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    DRUG CLASS:

    OX40 ligand inhibitor

    Related drugs:
    14d
    HYDRO: A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo (clinicaltrials.gov)
    P2, N=215, Recruiting, Sanofi | Trial completion date: Aug 2025 --> Feb 2026 | Trial primary completion date: Apr 2025 --> Nov 2025
    Trial completion date • Trial primary completion date
    18d
    T1D OBTAIN: Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule (clinicaltrials.gov)
    P2, N=84, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open
    2ms
    T1D OBTAIN: Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule (clinicaltrials.gov)
    P2, N=84, Not yet recruiting, Sanofi
    New P2 trial
    2ms
    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, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    2ms
    Generation and characterization of OX40-ligand fusion protein that agonizes OX40 on T-Lymphocytes. (PubMed, Front Immunol)
    A comparable antibody-fusion single-chain TNF protein incorporating 4-1BBL, CD70 (CD27L), or GITRL in place of OX40L elicited similar in vivo T cell responses. Thus, we propose that optimizing the multimerization of OX40L proteins through innovative design strategies may facilitate the development of more effective agonists for targeted immunotherapies.
    Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha) • CD70 (CD70 Molecule) • CD4 (CD4 Molecule) • TNFSF4 (TNF Superfamily Member 4)
    2ms
    HS OBTAIN: A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=86, Completed, Sanofi | Active, not recruiting --> Completed
    Trial completion
    |
    CRP (C-reactive protein)
    3ms
    RESULT: A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease (clinicaltrials.gov)
    P2, N=84, Recruiting, Sanofi | Initiation date: Aug 2024 --> Dec 2024
    Trial initiation date
    4ms
    Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    5ms
    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=150, Recruiting, Sanofi | Trial completion date: Feb 2026 --> Feb 2028
    Trial completion date
    6ms
    RESULT: A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease (clinicaltrials.gov)
    P2, N=84, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open
    6ms
    A First-in-human Study of APG990 in Healthy Participants (ACTRN12624000775516)
    P1, N=40, Recruiting, Apogee Therapeutics, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Trial initiation date
    6ms
    RIVER-AD: Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (clinicaltrials.gov)
    P2/3, N=1310, Recruiting, Sanofi | Phase classification: P2 --> P2/3
    Phase classification
    7ms
    A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease (clinicaltrials.gov)
    P2, N=204, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open
    8ms
    A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease (clinicaltrials.gov)
    P2, N=204, Not yet recruiting, Sanofi
    New P2 trial
    8ms
    A randomized, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple doses of SAR446422 in healthy, adult participants (ACTRN12623001176651)
    P1, N=120, Suspended, Sanofi-Aventis Australia Pty Ltd | Recruiting --> Suspended
    Trial suspension
    8ms
    RIVER-AD: Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (clinicaltrials.gov)
    P2, N=1310, Recruiting, Sanofi | N=450 --> 1310 | Trial completion date: Apr 2028 --> Dec 2028 | Trial primary completion date: Oct 2027 --> Dec 2028
    Enrollment change • Trial completion date • Trial primary completion date
    9ms
    Non-viral-mediated gene transfer of OX40 ligand for tumor immunotherapy. (PubMed, Front Immunol)
    Combining OX40L/PPT with PD-1 ICB significantly improved treatment efficacy in the CT26 subcutaneous colon cancer model, providing protective immunity against CT26 colon cancer cells. Overall, the anti-tumor efficacy observed with OX40L non-viral gene therapy, whether administered alone or in combination with ICB, highlights its potential to revolutionize cancer gene therapy, thus paving the way for unprecedented advancements in the cancer therapy field.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-1 (Programmed cell death 1) • TNFSF4 (TNF Superfamily Member 4)
    9ms
    RESULT: A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease (clinicaltrials.gov)
    P2, N=84, Not yet recruiting, Sanofi
    New P2 trial
    10ms
    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=150, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open
    10ms
    HS OBTAIN: A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=86, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CRP (C-reactive protein)
    10ms
    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=150, Not yet recruiting, Sanofi
    New P2 trial
    10ms
    CONQUEST: Platform Clinical Study for Conquering Scleroderma (clinicaltrials.gov)
    P2, N=400, Recruiting, Scleroderma Research Foundation, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    11ms
    ESTUARY: A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Monotherapy Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov)
    P3, N=961, Recruiting, Sanofi
    New P3 trial
    12ms
    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=901, Recruiting, Sanofi | N=571 --> 901 | Trial completion date: Oct 2027 --> Oct 2028 | Trial primary completion date: Oct 2027 --> Oct 2028
    Enrollment change • Trial completion date • Trial primary completion date
    1year
    OX40/OX40 ligand and its role in precision immune oncology. (PubMed, Cancer Metastasis Rev)
