TIDMHCM
Hutchmed (China) Limited
08 November 2021
Press Release
HUTCHMED Highlights HMPL-523 Clinical Data to be Presented at
the 2021 ASH Annual Meeting
Hong Kong, Shanghai & Florham Park, NJ - Monday, November 8,
2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that new analyses and updates on the
ongoing studies of HMPL-523 and HMPL-306 will be presented at the
upcoming 63(rd) American Society for Hematology's (ASH) Annual
Meeting and Exposition, taking place on December 11-14, 2021. The
meeting will be held virtually and in person at the Georgia World
Congress Center in Atlanta, Georgia US.
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 Epidemio-logical: 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 (w AIHA), 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).
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative,
commercial-stage, biopharmaceutical company. It is committed to the
discovery and global development and commercialization of targeted
therapies and immunotherapies for the treatment of cancer and
immunological diseases. It has more than 4,500 personnel across all
its companies, at the center of which is a team of over 1,400 in
oncology/immunology. Since inception it has advanced eleven cancer
drug candidates from in-house discovery into clinical studies
around the world, with its first three oncology drugs now approved
and marketed in China. For more information, please visit:
www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements reflect HUTCHMED's current expectations regarding future
events, including its expectations regarding the therapeutic
potential of HMPL-523 and HMPL-306 for patients, its expectations
as to whether any studies on HMPL-523 and HMPL-306 would meet their
primary or secondary endpoints, and its expectations as to the
timing of the completion and the release of results from such
studies. Forward-looking statements involve risks and
uncertainties. Such risks and uncertainties include, among other
things, assumptions regarding enrollment rates and the timing and
availability of subjects meeting a study's inclusion and exclusion
criteria; changes to clinical protocols or regulatory requirements;
unexpected adverse events or safety issues; the ability of HMPL-523
and HMPL-306, including as a combination therapy, to meet the
primary or secondary endpoint of a study, to obtain regulatory
approval in different jurisdictions and to gain commercial
acceptance after obtaining regulatory approval; the potential
market of HMPL-523 and HMPL-306 for a targeted indication; the
sufficiency of funding; and the impact of the COVID-19 pandemic on
general economic, regulatory and political conditions. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. For further discussion of these and other risks, see
HUTCHMED's filings with the U.S. Securities and Exchange
Commission, The Stock Exchange of Hong Kong Limited and on AIM.
HUTCHMED undertakes no obligation to update or revise the
information contained in this press release, whether as a result of
new information, future events or circumstances or otherwise.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, +1 (917) 570 7340 (Mobile)
Solebury Trout bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
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