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    DRUG:

    EO2401

    i
    Other names: EO2401, EO-2401, EO 2401
    Associations

    News

    Trials
    Company:
    Enterome
    Drug class:
    Immunostimulant, Cytotoxic T lymphocyte stimulant
    Related drugs:
    Associations

    News

    Trials
    2d
    ROSALIE: First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progressive Glioblastoma (clinicaltrials.gov)
    P1/2, N=100, Completed, Enterome | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Mar 2024 | Trial primary completion date: Dec 2024 --> Jan 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • EO2401
    2d
    Spencer: A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma (clinicaltrials.gov)
    P1/2, N=70, Terminated, Enterome | Active, not recruiting --> Terminated; Strategic decision
    Trial termination • Combination therapy • Checkpoint block • Metastases
    |
    Opdivo (nivolumab) • EO2401
    4ms
    Spencer: A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma (clinicaltrials.gov)
    P1/2, N=70, Active, not recruiting, Enterome | Trial completion date: Nov 2025 --> Oct 2024
    Trial completion date • Combination therapy • Checkpoint block • Metastases
    |
    Opdivo (nivolumab) • EO2401
    12ms
    ROSALIE: First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progressive Glioblastoma (clinicaltrials.gov)
    P1/2, N=100, Active, not recruiting, Enterome | Phase classification: P1b/2a --> P1/2
    Phase classification
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • EO2401
    12ms
    Spencer: A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma (clinicaltrials.gov)
    P1/2, N=70, Active, not recruiting, Enterome | Recruiting --> Active, not recruiting | N=120 --> 70 | Trial completion date: Dec 2024 --> Nov 2025
    Enrollment closed • Enrollment change • Trial completion date
    |
    Opdivo (nivolumab) • EO2401
    1year
    EO2401 peptide immunotherapy + nivolumab +/- bevacizumab in first recurrent glioblastoma: the phase 1/2 EOGBM1-18/ROSALIE study (NCT04116658) (SNO 2023)
    C2a/1vsC2a/2vsC3: median treatment duration 1.4vs3.2vs4.8 months, disease control rate 22%vs40%vs88%, median PFS 1.6vs3.6vs5.5 months; median survival 9.0vs12.6vstoo early (C3 median FU 8.3 mo, survival ongoing up to 2 years). Further follow-up will be presented.
    P1/2 data
    |
    CD8 (cluster of differentiation 8) • BIRC5 (Baculoviral IAP repeat containing 5) • CD4 (CD4 Molecule) • FOXM1 (Forkhead Box M1) • IL13RA2 (Interleukin 13 Receptor Subunit Alpha 2)
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • EO2401
    over1year
    EO2401 (E) peptide immunotherapy + nivolumab (N) in adrenocortical carcinoma (ACC) and metastatic pheochromocytoma/paraganglioma (MPP): EOADR1-19/SPENCER (ESMO 2023)
    Post-hoc analyses identified predictors of lack of efficacy (no mitotane, ECOG > 1, ACC 1st diagnosis ≤9 months(mo), lesion size >125 mm, >3 organs involved, lymphopenia >grade 1); C2-post hoc group was created applying these factors. Conclusions EO2401/N was well tolerated generating durable immune responses correlating with efficacy. Based on the greater efficacy in C2-post hoc group a randomized extension is currently recruiting.
    PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • BIRC5 (Baculoviral IAP repeat containing 5) • CD4 (CD4 Molecule) • FOXM1 (Forkhead Box M1) • IL13RA2 (Interleukin 13 Receptor Subunit Alpha 2)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Lysodren (mitotane) • EO2401
    2years
    EO2401, a novel microbiome-derived therapeutic vaccine for patients with recurrent glioblastoma: ROSALIE study. (EANO 2022)
    This ongoing Ph 1/2 trial (NCT04116658) investigates the safety and tolerability (primary) of EO (300 µg/peptide, SC Q2W X 4, then Q4W), EO with nivolumab (3 mg/kg Q2W; EN), and EN with bevacizumab (10 mg/kg Q2W; ENB) among four Cohorts (Cs) of pts with GB at first progression/recurrence after radiotherapy/temozolomide. EO2401 generated strong systemic immune responses and was well tolerated in combination with nivolumab ± bevacizumab. Preliminary ORR/DCR and mPFS for ENB, and survival for EN seem encouraging. Updated results from the current 40 patients and results from additional 35 patients who already started treatment with EN with the option for low-dose bevacizumab edema treatment at neurological symptoms will be presented.
    Clinical • PD(L)-1 Biomarker
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CD8 (cluster of differentiation 8) • BIRC5 (Baculoviral IAP repeat containing 5) • CD4 (CD4 Molecule) • FOXM1 (Forkhead Box M1) • IL13RA2 (Interleukin 13 Receptor Subunit Alpha 2)
    |
    IDH1 mutation
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • temozolomide • EO2401
    over3years
    ROSALIE: First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progressive Glioblastoma (clinicaltrials.gov)
    P1b/2a, N=52, Recruiting, Enterome | N=32 --> 52
    Clinical • Enrollment change
    |
    IFNG (Interferon, gamma)
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • EO2401