IMG-007 / Inmagene, Hutchmed - LARVOL DELTA

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

Inmagene Reports Positive Interim Results from Phase 2a Trial of IMG-007, a Nondepleting Anti-OX40 Monoclonal Antibody with an Extended Half-life, for the Treatment of Atopic Dermatitis (GlobeNewswire) - P2a | N=55 | NCT05984784 | Sponsor: Inmagene LLC | "Inmagene Biopharmaceuticals...today announced positive interim data from Phase 2a trial of IMG-007 in patients with AD....Baseline key disease characteristics included mean EASI of 29.5, mean body surface area (BSA) of 52.0%, and 61.5% patients with investigator’s global assessment (IGA=3) and 38.5% with IGA=4. IMG-007 treatment resulted in a rapid and marked improvement from baseline in EASI score as early as Week 1 and continued improvement over time after the last dose of IMG-007 at Week 4. The mean percent improvement from baseline in EASI was 23%, 29%, 47%, 66%, 68%,77%, and 87% at Weeks 1, 2, 4, 8, 12, 16, and 20, respectively. By Week 20, a total of 69%, 54%, and 31% of patients achieved EASI improvement of at least 50% (EASI-50), at least 75% (EASI-75), and at least 90% (EASI-90), respectively."

P2a data • Atopic Dermatitis • Immunology

Inmagene Announces Completion of Enrollment in Phase 2a Trial of IMG-007, a Nondepleting and Half-life Extended Anti-OX40 Monoclonal Antibody, in Patients with Alopecia Areata (GlobeNewswire) - "Inmagene Biopharmaceuticals...today announced that the Company completed target enrollment in its Phase 2a trial evaluating IMG-007 in adult patients with AA....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....The topline readout for the Phase 2a trial in AA is expected in Q4 2024."

Enrollment closed • P2a data • Alopecia • Immunology

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

Enrollment closed

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 | Recruiting ➔ Active, not recruiting

Enrollment closed • Alopecia • Dermatology • Immunology

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD) (clinicaltrials.gov) - P1/2 | N=55 | Active, not recruiting | Sponsor: Inmagene LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Inmagene LLC

New P1 trial

HUTCHMED Announces that Inmagene Exercises Option to License Two Drug Candidates as Part of Strategic Partnership (GlobeNewswire) - "HUTCHMED (China) Limited...today announced that, Inmagene Biopharmaceuticals ('Inmagene') has exercised options to license two drug candidates discovered by HUTCHMED, IMG-007 and IMG-004 (the 'Options') pursuant to the terms of the strategic partnership announced on January 11, 2021. Following the exercise of the Options and subject to receipt by HUTCHMED of ordinary shares representing approximately 7.5% of shares (fully diluted) in Inmagene, Inmagene will be granted an exclusive license to further develop, manufacture and commercialize these two drug candidates worldwide."

Licensing / partnership • Asthma • Atopic Dermatitis • CNS Disorders • Graft versus Host Disease • Immunology • Multiple Sclerosis • Rheumatoid Arthritis

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Inmagene LLC

New P1/2 trial • Alopecia • Immunology

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Inmagene LLC | Phase classification: P1b/2a ➔ P1/2

Phase classification • Alopecia • Immunology

Safety and Pharmacokinetics of IMG-007, an OX40 monoclonal antibody, in Healthy Adults (ACAAI 2023) - "Interim PK analysis suggested classic target-mediated drug disposition (TMDD) kinetics for IMG-007 with a generally dose-proportional PK from 30 mg to 600 mg, and a mean terminal half-life of 12.9 to 37.9 days in that dose range. Conclusion Single doses of IMG-007 up to 600 mg were well-tolerated in healthy participants and exhibited an extended half-life at high doses.IMG-007 represents a unique therapeutic candidate for treating AD and other T-cell mediated diseases."

Clinical • PK/PD data • Atopic Dermatitis • Contact Dermatitis • Dermatitis • Dermatology • Immunology

Inmagene Doses First Patient in Phase 2a Trial of IMG-007, an Anti-OX40 Monoclonal Antibody with an Extended Half-life, for the Treatment of Alopecia Areata (PRNewswire) - "Inmagene Biopharmaceuticals...announced that the first patient has been dosed in a global multicenter Phase 2a study of IMG-007 in adult patients with AA. The study will evaluate the safety, efficacy, pharmacokinetics, and biomarkers of IMG-007 in AA patients with 50% or greater scalp hair loss....In addition to the global Phase 2a study in AA patients, IMG-007 is also being evaluated in a global Phase 2a study in adult patients with AD with an interim data readout expected in Q2 2024."

P2a data • Trial status • Alopecia • Atopic Dermatitis • Immunology

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD) (clinicaltrials.gov) - P1/2 | N=55 | Recruiting | Sponsor: Inmagene LLC | N=24 ➔ 55 | Trial completion date: May 2024 ➔ Feb 2025 | Trial primary completion date: May 2024 ➔ Feb 2025

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

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