Press Release
HUTCHMED Announces that Inmagene Exercises Option to
License Two Drug Candidates as Part of Strategic Partnership
Hong Kong, Shanghai
& Florham Park, NJ - Friday, February 2, 2024: HUTCHMED
(China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announced that, Inmagene Biopharmaceuticals
("Inmagene") has exercised options to license two drug candidates
discovered by HUTCHMED, IMG-007 and IMG-004 (the "Options")
pursuant to the terms of the strategic partnership announced on
January 11, 2021. Following the exercise of the Options and subject
to receipt by HUTCHMED of ordinary shares representing
approximately 7.5% of shares (fully diluted) in Inmagene, Inmagene
will be granted an exclusive license to further develop,
manufacture and commercialize these two drug candidates
worldwide.
As part of the partnership, HUTCHMED granted Inmagene
exclusive options to multiple drug candidates solely for the
treatment of immunological diseases. Since the execution of the
Option agreement, Inmagene has funded and led two of these
candidates, IMG-004 and IMG-007, to clinical development. For each
of the drug candidates, IMG-004 and IMG-007, HUTCHMED is entitled
to receive potential payments subject to the achievement of
development milestones of up to US$92.5 million and subject to the
achievement of commercial milestones of up to US$135 million, as
well as royalties upon commercialization.
In 2023, Inmagene initiated two global Phase IIa
clinical trials in adults with moderate-to-severe atopic dermatitis
and in adults with alopecia areata, with the investigational OX40
antagonistic monoclonal antibody (mAb) IMG-007. It also completed a
Phase I single ascending dose (SAD) study of IMG-004, a reversible,
non-covalent, highly selective oral BTK inhibitor designed to
target immunological diseases.
Dr Weiguo Su, Chief Executive Officer and Chief
Scientific Officer of HUTCHMED, said: "This is an important step
for the progress of these two drug candidates in immunological
diseases and demonstrates the potential of the candidates
discovered by HUTCHMED. The success of this strategic partnership
provides further validation of HUTCHMED's in-house R&D engine
and our collaborative approach to developing some of our innovative
drug candidates. We look forward to continuing our partnership with
Inmagene and seeing the impact these drug candidates could have for
patients with immunological diseases."
About Inmagene
Inmagene is a global clinical-stage biotechnology
company developing novel therapeutics for immunological and
inflammatory diseases. The company's highly differentiated
clinical-stage pipeline has multiple candidates with best-in-class
potential. The lead asset IMG-007, a non-depleting anti-OX40 mAb,
is in two global Phase IIa clinical trials in atopic dermatitis and
alopecia areata. IMG-004, a non-covalent reversible BTK inhibitor
is in a Phase I multiple ascending dose (MAD) study. IMG-008, an
in-house developed long-acting anti-IL-36R mAb is entering global
Phase I clinical development.
For more information, please visit www.inmagenebio.com.
About IMG-007
IMG-007 is a humanized anti-OX40 IgG1 mAb, with an
elongated half-life and silenced antibody-dependent cell-mediated
cytotoxicity (ADCC) function. OX40-OX40L axis is important in T
cell activation, expansion, and survival, thereby having an
important role in the pathogenesis of a spectrum of immunological
and inflammatory diseases. In nonclinical studies, IMG-007
demonstrated the ability to selectively and potently block the
signaling between OX40 and OX40L. Phase I SAD data suggests a
31-day half-life at anticipated therapeutic dose levels, enabling
the potential for once every 12 weeks (Q12W) dosing, and a
favorable safety profile without any pyrexia and chills,
differentiating from similar molecules in development. It is being
evaluated for the treatment of moderate-to-severe atopic dermatitis
and alopecia areata in two Phase IIa studies.
About IMG-004
Designed specifically for inflammatory and autoimmune
diseases that usually require long-term treatment, IMG-004 is a
reversible, non-covalent, potent, highly selective and brain
permeable oral agent. Phase I SAD study results suggest a long
half-life and durable pharmacodynamics (PD) effect, enabling the
potential for once-daily (QD) dosing. Following the ongoing Phase I
MAD study, IMG-004 will be evaluated in chronic spontaneous
urticaria (CSU) and rheumatoid arthritis (RA).
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 approximately 5,000 personnel across
all its companies, at the center of which is a team of about 1,800
in oncology/immunology. Since inception it has focused on bringing
cancer drug candidates from in-house discovery to patients around
the world, with its first three medicines marketed in China, the
first of which is also marketed in the U.S. 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 HUTCHMED's current expectations
regarding future events, including but not limited to its
expectations regarding the therapeutic potential of IMG-004 and
IMG-007, the further clinical development for IMG-004 and IMG-007,
its expectations as to whether any studies on IMG-004 and IMG-007
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 the timing and outcome of
clinical studies and the sufficiency of clinical data to support
approval of IMG-004 and IMG-007 for the treatment of patients with
atopic dermatitis or other indications in jurisdictions such as
China, the U.S., the E.U. or Japan, the efficacy and safety profile
of IMG-004 and IMG-007;Inmagene's ability to fund, implement and
complete its further clinical development and commercialization
plans for IMG-004 and IMG-007; the timing of these events;
Inmagene's ability to satisfy the terms and conditions under the
license agreement, assumptions regarding changes to clinical
protocols or regulatory requirements; unexpected adverse events or
safety issues; the ability of IMG-004 and IMG-007, including as
combination therapies, 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 markets of IMG-004 and IMG-007 for a
targeted indication; the sufficiency of funding; Inmagene's ability
to successfully develop, manufacture and commercialize IMG-004 and
IMG-007, and the impact of COVID-19 or other infectious diseases 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
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+852 2121 8200 /
+1 973 306 4490 / ir@hutch-med.com
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Media Enquiries
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Ben Atwell /
Alex Shaw, FTI Consulting
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+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
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Zhou Yi, Brunswick
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+852 9783 6894 (Mobile) /
HUTCHMED@brunswickgroup.com
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Nominated Advisor
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Atholl Tweedie /
Freddy Crossley / Daphne Zhang,
Panmure Gordon
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+44 (20) 7886 2500
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