Inmagene Announces Positive Results for IMG-007 in Treating Atopic Dermatitis

In a recent development, Inmagene Biopharmaceuticals, a clinical-stage biotechnology company based in San Diego, announced promising results from their ongoing research on IMG-007, a novel monoclonal antibody. This innovative therapy is being tested for its efficacy in treating moderate-to-severe atopic dermatitis (AD), as well as its potential in addressing other immunological and inflammatory diseases.

IMG-007 uniquely targets the OX40/OX40L signaling pathway in both blood and tissues without depleting T cells, a significant advancement in the field of immunotherapy. The extended half-life of this antibody, combined with its demonstrated effectiveness, supports the possibility of longer dosing intervals, potentially every 24 weeks. This is particularly advantageous for maintenance therapy not only in AD but perhaps other conditions as well.

The Phase 2a trial, an open-label study conducted across centers in the US and Canada, involved 13 adult patients with moderate-to-severe AD. This trial assessed the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) IMG-007. Patients received doses at the start of the trial and at two subsequent intervals. Results indicated a strong and durable clinical response, as measured by the Eczema Area and Severity Index (EASI) and other metrics. After four weeks of treatment, a 77% mean percentage change in EASI and a 54% EASI-75 response rate were observed by the 16th week, aligning with outcomes from other investigational antibodies that target OX40/OX40L over longer treatment durations. Additionally, sustained inhibition of T helper cell-related inflammatory markers was noted for up to 24 weeks.

The safety profile of IMG-007 was favorable, with no reports of serious adverse events or discontinuation due to adverse effects. No occurrences of fever or chills were reported, underscoring the treatment’s tolerability.

In addition to the Phase 2a trial, a Phase 1 study assessed the subcutaneous (SC) formulation of IMG-007 in 16 healthy adults. The SC formulation’s PK profile mirrored that of the IV version. At the anticipated therapeutic dose, serum concentrations remained sufficient to block OX40/OX40L signaling throughout the 18-week follow-up. The SC formulation demonstrated a mean terminal half-life of 34.7 days, surpassing other similar antibodies in development. This formulation also showed a favorable safety profile; injection site reactions were mild and more common in the placebo group than in the treatment group.

Yufang Lu, M.D., Ph.D., Inmagene’s Chief Medical Officer, expressed optimism regarding these findings, emphasizing that the biological activity of OX40 blockade was maintained while improving tolerability. Lu highlighted the chronic nature of AD, which necessitates long-term management. Current biologics require frequent injections, often every 2 to 4 weeks, but the extended half-life and safety of IMG-007’s SC formulation could allow for more convenient dosing schedules.

Moving forward, Inmagene plans to launch a Phase 2b dose-finding study for the SC formulation of IMG-007 in patients with moderate-to-severe AD early in 2025. The company remains dedicated to advancing therapies for immunological and inflammatory diseases, with IMG-007 representing a significant step forward in this mission.