RCS - Hutchmed China Ltd - Inmagene Exercises Option for Two Drug Candidates

HUTCHMED (China)Announcement

02/02/2024 08:45

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RNS Number : 8561B  Hutchmed (China) Limited  02 February 2024

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 (https://www.hutch-med.com/) ")
(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
(https://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
(http://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 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                                                   +852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com
                                                                      (mailto:ir@hutch-med.com)

 Media Enquiries
 Ben Atwell / Alex Shaw, FTI Consulting                               +44 20 3727 1030 / +44 7771 913 902 (Mobile) /
                                                                      +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
                                                                      (mailto:HUTCHMED@fticonsulting.com)
 Zhou Yi, Brunswick                                                   +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                      (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon      +44 (20) 7886 2500

 

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