HUTCHMED Initiates Phase I Study of its novel SHP2 inhibitor HMPL-415 for Advanced Malignant Solid Tumors in China
10 Luglio 2023 - 2:00AM
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13)
today announces that it has initiated a Phase I study in China of
HMPL-415, an investigational novel selective allosteric inhibitor
targeting Src homology-2 domain-containing protein tyrosine
phosphatase-2 (“SHP2”). The first patient received their first dose
on July 6, 2023.
The clinical trial is a multi-center, open-label
study to evaluate the safety, tolerability, pharmacokinetics and
preliminary efficacy profile of HMPL-415 as a single agent in
patients with advanced malignant solid tumors. This study is
expected to enroll up to approximately 80 patients, including
patients as part of the dose escalation stage, and further patients
at the determined recommended Ph II dose (RP2D). The leading
principal investigators are Dr. Tianshu Liu of Zhongshan Hospital
Fudan University and Dr. Nong Yang of Hunan Cancer Hospital.
Additional details may be found at clinicaltrials.gov, using
identifier NCT05886374.
About HMPL-415
HMPL-415 is a novel, highly potent and selective
allosteric inhibitor targeting SHP2. SHP2 is a non-receptor protein
tyrosine phosphatase ubiquitously expressed mainly in the cytoplasm
of several tissues. SHP2 modulates diverse cell signaling events
that control metabolism, cell growth, differentiation, cell
migration, transcription and oncogenic transformation. It interacts
with diverse molecules in the cell and regulates key signaling
events including RAS/ERK, PI3K/AKT, JAK/STAT and PD-1 pathways
downstream of several receptor tyrosine kinases (RTKs) upon
stimulation by growth factors and cytokines. Dysregulation of SHP2
expression or activity causes many developmental diseases, and
hematological and solid tumors.1
HUTCHMED currently retains all rights to
HMPL-415 worldwide.
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
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-415, the further clinical development
for HMPL-415, its expectations as to whether any studies on
HMPL-415 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-415, 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-415 for a targeted indication; the sufficiency of
funding; and the impact of COVID-19 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 |
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Mark Lee, Senior Vice President |
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+852 2121 8200 |
Annie Cheng, Vice President |
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+1 (973) 306-4490 |
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Media Enquiries |
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Americas – Brad Miles, Solebury Strategic
Communications |
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+1 (917) 570 7340 (Mobile) /
bmiles@soleburystrat.com |
Europe – Ben Atwell / Alex Shaw,
FTI Consulting |
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+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) /
HUTCHMED@fticonsulting.com |
Asia – Zhou Yi, Brunswick |
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+852 9783 6894 (Mobile) /
HUTCHMED@brunswickgroup.com |
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Nominated Advisor |
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Atholl Tweedie / Freddy Crossley/ Daphne Zhang, Panmure Gordon |
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+44 (20) 7886 2500 |
1 Asmamaw, M.D., Shi, XJ., Zhang, LR. et al. A
comprehensive review of SHP2 and its role in cancer. Cell Oncol.
45, 729–753 (2022).
https://doi.org/10.1007/s13402-022-00698-1
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