Aptose Biosciences And Hanmi Pharmaceutical Enter New Loan Agreement To Accelerate Development Of Tuspetinib In Triplet Therapy For Acute Myeloid Leukemia (AML)

Aptose Biosciences Inc., a clinical-stage precision oncology company focused on developing targeted therapies for cancer, has entered into a new loan agreement with Hanmi Pharmaceutical Co. Ltd. The agreement is structured as an uncommitted facility of up to US $8.5 million and will be administered through multiple advances. The primary purpose of the funding is to support the ongoing clinical development of Aptose’s lead drug candidate, tuspetinib (TUS), in combination therapy for the treatment of newly diagnosed acute myeloid leukemia (AML).

The transaction qualifies as a “related-party transaction” under Canadian securities regulations, specifically within the framework of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions, as Hanmi is considered a related party to Aptose. However, Aptose has chosen to rely on the exemption from the formal valuation and minority shareholder approval requirements based on the “financial hardship” exemption provided in the regulation. Tuspetinib is an oral, once-daily investigational therapy that selectively targets multiple cancer-driving kinases, including SYK, both mutated and wild-type forms of FLT3, KIT mutations, JAK1/2, and RSK2. Unlike many existing therapies, it aims to avoid common toxicities, potentially offering a safer alternative for patients.

William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose, said, “Aptose is incredibly grateful for Hanmi’s continued support tuspetinib. Our data to date in the TUS+VEN+AZA triplet reveal promising antileukemic activity and safety across diverse AML populations – some with the greatest unmet needs.”

The funding will support Aptose’s ongoing Phase 1/2 clinical trial, known as the TUSCANY triplet study. This study is evaluating different doses and schedules of tuspetinib in combination with azacitidine and venetoclax, both of which are standard-of-care drugs. The trial focuses on newly diagnosed AML patients who are not eligible for intensive induction chemotherapy. Preliminary results from the first two dose cohorts have shown encouraging signs, including good tolerability, complete remissions, and evidence of minimal residual disease (MRD) negativity across patients with a wide range of genetic mutations.