RCS - Hutchmed China Ltd - Phase 1 Study of HMPL-415 Initiated

HUTCHMED (China)Announcement

10/07/2023 07:00

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RNS Number : 3771F  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 (https://www.hutch-med.com/) ") (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 (https://www.clinicaltrials.gov/ct2/show/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  (#_edn1)

 

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
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

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 (mailto:bmiles@soleburystrat.com)
                                                                 oleburystrat (mailto:bmiles@soleburystrat.com) .com
                                                                 (mailto:bmiles@soleburystrat.com)
 Europe - Ben Atwell / Alex Shaw,                                +44 20 3727 1030 / +44 7771 913 902 (Mobile) /

FTI Consulting                                                 +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
                                                                 (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi, Brunswick                                       +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                 (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley/ Daphne Zhang, Panmure Gordon  +44 (20) 7886 2500

 

 1  (#_ednref1) 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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