TIDMHCM
Hutchmed (China) Limited
09 August 2022
Press Release
Inmagene and HUTCHMED Announce First Participant in Global Phase
I Trial of IMG-004
San Diego, Shanghai and Hong Kong - Tuesday, August 9, 2022:
Inmagene Biopharmaceuticals ("Inmagene") and HUTCHMED (China)
Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) announce today that
the first participant, based in the United States, was dosed in a
global Phase I trial of IMG-004, a non-covalent, reversible,
third-generation Bruton Tyrosine Kinase ("BTK") inhibitor. Inmagene
is developing the drug candidate to potentially treat immunological
diseases.
The Phase I study is a double-blind, randomized,
placebo-controlled, single and multiple dose escalation study in
healthy subjects. The study aims to explore IMG-004's safety,
tolerability, pharmacokinetics, and pharmacodynamics in healthy
subjects. Additional details can be found at clinicaltrials.gov,
using identifier NCT05349097.
"IMG-004 is the second novel drug candidate under the
collaboration with HUTCHMED which Inmagene has successfully
advanced into clinical studies this year," said Dr Jonathan Wang,
Inmagene's Chairman and Chief Executive Officer. "Inmagene also
expects to submit another investigational new drug ("IND")
application for a third novel drug candidate in 2022. Such results
have demonstrated the Inmagene team's innovative and execution
capabilities."
Dr Jean-Louis Saillot, Chief Development Officer of Inmagene,
said, "IMG-004 was designed specifically for inflammatory and
autoimmune diseases, and in preclinical models, it has shown
improved activity, selectivity, and pharmacokinetic profile. We
welcome the start of the IMG-004 clinical program with the hope of
developing an innovative, safe and effective treatment option for
patients with immunological diseases."
About IMG-004
IMG-004 is a non-covalent, reversible small molecule inhibitor
targeting BTK. Designed specifically for inflammatory and
autoimmune diseases that usually require long-term treatment,
IMG-004 is potent, highly selective and brain permeable. It was
originally discovered by HUTCHMED, with Inmagene assuming
development responsibility at the candidate stage. Inmagene has an
exclusive option to in-license IMG-004's global rights for the
treatment of immunological diseases.
About BTK
BTK is a non-receptor tyrosine kinase in the Tec family of
protein tyrosine kinases. It is involved in innate and adaptive
immune responses related to certain immune-mediated diseases. Given
the central role of BTK in immunity pathways, BTK inhibitors may
offer a potential therapeutic approach for the treatment of a wide
range of inflammatory and autoimmune diseases.
About Inmagene
Inmagene is a global clinical-stage biotechnology company
focused on developing novel therapeutics for immunology-related
diseases. The company is building a robust pipeline of nearly
twenty drug development programs.
Inmagene's most advanced drug candidate is IMG-020 (izokibep),
which has successfully met the endpoints in global phase II studies
for both psoriasis and psoriatic arthritis ("PsA"). It has received
the IND approval from the Center for Drug Evaluation (CDE) of the
China National Medical Products Administration (NMPA) for phase III
studies in plaque psoriasis. Inmagene is working with its partners
to conduct global phase II studies for multiple autoimmune
diseases, including PsA, ankylosing spondylitis (AS) and uveitis.
In addition, IMG-004 and IMG-007, both of which with options on
global rights, are in global phase I studies.
Believing in "Borderless Innovation", the Inmagene team strives
to integrate efficient resources worldwide to develop novel
therapeutics for global patients. Based on its proprietary
QuadraTek(TM) drug discovery platform, Inmagene is operating 12
"Smart Innovation" programs to create and develop drug candidates
with global rights. Inmagene also in-licenses drug candidates and,
together with its partners, carries out global development
activities, including global multi-center clinical trials. Inmagene
has formed strategic partnerships with multiple partners, such as
HUTCHMED and Affibody AB, to develop highly innovative drug
candidates. For more information, please visit: www.inmagenebio.com
.
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 4,900 personnel across all
its companies, at the center of which is a team of about 1,800 in
oncology/immunology. Since inception it has advanced 13 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 Inmagene's and/or HUTCHMED's current
expectations regarding future events, including expectations
regarding the therapeutic potential of IMG-004 for the treatment of
patients with immunological diseases, the further clinical
development of IMG-004, expectations as to whether clinical studies
of IMG-004 would meet their primary or secondary endpoints, and
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 IMG-004 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 IMG-004 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 various risks applicable to
HUTCHMED, see HUTCHMED's filings with the U.S. Securities and
Exchange Commission, on AIM and with The Stock Exchange of Hong
Kong Limited. Neither Inmagene nor HUTCHMED undertakes to update or
revise the information contained in this press release, whether as
a result of new information, future events or circumstances or
otherwise.
INMAGENE CONTACTS
Investor Enquiries
Aaron Liu aaronliu@inmagenebio.com
Media Enquiries
Sinara Zhang zhangy@inmagenebio.com
HUTCHMED 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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