- Aptose Biosciences (NASDAQ:APTO;TSX:APS), a clinical-stage oncology stock, reports dose-escalation approval for tuspetinib, its drug candidate to treat newly diagnosed acute myeloid leukemia
- Dosing will rise from 40 mg to 80 mg based on favorable data from the first four patients in an ongoing clinical trial
- Aptose is a clinical-stage biotechnology company developing precision medicines in oncology, with an initial focus on hematology
- Aptose Biosciences stock is up by 26.19 per cent on the news but has given back 89.85 per cent year-over-year
Aptose Biosciences (NASDAQ:APTO;TSX:APS), a clinical-stage oncology stock, reports dose-escalation approval for tuspetinib, its drug candidate to treat newly diagnosed acute myeloid leukemia (AML) in patients ineligible for induction chemotherapy.
The decision was handed down by a cohort safety review committee (CSRC) monitoring Aptose’s phase 1/2 Tuscany clinical trial of tuspetinib in combination with standards of care venetoclax (VEN) and azacitidine (AZA).
Dosing will rise from 40 mg to 80 mg based on favorable data from the first four patients in the trial, who have reported no significant safety concerns or dose limiting toxicities (DLTs), including no prolonged myelosuppression of subjects in remission.
According to Thursday’s news release, all four subjects remain in the study amid ongoing enrollment for the 80 mg cohort. Aptose anticipates that it will onboard 18-24 patients across multiple U.S. sites by mid-late 2025.
The TUS+VEN+AZA triplet achieved complete responses in difficult-to-treat TP53-mutated/CK AML and FLT3-wildtype AML patients, including a measurable residual disease negative remission, positioning Aptose to capitalize on tuspetinib’s estimated billion-dollar addressable market (slide 2).
Leadership insights
“With a high level of enthusiasm, our CSRC – comprised of study investigators that include key leaders in the development of therapeutic agents for AML – recommended we escalate dosing in our Tuscany trial with tuspetinib,” Rafael Bejar, Aptose Biosciences’ chief medical officer, said in a statement. “The lack of prolonged myelosuppression with no DLTs and several complete responses, including an MRD-negative CRh noted early in treatment, is truly encouraging. As one of our chief investigators remarked, if the TUS+VEN+AZA triplet shows efficacy and tolerability in difficult-to-treat AML populations with little myelosuppression, tuspetinib could be a game-changer for frontline AML treatment.”
About Aptose Biosciences
Aptose is a clinical-stage biotechnology company developing precision medicines in oncology, with an initial focus on hematology.
Aptose Biosciences stock (TSX:APS) is up by 26.19 per cent on the news trading at C$0.26 per share as of 10:50 am ET. The stock has given back 89.85 per cent year-over-year.
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