RCS - Hutchmed China Ltd - First Participants in Phase I Trial of IMG-007

HUTCHMED (China)Announcement

06/07/2022 07:00

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RNS Number : 4867R  Hutchmed (China) Limited  06 July 2022

Press Release

 
Inmagene and HUTCHMED Announce First Participants in Global Phase I Trial of IMG-007

 

San Diego, Shanghai, Hong Kong and Sydney - Wednesday, July 6, 2022: Inmagene
Biopharmaceuticals ("Inmagene (https://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 Australia, was
dosed in a global Phase I trial of IMG-007, an investigational OX40
antagonistic monoclonal antibody.

 

The Phase I study is a multi-stage, double-blind, randomized,
placebo-controlled, dose-escalation study in healthy volunteers, and a
dose-escalation and parallel design, multiple-dose study in adult patients
with moderate to severe atopic dermatitis. The study will be used to evaluate
the safety, tolerability and efficacy of IMG-007 in patients with atopic
dermatitis. Additional details will be found at clinicaltrials.gov, using
identifier NCT05353972 (https://clinicaltrials.gov/ct2/show/NCT05353972) .

 

"Dosing the first participant is an important milestone for the IMG-007
program," said Dr Jonathan Wang, Chairman and Chief Executive Officer of
Inmagene. "We hope the data will help us demonstrate that IMG-007 is one of
the strongest OX40 antagonist drug candidates worldwide."

 

Dr Jean-Louis Saillot, Chief Development Officer of Inmagene, said, "IMG-007
blocks the OX40 activity and has demonstrated high potency in preclinical
studies, indicating a best-in-class potential. We welcome the start of the
IMG-007 clinical program with the hope of developing an innovative, safe and
effective treatment option for patients with atopic dermatitis and other
immunological diseases."

 

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of
HUTCHMED, said: "This is an exciting step towards taking our novel drug
candidates into immunological diseases, where Inmagene has significant
expertise, as we work to maximize the impact of our drug discovery engine."

 

About IMG-007

IMG-007 is a novel antagonistic monoclonal antibody targeting the OX40
receptor. 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/chi-med-and-inmagene-announce-strategic-partnership-to-develop-and-commercialize-portfolio-of-drug-candidates-for-immunological-diseases/)
to in-license IMG-007's global rights.

 

About OX-40 and Atopic Dermatitis

OX40 is a costimulatory receptor member of the tumor necrosis factor receptor
(TNFR) superfamily expressed predominantly on activated T cells. The ligation
of OX40 by its ligand OX40L leads to enhanced T cell survival, proliferation,
and effector functions. Preclinical research results show that IMG-007 can
bind to human OX40 receptor with high affinity, thereby inhibit the binding of
OX40 to OX40L, reducing OX40L-dependent downstream signaling and cytokine
release by OX40+ T cells. By selectively shutting down OX40+ T cell function,
IMG-007 may provide a treatment option for pathological OX40+ T cell-mediated
immune diseases, such as atopic dermatitis.

 

Atopic dermatitis is a chronic inflammatory skin condition that is estimated
to affect 8-19% of children and 2-5% of adults in US, Europe, and East
Asia. 1  (#_edn1) (, 2  (#_edn2) , 3  (#_edn3) )

 

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 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 over
1,800 in oncology/immunology. Since its inception, 13 drug candidates from
in-house discovery have entered into clinical studies around the world, with
the 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-007 for the treatment
of patients with atopic dermatitis and other immunological diseases, the
further clinical development of IMG-007, expectations as to whether clinical
studies of IMG-007 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-007 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-007 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
 Xinzhe Fang         fangx@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

 

 1  (#_ednref1) Silverberg JI, Barbarot S, Gadkari A, et al. Atopic dermatitis
in the pediatric population: A cross-sectional, international epidemiologic
study. Ann Allergy Asthma Immunol. 2021;126(4):417-428.e2.
doi:10.1016/j.anai.2020.12.020

 2  (#_ednref2) Barbarot S, Auziere S, Gadkari A, et al. Epidemiology of
atopic dermatitis in adults: Results from an international survey. Allergy.
2018;73(6):1284-1293. doi:10.1111/all.13401

 3  (#_ednref3) Ständer S. Atopic Dermatitis. N Engl J Med.
2021;384(12):1136-1143. doi:10.1056/NEJMra2023911

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