Aptose Biosciences Inc. (APTO), Thursday announced positive results from the first cohort of its Phase 1/2 TUSCANY trial, evaluating tuspetinib or TUS in combination with venetoclax or VEN and azacitidine or AZA as a frontline treatment for newly diagnosed acute myeloid leukemia or AML patients ineligible for induction chemotherapy.
The trial showed encouraging outcomes, including complete responses or CR and measurable residual disease or MRD-negative remission in patients with difficult-to-treat AML mutations, such as TP53 and FLT3.
Notably, there were no dose-limiting toxicities or DLTs or prolonged myelosuppression observed.
Key Highlights from the Phase 1/2 Trial:
-- Multiple complete responses or CR and CRh achieved in TP53-mutated/FLT3-wildtype AML patients.
-- No dose-limiting toxicities or prolonged myelosuppression observed in the first cohort.
-- Positive pharmacokinetic data showing no significant drug interactions between TUS, VEN, and AZA.
-- CSRC-approved dose escalation to 80 mg TUS following favorable safety and efficacy data from the 40 mg cohort.
Enrollment is now open for the 80 mg dosing cohort, with results from the next cohort expected in mid-2025.
Aptose plans to continue advancing the TUSCANY trial to further assess the potential of the TUS+VEN+AZA triplet in frontline AML treatment.
Currently, APTO is trading at $0.19, up by 26.43 percent on the Nasdaq.
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