Phase 2a Success: IMG-007 Nondepleting Anti-OX40 Antibody in Atopic Dermatitis

In a recent clinical trial, IMG-007, an innovative nondepleting anti-OX40 monoclonal antibody, has shown promising results for patients suffering from atopic dermatitis (AD). The treatment was observed to produce swift, significant, and long-lasting improvements in skin conditions for the participants. IMG-007 was found to be well-tolerated by the patients, with no instances of fever or chills reported.

IMG-007 is a monoclonal antibody that has been bioengineered to silence its antibody-dependent cellular cytotoxicity (ADCC) function and extend its half-life. In earlier studies involving healthy adults, this antibody displayed a favorable safety profile, which aligns with its lack of ADCC function. The slow clearance rate and a 31-day half-life suggest that IMG-007 could be administered every 12 weeks for induction therapy and even less frequently for maintenance therapy in AD.

The Phase 2a trial included 13 patients from the U.S. and Canada with moderate-to-severe AD who had not responded well to or could not tolerate topical treatments. The study excluded the use of other topical or systemic AD medications. Participants received three intravenous infusions of 300 mg of IMG-007 over a period of four weeks and were monitored for up to 24 weeks. The primary endpoints of the study focused on safety and the percentage change from baseline in the eczema area and severity index (EASI) over time.

The results were impressive, with a rapid improvement in EASI scores starting from the first week and continuing after the final dose at week four. By the 20th week, a considerable percentage of patients had achieved significant improvements in their condition, with 69%, 54%, and 31% reaching at least 50%, 75%, and 90% EASI improvement, respectively. The trial reported no serious adverse events, no adverse events leading to treatment discontinuation, and no treatment-related adverse events, including no reports of fever or chills.

Experts in the field have expressed excitement about the potential of inhibiting OX40-OX40L signaling to treat AD. The unique targeting of the OX40 receptor by IMG-007, without depleting T cells and with its long half-life, positions it as a best-in-class candidate. It offers the possibility of minimizing safety risks associated with T cell depletion and providing a more convenient dosing schedule for patients.

The company behind IMG-007, Inmagene Biopharmaceuticals, is encouraged by the efficacy demonstrated in a short 4-week treatment period and is looking forward to future studies that could reveal even more robust efficacy with continuous treatment. Inmagene is also exploring the potential of IMG-007 for other indications due to the important role of the OX40-OX40L axis in various immunological and inflammatory diseases.

In addition to the ongoing Phase 2a trial for AD, IMG-007 is also under evaluation in a global study for adult patients with alopecia areata, with initial data expected in the fourth quarter of 2024.

Inmagene is a global clinical-stage biotechnology company that is developing novel therapeutics for a range of immunological and inflammatory diseases. Their pipeline includes multiple candidates with the potential to be best-in-class treatments. IMG-007, the lead asset, is currently in two global Phase 2a clinical trials for atopic dermatitis and alopecia areata. Other candidates in the pipeline include IMG-004, a non-covalent reversible BTK inhibitor, and IMG-008, a long-acting anti-IL-36R monoclonal antibody, both of which are entering or completing Phase 1 clinical development.