olevaprubart (IMG-007) / Hutchmed, ImageneBio - LARVOL DELTA

IMG-007 a non-depleting OX40 mAb produces durable shift in TCR repertoire and T cell function: Early biomarker insights from a phase 1b/2a trial in immune-mediated alopecias (EADV 2026) - No abstract available

Biomarker • IO biomarker • P1/2 data • Alopecia • Immunology

IMG-007, a non-depleting OX40 antagonist: Optimizing Peak Loading Concentration and Exposure Range to Unlock the Full Potential of OX40-OX40L Pathway Targeting in Immune Mediated Diseases (EADV 2026) - No abstract available

Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology • TNFSF4

ImageneBio is developing IMG-007, a non-T cell depleting, antibody-dependent cell-mediated cytotoxicity -silenced OX40 antagonist discovered by HUTCHMED (The Manila Times) - "Phase IIb trial (NCT07037901) in patients with moderate-to-severe atopic dermatitis progressing, with an amended protocol and topline data anticipated in the fourth quarter of 2027; Phase II trial initiation in patients with alopecia areata expected in 2026, with initial data expected in 2028."

New P2 trial • P2b data • Alopecia • Atopic Dermatitis • Immunology

Long-term Safety and Efficacy Evaluation of IMG-007 in Participants With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=400 | Enrolling by invitation | Sponsor: Inmagene LLC

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Olevaprubart Program Updates:…Alopecia Areata (GlobeNewswire) - "Imagene remains on track to initiate a Phase 2 study of olevaprubart in alopecia areata in 2026. Initial data expected in 2028, leveraging the clinical operations and investigator network the Company has developed through its atopic dermatitis program."

New P2 trial • P2 data • Alopecia • Immunology

Olevaprubart Program Updates: Atopic Dermatitis (GlobeNewswire) - "The previously announced protocol amendment to the ADAPTIVE trial has been implemented, and the study continues to progress under the amended protocol. The amended protocol introduces a robust design intended to further evaluate the potential of olevaprubart in moderate-to-severe atopic dermatitis. Topline data from the study is anticipated in the fourth quarter of 2027. A long-term extension study has been opened for those who have completed one year in the ADAPTIVE study (NCT07734415) and patients are actively moving into the LTE. The Independent Data Monitoring Committee (IDMC) for the ADAPTIVE study recommended the study proceed with no changes to the protocol or monitoring on July 23, 2026."

P2 data • Trial status • Atopic Dermatitis

ADAPTIVE: A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=405 | Recruiting | Sponsor: Inmagene LLC | N=220 ➔ 405 | Trial completion date: Oct 2027 ➔ Aug 2028 | Trial primary completion date: Nov 2026 ➔ Dec 2027

Enrollment change • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Preclinical characterization of IMG-007, a high-affinity, non-depleting anti-OX40 monoclonal antibody for the treatment of inflammatory and autoimmune disease (SID 2026) - P1/2, P2 | "IMG-007 activity was benchmarked against a representative anti-OX40 antibody without Fc modifications, GBR 830, comparable to those in clinical development. Lastly, in a graft-versus-host disease model using lymphopenic NCG mice, IMG-007 suppressed T cell expansion and extended median survival from 32.5 days in the isotype group to more than 70 days (study termination). Taken together, IMG-007 combines high-affinity OX40 binding with potent inhibition of OX40-OX40L interactions and minimal Fc receptor engagement, supporting a unique non-depleting mechanism well suited for therapeutic modulation of pathogenic T cell responses."

IO biomarker • Preclinical • Alopecia • Atopic Dermatitis • Dermatitis • Graft versus Host Disease • Immunology • FCGR2A • FCGR2B • IFNG • TNFSF4

ImageneBio Reports First Quarter 2026 Financial Results and Provides IMG-007 Program Update (GlobeNewswire) - "IMG-007 is the leading receptor-targeting, non-T cell-depleting OX40 antagonist in active clinical development. The Phase 2b ADAPTIVE trial is progressing under the previously announced amended protocol in North America, with topline data anticipated in the fourth quarter of 2027; The Company will present preclinical data on IMG-007 at the 83rd Annual Society for Investigative Dermatology (SID) Meeting in May 2026 in Chicago, IL. The oral presentation will characterize how IMG-007’s distinctive design, which targets the OX40 receptor for efficacy while not depleting a patient’s T cells for safety, distinguishes it from other agents in the OX40 class."

