RCS - Hutchmed China Ltd - Phase Ib/II Combination Study of HMPL-453

HUTCHMED (China)Announcement

04/02/2022 09:30

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RNS Number : 7470A  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 (https://www.hutch-med.com/) ")
(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 (https://clinicaltrials.gov/ct2/show/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
(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, 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 (mailto:bmiles@troutgroup.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,                    +852 9783 6894 (Mobile)

Brunswick                         HUTCHMED@brunswickgroup.com (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley,  +44 (20) 7886 2500

Panmure Gordon (UK) Limited

 

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