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    DRUG:

    vopratelimab (JTX-2011)

    i
    Other names: JTX-2011, JTX 2011, JTX2011
    Company:
    Concentra Biosci
    Drug class:
    ICOS agonist
    Related drugs:
    6ms
    CD28 and ICOS in immune regulation: Structural insights and therapeutic targeting. (PubMed, Bioorg Med Chem Lett)
    Key therapeutic approaches include CTLA-4-Ig fusion proteins (abatacept, belatacept) for autoimmune diseases, ICOS agonists (feladilimab, vopratelimab) to enhance anti-tumor immunity, and bispecific CD28-engaging antibodies (CD28xCD3, CD28xPSMA) for cancer immunotherapy. By integrating structural insights with translational drug development, this review provides a framework for optimizing CD28- and ICOS-targeted therapies. Further advancements in biologics, peptide-based inhibitors, and immune checkpoint modulation will enhance the precision and efficacy of immunotherapeutic strategies.
    Review • Journal
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • ICOS (Inducible T Cell Costimulator)
    |
    feladilimab (GSK3359609) • vopratelimab (JTX-2011)
    over1year
    Vopratelimab (JTX-2011) Alone and in Combination With Anti-Programmed Cell Death Protein 1 (PD-1) or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) in Subjects With Advanced and/or Refractory Solid Tumors (clinicaltrials.gov)
    P1/2, N=4, Terminated, Jounce Therapeutics, Inc. | Completed --> Terminated; Sponsor decision to discontinue providing study drug to patients who have been on study treatment for more than two years
    Trial termination • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • vopratelimab (JTX-2011)
    over1year
    Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (clinicaltrials.gov)
    P2, N=69, Terminated, Jounce Therapeutics, Inc. | Active, not recruiting --> Terminated; The Sponsor decided to discontinue development of pimivalimab prior to the planned study completion. At the time of the decision to discontinue development, enrollment in the study had been completed.
    Trial termination
    |
    pimivalimab (JTX-4014) • vopratelimab (JTX-2011)
    over1year
    Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (clinicaltrials.gov)
    P2, N=69, Active, not recruiting, Jounce Therapeutics, Inc. | Trial primary completion date: Sep 2022 --> May 2024
    Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    pimivalimab (JTX-4014) • vopratelimab (JTX-2011)
    over2years
    Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (clinicaltrials.gov)
    P2, N=69, Active, not recruiting, Jounce Therapeutics, Inc. | Trial completion date: Mar 2023 --> May 2024
    Trial completion date • Combination therapy • IO biomarker • Metastases
    |
    pimivalimab (JTX-4014) • vopratelimab (JTX-2011)
    over3years
    First in Human Phase 1/2 ICONIC Trial of the ICOS agonist vopratelimab alone and with nivolumab: ICOS high CD4 T cell populations and predictors of response. (PubMed, Clin Cancer Res)
    Vopratelimab demonstrated a favorable safety profile alone and in combination with nivolumab. Efficacy was observed only in a subset of patients with a vopratelimab-specific pharmacodynamic biomarker. A potential predictive biomarker of response was identified, which is being prospectively evaluated in a randomized Phase 2 non-small cell lung cancer trial.
    P1/2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator)
    |
    Opdivo (nivolumab) • vopratelimab (JTX-2011)
    over4years
    [VIRTUAL] Phase 2 study of PD-1 inhibitor JTX-4014 alone and in combination with vopratelimab, an ICOS agonist, in biomarker-selected subjects with metastatic NSCLC after one prior platinum-containing regimen (SELECT). (ASCO 2021)
    The preliminary efficacy of vopratelimab +/- nivolumab was assessed in the phase 1/2 ICONIC study in which durable responses were observed in a subset of patients who demonstrated on treatment emergence of peripheral ICOS hi CD4 T effector cells . Secondary endpoints include ORR and PFS according to RECIST v1.1, OS, safety, and association of baseline TIS score with clinical outcomes . The study has a target enrollment goal of approximately 75 patients; the first patient was dosed October 2020.
    Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator)
    |
    EGFR mutation
    |
    Opdivo (nivolumab) • pimivalimab (JTX-4014) • vopratelimab (JTX-2011)
    5years
    ICOS agonism by JTX-2011 (vopratelimab) requires initial T cell priming and Fc cross-linking for optimal T cell activation and anti-tumor immunity in preclinical models. (PubMed, PLoS One)
    Additional benefit is observed when the ICOS antibodies are administered in combination with anti-PD-1 and anti-CTLA-4 therapies. Based on the preclinical data, JTX-2011 is currently being developed in the clinical setting for the treatment of solid tumors.
    Preclinical • Journal
    |
    ICOS (Inducible T Cell Costimulator)
    |
    vopratelimab (JTX-2011)