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.
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