IMG-007 / Hutchmed, ImageneBio - LARVOL DELTA

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

Inmagene Doses First Patient in the ADAPTIVE Phase 2b Trial of IMG-007, a Nondepleting Anti-OX40 mAb with an Extended Half-life, in Patients with Moderate-to-Severe Atopic Dermatitis (GlobeNewswire) - "Inmagene Biopharmaceuticals...announced the successful dosing of the first patient in its global multicenter Phase 2b dose-finding study (ADAPTIVE Trial, NCT07037901) of IMG-007 in patients with moderate-to-severe atopic dermatitis (AD)....The trial aims to enroll approximately 220 patients across four treatment arms (high, medium, low dose of IMG-007 and placebo) in a 1:1:1:1 ratio....Topline results from the Phase 2b ADAPTIVE trial are expected in the fourth quarter of 2026."

P2b 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=220 | Recruiting | Sponsor: Inmagene LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

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=220 | Not yet recruiting | Sponsor: Inmagene LLC

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

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants (clinicaltrials.gov) - P1/2 | N=29 | Completed | Sponsor: Inmagene LLC | Active, not recruiting ➔ Completed

Trial completion • Alopecia • Dermatology • Immunology

Inmagene Reports Topline Results from Phase 2a Study of IMG-007, a Nondepleting Anti-OX40 Monoclonal Antibody with an Extended Half-life, in Patients with Alopecia Areata (GlobeNewswire) - P1b/2a | N=30 | NCT06060977 | Sponsor: Inmagene LLC | "The Phase 2a trial (NCT06060977) was a multiple ascending dose study evaluating the safety, pharmacokinetics, and efficacy of IMG-007 in adult AA patients with 50% or greater scalp hair loss, measured by the SALT score...Key disease characteristics at baseline included a mean duration of current AA episode of 3.0 years and a mean SALT score of 80.4. Nine of 29 (31%) enrolled patients had baseline SALT scores of 95 or greater. Scalp biopsy samples were collected at Baseline and Week 16 for the evaluation of inflammatory biomarkers. Key study endpoints included safety and percentage change from baseline in SALT score over time...The four-week treatment resulted in a dose-related clinical activity of hair regrowth...IMG-007 was generally well-tolerated, with no serious adverse events (SAEs)....Data from this study will be presented at an upcoming scientific conference."

P2a data • Alopecia

Inmagene Reports Positive Topline Results of IMG-007, a Nondepleting Anti-OX40 Monoclonal Antibody with an Extended Half-Life, for the Treatment of Atopic Dermatitis (GlobeNewswire) - P1b/2a | N=13 | NCT05984784 | Sponsor: Inmagene LLC | "After 4 weeks of treatment with IMG-007, the mean percent change of EASI and the EASI-75 response at Week 16 were 77% and 54%, respectively, which are within the range shown by other investigational OX40/OX40L-targeting mAbs with longer duration (at least 16 weeks) of treatments. In addition, durable inhibition of serum inflammatory markers of diverse T helper (Th) cells, including Th1, Th2 and Th17 cells, was observed for up to 24 weeks. IMG-007 was generally well-tolerated, with no serious adverse events (SAEs), no adverse events (AEs) leading to treatment discontinuation, and no treatment-related AEs. There were no reports of pyrexia or chills."

P2a data • Atopic Dermatitis

Inmagene Reports Positive Topline Results of IMG-007, a Nondepleting Anti-OX40 Monoclonal Antibody with an Extended Half-Life, for the Treatment of Atopic Dermatitis (GlobeNewswire) - P1 | N=16 | NCT06304740 | Sponsor: Inmagene LLC | "Overall, the PK profile of the SC formulation is consistent with that of the IV formulation. At the projected therapeutic dose level, the serum concentrations were maintained above the level needed for blocking OX40/OX40L signaling in circulation for the entire follow-up period of 18 weeks. A single SC dose of IMG-007 demonstrated a mean terminal half-life of 34.7 days, which is substantially longer than that of other OX40/OX40L mAbs in clinical development. The IMG-007 SC formulation exhibited a well-tolerated safety profile...Inmagene is planning to initiate a Phase 2b dose-finding study with IMG-007’s SC formulation in patients with moderate-to-severe AD in Q1 2025."