P2b data • Preclinical • Atopic Dermatitis • Immunology

ImageneBio Announces $30 Million Private Placement (GlobeNewswire) - "The company intends to use the proceeds from the offering to support further development of IMG-007 in alopecia areata and late-stage development activities in atopic dermatitis."

Financing • Alopecia • Atopic Dermatitis

IMG-007 Program Updates (GlobeNewswire) - "A blinded safety review was conducted in March 2026 to assess the consistency of IMG-007’s emerging tolerability profile; A total of two serious adverse events, both deemed unrelated to IMG-007, have been observed to date across all studies of IMG-007, including in the ADAPTIVE Phase 2b trial; Consistent with previous reporting, no cases of administration-associated pyrexia or chills, aphthous or gastrointestinal ulcers, serious infections or malignancies have been observed with IMG-007 treatment to date....The ADAPTIVE study is meeting enrollment expectations and, consistent with previous guidance, remains on track for a topline readout in 2027 with continued strong interest from investigators."

P2b data • Atopic Dermatitis

A previously announced protocol amendment to the ADAPTIVE trial was submitted… (GlobeNewswire) - "Expand the number and exposure range of dosing regimens studied to fully characterize the clinical profile of IMG-007; 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 study execution."

Clinical protocol • Atopic Dermatitis

Imagene will deliver an oral presentation of preclinical data, including characterization of IMG-007’s non-T cell depleting profile, at the 83rd Annual Society for Investigative Dermatology (SID) Meeting in May 2026 in Chicago, IL. (GlobeNewswire)

Preclinical • Immunology • Inflammation

IMG-007-203: A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis (ADAPTIVE) (clinicaltrialsregister.eu) - P1/2 | N=132 | Not yet recruiting | Sponsor: Inmagene LLC

New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ImageneBio Appoints Immunology Drug Development Veteran Dr. Ben Porter-Brown as Chief Medical Officer (GlobeNewswire) - "Will build and lead Imagene’s clinical organization and drive completion of the Phase 2b ADAPTIVE trial in atopic dermatitis; Will expand Phase 2b trial footprint with planned international sites including in the UK and Europe."

Trial status • Atopic Dermatitis

The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis. (PubMed, BioDrugs) - "Amlitelimab, an anti-OX40L monoclonal antibody, has demonstrated sustained efficacy and a favorable safety profile in phase IIa and IIb trials. Rocatinlimab, targeting OX40, has also shown promising results in a phase IIb study and has progressed into multiple phase III trials, with supportive top-line data. In contrast, telazorlimab has shown more modest efficacy and has not advanced to later-stage development. Next-generation agents, including IMG-007, STAR-0310, APG990, and APG279, have been engineered with extended half-lives and attenuated antibody-dependent cellular cytotoxicity to support longer dosing intervals and improve tolerability. While these findings are encouraging, direct comparative studies among agents and versus established therapies are lacking, and long-term efficacy and safety data are still needed. This narrative review explores the role of the OX40/OX40L axis in atopic dermatitis pathogenesis and critically evaluates emerging therapies targeting..."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • TNFSF4

Anti-OX40 monoclonal antibody IMG-007 exhibited clinical activity of hair regrowth, suppressed scalp inflammatory biomarkers in patients with severe alopecia areata in a Ph1b/2a study (ISDS 2025) - "A trend of decreased CD3 and CD8 and increased KRT35 IHC expression in lesions were also noted at week 16. These results suggest that blocking OX40-OX40L signaling with IMG-007 could be a potential therapeutic strategy for treating AA patients."

Biomarker • Clinical • IO biomarker • Alopecia • Immunology • CD8 • TNFSF4

IMG-007, a non-depleting anti-OX40 monoclonal antibody, reduced skin lesion severity and serum inflammatory markers in adults with moderate-to-severe atopic dermatitis in a Phase 1b/2a study (ISDS 2025) - "All AEs were mild or moderate, except in one participant who had erythrodermic AD at baseline and experienced a severe AD flare, which was deemed unrelated to treatment. Results from this study support further clinical investigation of IMG-007 as a potentially differentiated therapeutic candidate for AD treatment."

Clinical • IO biomarker • P1/2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • TNFSF4

Ongoing Phase 2b Clinical Trial and Upcoming Protocol Amendment (GlobeNewswire) - "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."

Clinical protocol • Enrollment status • P2b data • Atopic Dermatitis

Imagene will have two posters and an oral presentation at the upcoming 6th Annual Inflammatory Skin Disease Summit (ISDS) in New York November 12-15, 2025…Accompanying poster date and time: Thursday, November 13, 2025, 7:30-10:00 pm ET (GlobeNewswire) - "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; IMG-007 was well tolerated overall by patients with severe AA with no pyrexia or chills reported."

