Affibody AB

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, Oct. 13, 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 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. Media For inquiries, please contact: Anna Vardanyan public.relations@inmagenebio.com SOURCE Inmagene

IMG-007 has the potential to provide Q12W or less frequent dosing based on an extended half-life IMG-007 has demonstrated a favorable safety profile, consistent with a silenced ADCC function via bioengineering IMG-007 is being evaluated in two global proof-of-concept trials SAN DIEGO, Aug. 18, 2023 /PRNewswire/ -- Inmagene Biopharmaceuticals ("Inmagene"), a clinical stage biotechnology company developing innovative and differentiated therapies for immunological and inflammatory diseases, announced topline results from a Phase 1 study of IMG-007, an anti-OX40 monoclonal antibody (mAb). The key objective of this randomized, double-blind, placebo-controlled, single ascending dose study was to assess the safety and pharmacokinetics of IMG-007 in healthy adults. A total of 30 participants received IMG-007, up to 600 mg, and 14 received placebo. Participants were followed up for up to 18 weeks. IMG-007 is a humanized IgG1 mAb that specially binds to the OX40 receptor with high affinity. It has been engineered in the Fc region to silence the antibody-dependent cell-mediated cytotoxicity (ADCC) function to minimize potential safety risks. In this Phase 1 study, IMG-007 demonstrated a favorable safety profile, with no notable adverse events occurring more frequently in IMG-007 than the placebo group, except for isolated COVID-19 cases with no dose-related trend. No participants reported any treatment-related adverse events. Importantly, there were no reports of pyrexia or chills. The overall favorable safety profile is consistent with a silenced ADCC function. At projected therapeutic dose levels, IMG-007 demonstrated a mean terminal half-life of 31 days, longer than the average half-life of typical IgG mAbs. A single treatment of IMG-007 at projected therapeutic dose levels maintained the target exposure for 12 to 18 weeks, which would allow IMG-007 to be potentially administered every 12 weeks or less frequently. "IMG-007 is significantly different from other OX40/OX40L drug candidates due to its extended half-life and silenced ADCC function," said Jonathan Wang, PhD, Chief Executive Officer of Inmagene. "IMG-007's potential to provide patients with long 'drug holidays', combined with a favorable safety profile, supports its best-in-class potential as an OX40 targeted therapy." A global proof-of-concept (POC) trial of IMG-007 in adult patients with moderate-to-severe atopic dermatitis is actively enrolling patients. Another POC trial in a first-in-class indication has also been initiated. 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 POC clinical trials. IMG-004, a non-covalent, reversible Bruton's tyrosine kinase (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 compared to 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 owns an exclusive option for IMG-007's global rights. 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. SOURCE Inmagene

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