Inmagene Biopharmaceuticals (Hangzhou) Co., Ltd.

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

SAN DIEGO, Sept. 21, 2023 /PRNewswire/ -- Inmagene Biopharmaceuticals (Inmagene), a clinical-stage biotech company developing innovative and differentiated therapies for immunological and inflammatory diseases, today announced its partnership with Aditum Bio to create Celexor Bio (Celexor), a new biotech company focused on cell depletion of pathologic cells in autoimmune and inflammatory disorders. Celexor has been formed based on Inmagene's IMG-018, a pDC depleting antibody targeting immunoglobulin-like transcript 7 (ILT7). Celexor will obtain the exclusive global rights to develop, manufacture, and commercialize IMG-018, which will be renamed CLXR-901, in a transaction anticipated to close later this month. "We are pleased to partner with Aditum Bio, a highly innovative venture capital firm established by pharma industry leaders with deep drug development experience," said Jonathan Wang, PhD, Chief Executive Officer of Inmagene. "The formation of Celexor, based on IMG-018, has demonstrated Inmagene's strengths in discovering innovative and differentiated drug candidates." "Aditum Bio's unique incubator model enables us to accelerate the development of novel medicines, and we look forward to bringing this promising therapy to patients in need," said Joe Jimenez, Co-Founder and Managing Director of Aditum Bio. Under the terms of the agreement, Inmagene will be paid an upfront fee and is eligible to receive up to $287 million in development and sales milestone payments, as well as royalties on future product sales. In addition, Inmagene will be granted an equity stake in Celexor Bio. About IMG-018 (to be renamed CLXR-901) Created by Inmagene's proprietary QuadraTek® technology platform, IMG-018 is a monoclonal antibody that binds to the ILT7 receptor on the surface of plasmacytoid dendritic cells (pDCs) and recruits effector cells which help deplete pDCs. IMG-018/CLXR-901 has an enhanced effector function and allows for pDC depletion via the engagement of multiple cell types. These features have the potential to differentiate the ability of IMG-018/CLXR-901 to address immune disorders where ILT7 receptor and pDCs are involved. About Inmagene Biopharmaceuticals Inmagene is a global clinical-stage biotech company focused on developing novel therapeutics for immunological and inflammatory diseases. It has four clinical assets and an innovative preclinical pipeline. The company is developing its highly differentiated clinical assets, including IMG-007 (anti-OX40 mAb with extended half-life and silenced ADCC function), IMG-004 (BTKi with long half-life and pharmacodynamic duration) and IMG-008 (long-acting anti-IL-36R mAb). With its partners, Inmagene is co-developing IMG-020 (izokibep, an anti-IL-17 fusion protein), in which Inmagene owns certain global upside as well as development and commercialization rights in certain Asia regions. Further information is available at . About Aditum Bio Aditum Bio is committed to improving public health by accelerating R&D in disease areas with both large and more targeted patient populations, where medical innovation can have a significant impact. Aditum Bio focuses on mechanisms of disease, in-licenses promising drug candidates directed at such pathophysiology, and spins out individual companies dedicated to bringing each candidate through clinical trials. For more information, please visit . Media For inquiries, please contact: Anna Vardanyan [email protected] SOURCE Inmagene

Celexor Bio is the tenth company formed by Aditum Bio OAKLAND, Calif. , Sept. 21, 2023 /PRNewswire/ -- Aditum Bio, the biotech investment firm cofounded in 2019 by former Novartis CEO Joe Jimenez and former President of the Novartis Institutes for BioMedical Research (NIBR) Dr. Mark Fishman, today announced the formation of Celexor Bio, a portfolio company created for the development of novel therapies for inflammatory disorders. Celexor Bio is being formed in connection with the in-licensing of a depleting antibody targeting immunoglobulin-like transcript 7 (ILT7), a highly specific cell surface marker found on plasmacytoid dendritic cells (pDCs), which is anticipated to close later this month. The compound (IMG-018) is being licensed from Inmagene Biopharmaceuticals and will be renamed CLXR-901. pDCs are a dendritic cell subtype specialized in secreting high levels of Type I interferons and other pro-inflammatory cytokines. The pathological activation of pDCs has been implicated in the pathophysiology of several autoimmune and inflammatory diseases. CLXR-901 rapidly and potently depletes these pathological cells, offering a potentially safe and effective alternative for severe autoimmune and inflammatory disorders. "Aditum Bio's unique incubator model enables us to accelerate the development of novel medicines, and we look forward to bringing this promising therapy to patients in need" said Joe Jimenez, Co-Founder and Managing Director of Aditum Bio. Dr. Mark Fishman, Co-Founder and Chair of the Medical and Scientific Advisory Boards, added, "pDCs play a key role in the pathophysiology of multiple autoimmune and inflammatory diseases. By directly depleting the pathological cells, CLXR-901 may offer a safe and effective alternative for these challenging disorders." Celexor Bio is the tenth company launched by Aditum Bio, whose mission is to give large patient populations access to medicines which otherwise may not be developed. To speed these drugs to market, Aditum Bio fosters an incubator model, focusing on the translational phase of drug development. The "spin out" model enables a nimble, start-up culture with a dedicated team of managers supported by Aditum's in-house team of operational and technical area experts, ranging from nonclinical pharmacology and CMC to regulatory affairs and clinical operations. About Aditum Bio Aditum Bio is committed to improving public health by accelerating R&D in disease areas with both large and more targeted patient populations, where medical innovation can have a significant impact. Aditum Bio focuses on mechanisms of disease, in-licenses promising drug candidates directed at such pathophysiology, and spins out individual companies dedicated to bringing each candidate through clinical trials. For more information, please visit . About Inmagene Biopharmaceuticals Inmagene is a global clinical-stage biotech company focused on developing novel therapeutics for immunological and inflammatory diseases. It has four clinical assets and an innovative preclinical pipeline. The company is developing its highly differentiated clinical assets, including IMG-007 (anti-OX40 mAb with extended half-life and silenced ADCC function), IMG-004 (BTKi with long half-life and pharmacodynamic duration) and IMG-008 (long-acting anti-IL-36R mAb). With its partners, Inmagene is co-developing IMG-020 (izokibep, an anti-IL-17 fusion protein), in which Inmagene owns certain global upside in addition to development and commercialization rights in some Asia regions. Further information is available at . SOURCE Aditum Bio