P1/2 data • Alopecia

Poster Presentation: IMG-007, a non-depleting anti-OX40 monoclonal antibody, reduced skin lesion severity and serum inflammatory markers in adults with moderate-to-severe atopic dermatitis in a Phase 1b/2a study (GlobeNewswire) - "Poster (encore presentation) date and time: Thursday, November 13, 2025, 7:30-10:00 pm EST: Mean reduction in EASI score from baseline at week 16 of 77% among 13 patients treated with up to 3 doses of IMG-007 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."

P1/2 data • Atopic Dermatitis

Inmagene’s anti-OX40 mAb demonstrated an extended half-life and a favorable safety profile in a Phase I study (PRNewswire) - P1 | N=44 | NCT05353972 | Sponsor: Inmagene LLC | "Inmagene Biopharmaceuticals...announced topline results from a Phase 1 study of IMG-007, an anti-OX40 monoclonal antibody (mAb)....In this Phase 1 study, IMG-007 demonstrated a favorable safety profile, with no notable adverse events occurring more frequently in IMG-007 than the placebo group, except for isolated COVID-19 cases with no dose-related trend. No participants reported any treatment-related adverse events....At projected therapeutic dose levels, IMG-007 demonstrated a mean terminal half-life of 31 days, longer than the average half-life of typical IgG mAbs. A single treatment of IMG-007 at projected therapeutic dose levels maintained the target exposure for 12 to 18 weeks, which would allow IMG-007 to be potentially administered every 12 weeks or less frequently."

P1 data • Acute Graft versus Host Disease • Atopic Dermatitis • Dermatitis • Graft versus Host Disease • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Inmagene Biopharmaceuticals Announces Completion of Merger with Ikena Oncology and Concurrent Private Placement of $75 Million (GlobeNewswire) - "Inmagene Biopharmaceuticals...announced the completion of its previously announced merger with Ikena Oncology....The combined company will operate under the name ImageneBio, Inc. ('ImageneBio') and will trade on The Nasdaq Capital Market ('Nasdaq') under the ticker symbol 'IMA' beginning at market open on July 28, 2025....ImageneBio, Inc. will continue to drive the ongoing Phase 2b clinical trial of non-depleting anti-OX40 monoclonal antibody, IMG-007, in patients with moderate-to-severe atopic dermatitis."

M&A • Atopic Dermatitis

Ikena Oncology Announces Stockholder Approval of Merger with Inmagene Biopharmaceuticals (GlobeNewswire) - "Ikena Oncology...announced the results of the annual meeting of its stockholders held on July 15, 2025. At the annual meeting, Ikena’s stockholders voted in favor of all proposals, including a proposal approving the previously announced merger with Inmagene Biopharmaceuticals ('Inmagene'). The merger proposal allows for the issuance of shares of Ikena’s common stock both to the shareholders of Inmagene and to the investors of the financing concurrent to the merger. Following the closing of the merger, the combined company plans to change its name from Ikena Oncology, Inc. to ImageneBio, Inc. and trade on The Nasdaq Capital Market ('Nasdaq') under the ticker symbol 'IMA'....The company’s lead asset IMG-007, a nondepleting anti-OX40 mAb, recently completed Phase 2a clinical trials in atopic dermatitis and alopecia areata."

M&A • Alopecia • Atopic Dermatitis

Ikena Oncology Announces ISS and Glass Lewis Recommend Stockholders Vote “FOR” Proposed Merger with Inmagene Biopharmaceuticals (GlobeNewswire) - "Ikena Oncology...announced that Institutional Shareholder Services Inc. ('ISS') and Glass, Lewis & Co. ('Glass Lewis') recommend that stockholders vote FOR the issuance of shares in connection with the previously disclosed proposed merger with Inmagene Biopharmaceuticals ('Inmagene') at Ikena’s upcoming Annual Meeting of Stockholders on July 15, 2025....Inmagene is a privately held, clinical stage biopharmaceutical company focused on developing IMG-007, a nondepleting anti-OX40 monoclonal antibody (mAb)....'With the recent progress the company made treating the first patients in the global Phase 2B study in atopic dermatitis, and the advancements and opportunities that we are seeing broadly across I&I, the Ikena Board is encouraged and remains committed to the merger with Inmagene."

M&A • Atopic Dermatitis