Inmagene's OX40 mAb, with an extended half-life and silenced ADCC, enters POC study in Atopic Dermatitis

SAN DIEGO,SHANGHAI and SYDNEY,Aug. 15,2023 --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 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-007is 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."

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,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.

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 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).

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.

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,Guttman-Yassky E. Ann Allergy Asthma Immunol 2018;120(1): 34–41.