TIDMHCM
Hutchmed (China) Limited
09 June 2023
Press Release
HUTCHMED Highlights Presentations for Hematological Malignancy
Programs at the 2023 EHA and ICML Meetings
Hong Kong, Shanghai & Florham Park, NJ - Friday, June 9,
2023: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:
13) today announces that new and updated clinical data related to
two novel investigational hematological malignancy therapies,
HMPL-306 and amdizalisib, will be presented at the upcoming
European Hematology Association ("EHA") Annual Meeting, taking
place June 8-11, 2023 in Frankfurt, and the 17(th) International
Conference on Malignant Lymphoma ("ICML") taking place June 13-17,
2023 in Lugano.
HMPL-306: first in human results
Title: A phase 1 study of HMPL-306, a dual inhibitor of mutant
isocitrate dehydrogenase (IDH) 1 and 2, in pts with
relapsed/refractory myeloid hematological malignancies
harboring IDH1 and/or 2 mutations
Lead Author: Lijuan Hu, MD, Peking University People's Hospital
Meeting: EHA poster presentation
Session: Myeloproliferative neoplasms - Clinical
Abstract # Abstract #P539
& Link:
Mutations in isocitrate dehydrogenase ("IDH") 1/2 are frequently
identified in various cancers, such as acute myeloid leukemia
("AML"), cholangiocarcinoma, chondrosarcoma and glioma. Mutant IDHs
cause accumulated 2-hydroxyglutarate, leading to blockage of cell
differentiation, thereby inducing malignant transformation. Mutant
IDH isoform switching, from mutant IDH1 to mutant IDH2 and vice
versa, have been reported as a mechanism of acquired resistance to
IDH inhibition in AML and cholangiocarcinoma, as well as cases
initially carrying co-existing mutations.
Preclinical data presented at the American Association for
Cancer Research Annual Meeting 2023 (AACR 2023) demonstrated that
HMPL-306 is a potent, durable, dual inhibitor of IDH1/2 mutation
that crosses the blood brain barrier and affects pharmacodynamic
("PD") markers that lead to the differentiation of immature
malignant cells to mature normal cells. It is being evaluated in
clinical trials (NCT04272957, NCT04762602, NCT04764474).
This first-in-human, dose-escalation study data presents
HMPL-306 in patients with relapsed/refractory myeloid hematological
malignancies harboring IDH1 and/or IDH2 mutations. Based on PD,
pharmaco-kinetic ("PK"), and preliminary clinical findings, a
recommended Phase II dose was nominated for the dose expansion
phase of the study.
Amdizalisib: updates from Phase Ib
Title: Updated results from a phase 1b study of amdizalisib,
a novel inhibitor of phospho-inositide 3-kinase-delta
(PI3K ), in patients with relapsed or refractory lymphoma
Lead Author: Junning Cao, MD, Fudan University Shanghai Cancer Center
Meeting: ICML Publication
Session: Phase I-II trials
Abstract #: Abstract #653
Amdizalisib (HMPL-689) is a novel, selective and potent oral
inhibitor targeting the isoform PI3K . Amdizalisib's PK properties
are favorable with good oral absorption, moderate tissue
distribution and low clearance in preclinical PK studies,
suggesting a low risk of drug accumulation and drug-to-drug
interaction. Because of its high target selectivity and optimal PK
profile, amdizalisib has the potential to demonstrate an optimal
benefit-risk profile in this class. Amdizalisib is currently being
evaluated in a Phase II registration trial in relapsed or
refractory follicular lymphoma ("FL") and marginal zone lymphoma
("MZL") as a single agent (NCT04849351), as well as in combination
with tazemetostat (a methyl-trans-ferase inhibitor of EZH2) in
patients with relapsed or refractory lymphoma in a Phase II study
in China (NCT05713110).
Here we report updated results from a Phase Ib study of
amdizalisib in patients with various subtypes of non--Hodgkin's
lymphoma ("NHL"). In this update, more mature data were available
from the FL cohorts, at median follow-up duration of 22.1 months.
Median duration of response ("DoR") and progression free survival
("PFS") were not reached for the 26 efficacy evaluable patients in
the FL cohort. PFS and DoR from the MZL cohort were presented for
the first time, at median follow-up duration of 20.3 months. Median
DoR was not reached and median PFS was 26.8 months for the 16
efficacy evaluable patients in the MZL cohort. Safety data were
reported from 153 patients with median exposure duration of 8.7
months. The most common treatment emergent adverse events (TEAEs)
of Grade >=3 (>=5%) were pneumonia (15.7%), neutrophil count
decreased (12.4%), lipase increased (7.8%), and rash (5.9%). The
treatment discontinuation rate due to adverse events was 11.8%.
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 approximately 5,000 personnel across
all its companies, at the center of which is a team of about 1,800
in oncology/ immunology. Since inception it has focused on bringing
cancer drug candidates from in-house discovery to patients 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-306 and amdizalisib, the further clinical
development for HMPL-306 and amdizalisib, its expectations as to
whether any studies on HMPL-306 and amdizalisib 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-306
and amdizalisib, 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-306 and amdizalisib 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) 306 4490
Media Enquiries
Americas - Brad Miles, Solebury Strategic Communications +1 (917) 570 7340 (Mobile) / bmiles@s oleburystrat .com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
FTI Consulting 545 055 (Mobile) / HUTCHMED@fticonsulting.com
Asia - Zhou Yi, Brunswick +852 97 83 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure
Gordon +44 (20) 7886 2500
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