The History of Tuspetinib
Tuspetinib (HM43239) was originally discovered by Hanmi Pharmaceutical. Initial in vitro and in vivo work suggested that tuspetinib specifically targets mutations commonly found in AML patients, while overcoming drug resistance observed with currently approved drugs. Based on its unique and promising preclinical profile, Hanmi advanced tuspetinib to a Phase 1 clinical study enrolling patients initially in South Korea and later also in the United States. In October 2018, tuspetinib was granted Orphan Drug Designation (ODD) in AML in the US. On November 4, 2021, Aptose and Hanmi entered into an exclusive worldwide license agreement for the development and commercialization of tuspetinib, and on January 1, 2022, Aptose took over the management of the ongoing study and clinical program. The dose escalation portion of the ongoing study thus far has delivered multiple complete responses in a diverse set of patients with various AML genotypes, and no toxicity trends that prevent further dose escalation to date.
