^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    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:
    9d
    Summary of second-line treatment of stage IV NSCLC without oncogenic addiction (PubMed, Bull Cancer)
    The introduction of immune checkpoint inhibitors (anti-PD-1/PD-L1) has revolutionized first-line treatment, but second-line options remain largely dependent on older chemotherapies such as docetaxel or pemetrexed...Innovative strategies are under investigation: antibody-drug conjugates (anti-TROP-2, anti-CEACAM-5), cancer vaccines (TEDOPI), external electric fields (TTFields), oncolytic viruses, and PROTACs. While some of these show promise in progression-free survival, global survival benefit remains modest. The identification of robust predictive biomarkers is essential for tailoring future therapies.
    Clinical • Clinical guideline • Clinical protocol • Observational data • Preclinical • Retrospective data • Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PTEN (Phosphatase and tensin homolog) • CD8 (cluster of differentiation 8)
    |
    PTEN mutation
    |
    docetaxel • pemetrexed • Tedopi (OSE 2101)
    16d
    A Phase 1 dose-escalation study to evaluate safety, pharmacokinetics, and pharmacodynamics of OSE-279, an anti-PD-1 monoclonal antibody in patients with advanced solid tumours. (PubMed, Eur J Cancer)
    OSE-279 monotherapy was well tolerated with durable responses in patients with advanced solid tumours. The trial is continuing with OSE-279 combined with OSE2101, a therapeutic cancer vaccine in 1st line HLA-A2 positive PD-L1 ≥ 50% NSCLC. CLINICAL TRIAL REGISTRATION (NCT NUMBER: NCT05751798).
    P1 data • PK/PD data • Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HLA-A*02 positive
    |
    Tedopi (OSE 2101) • OSE-279
    3ms
    Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED) (clinicaltrials.gov)
    P2, N=105, Active, not recruiting, Fondazione Ricerca Traslazionale | Recruiting --> Active, not recruiting | Trial completion date: May 2025 --> Sep 2028 | Trial primary completion date: Oct 2023 --> Sep 2027
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • docetaxel • Tedopi (OSE 2101)
    5ms
    A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study. (clinicaltrials.gov)
    P2, N=160, Recruiting, Fondazione Ricerca Traslazionale
    New P2 trial • Circulating tumor DNA
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • Tedopi (OSE 2101)
    8ms
    Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas (clinicaltrials.gov)
    P1/2, N=41, Recruiting, OSE Immunotherapeutics | N=24 --> 41
    Enrollment change
    |
    MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    Tedopi (OSE 2101) • OSE-279
    10ms
    TEDOPAM: OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC (clinicaltrials.gov)
    P2, N=106, Active, not recruiting, GERCOR - Multidisciplinary Oncology Cooperative Group | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Tedopi (OSE 2101)
    over1year
    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, Recruiting, OSE Immunotherapeutics | Not yet recruiting --> Recruiting | Initiation date: Jun 2024 --> Dec 2024
    Enrollment open • Trial initiation date • Checkpoint inhibition • Metastases
    |
    docetaxel • Tedopi (OSE 2101)
    over1year
    TEDOVA: OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC (clinicaltrials.gov)
    P2, N=180, Active, not recruiting, ARCAGY/ GINECO GROUP | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    HLA-A2 positive • HLA-A positive
    |
    Keytruda (pembrolizumab) • Tedopi (OSE 2101)
    almost2years
    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)
    2years
    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)
    over2years
    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)
    over2years
    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)