Aptose Enrollment is Open for 160 mg Dosing Cohort of Tuspetinib in Phase 1/2 TUSCANY Trial of Frontline Triple Drug Therapy

Core Insights - Aptose Biosciences is advancing its clinical-stage precision oncology drug, tuspetinib (TUS), in a Phase 1/2 trial called TUSCANY, focusing on a triplet therapy for newly diagnosed acute myeloid leukemia (AML) patients [1][6][10] - The Cohort Safety Review Committee has approved an increase in the TUS dosage from 120 mg to 160 mg based on positive safety and efficacy data [1][9] - The triplet therapy (TUS+VEN+AZA) aims to provide a safe and effective treatment for a diverse population of AML patients who cannot undergo induction chemotherapy [3][6] Financial Updates - Aptose has received an additional advance of US$1.1 million from Hanmi Pharmaceutical as part of an US$8.5 million loan facility agreement, totaling US$5.6 million received to date [2][9] Clinical Trial Details - The TUSCANY trial is designed to evaluate the safety and efficacy of TUS in combination with standard doses of venetoclax (VEN) and azacitidine (AZA) [7][9] - The trial is being conducted at 10 leading U.S. clinical sites, with an expected enrollment of 18-24 patients by late 2025 [7][9] - Initial cohorts at 40 mg, 80 mg, and 120 mg doses have shown no significant safety concerns or dose-limiting toxicities, with patients achieving complete remissions and minimal residual disease negativity [3][4][5] Therapeutic Potential - The TUS+VEN+AZA triplet therapy is positioned as a unique, mutation-agnostic frontline treatment for newly diagnosed AML patients, particularly those with adverse mutations [5][6] - Data from the trial indicate that patients with challenging mutations, such as biallelic TP53 or FLT3-ITD, have achieved complete remissions safely [5][9]