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Chi-Med Initiates Phase I Trial of HMPL-306 in Hematological Malignancies With IDH1/2 Mutations

NEW YORK − Hutchison Medipharma, a subsidiary of Chi-Med, said on Friday that it has started a Phase I trial in China for HMPL-306 in patients with IDH1 and IDH2-mutated relapsed or refractory myeloid leukemia or neoplasms and has dosed the first patient.

HMPL-306 is a novel selective small molecule dual inhibitor of mutated IDH1 and IDH2. The multi-center study will evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of HMPL‑306. The dose escalation portion of the study will determine the maximum tolerated dose and the recommended Phase II dose. The study will also include a dose expansion portion, which will sort patients into three cohorts and evaluate the clinical activity of HMPL-306.

Patients who have central nervous system metastases or have previously progressed after treatment with an IDH1 inhibitor, IDH2 inhibitor, or IDH1/IDH2 double-targeted therapy will be excluded from the study. 

Agios, Forma Therapeutics, and Celgene are all exploring the potential of IDH inhibitors as both a monotherapy and in combination with other drugs for treating patients with leukemia and glioma.