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    DRUG:

    soquelitinib (CPI-818)

    i
    Other names: CPI-818, CPI 818, CPI818
    Associations

    News

    Trials
    Company:
    Angel Pharma, Corvus Pharma
    Drug class:
    ITK inhibitor
    Related drugs:
    Associations

    News

    Trials
    25d
    Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma (clinicaltrials.gov)
    P3, N=150, Recruiting, Corvus Pharmaceuticals, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Beleodaq (belinostat) • Folotyn (pralatrexate) • soquelitinib (CPI-818)
    3ms
    Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma (clinicaltrials.gov)
    P3, N=150, Not yet recruiting, Corvus Pharmaceuticals, Inc.
    New P3 trial
    |
    Beleodaq (belinostat) • Folotyn (pralatrexate) • soquelitinib (CPI-818)
    7ms
    Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD (clinicaltrials.gov)
    P1, N=64, Recruiting, Corvus Pharmaceuticals, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    soquelitinib (CPI-818)
    8ms
    Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD (clinicaltrials.gov)
    P1, N=64, Not yet recruiting, Corvus Pharmaceuticals, Inc.
    New P1 trial
    |
    soquelitinib (CPI-818)
    8ms
    A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma (clinicaltrials.gov)
    P1, N=151, Active, not recruiting, Corvus Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    soquelitinib (CPI-818)
    1year
    Dynamic Single-Cell Profiling Reveals Novel Immune Regulatory Mechanism of ITK Inhibitor Soquelitinib in Refractory T Cell Lymphoma (ASH 2023)
    Conclusions Our findings reveal a novel immune regulatory mechanism by which the ITK inhibitor soquelitinib induced normal CD4+ Th1 cells and CD8+ TEMRA cells and reduced CD4+ Treg cells in the tumor microenvironment in responding patients. These findings demonstrate the potential of soquelitinib as a novel immunotherapy for the treatment of T-cell lymphomas and solid tumors.
    PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • TNFA (Tumor Necrosis Factor-Alpha) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • GZMB (Granzyme B) • TBX21 (T-Box Transcription Factor 21) • GZMA (Granzyme A) • GZMH (Granzyme H) • GZMK (Granzyme K) • ITK (IL2 Inducible T Cell Kinase) • PRF1 (Perforin 1) • NKG7 (Natural Killer Cell Granule Protein 7)
    |
    soquelitinib (CPI-818)
    over1year
    Selective ITK blockade induces antitumor responses and enhances efficacy to immune checkpoint inhibitors in preclinical models (AACR 2023)
    Levels of several exhaustion makers were down-regulated by treatment with CPI-818, suggesting that inhibition of ITK by CPI-818 produces favorable changes in the tumor microenvironment. Our findings provide insights into the effects of selective ITK blockade on tumor immunity and its potential role in immunotherapy.
    Preclinical • Checkpoint inhibition
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • ITK (IL2 Inducible T Cell Kinase)
    |
    soquelitinib (CPI-818)
    3years
    Highly Selective Irreversible ITK Inhibitor Cpi-818 Reduces Acute Graft-Versus Host Disease (ASH 2021)
    Conclusion These data in two clinically relevant GVHD models demonstrate that ITK inhibition has potential as a novel targeted approach to prevent aGVHD through a) the suppression of T cell activation and proliferation, b) decreased concentrations of pro-inflammatory cytokines and increased concentration of anti-inflammatory cytokines. CPI-818 is the most potent and selective ITK inhibitor reported to date and these data highlight its promise as a novel agent for the prevention of aGVHD.
    IO biomarker
    |
    CD8 (cluster of differentiation 8) • BTK (Bruton Tyrosine Kinase) • IL2RA (Interleukin 2 receptor, alpha) • CD4 (CD4 Molecule) • IL10 (Interleukin 10) • FOXP3 (Forkhead Box P3) • IL17A (Interleukin 17A) • ITK (IL2 Inducible T Cell Kinase)
    |
    IL2RA expression
    |
    soquelitinib (CPI-818)
    4years
    [VIRTUAL] Cpi-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, Is Well-Tolerated and Active in Patients with T-Cell Lymphoma (ASH 2020)
    The dose-escalation part of the CPI-818-001 trial demonstrated that the 100, 200, 400 and 600 mg BID doses are well tolerated. Clinical activity was observed in both PTCL-NOS and CTCL. Reduction of serum levels of canonical T cell cytokines is consistent with on-mechanism drug inhibition of inflammatory T cell pathways.
    Clinical • IO biomarker
    |
    IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • ITK (IL2 Inducible T Cell Kinase)
    |
    soquelitinib (CPI-818)
    4years
    [VIRTUAL] The ITK Inhibitor Cpi-818 Blocks Activation of T Cells from Autoimmune Lymphoproliferative Syndrome (ALPS) Patients and Is Active in a Murine Model of ALPS (ASH 2020)
    This suggests that the dysregulated growth of Fas-deficient DN T cells requires functional TCR signaling. Further, our data suggests that blocking TCR signaling by targeting ITK may be an effective strategy for treating adult and pediatric ALPS.
    IO biomarker
    |
    CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • ITK (IL2 Inducible T Cell Kinase)
    |
    CD8 expression
    |
    cyclophosphamide • soquelitinib (CPI-818)