On June 7, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that it has initiated Phase I clinical trial of its menin inhibitor HMPL-506 in patients with hematological malignancies in China (Press release, Hutchison China MediTech, JUN 7, 2024, View Source [SID1234644193]). The first patient received their first dose on May 31, 2024.

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This is a Phase I, multicenter, open-label clinical study to evaluate the safety, pharmacokinetics and efficacy of HMPL-506 in patients with hematological malignancies. The study is divided into two phases, a dose escalation phase and a dose expansion phase. The study is expected to enroll at least 60 patients. The lead principal investigators are Dr. Jianxiang Wang and Dr. Hui Wei of Chinese Academy of Medical Sciences Blood Diseases Hospital. Additional details may be found at clinicaltrials.gov, using identifier NCT06387082.

About HMPL-506 and Menin

HMPL-506 is a novel, investigational, selective small molecule inhibitor for oral administration targeting the menin protein. The menin protein is a scaffold protein that controls gene expression and cell signaling. Mixed-lineage leukemia ("MLL", also known as KMT2A) rearrangement and nucleophosmin 1 ("NPM1") mutation play key roles in acute myeloid leukemia ("AML"). MLL-rearranged AML accounts for approximately 5% of adult AML and NPM1-mutant AML accounts for approximately 30% of AML.[1],[2],[3] Current research has demonstrated that the inhibition of menin-MLL interaction is a feasible therapeutic strategy in MLL-rearranged and/or NPM1-mutant AML.[4],[5],[6],[7] Currently there is no menin inhibitor approved worldwide. HUTCHMED currently retains all rights to HMPL-506 worldwide.

According to the National Cancer Institute (NCІ), there will be approximately 20,380 new cases of AML in the U.S. in 2023 and the five-year relative survival rate is 31.7%.[8] There were an estimated 19,700 new cases of AML in China in 2018 and is estimated to reach 24,200 in China in 2030.