Inmagene Doses First Patient in Phase 2a Trial of IMG-007, an Anti-OX40 Monoclonal Antibody with an Extended Half-life, for the Treatment of Alopecia Areata

  • IMG-007 is a novel anti-OX40 monoclonal antibody (mAb) engineered for potentially once every 12 weeks dosing and an improved safety profile

  • IMG-007 is being evaluated for the treatment of alopecia areata (AA) and atopic dermatitis (AD)

  • An interim data readout in AA is expected in Q3 2024

San Diego, CA, October 13, 2023 – Inmagene Biopharmaceuticals (“Inmagene”), a clinical stage biotechnology company developing innovative and differentiated therapies for immunological and inflammatory diseases, announced that the first patient has been dosed in a global multicenter Phase 2a study of IMG-007 in adult patients with AA. The study will evaluate the safety, efficacy, pharmacokinetics, and biomarkers of IMG-007 in AA patients with 50% or greater scalp hair loss. More information about the study can be found here NCT06060977

“Alopecia areata is a devastating disease which affects approximately 147 million people globally. Currently, there are limited treatment options and no approved biologics for AA. Better treatment options are needed,” said Jonathan Wang, Ph.D., Chief Executive Officer of Inmagene. “IMG-007 could potentially provide a safe and effective biologic therapy with once every 12 weeks dosing regimen for AA patients.”

IMG-007 is a humanized IgG1 mAb that specifically binds to the OX40 receptor and potently blocks the signaling between OX40 and its ligand. IMG-007 has been engineered to have an extended half-life to allow less frequent dosing and a silenced antibody-dependent cell-mediated cytotoxicity (ADCC) function to reduce safety risks.  In a Phase 1 study in healthy adult participants, IMG-007 has demonstrated a favorable safety profile, without any reports of pyrexia or chills. A single treatment of IMG-007 at projected therapeutic dose levels maintained the target exposure for 12 to 18 weeks, which may allow IMG-007 for every 12 weeks administration.

In addition to the global Phase 2a study in AA patients, IMG-007 is also being evaluated in a global Phase 2a study in adult patients with AD with an interim data readout expected in Q2 2024.

About Inmagene
Inmagene is a global clinical-stage biotechnology company focused on developing novel therapeutics for immunological and inflammatory diseases. It has four clinical-stage drug candidates. The lead compound, IMG-007, an OX40 antagonist mAb with an extended half-life and a silenced ADCC function, is in two global Phase 2a clinical trials. IMG-004, a non-covalent, reversible BTK inhibitor, which has demonstrated a more durable pharmacodynamic effect and longer half-life than most leading BTK inhibitors, is completing Phase 1 clinical development. IMG-008, a long-acting anti-IL-36R mAb with a longer half-life and higher exposure than an approved IL-36R antagonist, is entering global Phase 1 clinical development. Moreover, IMG-020 (izokibep), an anti-IL-17 small protein therapeutic, is in global clinical development for 5 indications, including 2 pivotal trials, in collaboration with global partners. 

Based on its proprietary QuadraTek® platform, Inmagene discovers and develops novel drug candidates. Inmagene has out-licensed IMG-018, a differentiated anti-ILT7 mAb drug candidate, to establish a new drug development company Celexor Bio, in collaboration with Aditum Bio. Inmagene has formed strategic partnerships with multiple partners, such as HUTCHMED and Affibody AB, to develop highly innovative drug candidates.

About IMG-007
IMG-007 is a humanized IgG1 mAb specifically binds to OX40, a co-stimulatory receptor that is present primarily on activated T cells. 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 potently blocks the signaling between OX40 and OX40L. IMG-007 was discovered by HUTCHMED, with Inmagene assuming global development responsibility at the candidate stage. Inmagene owns global rights for IMG-007.

About Alopecia Areata
Alopecia areata is a chronic autoimmune disease characterized by nonscarring hair loss involving the scalp, face, and/or body. It can affect people of all ages. Approximately 2% of the general population can be affected by AA during their lifetime1,2.  Approximately 43% of AA patients have over 50% hair loss3. AA significantly impacts patients’ daily life and often leads to profound psychological distress, social isolation, anxiety, and depression. The immunopathogenesis of AA and AD largely overlaps, and AA and AD coexist in many patients4,5.

Forward-Looking Statements
This press release contains forward-looking statements. While Inmagene believes the projections to be based on reasonable assumptions, these forward-looking statements may be called into question by a number of hazards and uncertainties, so that actual results may differ materially from those anticipated in such forward-looking statements.

1Pratt CH, King LE Jr, Messenger AG, et al. Nat Rev Dis Primers 2017;3:17011.

2Mirzoyev1 SA, Schrum AG, Davis M, et al. J Invest Dermatol. 2014;134(4):1141–1142.

3Benigno M, Anastassopoulos KP, Mostaghimi A, et al. Clin Cosmetic Invest Dermatol. 2020;13:259–266.

4Kageyama R, Ito T, Hanai S, et al. Int. J Mol Sci 2021;22(5):2618.

5Kridin K, Renert-Yuval Y, Guttman-Yassky E, et al. J Allergy Clin Immunol Pract 2020,8(4):1323-1328.

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