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    DRUG:

    OBT076

    i
    Other names: OBT076, MEN1309, MEN 1309, MEN-1309, OBT 076
    Company:
    Menarini, Oxford BioTherap
    Drug class:
    Microtubule inhibitor, CD205-targeted antibody-drug conjugate
    Related drugs:
    25d
    AdCC_2023-01: Study of OBT076 Associated or Not in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck (clinicaltrials.gov)
    P1, N=19, Completed, Groupe Oncologie Radiotherapie Tete et Cou | Suspended --> Completed | N=32 --> 19 | Trial completion date: Sep 2027 --> Oct 2024 | Trial primary completion date: Sep 2026 --> Oct 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • IO biomarker • Metastases
    |
    balstilimab (AGEN2034) • OBT076
    5ms
    AdCC_2023-01: Study of OBT076 Associated or Not in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck (clinicaltrials.gov)
    P1, N=32, Suspended, Groupe Oncologie Radiotherapie Tete et Cou | Recruiting --> Suspended
    Trial suspension • IO biomarker • Metastases
    |
    balstilimab (AGEN2034) • OBT076
    1year
    Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors (clinicaltrials.gov)
    P1, N=200, Recruiting, Oxford BioTherapeutics Ltd | N=150 --> 200 | Trial completion date: Dec 2024 --> Dec 2027 | Trial primary completion date: Dec 2023 --> Dec 2026
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    LY75 (Lymphocyte Antigen 75)
    |
    CD20 positive
    |
    OBT076
    over1year
    AdCC_2023-01: Study of OBT076 Associated or Not in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck (clinicaltrials.gov)
    P1, N=32, Not yet recruiting, Groupe Oncologie Radiotherapie Tete et Cou
    New P1 trial • IO biomarker • Metastases
    |
    balstilimab (AGEN2034) • OBT076
    almost3years
    Potential novel Immuno-oncology mechanism revealed during translational phase I Immuno-blood profiling of experimental ADC medicine OBT076 in a gastric cancer patient (AACR 2022)
    Here we report on a potential novel immuno-oncology mechanism revealed during the Translational Phase I (NCT04064359) immuno-blood profiling of a chemo-refractory patient treated with OBT076, an experimental CD205-directed ADC.A chemo-refractory advanced gastric cancer patient with 60% CD205 expression in the primary tumor via IHC and having previously undergone 2 lines of chemotherapy treatment (Docetaxel/cisplatin/5FU and Ramucirumab/Paclitaxel), received five 21-day cycles of OBT076 (one at 2.5mg/kg and four cycles at 2.0 mg/kg) followed by 1 cycle of Pembrolizumab (PZ; 200mg) ~4 weeks later...These findings suggest that OBT076 activates the patient’s immune response against the tumor through a potentially novel mechanism: drug-induced depletion of CD8+ CD205+ immuno-suppressive cells and subsequent T-cell activation. Additionally, our data support the use of immune checkpoint inhibitors in conjunction with OBT076 to achieve favorable clinical outcomes.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
    |
    Keytruda (pembrolizumab) • cisplatin • paclitaxel • docetaxel • 5-fluorouracil • Cyramza (ramucirumab) • OBT076