R&D

Pipeline

The hero of the global First-in Class is Hanmi Pharmaceutical.
Hanmi Pharmaceutical is developing in the areas of anti-cancer,
obesity, diabetes, and rare diseases.

Focused Pipeline

Overview

HM43239 is an orally active small molecule inhibitor of fms-like tyrosine kinase 3 (FLT3) that selectively inhibits not only FLT3 wild type, internal tandem duplication (ITD) mutation or tyrosine kinase domain (TKD) mutation, but also FLT3 ITD/TKD double mutations.

HM43239 also demonstrated inhibition of spleen tyrosine kinase (SYK), known to be involved in tumor cell proliferation and/or differentiation.

Monotherapy of HM43239 induced dose-dependent regression of tumor growth in FLT3 wild-type and FLT3 mutated leukemia cancer cell lines. Moreover, HM43239 overcomes the stromal cell induced AML resistance by inhibiting of SYK signaling pathway. HM43239 prolonged survival in a FLT3 ITD/TKD double mutated xenograft mouse model. The anti-leukemic activity of HM43239 monotherapy in in vivo studies showed the potency for the targeting target leukemia stem cells (LSCs). HM43239 might be an effective agent in patients with hematologic malignancies including acute myeloid leukemia (AML), to target various mutant types of FLT3.

Clinical Development

We are currently conducting the Phase I/II clinical trial in patients with AML. This clinical trial consists of dose escalation (Part A) and dose expansion (Part B) stages to access the overall safety and efficacy findings. HM43239 was granted Orphan Drug Designation(ODD) in AML by US(Oct. 2018) and KR(Feb. 2019). For more information, please visit clinicaltrials.gov (NCT03850574)

Publications
Antitumor activity of the potent and novel FLT3 inhibitor HM43239 in acute myeloid leukemia
Poster, American association for cancer research (AACR) 109th Annual meeting, 2018
HM43239, a novel FLT3 inhibitor in overcoming resistance for acute myeloid leukemia
Poster, American association for cancer research (AACR) 110th Annual meeting, 2019
HM43239, a novel potent small molecule FLT3 Inhibitor, in acute myeloid leukemia (AML) with FMS-like tyrosine kinase 3 (FLT3) mutations: phase 1/2 Study
Poster, American society of hematology (ASH) 61st Annual meeting, 2019
Press Releases