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    DRUG:

    adagloxad simolenin (OBI 822)

    i
    Other names: Globo-H vaccine, Globo H-KLH vaccine, OBI 822, OPT-22
    Associations

    News

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

    News

    Trials
    10ms
    Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC (clinicaltrials.gov)
    P3, N=575, Active, not recruiting, OBI Pharma, Inc | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    HER-2 negative • ER negative
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    capecitabine • adagloxad simolenin (OBI 822)
    over2years
    Heat-shock protein 90α protects NME1 against degradation and suppresses metastasis of breast cancer. (PubMed, Br J Cancer)
    These results not only reveal a new mechanism of NME1 degradation but also pave the way for the development of new and effective approaches to metastatic cancer therapy.
    Journal
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    HSP90AA1 (Heat Shock Protein 90 Alpha Family Class A Member 1Heat Shock Protein 90 Alpha Family Class A Member 1)
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    adagloxad simolenin (OBI 822)
    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
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    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)
    over5years
    Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC (clinicaltrials.gov)
    P3, N=668, Recruiting, OBI Pharma, Inc | Trial completion date: Nov 2025 --> Dec 2027
    Clinical • Trial completion date
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER negative • PGR negative
    |
    capecitabine • adagloxad simolenin (OBI 822)
    over5years
    Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 in patients with metastatic breast cancer: phase II randomized, placebo-controlled study. (PubMed, J Immunother Cancer)
    AS/OBI-821 did not improve PFS in patients with previously treated MBC. However, humoral immune response to Globo H correlated with improved PFS in AS/OBI-821 recipients, leading the way to further marker-driven studies. Treatment was well tolerated.NCT01516307.
    Clinical • P2 data • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    adagloxad simolenin (OBI 822) • cyclophosphamide intravenous
    almost6years
    [VIRTUAL] Phase III, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of adagloxad simolenin (OBI-822) and OBI-821 treatment in patients with early-stage triple-negative breast cancer (TNBC) at high risk for recurrence. (ASCO 2020)
    Survival follow-up is for 5 years from randomization of last subject. Research Funding: OBI Pharma Inc.
    Clinical • P3 data
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    adagloxad simolenin (OBI 822)