New P2b trial • P1 data • Atopic Dermatitis

Ikena Oncology and Inmagene Biopharmaceuticals Announce Agreement for Merger and Private Placement (GlobeNewswire) - "The combined company will focus on the development of IMG-007, a monoclonal antibody (mAb) targeting OX40, for the treatment of atopic dermatitis. The combined company plans to operate under the name 'ImageneBio, Inc.' ('ImageneBio')....IMG-007 is a mAb targeting OX40 with potential utility in a wide range of inflammatory indications, including atopic dermatitis, asthma, hidradenitis suppurativa, systemic sclerosis and others....The transaction is expected to close in mid-2025....IMG-007’s Phase 2b clinical trial in atopic dermatitis is expected to begin in early 2025."

M&A • New P2b trial • Asthma • Atopic Dermatitis • Hidradenitis Suppurativa • Systemic Sclerosis

Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Terminated | Sponsor: Inmagene LLC | Cohort 3 was cancelled because it was no longer necessary based on information from another study. No safety concerns were noted.

Trial termination

Inmagene to Host Virtual KOL Event on the Inhibition of the OX40/OX40L Signaling in the Treatment of Atopic Dermatitis and Alopecia Areata (GlobeNewswire) - "Inmagene Biopharmaceuticals...announced it will host a virtual key opinion leader (KOL) event at 10:00 AM ET on Thursday, October 31, 2024. The event will feature Jonathan Silverberg...Maryanne Senna...and Yufang Lu...who will discuss the potential role of anti-OX40/OX40L monoclonal antibodies (mAbs) in the treatment of atopic dermatitis (AD) and alopecia areata (AA). The event will discuss data from emerging OX40/OX40L inhibitors, including Inmagene’s IMG-007 - the only clinical-stage non-depleting anti-OX40 mAb."

Clinical • Atopic Dermatitis

Safety and efficacy of IMG-007, a nondepleting anti-OX40 monoclonal antibody, in adult patients with moderate-to-severe atopic dermatitis: results from a phase 2a study (EADV 2024) - "IMG-007, a novel nondepleting OX40 mAb, was safe and well tolerated without any reports of pyrexia or chills in patients with moderate-to-severe AD. The favorable safety profile is consistent with a silenced ADCC function. Treatment with IMG-007 for 4 weeks led to rapid and sustained improvements in AD disease activity."

Clinical • IO biomarker • P2a data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

IMG-007, a novel nondepleting anti-OX40 monoclonal antibody, showed potent in vitro and in vivo inhibitory effects on OX40-OX40L signalling (EADV 2024) - "IMG-007, a novel nondepleting anti-OX40 mAb with a slienced ADCC function, exhibited potent inhibition of OX40-OX40L signaling in vitro and protective efficacy in a xeno-GvHD mouse model in vivo. IMG-007 represents a promising OX40 antagonist potentially for the treatment of I&I diseases."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Graft versus Host Disease • Immunology • IFNG • TNFSF4

Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Inmagene LLC | Active, not recruiting ➔ Completed | N=24 ➔ 16

Enrollment change • Trial completion

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: Inmagene LLC | Trial completion date: Oct 2024 ➔ Jan 2025 | Trial primary completion date: Oct 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Alopecia • Dermatology • Immunology

Extended Half-life Antibodies: A Narrative Review of a New Approach in the Management of Atopic Dermatitis. (PubMed, Dermatol Ther (Heidelb)) - "APG777, targeting interleukin-13 (IL-13), and IMG-007, targeting OX40 receptor, have shown promising preclinical and early clinical results...As research continues, extended half-life antibodies could significantly improve AD management and patient quality of life. Further studies will determine the long-term safety and efficacy of extended half-life antibodies, with ongoing innovations in antibody engineering likely to broaden their applications and benefits."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immune Modulation • Immunology • Inflammation • Pruritus • IL13

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD) (clinicaltrials.gov) - P1/2 | N=13 | Terminated | Sponsor: Inmagene LLC | N=55 ➔ 13 | Trial completion date: Feb 2025 ➔ Apr 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2025 ➔ Apr 2024; Terminated because the sponsor believes that results from Cohort 1 will provide reliable information for further development decision. No safety concerns were noted.

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