On November 8, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that new analyses and updates on the ongoing studies of HMPL-523 and HMPL-306 will be presented at the upcoming 63rd American Society for Hematology’s (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place on December 11-14, 2021 (Press release, Hutchison China MediTech, NOV 8, 2021, View Source [SID1234594662]). The meeting will be held virtually and in person at the Georgia World Congress Center in Atlanta, Georgia US.
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Further details of the presentations are as follows:
HMPL-523 Clinical Data Presentations
Title: Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Patients with Primary Immune Thrombocytopenia: A Randomized, Double-Blind and Placebo-Controlled Phase Ib Study
Presenter: Renchi Yang, MD, Hematology Hospital of the Chinese Academy of Medical Sciences
Session: 311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Treatment of Immune Thrombocytopenia
Abstract No.: 149895
Date & Time: Saturday, December 11, 2021 9:30am – 11am ET
Location: Georgia World Congress Center, C101 Auditorium and virtually
Title: Preliminary Results from a Phase I Study of HMPL-523, a Selective, Oral Syk Inhibitor, in Patients with Relapsed or Refractory Lymphoma
Presenter: Paolo Strati, MD, The University of Texas MD Anderson Cancer Center
Session: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II
Abstract No.: 2432
Date & Time: Sunday, December 12, 2021 6:00pm – 8:00pm ET
Location: Georgia World Congress Center, Hall B5 and virtually
HMPL-306 (Trial in Progress)
Title: A Phase I, Open-Label, Multicenter Study of HMPL-306 in Advanced Hematological Malignancies with Isocitrate Dehydrogenase (IDH) Mutations
Lead Author: Anu Doraiswamy, MD, Rutgers Cancer Institute of New Jersey
Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies
Abstract No.: 4438
Date available: November supplemental issue of ‘Blood’
About HMPL-523
HMPL-523 is a novel, investigational, selective small molecule inhibitor for oral administration targeting spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders.
HUTCHMED currently retains all rights to HMPL-523 worldwide. The ESLIM-01 Phase III trial is underway to evaluate the efficacy and safety of HMPL-523 in treating adult patients with primary immune thrombocytopenia (ITP), an autoimmune disorder that can lead to increased risk of bleeding. Additional details may be found at clinicaltrials.gov, using identifier NCT05029635 . HMPL-523 is also being studied in indolent non-Hodgkin’s lymphoma and multiple subtypes of B-cell malignancies in China (NCT02857998 ), the U.S. and Europe (NCT03779113 ). A trial to study HMPL-523 in patients with warm autoimmune hemolytic anemia (wAIHA), another autoimmune disorder, is also planned.
About HMPL-306
HMPL-306 is an investigative and selective small molecule inhibitor of IDH1 and IDH2, and the company’s sixth novel oncology candidate to enter global clinical development. IDH1 and IDH2 mutations have been implicated as drivers of certain hematological malignancies, gliomas and solid tumors, particularly among acute myeloid leukemia patients. Cytoplasmic mutant IDH1 and mitochondrial mutant IDH2 have been known to switch to the other form when targeted by an inhibitor of IDH1 mutant alone or IDH2 mutant alone. Targeting both IDH1 and IDH2 mutations could potentially provide therapeutic benefits in cancer patients harboring either IDH mutation, and may address acquired resistance to IDH inhibition through isoform switching.
HUTCHMED currently retains all rights to HMPL-306 worldwide. Phase I studies have been initiated in patients with hematological malignancies in China (NCT04272957 ) and the U.S. and Europe (NCT04764474 ), and in patients with solid tumors in the U.S. and Europe (NCT04762602 ).