Hutchmed Commences Phase I trial of Menin Inhibitor HMPL-506 in Patients

Hutchmed (China) Limited has started a phase I clinical trial of its menin inhibitor HMPL-506 in patients with haematological malignancies in China. The very first patient received their initial dose on May 31, 2024.

This is a stage I, multicenter, open-label clinical study to determine the safety, pharmacokinetics, and effectiveness of HMPL-506 in patients with haematological malignancies. The trial is split into two phases: dosage escalation and dose expansion. The trial is intended to include at least 60 individuals. The main principal investigators are Dr. Jianxiang Wang and Dr. Hui Wei from the Chinese Academy of Medical Sciences Blood Diseases Hospital.  

HMPL-506 is a novel, experimental, selective tiny molecule inhibitor for oral administration that targets the menin protein. Menin is a scaffold protein that regulates gene expression and cell signaling. AML is characterized by mixed-lineage leukaemia (MLL), commonly known as KMT2A rearrangement, and nucleophosmin 1 (NPM1) mutations. MLL-rearranged AML constitutes around 5% of adult AML, while NPM1-mutant AML accounts for roughly 30% of AML.

According to the National Cancer Institute (NC?), the US will have around 20,380 new cases of AML in 2023, with a five-year relative survival rate of 31.7%. In 2018, there were approximately 19,700 new cases of AML in China, with the number expected to rise to 24,200 by 2030.