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    DRUG:

    Tedopi (OSE 2101)

    i
    Other names: EP-2101, OSE-2101, IDM 2101, OSE 2101, IDM-2101
    Company:
    Chong Kun Dang, OSE Immunotherapeutics
    Drug class:
    Immunostimulant
    Related drugs:
    5ms
    ARTEMIA: Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor (clinicaltrials.gov)
    P3, N=363, Not yet recruiting, OSE Immunotherapeutics
    New P3 trial • Checkpoint inhibition • Metastases
    |
    docetaxel • Tedopi (OSE 2101)
    9ms
    ATALANTE 1: OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure (clinicaltrials.gov)
    P3, N=219, Terminated, OSE Immunotherapeutics | N=363 --> 219 | Active, not recruiting --> Terminated; due to COVID-19
    Enrollment change • Trial termination • Checkpoint inhibition • Metastases
    |
    docetaxel • pemetrexed • Tedopi (OSE 2101)
    12ms
    TEDOVA: OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC (clinicaltrials.gov)
    P2, N=180, Recruiting, ARCAGY/ GINECO GROUP | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HLA-A2 positive • HLA-A positive
    |
    Keytruda (pembrolizumab) • Tedopi (OSE 2101)
    1year
    OSE Immunotherapeutics Announces a Collaboration Agreement with GenDx for the Development of a Companion Diagnostic for Epitope-Based Cancer Vaccine Candidate Tedopi (Businesswire)
    "OSE Immunotherapeutics SA...today announced that the Company has entered into a collaboration with GenDx (a Eurobio Scientific Company, a key player in the field of specialty in vitro diagnostics) to develop and validate a companion diagnostic (CDx) test to support the confirmatory pivotal Phase 3 clinical trial of Tedopi cancer vaccine candidate in preparation in Non-Small Cell Lung Cancer (NSCLC) second line treatment....Under the Master Collaboration Agreement, GenDx will develop and validate a companion diagnostic (CDx) unique test for a predictive immunological biomarker to identify patients with HLA-A*02 genotype (1) who are biological responders to Tedopi epitopes."
    Licensing / partnership
    |
    Tedopi (OSE 2101)
    1year
    Randomized Open-Label Controlled Study of Cancer Vaccine OSE2101 Versus Chemotherapy in HLA-A2-positive Patients with Advanced Non-Small Cell Lung Cancer with Resistance to Immunotherapy: ATALANTE-1. (PubMed, Ann Oncol)
    In HLA-A2-positive patients with advanced NSCLC and secondary resistance to immunotherapy, OSE2101 increased survival with better safety compared to CT. Further evaluation in this population is warranted.
    Journal • Metastases
    |
    HLA-A2 positive
    |
    docetaxel • pemetrexed • Tedopi (OSE 2101)
    over1year
    TEDOPAM: Maintenance With OSE2101 Plus FOLFIRI, or FOLFIRI After FOLFIRINOX-based Induction Therapy in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P2, N=106, Recruiting, GERCOR - Multidisciplinary Oncology Cooperative Group | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Tedopi (OSE 2101)
    3years
    TEDOPAM: Maintenance With OSE2101 Plus FOLFIRI, or FOLFIRI After FOLFIRINOX-based Induction Therapy in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P2, N=106, Recruiting, GERCOR - Multidisciplinary Oncology Cooperative Group | N=156 --> 106
    Clinical • Enrollment change
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1
    |
    5-fluorouracil • irinotecan • leucovorin calcium • Tedopi (OSE 2101)
    3years
    Combined exploratory immunophenotyping and transcriptomic tumor analysis in patients treated with OSE2101 vaccine in HLA-A2+ advanced non-small cell lung cancer (NSCLC) from the ATALANTE-1 trial (SITC 2021)
    P3 | "These data will be validated on larger number of patients treated with Tedopi® after the step 2 analysis. EudraCT number 2015-003183-36; NCT number: NCT02654587"
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    HER-2 expression
    |
    Immunoscore®
    |
    Tedopi (OSE 2101)
    over4years
    [VIRTUAL] Activity of OSE-2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (ICI): Step 1 results of phase III ATALANTE-1 randomised trial (ESMO 2020)
    Methods HLA-A2+ NSCLC patients, EGFR and ALK negative, having progressed to platinum-based chemotherapy (CT) and anti-PD(L)1, ECOG PS 0-1 were randomized 2:1 to receive Tedopi® subcutaneously Q3W for 6 cycles, followed by maintenance Q8W up to first year, then Q12W, or SoC (docetaxel 75 mg/m2 Q3W or pemetrexed 500 mg/m2 Q3W). Funding: OSE Immunotherapeutics. Clinical trial identification: EudraCT: 2015-003183-36; NCT02654587.
    Clinical • P3 data • Checkpoint inhibition
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression • ALK negative
    |
    docetaxel • pemetrexed • Tedopi (OSE 2101)