San Diego, CA, September 20, 2024 – Inmagene Biopharmaceuticals (“Inmagene” or the “Company”), a clinical stage biotechnology company developing innovative and differentiated therapies for immunological and inflammatory diseases, today announced that positive efficacy, safety and biomarker data from its Phase 2a clinical trial of IMG-007 (a nondepleting anti-OX40 monoclonal antibody) in patients with atopic dermatitis (AD) and data from pharmacodynamic studies of IMG-004 (a noncovalent reversible BTK inhibitor) will be presented at the 2024 European Academy of Dermatology and Venereology (EADV) Congress, taking place September 25–28, 2024 in Amsterdam, Netherlands.
The three poster presentations will be available during the “Atopic Dermatitis/Eczema” E-poster session starting on September 25, 2024, at 9am EDT:
Title: Safety and efficacy of IMG-007, a nondepleting anti-OX40 monoclonal antibody in adult patients with moderate-to-severe atopic dermatitis: results from a phase 2a study
Abstract ID: P0676
Title: IMG-007, a novel nondepleting anti-OX40 monoclonal antibody, showed potent in vitro and in vivo inhibitory effects on OX40-OX40L signalling
Abstract ID: P0606
Title: IMG-004, a selective noncovalent reversible Bruton’s tyrosine kinase inhibitor, demonstrated potent pharmacodynamic effects
Abstract ID: P0842
About Inmagene
Inmagene is a global clinical-stage biotechnology company developing novel therapeutics for immunological and inflammatory (I&I) diseases. The company’s highly differentiated clinical-stage pipeline has several assets with best-in-class potentials. The lead asset IMG-007, a nondepleting anti-OX40 mAb, is in Phase 2 development for the treatment of atopic dermatitis (AD) and alopecia areata (AA). IMG-004, a non-covalent reversible BTK inhibitor with an extended half-life and durable pharmacodynamic effect, enabling its potential for once-daily (QD) dosing, is ready for Phase 2 development. For more information, please visit www.inmagenebio.com.
About IMG-007
IMG-007 is a humanized anti-OX40 IgG1 mAb, with an extended half-life and silenced antibody-dependent cellular 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 I&I diseases. In nonclinical studies, IMG-007 potently blocked the signalling between OX40 and OX40L. IMG-007 is being evaluated for the treatment of moderate-to-severe atopic dermatitis (AD) and severe alopecia areata (AA). In a Phase 2a study in AD patients, a short 4-week treatment with IMG-007 resulted in a rapid and marked improvement in the extent and severity of skin lesions in AD patients. Interim data from a pharmacokinetic study showed that subcutaneous IMG-007 demonstrated an exceptionally long half-life, which would enable its potential for every six months (Q6M) dosing for AD maintenance therapy. Separately, its silenced ADCC function has led to a favorable safety profile, without any reports of pyrexia and chills, differentiating it from a competing ADCC-enhanced anti-OX40 mAb. IMG-007 was originally discovered by HUTCHMED, with Inmagene assuming the development responsibility at the candidate stage.
About IMG-004
IMG-004 is a non-covalent, reversible small molecule inhibitor targeting BTK. Designed specifically for inflammatory and autoimmune diseases that usually require long-term treatment, IMG-004 is potent, highly selective and brain permeable. In a Phase 1 study in healthy adults, IMG-004 exhibited a half-life of 26-37 hours, which is longer than most leading BTK inhibitors. Additionally, once daily dosing of IMG-004 50 mg to 300 mg resulted in a sustained pharmacodynamic effect and favorable safety profile across all doses supporting a wide safety margin. IMG-004 is planned to be initially evaluated for the treatment of chronic spontaneous urticaria and hidradenitis suppurativa. IMG-004 was originally discovered by HUTCHMED, with Inmagene assuming the development responsibility at the candidate stage.
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.
For further information, please contact:
Inmagene:
Anna Vardanyan, MD, PhD
SVP of Corporate and Business Development
vardanyana@inmagenebio.com
Investor Relations:
Bruce Mackle
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com