US-Korea leukemia new drug 'HM43239' confirms 'complete remission' cases in clinical trials

Hanmi Pharm Headquarters View (Photo by Hanmi Pharm)

[Asia Economy Reporter Chunhee Lee] Complete remission (CR) cases have been continuously confirmed in various mutant patient groups treated with Hanmi Pharmaceutical's innovative acute myeloid leukemia (AML) treatment drug 'HM43239.'

Hanmi Pharmaceutical's partner, Aptose, announced at the 'Key Opinion Leader (KOL)' webinar held on the 3rd that "successful results were obtained, including confirmation of complete remission cases in all dosage groups (80 mg, 120 mg, 160 mg) of HM43239 in global Phase 1 and 2 clinical trials targeting relapsed or refractory AML patients." Aptose plans to present detailed findings of this study at the 64th American Society of Hematology (ASH) meeting to be held in Los Angeles, USA, from December 10 to 13.

HM43239 is a once-daily oral myeloid kinome inhibitor (MKI) targeting key kinases acting in myeloid malignancies. It has been designated by the U.S. Food and Drug Administration (FDA) as a fast-track development drug and an orphan drug (OD).

Following the successful results of this clinical trial, Aptose plans to conduct expanded clinical trials for both monotherapy and combination therapy. In the monotherapy expansion trial, the efficacy of HM43239 120 mg will be confirmed in AML patient groups including FLT3 mutant patients who show no response to existing FLT3 inhibitors. Additionally, combination clinical trials of HM43239 80 mg with the existing AML treatment drug 'Venetoclax' are also planned.

Meanwhile, at this KOL, Aptose announced that "the United States Adopted Names Council (USAN) has decided the generic name of HM43239 as 'Tuspetinib'." Accordingly, Aptose will use the name Tuspetinib for HM43239 in official publications and corporate materials going forward.

This content was produced with the assistance of AI translation services.