RCS - Hutchmed China Ltd - HUTCHMED Initiates Phase I Trial of HMPL-653

HUTCHMED (China)Announcement

20/01/2022 07:05

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RNS Number : 9590Y  Hutchmed (China) Limited  20 January 2022

Press Release

 

HUTCHMED Initiates a Phase I Trial of HMPL-653 in Patients with Advanced Malignant Solid Tumors and TGCT in China

 

 

Hong Kong, Shanghai & Florham Park, NJ - Thursday, January 20, 2022:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase I
trial in China of HMPL-653, an investigational novel, highly selective, and
potent colony-stimulating factor 1 receptor ("CSF-1R") inhibitor. The first
patient received their first dose on January 18, 2022.

 

The Phase I trial is a multicenter, open-label, single-arm study to evaluate
the safety, tolerability, pharmacokinetics and preliminary efficacy of
HMPL-653 in the treatment of patients with advanced or metastatic solid tumors
and tenosynovial giant cell tumors ("TGCT"). Approximately 110 patients are
expected to be enrolled in the dose escalation and expansion phase of this
study. The primary endpoints are dose limiting toxicity, safety, tolerability,
recommended phase II dose and maximum tolerated dose. The secondary endpoints
include pharmacokinetics, objective response rate, progression free survival,
disease control rate, and overall survival. The lead principal investigator is
Dr Cheng Ying of the Jilin Cancer Hospital, which is the lead institution for
this study.

 

About HMPL-653

HMPL-653 is an investigational novel, highly selective, and potent CSF-1R
inhibitor designed to target malignant driven tumors as a monotherapy or in
combination with other drugs.

 

CSF-1R is usually expressed on the surface of macrophages and can promote
growth and differentiation of macrophages after binding with its ligand,
CSF-1. A number of studies have shown that blocking the CSF-1R signaling
pathway could effectively modulate the tumor microenvironment, relieve tumor
immunosuppression, and synergize with other anti-cancer therapies such as
immune checkpoint inhibitors to achieve tumor inhibition. It has been
demonstrated in several clinical studies that other CSF-1R inhibitors, by
inhibiting CSF-1R activity, could be used to treat TGCT, and to treat a
variety of malignancies through combination with immuno-oncology and/or other
therapeutic agents. Currently no CSF-1R inhibitor has been approved in China.

 

HUTCHMED currently retains all rights to HMPL-653 worldwide.

 

About TGCT

TGCT is a very rare type of soft tissue tumor caused by abnormal proliferation
and inflammation of giant cells, monocytes and inflammatory cells. These
tumors are mainly characterized by the expression of CSF-1. Targeting CSF-1R
has become an effective therapeutic strategy for TGCT. The incidence of TGCT
is approximately between 1.8 and 50 per 1 million people. 1  Surgery is the
standard treatment for TGCT patients. However, among patients with diffuse or
recurrent/refractory TGCT, tumors are wrapped in peripheral organs such as
bone, tendon, ligament and joint, which makes removal by surgery difficult.
The recurrence rate of diffuse-type cases is estimated to be 21% to 50%. 2 
There is a high unmet need for effective and safe treatment for these
patients.

 

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 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, including its expectations regarding the
therapeutic potential of HMPL-653 for patients, its expectations as to whether
any studies on HMPL-653 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-653, 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-653 for a targeted indication; the
sufficiency of funding; and the impact of the COVID-19 pandemic 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) 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

 

 

 1  Rockberg J, Bach BA, Amelio J, et al. J Bone Joint Surg Am.
2015;97:1756-66.

 2  Gouin F, Noailles T. Orthop Traumatol Surg Res. 2017;103(1S):S91-S97.

 

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