combinations for genetically complex AML/MDS populations. “We’re honored to collaborate with the NCI on this one-of-a-kind initiative,” said William G. Rice, Ph.D., CEO of Aptose. “Tuspetinib’s breadth of activity and safety profile make it ideal for combination therapies, including triplet regimens that could achieve significant breakthroughs.”

Additionally, Aptose is independently developing tuspetinib in combination with venetoclax and azacitidine (TUS+VEN+AZA) for newly diagnosed AML patients unfit for chemotherapy. The Phase 1/2 TUSCANY study is set to begin in Q4 2024, starting at a 40 mg dose of tuspetinib, which previously showed activity in relapsed/refractory AML patients. This dose may be escalated following safety reviews.

“This collaboration highlights the potential for tuspetinib to transform treatment paradigms in AML and MDS,” said Rafael Bejar, M.D., Ph.D., Aptose’s Chief Medical Officer. The CRADA with NCI and the initiation of the TUSCANY trial reinforce tuspetinib’s role in advancing precision medicine for these challenging hematologic malignancies.