About IMG-007 ADAPTIVE Trial
The ADAPTIVE trial (NCT07037901) is an ongoing Phase 2b, randomized, placebo-controlled dose ranging 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.
About Atopic Dermatitis
Atopic
dermatitis (AD) is a chronic, relapsing inflammatory skin disease characterized by intense itch, recurrent eczematous lesions, and significant impacts on sleep, mental health, and quality of life. AD affects approximately 26 million people in
the United States and 237 million people globally, with approximately 6.8 million adults in the United States and 49 million people worldwide living with
moderate-to-severe disease. Despite the availability of advanced therapies including biologics and JAK inhibitors, 30–40% of patients on these treatments continue
to report inadequate disease control, and only approximately 15% of biologic-eligible patients are receiving treatment. Existing options also impose meaningful treatment burden, requiring daily or bi-weekly
dosing over what is often a lifetime of disease management. Substantial unmet need remains for therapies that deliver deeper and more durable disease control with dosing schedules patients can sustain.
About Alopecia Areata
Alopecia areata (AA) is a chronic
autoimmune disease in which T cell–mediated attack on the hair follicle, resulting from loss of immune-protection of the follicle, causes hair loss across the scalp, face, and body. The disease can affect people of all ages, ethnicities, and
races, and approximately 1 in 50 people will develop AA over their lifetimes. Beyond its visible physical impact, AA carries a significant psychosocial and emotional burden, often persisting for years and recurring unpredictably. JAK inhibitors are
the only approved targeted treatment for AA and are indicated only for severe disease. They require at least daily oral dosing with sustained adherence to maintain hair regrowth and carry a boxed warning. There are no approved biologics for AA.
Substantial unmet need remains for treatments that are durable, well tolerated, and able to address the full spectrum of disease severity.
About
ImageneBio, Inc.
Imagene is a clinical-stage biotechnology company dedicated to developing therapeutics for patients with immunological,
autoimmune and inflammatory diseases with differentiated clinical profiles. The Company’s program, IMG-007, is a receptor targeting, non-T cell-depleting,
ADCC-silenced, anti-OX40 monoclonal antibody with an approximately 5-week half-life. Imagene has completed proof-of-concept
clinical trials of IMG-007 in both atopic dermatitis and alopecia areata and is currently conducting a Phase 2b clinical trial of IMG-007 in patients with moderate-to-severe atopic dermatitis.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities
Litigation Reform Act of 1995, including, without limitation, statements regarding: the ongoing Phase 2b ADAPTIVE study, including the potential benefits from the protocol amendment thereto; belief that the anti-OX40/OX40L class is on a promising
path towards adoption in AD and other inflammatory and autoimmune indications; the potential benefits of OX40/OX40L antagonists generally and IMG-007 specifically in AD and AA;
IMG-007 is the right molecule to showcase the benefits of the OX40 target; the Company’s expected cash runway, including that it is sufficient to achieve inflection points in the development of both AD
and AA; the anticipated timing for initiating clinical trials and reporting clinical trial results; whether the efficacy dataset from the ADAPTIVE trial will enable a registrational Phase 3 trial; and other statements regarding management’s
intentions, plans, beliefs, expectations or forecasts for the future. Words such as “will,” “can,” “expect,” “may,” “plan,”