HMPL-506 / Hutchmed - LARVOL DELTA

Menin inhibitors from monotherapies to combination therapies: clinical trial updates from 2024 ASH annual meeting. (PubMed, J Hematol Oncol) - "Following the promising outcomes of the two pioneering menin inhibitors, revumenib and ziftomenib, other menin inhibitors, including bleximenib, enzomenib, BN-104 and HMPL-506 are currently under investigation in clinical trials. Several trials presented their initial outcomes at the 2024 ASH Annual Meeting. This review highlights the key outcomes of these pivotal clinical trials."

Journal • Review • Hematological Malignancies • Leukemia • Oncology • KMT2A • MEIS1 • NPM1 • NUP98

A Clinical Study of HMPL-506 in Patients With Hematological Malignancies (clinicaltrials.gov) - P1 | N=132 | Recruiting | Sponsor: Hutchmed | N=98 ➔ 132

Enrollment change • Hematological Disorders • Hematological Malignancies • Oncology • HOXA9 • ITGAM

A Clinical Study of HMPL-506 in Patients With Hematological Malignancies (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Hutchmed | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hematological Malignancies • Oncology • HOXA9 • ITGAM

HUTCHMED Initiates Phase I Trial of Menin Inhibitor HMPL-506 in Patients with Hematological Malignancies in China (GlobeNewswire) - "HUTCHMED (China) Limited...announces that it has initiated Phase I clinical trial of its menin inhibitor HMPL-506 in patients with hematological malignancies in China. The first patient received their first dose on May 31, 2024. 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."

Trial status • Hematological Malignancies

A Clinical Study of HMPL-506 in Patients With Hematological Malignancies (clinicaltrials.gov) - P1 | N=98 | Not yet recruiting | Sponsor: Hutchmed

New P1 trial • Hematological Disorders • Hematological Malignancies • Oncology • HOXA9 • ITGAM

HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of MLL-rearrangedand NPM1mutant acute leukemia in preclinical models (AACR 2024) - "For instance, in MV-4-11 subcutaneous model, once daily oral administration of HMPL-506 at 5, 10 and 25 mg/kg for 4 days in BALB/c nude mice induced dose-dependent inhibition of MEIS1 gene expression, positively correlating with compound exposures in tumor tissues; continuous dosing of HMPL-506 at 5 mg/kg for 28 days reduced the tumor growth by 86%, which was comparable to the efficacy induced by SNDX-5613 at 50 mg/kg...Furthermore, HMPL-506 synergistically improved anti-tumor effect of azacytidine, venetoclax and gilteritinib against MLL-r leukemias both in vitro and in vivo... HMPL-506 is a novel and highly differentiated menin-MLL inhibitor with robust anti-tumor activities, favorable ADME properties and low risk of cardiac toxicity, warranting it further clinical development for treatment of MLL-r and NPM1m acute leukemias. HMPL-506 IND is expected to be cleared in H1 2024."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • HOXA9 • ITGAM • KMT2A • MEIS1 • NPM1

HUTCHMED Highlights Data to be Presented at AACR Congress 2024 (GlobeNewswire) - "Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of certain types of acute leukemia. Compared with five other menin inhibitors in clinical development, HMPL-506 showed the stronger inhibitory potency in MLL-rearranged and NPM1 mutant leukemia cell line models. Furthermore, HMPL-506 in combination with azacytidine, venetoclax or gilteritinib synergistically improved the anti-tumor effect against MLL-rearranged leukemias both in vitro and in vivo....A Phase I study of HMPL-506 is planned for the second half of 2024."

New P1 trial • Preclinical • Acute Myelogenous Leukemia