Hutchmed (China) Limited Phase Ib/II Combination Study of HMPL-453
04 Février 2022 - 10:29AM
RNS Non-Regulatory
TIDMHCM
Hutchmed (China) Limited
04 February 2022
Press Release
HUTCHMED Initiates Phase Ib/II Study of HMPL-453 in Combination
with Chemotherapy or Toripalimab for Advanced Solid Tumors in
China
Hong Kong, Shanghai & Florham Park, NJ - Friday , February 4
, 2022: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that it has initiated a Phase Ib/II study
in China of HMPL-453, an investigational novel selective inhibitor
targeting fibroblast growth factor receptors ("FGFR") 1/2/3, in
combination with chemotherapy or the anti-PD-1 therapy,
toripalimab. The first patient received their first dose on January
22, 2022.
The clinical trial is a multi-center, two-stage, open-label
study to evaluate the safety, tolerability, pharmacokinetics and
preliminary efficacy profile of HMPL-453 combination therapy in
patients with specific advanced or metastatic solid tumors.
The first stage of the study is a dose escalation phase to
determine the dose limiting toxicity (DLT) and recommended Phase II
dose ("RP2D") of HMPL-453 in combination with chemotherapy
(gemcitabine and cisplatin) or toripalimab. The second stage of the
study is a dose expansion phase in solid tumor patients with either
gastric cancer, intrahepatic cholangiocarcinoma, or urothelial
carcinoma, harboring specific FGFR gene alterations. Each solid
tumor cohort will be treated with a specific combination of HMPL --
453 and a chemotherapy or anti-PD-1 therapy to further evaluate the
preliminary efficacy, safety and tolerability at the RP2D.
A Phase II study of HMPL-453 monotherapy is also underway in
patients with advanced intrahepatic cholangiocarcinoma (IHCC) in
China (clinicaltrials.gov identifier NCT04353375).
About HMPL--453
HMPL--453 is a novel, highly selective and potent inhibitor
targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found
to be a driving force in tumor growth (through tissue growth and
repair), promotion of angiogenesis and resistance to anti-tumor
therapies. Abnormal FGFR gene alterations are believed to be the
drivers of tumor cell proliferation in several solid tumor
settings.
HUTCHMED currently retain all rights to HMPL-453 worldwide.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative,
commercial-stage, biopharma-ceutical company. It is committed to
the discovery and global develop-ment and commercial-ization of
targeted therapies and immuno-therapies for the treatment of cancer
and immuno-logical diseases. It has more than 4,600 personnel
across all its companies, at the center of which is a team of about
1,500 in oncology/ immunology. Since inception it has advanced 12
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, includ-ing its expectations regarding the thera-peutic
potential of HMPL-453, the further clinical develop-ment for
HMPL-453, its expectations as to whether any studies on HMPL-453
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-453, 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-453 for a targeted indication; the sufficiency of
funding; and the impact of the COVID-19 pandemic on general
economic, regulatory and political conditions. In addition, as
certain studies rely on the use of gemcitabine, cisplatin,
docetaxel and toripalimab as combination therapeutics with
HMPL-453, such risks and uncertainties include assum-ptions
regarding the safety, efficacy, supply and continued regulatory
approval of these therapeutics. 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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