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    DRUG:

    OBI-833

    i
    Other names: OBI833, OBI833/OBI821, OBI-833, Globo H-CRM197, OBI-833/OBI-821, Globo H-CRM 197, OBI 833, OBI 833/OBI 821, Globo H-CRM-197
    Associations

    News

    Trials
    Company:
    OBI Pharma
    Drug class:
    Globo H modulator
    Related drugs:
    Associations

    News

    Trials
    7ms
    To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, OBI Pharma, Inc | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    erlotinib • OBI-833
    over1year
    Phase 2 Study: OBI-833/OBI-821 Maintenance for Globo H+ Advanced Biliary Tract Cancer After Gemcitabine/Cisplatin (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Chang Gung Memorial Hospital
    New P1 trial • IO biomarker • Metastases
    |
    cisplatin • gemcitabine • OBI-833
    2years
    To Evaluate OBI-833/OBI-821 in Patients With Locally Advanced, Globo H-Positive Esophageal Cancer for Recurrence (clinicaltrials.gov)
    P2, N=60, Recruiting, National Taiwan University Hospital
    Trial completion date • Trial primary completion date • Metastases
    |
    OBI-833
    almost3years
    Globo H-targeted CAR T cell cancer immunotherapy (AACR 2023)
    Clinical studies with the Globo H vaccines (OBI-822 and OBI-833) and the humanized anti-Globo H antibody (OBI-888) demonstrating an excellent safety profile...As a result, development of CAR T targeting GH may offer a novel anticancer therapeutic agent.Aim: The aim of this study was to develop a CAR T cell therapy targeted against Globo H (obi-R007) using lentivirus-mediated genetic engineering with a proprietary Globo H-specific antibody... In conclusion, our in vitro and in vivo pharmacology and preliminary toxicology studies support clinical development of Globo H CAR T immunotherapy for patients with cancer.
    CAR T-Cell Therapy • PD(L)-1 Biomarker • IO biomarker
    |
    PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • IL2RA (Interleukin 2 receptor, alpha) • CD69 (CD69 Molecule) • IL2 (Interleukin 2) • GZMB (Granzyme B)
    |
    OBI-833 • OBI-888 • OBI-R007 • adagloxad simolenin (OBI 822)
    over3years
    To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, OBI Pharma, Inc | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    erlotinib • OBI-833
    over3years
    To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, OBI Pharma, Inc
    New P2 trial • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    erlotinib • OBI-833
    almost5years
    [VIRTUAL] Globo H expression in metastatic colorectal cancer (CRC). (ASCO 2021)
    An attractive therapeutic target, Globo H-targeted agents are being tested in early clinical trials (e.g., OBI-833, a Globo H antigen conjugated to a mutated diphtheria toxin with potential antineoplastic activities, and OBI-999, an antibody-drug conjugate (ADC) consisting of a Globo H monoclonal antibody with a synthetic antineoplastic agent) . The association with TMB-H, MSI-H, and PD-L1 status suggests that in some tumors Globo H may be a promising target for combination therapy with immune checkpoint inhibition . The association with different cell populations suggests manipulating the cellular balance in the TME as an approach to improve the efficacy of treatment . NK cell checkpoint inhibitors are in clinical trials and might be utilized in high Globo H cancers; treatments inducing DCs in tumors have been shown to enhance responses to BRAF and PD-L1 blockade and might be applicable in the context of Globo H immunotherapy to overcome Treg immune suppression .
    PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • CD4 (CD4 Molecule) • RSPO3 (R-Spondin 3)
    |
    PD-L1 expression • KRAS mutation • TMB-H • MSI-H/dMMR • BRAF mutation • MYC amplification
    |
    OBI-999 • OBI-833
    almost5years
    Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects (clinicaltrials.gov)
    P1, N=25, Completed, OBI Pharma, Inc | Recruiting --> Completed
    Clinical • Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    OBI-833
    almost6years
    Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects (clinicaltrials.gov)
    P1, N=25, Recruiting, OBI Pharma, Inc | Trial completion date: Jul 2020 --> Mar 2021 | Trial primary completion date: Jan 2020 --> Dec 2020
    Clinical • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    OBI-833