SAN DIEGO, SHANGHAI and SYDNEY, Aug. 15, 2023 /PRNewswire/ -- 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 proof-of-concept (POC) study of IMG-007 in adult patients with moderate-to-severe atopic dermatitis (AD). The objective of the study is to assess the safety, pharmacokinetics, and efficacy of IMG-007 in AD patients. Additional information can be found at www.clinicaltrials.gov (NCT05984784).
IMG-007 is a humanized IgG1 monoclonal antibody (mAb) that specifically binds to the OX40 receptor. Its Fc region has been bioengineered, resulting in an extended half-life and a silenced antibody-dependent cell-mediated cytotoxicity (ADCC) function. In a single ascending dose study in healthy adults, IMG-007 demonstrated a half-life that exceeds the average half-life for conventional IgG antibodies. At anticipated therapeutic dose levels, target serum concentration is maintained for approximately 12-18 weeks after a single dose, which enables the potential for IMG-007 to be dosed every 12 weeks or less frequently, thereby potentially allowing long "drug holidays". IMG-007, up to 600 mg, was well tolerated with no serious or severe adverse events and no reports of pyrexia or chills.
"IMG-007 represents an investigational drug with multiple potential indications," said Yufang Lu, MD, PhD, Chief Medical Officer of Inmagene. "We are excited to begin this trial of IMG-007 in AD patients, following favorable safety and highly differentiated pharmacokinetic results of the earlier trial. We are continuing our evaluations of IMG-007's potential in other diseases where OX40 signaling pathway plays an important pathogenic role."
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, a unique OX40 antagonist mAb with an extended half-life and a silenced ADCC function, is in two global POC clinical trials. IMG-004, a non-covalent, reversible BTK inhibitor, which has demonstrated more durable pharmacodynamic effect and longer half-life than any of the leading BTK inhibitors, is completing Phase 1 clinical development. IMG-008, a long-acting mAb against IL-36R with an extended half-life and enhanced antibody 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 also sources innovation via in-licensing activities and, together with its partners, carries out global development activities. Inmagene has formed strategic partnerships with multiple partners, such as HUTCHMED and Affibody AB, to develop highly innovative drug candidates.
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 and completely blocks signaling between OX40 and OX40L. IMG-007 was discovered by HUTCHMED, with Inmagene assuming global development responsibility at the candidate stage. Inmagene has an exclusive option for IMG-007's global rights for the treatment of immunological diseases.
About Atopic Dermatitis (AD)
AD is a chronic relapsing inflammatory skin disease characterized by itch and eczematous skin lesions (1). It is one of the most common skin diseases, affecting up to 10% of adults and up to 20% of children worldwide (2). AD is due to chronic inflammation of the skin and is primarily driven by various subtypes of activated T cells (3).
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.
1. Eichenfield LF, Tom WL, Chamlin SL, et al. J Am Acad Dermatol. 2014;70(2):338-351.
2. Laughter MR, Maymone MBC, Mashayekhi S, et al. Br J Dermatol 2021;184:304-9.
3. Brunner PM, Leung DYM, MD, Guttman-Yassky E. Ann Allergy Asthma Immunol 2018;120(1): 34-41.