- Aptose Biosciences (NASDAQ:APTO;TSX:APS), a clinical-stage oncology stock, achieved positive safety and response results from newly diagnosed acute myeloid leukemia patients in its ongoing phase 1/2 Tuscany clinical trial
- The company estimates that its drug candidate tuspetinib represents an over $1 billion market opportunity
- Aptose is a clinical-stage biotechnology company developing precision medicines in oncology, with an initial focus on hematology
- Aptose Biosciences stock is up by 25.49 per cent on the news but has given back 88.49 per cent year-over-year
Aptose Biosciences (NASDAQ:APTO;TSX:APS), a clinical-stage oncology stock, achieved positive safety and response results from newly diagnosed acute myeloid leukemia (AML) patients in its ongoing phase 1/2 Tuscany clinical trial.
Patients were dosed with 40 mg of tuspetinib in combination with standard of care venetoclax and azacitidine (TUS+VEN+AZA triplet) to treat mutationally diverse, newly diagnosed AML patients ineligible for induction chemotherapy. According to Aptose’s latest investor presentation, the drug candidate represents an over $1 billion market opportunity.
Among the four patients dosed to date, three with unmutated (wildtype) FLT3 (FLT3-WT) completed cycle 1 of treatment with no dose-limiting toxicities and no dose adjustments:
- Two FLT3-WT patients achieved complete remissions by the end of cycle 1, including a patient with biallelic TP53 mutations and a complex karyotype.
- The third FLT3-WT patient experienced considerable reductions in bone marrow leukemic blasts during cycle 1 and is continuing therapy on cycle 2.
- The fourth patient, with FLT3-ITD and NPM1 mutations, is dosing in cycle 1 and is not yet eligible for response evaluation.
Aptose intends to enroll 18-24 patients in the phase 1/2 clinical trial by mid-to-late 2025.
The news follows previous trials of TUS as a single agent and in combination as TUS+VEN demonstrating “favorable safety and broad activity in diverse relapsed or refractory AML populations,” according to Wednesday’s news release, extending “beyond the more prognostically favorable NPM1 and IDH mutant subgroups.”
Leadership insights
“These are very promising early results from the Tuscany trial of TUS+VEN+AZA and the first indicators of the safety and efficacy we expected to see in newly diagnosed AML patients,” Rafael Bejar, Aptose Biosciences’ chief medical officer, said in a statement. “To achieve a complete remission in cycle 1 in a subject harboring a TP53 mutation – one of the most adverse forms of AML – is particularly encouraging. With enrollment ongoing in the Tuscany study, we look forward to reporting additional data as it becomes available.”
“TUS+VEN+AZA triplet therapy has the potential to treat large AML patient populations, including those with traditionally difficult-to-treat mutations, and improve patient outcomes right from the outset of treatment,” added William G. Rice, Aptose’s chairman, president and chief executive officer. “The ability to treat such diverse AML populations – including FLT3 wildtype patients – with a favorable safety profile and without having to alter the standard of care dosing, differentiates our drug from many AML drugs in development.”
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 25.49 per cent on the news trading at C$0.32 as of 10:57 am ET. The stock has given back 88.49 per cent year-over-year.
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