Hutchmed (China) Limited Phase 1 Study of HMPL-415 Initiated
July 10 2023 - 2:00AM
RNS Non-Regulatory
TIDMHCM
Hutchmed (China) Limited
10 July 2023
Press Release
HUTCHMED Initiates Phase I Study of its novel SHP2 inhibitor
HMPL-415 for Advanced Malignant Solid Tumors in China
Hong Kong, Shanghai & Florham Park, NJ - Monday, July 10,
2023: 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 thera-peutic
potential of HMPL-415, the further clinical develop-ment 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
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
[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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