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    DRUG:

    pimivalimab (JTX-4014)

    i
    Other names: JTX-4014, JTX 4014, JTX4014
    Company:
    Concentra Biosci
    Drug class:
    PD1 inhibitor
    Related drugs:
    7ms
    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)
    9ms
    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)
    10ms
    INNATE: Study of JTX 8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1/2, N=190, Completed, Jounce Therapeutics, Inc. | Active, not recruiting --> Completed | N=281 --> 190
    Trial completion • Enrollment change • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • FGFR (Fibroblast Growth Factor Receptor)
    |
    EGFR mutation • IDH1 mutation • ALK rearrangement • FGFR mutation
    |
    pimivalimab (JTX-4014) • polzastobart (JTX-8064)
    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 completion date: Mar 2023 --> May 2024
    Trial completion date • Combination therapy • IO biomarker • Metastases
    |
    pimivalimab (JTX-4014) • vopratelimab (JTX-2011)
    over1year
    INNATE: Study of JTX 8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1/2, N=281, Active, not recruiting, Jounce Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • FGFR (Fibroblast Growth Factor Receptor)
    |
    EGFR mutation • IDH1 mutation • ALK rearrangement • FGFR mutation
    |
    pimivalimab (JTX-4014) • polzastobart (JTX-8064)
    almost3years
    INNATE: Study of JTX 8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1/2, N=281, Recruiting, Jounce Therapeutics, Inc. | Phase classification: P1 --> P1/2
    Phase classification • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK rearrangement
    |
    pimivalimab (JTX-4014) • polzastobart (JTX-8064)
    over3years
    INNATE: Study of JTX 8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1, N=281, Recruiting, Jounce Therapeutics, Inc. | N=40 --> 281 | Trial completion date: Sep 2022 --> Jan 2024 | Trial primary completion date: Jul 2022 --> Sep 2023
    Clinical • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK rearrangement
    |
    pimivalimab (JTX-4014) • polzastobart (JTX-8064)
    over3years
    [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)