2024-04-10 09:34:37
Partner company Aptoz announces plan for combination use of tuspetinib triple drug
Including a schedule of presentations at world-class academic conferences… Preliminary research results to be released next year
Goal of developing first-line treatment for AML patients unsuitable for induction chemotherapy
Aptoz Chairman: “There are very few drugs that show such broad activity.”
Hanmi Pharmaceutical launched ‘Tuspetinib’, an innovative new drug for the treatment of acute myeloid leukemia (AML), thanks to its excellent safety and broad-spectrum activity. Topic) It was announced on the 9th that it will be used for preliminary (pilot) research.
Aptoz, a Hanmi Pharmaceuticals partner company developing tuspetinib, is said to have disclosed advanced clinical data and future major plans for tuspetinib in a recent business performance announcement. Tuspetinib is an innovative new drug that targets major kinases that act on myeloid malignant tumors in a differentiated pattern. It is being developed as an oral treatment administered once a day.
Aptoz reported that more than 170 patients with severe relapsed or refractory (R/R) AML received tuspetinib alone or in combination with venetoclax (VEN) in the phase 1/2 clinical trial. In monotherapy with 80 mg of tuspetinib, the recommended dose for phase 2 clinical trials, 36% of patients with no VEN treatment experience showed complete response (CR) or complete response with partial hematological recovery (CRh), confirming an excellent safety profile. . Complete response does not mean complete cure, but refers to a state in which all symptoms of the disease disappear after treatment and the presence of the disease cannot be detected.
Aptoz also explained that when tuspetinib was combined with VEN in patients with relapsed or refractory (R/R) AML, an excellent safety profile and drug response were confirmed regardless of whether the patient had prior VEN treatment.
In particular, when administering tuspetinib, there were no notable side effects or typical toxic reactions observed with other drugs in the same class, and it was said to show broad activity across AML patients with various genetic mutations.
Aptoz also shared its research and development schedule for the three-drug combination therapy. The plan is to present data related to tuspetinib and VEN combination therapy at the 2024 European Hematology Association (EHA) and to initiate a preliminary study of the triple combination therapy for AML patients this summer. Subsequently, the initial efficacy and safety data of the triple combination therapy study will be announced at the 2024 American Society of Hematology (ASH).
Next year, we plan to select and announce the dosage of tuspetinib in triple combination therapy at the 2025 European Society of Hematology and complete the preliminary research. The plan is to begin phase 2 and 3 clinical trials for the triple combination therapy in the second half of next year. The plan, which includes a number of world-class academic conferences, shows Aptose’s confidence in the tuspetinib research and clinical data that will be compiled in the future.
William Rice, founder and CEO of Aptoz, said, “When administered alone or in combination with VEN to patients with relapsed and refractory AML, tusfetinib showed remarkable results in patients with various types of AML gene mutations. “It demonstrated acceptable safety and broad-spectrum activity,” he said. “The same profile was confirmed in the FLT3 wild-type patient group, which accounts for more than 70% of AML patients.” He especially emphasized, “Among the drugs currently under development, there are very few substances that show such a broad spectrum of activity.”
Chairman William Rice then explained, “Based on the clinical data to date, we are planning a triple-drug combination therapy study to develop tuspetinib as a first-line treatment for newly diagnosed AML patients who are not suitable for induction chemotherapy.” .
Kim Min-beom, Donga.com reporter [email protected]
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2024-04-10 09:34:37