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    DRUG CLASS:

    OX40 ligand inhibitor

    Related drugs:
    23h
    Is Kaposi's sarcoma the end of the OX40/OX40L axis in atopic dermatitis? (PubMed, Front Immunol)
    The discontinuation of rocatinlimab after confirmed and suspected cutaneous Kaposi's sarcoma cases, together with two cumulative cases reported in the amlitelimab program in patients with known risk factors, has changed the discussion from early promise to mechanism, risk, and therapeutic strategy. The central challenge is now to determine how the axis can be targeted, in which patients, and in what therapeutic context, to maximize clinical benefit while managing risk. Rather than signaling the end of the axis in atopic dermatitis, Kaposi's sarcoma may instead mark the limits of a first-generation development strategy and the beginning of a more selective approach built around molecule design, therapeutic context, and prospective risk mitigation.
    Review • Journal
    |
    TNFSF4 (TNF Superfamily Member 4)
    3d
    A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants (clinicaltrials.gov)
    P1, N=40, Active, not recruiting, AbCellera Biologics Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • First-in-human
    9d
    A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata (clinicaltrials.gov)
    P2, N=166, Terminated, Sanofi | Trial completion date: Jan 2028 --> May 2026 | Active, not recruiting --> Terminated; Sponsor decision; the decision is not related to any safety concern
    Trial completion date • Trial termination
    13d
    Machine learning models predict the immunotherapy response in tumors on the basis of DNA methylation. (PubMed, Epigenomics)
    Differentially methylated sites enriched the ubiquitin-proteasome pathway, with most loci located in the N shore region of CpG islands...Tumor methylation sites hold promise as predictive biomarkers for immunotherapy efficacy. The SVM model is the optimal machine learning approach for predicting methylation sites in immunotherapy.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    TMB (Tumor Mutational Burden) • CXCR4 (Chemokine (C-X-C motif) receptor 4)
    30d
    RIVER-ASTHMA: Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study (clinicaltrials.gov)
    P2, N=335, Active, not recruiting, Sanofi | Trial completion date: Jun 2029 --> Sep 2026 | Trial primary completion date: Jun 2029 --> Sep 2026
    Trial completion date • Trial primary completion date
    1m
    SAPIOX: A FIRST-IN-HUMAN PHASE I TRIAL OF OX118 IN HEALTHY VOLUNTEERS (2024-515378-28-00)
    P1, N=32, Completed, Oxion Biologics AB | Recruiting --> Completed
    Trial completion • First-in-human
    1m
    AQUA: A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor (clinicaltrials.gov)
    P3, N=636, Recruiting, Sanofi | N=390 --> 636 | Trial completion date: Sep 2026 --> Sep 2028 | Trial primary completion date: May 2026 --> Sep 2027
    Enrollment change • Trial completion date • Trial primary completion date
    2ms
    Targeting Human Epidermal Growth Factor Receptor 2 in Bladder Cancer: Evaluating Its Role as a More Robust Clinicopathological Biomarker Compared to Programmed Death Ligand 1 Expression. (PubMed, Urol Res Pract)
    The HER2/neu was an independent clinicopathological biomarker associated with nodal involvement and aggressive tumor biology in urothelial carcinoma. PD-L1 showed limited clinicopathological utility in this cohort, though it retains predictive value for immune checkpoint inhibitor therapy.   Cite this article as: Mittal A, Malhotra K, Panwar V, Kishore S, Taher M, Singhal A. Targeting human epidermal growth factor receptor 2 in bladder cancer: evaluating its role as a more robust clinicopathological biomarker compared to programmed death ligand 1 expression. Urol Res Pract. 2026, 52, 0061, doi: 10.5152/tud.2026.25061.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • NODAL (Nodal Growth Differentiation Factor)
    |
    PD-L1 expression • HER-2 overexpression • PD-L1 expression + HER-2 overexpression
    2ms
    A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of subcutaneous NAV-242 in Healthy Adults. (ACTRN12626000155392)
    P1, N=48, Recruiting, Navigator Medicines | Not yet recruiting --> Recruiting
    Enrollment open • Trial initiation date
    2ms
    Mainsail: A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=150, Recruiting, Navigator Medicines, Inc.
    Trial initiation date
    2ms
    ATLANTIS: Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov)
    P2, N=999, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    2ms
    A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=212, Completed, Sanofi | Active, not recruiting --> Completed
    Trial completion