IMG-008

IMG-004 was well tolerated across once daily (QD) doses ranging 50 mg to 300 mg for 10 days. Key liver function parameters remained within the normal reference range for all tested doses. No reports of bleeding events in the study.Robust pharmacodynamic (PD) effect was sustained during dosing intervals across all QD dose regimens. Preliminary pharmacokinetic (PK)/PD modeling supports 50 mg QD as a potential therapeutic dose. Data supports advancement of IMG-004 as a differentiated treatment for BTK-mediated immunological diseases. SAN DIEGO, June 27, 2024 (GLOBE NEWSWIRE) -- Inmagene Biopharmaceuticals ("Inmagene" or the “Company”), a clinical-stage biotechnology company developing innovative and differentiated therapies for immunological and inflammatory (I&I) diseases, today announced positive topline results from the multiple ascending dose (MAD) portion of its randomized, double-blind, placebo-controlled Phase 1 study of IMG-004, a potent, non-covalent, reversible, and brain permeable Bruton’s tyrosine kinase (BTK) inhibitor. In a prior Phase 1 single ascending dose (SAD) study of 30 to 600 mg in healthy adults, IMG-004 was well-tolerated and exhibited a terminal half-life ranging from 26 to 37 hours and robust PD effect, which supported further exploration of IMG-004 QD dose regimens. The Phase 1 MAD study evaluated the safety, PK, and PD of IMG-004 in 24 healthy adults. Participants received IMG-004 50 mg, 150 mg, 300 mg or placebo QD for 10 days. The study showed that doses of up to 300 mg IMG-004 QD were well tolerated. No severe or serious adverse events (SAEs) were reported. All adverse events (AEs) were judged as unrelated to the study treatment except for one mild AE of constipation. There were no reports of bleeding events. Additionally, key liver function tests, including aspartate transaminase (AST), alanine transaminase (ALT), and total bilirubin, remained within the normal reference ranges for all tested QD doses. Plasma exposure of IMG-004 was approximately dose proportional. Pharmacodynamic assessment, using an ex-vivo basophil inhibition assay, demonstrated that high-level inhibition was achieved throughout the dosing intervals and was sustained for at least 24 hours post dose in all QD doses. All three doses tested in this study provided a steady-state exposure over the entire dosing interval which achieved at least 90% maximal inhibitory concentration (IC90), estimated based on PK/PD modeling. Taken together, the data supports a potential therapeutic dose regimen of 50 mg QD for IMG-004, with a wide safety margin relative to the highest tested 300 mg QD dose that was well-tolerated. “We are very pleased with the results of this study. BTK inhibitors have been clinically validated in nearly ten I&I indications to date. The class, however, has been limited by significant safety concerns and inconvenient dosing regimens,” said Yufang Lu, M.D., Ph.D., Chief Medical Officer of Inmagene. “The robust and durable BTK inhibition and favorable safety profile that IMG-004 demonstrated in this study support its potential as best-in-class and allows to explore a wide range of QD doses to identify an optimal dose regimen in future trials.” 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 multiple candidates with best-in-class potential. The lead asset IMG-007, a nondepleting anti-OX40 mAb, is in two global Phase 2a clinical trials in atopic dermatitis and alopecia areata. IMG-004, a non-covalent reversible BTK inhibitor with an extended half-life and durable pharmacodynamic effect, enabling its potential for once-daily dosing and is ready for Phase 2 development. IMG-008, a long-acting anti-IL-36R mAb is entering global Phase 1 clinical development. For more information, please visit www.inmagenebio.com. 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 single ascending dose (SAD) study of IMG-004 in healthy adults, IMG-004 exhibited a half-life of 26-37 hours, which is longer than most leading BTK inhibitors. Additionally, its sustained pharmacodynamic effect has enabled the potential for once daily dosing. 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, PhDVice President of Business Developmentpublic.relations@inmagenebio.com Investor Relations:Bruce MackleLifeSci Advisors, LLCbmackle@lifesciadvisors.com

IMG-007, the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb), is being evaluated in adult patients with alopecia areata (AA) and atopic dermatitis (AD). The enrollment of the Phase 2a study in AA patients has been completed. Topline results are anticipated in Q4 2024. May 07, 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 the Company completed target enrollment in its Phase 2a trial evaluating IMG-007 in adult patients with AA. IMG-007 is a nondepleting anti-OX40 mAb engineered to have a silenced ADCC function to minimize safety risk and a prolonged half-life to enable once every 12 weeks (Q12W) dosing. The Phase 2a open label trial (NCT06060977) enrolled 29 AA patients with 50% or greater scalp hair loss from 11 sites in the U.S. and Canada. Eligible patients were to receive three intravenous infusions of 300 mg or 600 mg IMG-007 over 4 weeks (Week 0, 2 and 4) and to be followed up for 24 weeks. Key study endpoints include safety and efficacy as measured by the severity of alopecia tool (SALT) score. “Emerging evidence supports an important role of OX40-OX40L signaling pathway in AA pathogenesis. IMG-007 is the first OX40/OX40L antagonist being evaluated in a clinical trial in AA patients,” said Yufang Lu, MD, PhD, Chief Medical Officer of Inmagene. “This trial will not only evaluate IMG-007’s efficacy in AA, but also include robust biomarker analysis to help us better understand how OX40 inhibition may alter disease patholophysiology and its relationship to clinical outcomes in AA patients.” 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 multiple candidates with best-in-class potential. The lead asset IMG-007, a nondepleting anti-OX40 mAb, is in two global Phase 2a clinical trials in atopic dermatitis (AD) and alopecia areata (AA). IMG-004, a non-covalent reversible BTK inhibitor with an extended half-life and pharmacodynamic effect, enabling its potential for once-daily dosing, is completing a Phase 1 multiple-dose study. IMG-008, a long-acting anti-IL-36R mAb is entering global Phase 1 clinical development. IMG-007 is a humanized anti-OX40 IgG1 mAb, with a silenced ADCC function and an extended half-life. The 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 signaling between OX40 and OX40L. Phase 1 single dose study demonstrated a 31-day half-life at anticipated therapeutic dose levels, enabling the potential for once every 12 weeks (Q12W) dosing, and a favorable safety profile, without any reports of pyrexia or chills. IMG-007 is being evaluated for the treatment of moderate-to-severe atopic dermatitis and alopecia areata in two Phase 2a studies. The content above comes from the network. if any infringement, please contact us to modify.