ImageneBio Advances Anti-OX40 Antibody IMG-007 with Protocol Amendment for Phase 2b Atopic Dermatitis Trial
Key Insights
ImageneBio (search) announced a protocol amendment for its ongoing Phase 2b ADAPTIVE study of IMG-007 in atopic dermatitis (search) to optimize study design and expand dosing regimens based on the drug's unique molecular attributes.
The company will present novel alopecia areata (search) data at the Inflammatory Skin Disease Summit, showing dose-related hair regrowth and biomarker suppression in Phase 1b/2a trials.
IMG-007 demonstrated a 77% mean reduction in EASI score at week 16 in atopic dermatitis (search) patients, with 54% achieving EASI-75 response and 31% reaching EASI-90 response.
ImageneBio (search), Inc. announced plans to amend the protocol for its ongoing Phase 2b ADAPTIVE study of IMG-007, an anti-OX40 (search) monoclonal antibody, in patients with moderate-to-severe atopic dermatitis (search). The clinical-stage biotechnology company reported the decision follows extensive engagement with key opinion leaders and analysis of recent OX40-targeting data from competitors.
Phase 2b Study Protocol Amendment
The protocol amendment will be submitted to regulatory agencies with the intent to expand the number and exposure range of dosing regimens studied to fully characterize IMG-007's clinical profile. The amendment aims to characterize the role of loading doses in driving efficacy magnitude and time to onset, evaluate patient-friendly dosing intervals, and understand the role of short- and longer-term treatment.
"Our recent learnings reinforce our belief that the anti-OX40 (search)/OX40L class, with its unique mechanism, is on a promising path towards adoption in atopic dermatitis (search) and other inflammatory and autoimmune indications," commented Kristin Yarema, Ph.D., Chief Executive Officer. "However, the peer data to date also highlight the need for a differentiated anti-OX40 treatment that is safe and can be administered at optimal doses for maximum efficacy."
The Phase 2b ADAPTIVE trial is a randomized, placebo-controlled dose-finding study recruiting both biologic- and/or JAK inhibitor-experienced and naive patients. Enrollment continues at North American sites, with topline data expected in 2027.
Clinical Efficacy Data
ImageneBio (search) will present data from Phase 1b/2a studies at the 6th Annual Inflammatory Skin Disease Summit in New York. In atopic dermatitis (search) patients, IMG-007 demonstrated a mean reduction in EASI score from baseline at week 16 of 77% among 13 patients treated with up to 3 doses over 4 weeks.
EASI-75 response (at least 75% reduction from baseline EASI score) was achieved by 54%, 54% and 46% of participants at weeks 16, 20, and 24, respectively. EASI-90 response (at least 90% reduction in EASI score) was achieved by 31% of participants at week 16 and maintained through week 24. IMG-007 was well tolerated overall by AD patients with no reports of pyrexia or chills.
Alopecia Areata Breakthrough
The company will also present the first clinical results for an anti-OX40 (search)/OX40L agent in patients with severe alopecia areata (search). Treatment with three doses of IMG-007 over four weeks resulted in a dose-related signal of hair regrowth. Four-week treatment with IMG-007 600 mg also resulted in broad and durable suppression of activated T cell biomarkers and partial restoration of hair keratins in scalp biopsies.
"Our AA data represent the first clinical results for an anti-OX40 (search)/OX40L agent in patients with severe alopecia areata (search), a disease for which there are few treatment options and no targeted biologics approved," Dr. Yarema noted. "The promising early data IMG-007 has shown in AA patients illustrates this program's potential as a 'pipeline in a product.'"
Differentiated Mechanism of Action
IMG-007 is positioned as the only anti-OX40 (search) in mid- to late-stage clinical development that is non-T cell depleting and receptor-targeting, with a roughly 5-week half-life. This combination of mechanistic and pharmacologic properties has the potential to offer a best-in-class profile for patients, according to the company.
The company noted that despite the impressive multibillion dollar atopic dermatitis (search) market size, only around 15% of eligible patients receive advanced therapy including biologics, and more than a third of those patients do not receive sufficient relief from that treatment.
Financial Position and Leadership
ImageneBio (search) reported cash, cash equivalents, and marketable securities of $142.6 million as of September 30, 2025, compared to $12.1 million as of December 31, 2024. The increase resulted from completion of the merger between Inmagene Biopharmaceutics with Ikena Oncology, Inc., and a concurrent $75.0 million private placement.
The company strengthened its leadership team with the addition of Dr. Kristin Yarema as Chief Executive Officer, Dr. Kurinji Pandiyan as Chief Strategy and Operations Officer, Dr. Renuka Sivendran as Chief Technical Officer, and Joe Slattery as an independent director.