RCS - Hutchmed China Ltd - First Participant in Phase I Trial of IMG-004

HUTCHMED (China)Announcement

09/08/2022 09:30

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RNS Number : 3931V  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 (https://www.inmagenebio.com/) ") and HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (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 (https://clinicaltrials.gov/ct2/show/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
(https://www.hutch-med.com/sc/chi-med-and-inmagene-announce-strategic-partnership-to-develop-and-commercialize-portfolio-of-drug-candidates-for-immunological-diseases/)
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™ 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 (https://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 (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 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 (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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