Hanmi Pharmaceutical said on Monday its U.S. partner Aptose Biosciences will expand global clinical trials of investigative oral drug HM43239 for the treatment of acute myeloid leukemia (AML) following complete remission (CR) was confirmed in its phase 1/2 trials conducted in the U.S. and Korea.

HM43239, a novel FLT3 inhibitor that potently inhibits FLT3 mutants, was licensed out to Aptose in November last year. It was granted Orphan Drug Designation (ODD) in the U.S. in 2018.

The latest data from phase 1/2 clinical studies announced by Aptose in June showed complete remission in all three doses of 80 mg, 120 mg, and 160 mg in relapsed and refractory AML patients.

Aptose plans to expand monotherapy and combination therapy trials by starting a study to evaluate the efficacy of HM43239 120 mg in FLT3-mutant patients who do not respond to existing FLT3 inhibitors.

The company will also conduct a clinical trial of HM43239 80 mg in combination with existing AML treatment Venclexta (venetoclax).

Meanwhile, the United States Adopted Name (USAN) Council recommended tuspetinib as the ingredient name for HM43239.

Hanmi shares gained 1.14 percent to close at 266,500 won on Monday.

By Pulse

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