Hanmi Pharmaceutical said it licensed out FLT3 inhibitor (HM43239), an investigational treatment for acute myeloid leukemia (AML), to Aptose Biosciences, a U.S. biotech firm.
Aptose is a Nasdaq-listed firm specializing in research and development in hematology, and its headquarters is located in Toronto, Canada.
Aptose has four experimental drugs to treat hematologic malignancies such as relapsed or refractory AML and high-risk myelodysplastic syndrome (MDS). In 2016, Aptose licensed-in CG-806, an FLT3/BTK multi-cluster kinase inhibitor, from Korean biotech company CrystalGenomics.
Under the agreement with Hanmi, Aptose will secure the exclusive rights to develop and commercialize HM43239 around the world.
Under the deal, Hanmi will receive an upfront payment of $12.5 million, including $5 million in cash and $7.5 million in Aptose shares. In addition, Hanmi can also receive up to $407.5 million in future milestone payments upon achieving clinical, regulatory, and sales milestones on various indications and royalties according to net sales, the company said.
HM43239 inhibits FLT3 mutation (FMS-like tyrosine kinase 3 ITD and TKD) and SYK that causes AML. Thus, the drug is involved in the proliferation, differentiation, and resistance of myeloid malignancies.
Hanmi had said that it confirmed complete response in HM43239-treated patients who did not respond to existing therapies. The drug could help overcome drug resistance in patients with intractable blood diseases.
A phase 1/2 clinical trial in relapsed or refractory AML is ongoing in the U.S., and the dose-escalation portion of the study confirmed a potent anti-cancer effect, Hanmi said.
HM43239 obtained orphan drug designation (ODD) from the U.S. FDA in 2018 and a clinical-stage orphan drug status from Korea’s Ministry of Food and Drug Safety in 2019.
“HM43239 is a well-tolerated, once-daily oral agent with validated anti-leukemic activity in a highly challenging and heterogeneous malignancy like AML,” said William G. Rice, chairman of Aptose Biosciences. “We believe that HM43239 has a clear development and commercial path while being a natural fit with our strategic focus, technical expertise, and clinical experience.”
Jotin Marango, senior vice president of Aptose, said that he was pleased to add the new clinical compound to the company’s pipeline and that the latest agreement would bring significant value to the company and shareholders.
Marango added that HM43239 would enhance the company’s leukemia and lymphoma therapeutics lineup along with luxeptinib.
Hanmi Pharmaceutical CEO Kwon Se-chang said HM43239 is a promising drug that can specifically target mutations found in AML and overcome the drug resistance of existing drugs.
Through the partnership with Aptose, which has strong expertise in hematology, Hanmi will accelerate clinical development and commercialization, he said.