HUTCHMED Begins Phase I Trial of Menin Inhibitor HMPL-506 in Chinese Patients with Blood Cancers

HUTCHMED (China) Limited has announced the initiation of a Phase I clinical trial for its menin inhibitor, HMPL-506, aimed at treating patients with hematological malignancies in China. This open-label, multicenter study began with the first patient receiving the initial dose on May 31, 2024.

The clinical trial is structured into two phases: dose escalation and dose expansion, with the goal of assessing the safety, pharmacokinetics, and efficacy of HMPL-506. The trial plans to enroll at least 60 patients and is led by Dr. Jianxiang Wang and Dr. Hui Wei from the Chinese Academy of Medical Sciences Blood Diseases Hospital.

HMPL-506 is an innovative, selective small molecule inhibitor designed for oral administration, targeting the menin protein. Menin, a scaffold protein, plays a crucial role in controlling gene expression and cell signaling, particularly in cases involving mixed-lineage leukemia (MLL) and nucleophosmin 1 (NPM1) mutations. MLL-rearranged acute myeloid leukemia (AML) accounts for about 5% of adult AML cases, while NPM1-mutant AML constitutes approximately 30%. Recent studies indicate that inhibiting the menin-MLL interaction can be an effective therapeutic approach for treating MLL-rearranged and NPM1-mutant AML. Currently, no menin inhibitors have been approved globally, and HUTCHMED retains all rights to HMPL-506.

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

HUTCHMED, listed on Nasdaq and AIM under the ticker HCM and on HKEX under the symbol 13, is a biopharmaceutical company dedicated to developing and commercializing targeted therapies and immunotherapies for cancer and immunological diseases. The company employs around 5,000 people, with a significant portion of its workforce, approximately 1,800 individuals, focused on oncology/immunology. HUTCHMED has a history of taking cancer drug candidates from in-house discovery to market, with its first three oncology drugs already marketed in China, and the first of these also available in the U.S.

In summary, HUTCHMED's Phase I clinical trial for HMPL-506 represents a significant development in the treatment of hematological malignancies, specifically targeting the menin protein involved in MLL-rearranged and NPM1-mutant AML. With no current menin inhibitors approved worldwide, HUTCHMED's progress in this field is particularly noteworthy. The company's commitment to innovative cancer therapies is further evidenced by its extensive workforce and successful track record in bringing oncology drugs to market.