RARE Daily

Aptose Receives Global Rights to Hanmi’s Experimental Therapeutic Targeting Myeloid Malignancies

November 5, 2021

Aptose Biosciences entered into an exclusive license agreement with Hanmi Pharmaceutical of South Korean to develop and commercialize HM43239, an oral, highly potent, clinical-stage myeloid kinome inhibitor that is designed to target a distinct constellation of kinases operative in myeloid malignancies, including SYK, FLT3, and others.

Photo: William Rice, chairman, president and CEO of Aptose

Myeloid malignancies comprise a group of rare hematologic cancers that include myelodysplastic syndromes, myelofibrosis, and myeloid leukemia. HM43239 has demonstrated significant genotype-agnostic anti-leukemic activity in an ongoing phase 1/2 clinical trial, including multiple complete responses in patients with relapsed or refractory acute myeloid leukemia (AML).

Under the terms of their agreement, Hanmi has granted Aptose exclusive worldwide rights to HM43239 for all indications. Hanmi will receive an upfront payment of $12.5 million, including $5 million in cash and $7.5 million in Aptose shares. Hanmi will also receive up to $407.5 million in future milestone payments contingent upon the achievement of certain clinical, regulatory and sales milestones across several potential indications, as well as tiered royalties on net sales.

“Our deep experience with kinase inhibitors has led us to appreciate and develop agents covering constellations of kinases associated with specific malignancies,” said William Rice, chairman, president and CEO of Aptose. “HM43239 is a well-tolerated, once-daily oral agent with validated anti-leukemic activity in a highly challenging and heterogeneous malignancy like AML. 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.”

HM43239 is an oral genotype agnostic small molecule inhibitor of a constellation of kinases operative in myeloid malignancies and known to be involved in tumor proliferation, resistance to therapy, and differentiation. Preclinical in vitro and in vivo studies suggest that HM43239 may be an effective monotherapy and combination therapy in patients with hematologic malignancies including AML. An international phase 1/2 clinical trial in patients with relapsed or refractory AML is ongoing. The dose escalation portion of this study thus far has delivered multiple complete responses in a diverse set of patients with various disease genotypes, and no toxicity trends that prevent further dose escalation to date. HM43239 was granted Orphan Drug designation in AML By the U.S. Food and Drug Administration in October 2018.

“We view HM43239 as a promising drug for the treatment of myeloid hematologic malignancies, which can specifically target mutations that are commonly found in AML patients, while overcoming drug resistance observed with currently approved drugs,” said Se-Chang Kwon, CEO of Hanmi Pharmaceutical.

Author: Rare Daily Staff

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