ImageneBio Announces It Intends To Submit Protocol Amendment For Phase 2b ADAPTIVE Study To Expand Number, Exposure Range Of Dosing Regiments, Optimize Feasibility Of Study

ImageneBio, Inc. (Nasdaq: IMA, "Imagene," or the "Company"), a clinical-stage biotechnology company developing therapeutics for patients with immunological, autoimmune and inflammatory diseases, including IMG-007, an anti-OX40 monoclonal antibody with multiple differentiating features, today announced financial results for the quarter ended September 30, 2025, and provided an update on its program.

The Phase 2b ADAPTIVE trial is a randomized, placebo-controlled dose-finding study designed to evaluate the efficacy and safety of various dose regimens of IMG-007 in adults with moderate-to-severe AD, recruiting both biologic- and/or JAK inhibitor-experienced and naive patients.

• A protocol amendment will be submitted to the regulatory agencies with the intent to:
  • Expand the number and exposure range of dosing regimens studied to fully characterize the clinical profile, given the molecular features of IMG-007 and favorable tolerability profile seen to date
  • Characterize the role of loading doses in driving the magnitude of efficacy and time to onset of effect
  • Evaluate patient-friendly dosing intervals
  • Understand the role of short- and longer-term treatment
  • Optimize feasibility of successful study execution
• Enrollment in the study is ongoing at North American sites and will continue
• Topline data from the study is expected in 2027