    Transcriptomic profiling reveals that OX40 and OX40L expression vary between and within tumor types, and that only ~ 17% of cancer patients have high OX40 and low OX40L, one of the expression patterns that might be theoretically amenable to OX40 agonist enhancement. Taken together, the data suggest that the OX40/OX40L machinery is a critical part of the immune stimulatory system and that understanding endogenous expression patterns of these molecules and co-existing checkpoints merits further investigation in the context of a precision immunotherapy strategy for cancer therapy.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • TNFRSF8 (TNF Receptor Superfamily Member 8) • LAG3 (Lymphocyte Activating 3) • TNFA (Tumor Necrosis Factor-Alpha) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • TNFRSF9 (TNF Receptor Superfamily Member 9) • TNFRSF18 (TNF Receptor Superfamily Member 18) • TNFSF4 (TNF Superfamily Member 4)
    1year
    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=249, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open
    1year
    Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study (clinicaltrials.gov)
    P2, N=390, Completed, Kymab Limited | Active, not recruiting --> Completed | Phase classification: P2b --> P2
    Trial completion • Phase classification
    1year
    AQUA: A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Adults With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor (clinicaltrials.gov)
    P3, N=249, Not yet recruiting, Sanofi
    New P3 trial
    1year
    SHORE: A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 18 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids (clinicaltrials.gov)
    P3, N=496, Recruiting, Sanofi
    New P3 trial
    1year
    OX40 in the Pathogenesis of Atopic Dermatitis-A New Therapeutic Target. (PubMed, Am J Clin Dermatol)
    As the OX40 pathway is critical for expansion, differentiation, and survival of effector and memory T cells, its targeting might be a promising therapeutic approach to provide sustained inhibition of pathogenic T cells and associated inflammation and broad disease control. Antibodies against OX40 [rocatinlimab (AMG 451/KHK4083) and telazorlimab (GBR 830)] or OX40L [amlitelimab (KY1005)] have shown promising results in early-phase clinical studies of moderate-to-severe AD, highlighting the importance of OX40 signaling as a new therapeutic target in AD.
    Review • Journal • IO biomarker
    |
    TNFA (Tumor Necrosis Factor-Alpha) • TNFRSF4 (TNF Receptor Superfamily Member 4) • TNFSF4 (TNF Superfamily Member 4)
    |
    TNFRSF4 expression
    1year
    A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 18 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2) (clinicaltrials.gov)
    P3, N=420, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open
    over1year
    A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 18 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2) (clinicaltrials.gov)
    P3, N=420, Not yet recruiting, Sanofi
    New P3 trial
    over1year
    Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (clinicaltrials.gov)
    P2, N=450, Recruiting, Sanofi | N=300 --> 450 | Trial completion date: Oct 2027 --> Apr 2028
    Enrollment change • Trial completion date
    over1year
    Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=84, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open
    over1year
    TIDE-asthma: Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma (clinicaltrials.gov)
    P2, N=446, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    over1year
    RIVER-ASTHMA: Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderatetosevere Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study (clinicaltrials.gov)
    P2, N=380, Recruiting, Sanofi | Trial completion date: Jun 2030 --> Jun 2029 | Trial primary completion date: Jun 2030 --> Jun 2029
    Trial completion date • Trial primary completion date
    over1year
    COAST 1: A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 18 Years and Older With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov)
    P3, N=420, Recruiting, Sanofi
    New P3 trial
    over1year
    Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=84, Not yet recruiting, Sanofi
    New P2 trial
    over1year
    HYDRO: A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo (clinicaltrials.gov)
    P2, N=166, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open
    over1year
    RIVER-ASTHMA: Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderatetosevere Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study (clinicaltrials.gov)
    P2, N=380, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open
    2years
    Natural killer cell therapy potentially enhances the antitumor effects of bevacizumab plus irinotecan in a glioblastoma mouse model. (PubMed, Front Immunol)
    In conclusion, the potential therapeutic effect of NK cells combined with Bev plus Iri against GBM cells was limited in this study. Accordingly, further research is required to improve the accessibility and strength of NK cell function in this combination treatment.
    Preclinical • Journal • IO biomarker
    |
    IL18 (Interleukin 18) • IL21 (Interleukin 21)
    |
    TNFRSF4 expression
    |
    Avastin (bevacizumab) • irinotecan
    over2years
    IL-33-ILC2 axis promotes anti-tumor CD8 T cell responses via OX40 signaling. (PubMed, Biochem Biophys Res Commun)
    Co-culture of CD8 T cells expressing OX40 with IL-33-stimulated ILC2 expressing OX40L promoted cell activation and proliferation of CD8 T cells, which was significantly suppressed by administration of anti-OX40L blocking antibody. Thus, the IL-33-ILC2 axis promotes CD8 T cell responses via OX40/OX40L interaction and exerts an anti-tumor effect.
    Journal
    |
    CD8 (cluster of differentiation 8) • IL33 (Interleukin 33)
    |
    CD8 expression • TNFRSF4 expression