Inmagene Receives FDA's IND Clearance for OX40 Antagonist

Written by PR Newswire

SAN DIEGO and SHANGHAI and SYDNEY, April 30, 2022 /PRNewswire/ -- Inmagene Biopharmaceuticals ("Inmagene") announces that the U.S. Food and Drug Administration (FDA) has cleared drug candidate IMG-007, a monoclonal antibody against OX40, to proceed to Phase I clinical development. Inmagene is developing IMG-007 in partnership with HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13).

IMG-007 is highly potent at blocking the binding of OX40 to OX40L, thereby reducing OX40L-dependent downstream signaling and cytokine release by T cells. It has the potential to treat OX40+ T cell-mediated immune diseases, including atopic dermatitis (AD).

The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients. The study will be used to explore IMG-007's safety and tolerability in healthy subjects, and its efficacy and safety in AD patients.

In Australia, this Phase 1 study has also received the approval from the Human Research Ethics Committee (HREC) and the acknowledgement of clinical trial repository from the Therapeutic Goods Administration (TGA).

"Research data has given us the confidence that IMG-007 is one of the strongest OX40 drug candidates worldwide," said Dr. Jonathan Wang, Chairman and CEO of Inmagene. "Inmagene is taking many innovative drug candidates like IMG-007 from discovery or candidate stage to global clinical studies."

Dr. Jean-Louis Saillot, Inmagene's Chief Development Officer, said, "The antagonism of the OX40/OX40L interaction by monoclonal antibodies has been shown to be successful in phase 2 clinical trials, which highlights the importance of targeting this axis as a promising approach for the treatment of immune disorders, including AD. IMG-007 has demonstrated a best-in-class potential in preclinical studies. We look forward to the initiation of the IMG-007 clinical program with the hope of developing an innovative, safe and effective treatment option for patients with AD and other immunological diseases."

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 to license IMG-007's global rights.

OX40 is a costimulatory receptor member of the NGFR/TNFR superfamily expressed predominantly on activated T cells. 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 efficiently blocking the binding of OX40 to OX40L. This blockade can effectively reduce the OX40L-dependent downstream signaling and cytokine release by T cells. By selectively shutting down OX40+ T cell function, IMG-007 may potentially provide treatment option for pathological OX40+ T cell-mediated immune diseases, such as atopic dermatitis.

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 development pipeline of 19 drug candidates.

Inmagene pipeline's most advanced compound is IMG-020, or izokibep. It has multiple global phase II studies ongoing for the treatment of autoimmune diseases, including psoriatic arthritis, ankylosing spondylitis, uveitis, etc. IMG-020 has also received IND approval from CDE for phase III in plaque psoriasis. In addition, IMG-004 and IMG-007 are initiating phase I studies globally in the next few months.

Believing in "Borderless Innovation", the Inmagene team strives to integrate efficient resources worldwide to make such therapeutics available to patients globally. Based on its proprietary QuadraTek™ drug discovery platform, Inmagene is operating 12 "Smart Innovation" programs to create and develop novel 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 ^[1]

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 4,600 personnel across all its companies, at the center of which is a team of about 1,500 in oncology/immunology. Since inception it has advanced 12 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.

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 AD 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 IMG-007's potential to successfully advance in clinical studies and to eventually gain approvals in any jurisdiction, the safety profile of IMG-007, the timing of these events, 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.

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