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    DRUG:

    belzupacap sarotalocan (AU-011)

    i
    Other names: AU-011, AU 011, bel-sar
    Company:
    Aura Biosci
    Drug class:
    Reactive oxygen species stimulant
    Related drugs:
    3ms
    Study in Subjects With Small Primary Choroidal Melanoma (clinicaltrials.gov)
    P1/2, N=57, Completed, Aura Biosciences | Phase classification: P1b/2 --> P1/2
    Phase classification
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    belzupacap sarotalocan (AU-011)
    3ms
    Tumor Pigmentation Does Not Affect Light-Activated Belzupacap Sarotalocan Treatment but Influences Macrophage Polarization in a Murine Melanoma Model. (PubMed, Invest Ophthalmol Vis Sci)
    Pigmentation influenced the type of infiltrating macrophages in the tumor, with more M1 macrophages in pigmented tumors. Belzupacap sarotalocan treatment induced immunogenic cell death and tumor growth delay in pigmented as well as in nonpigmented models and stimulated M1 macrophage influx in both models.
    Preclinical • Journal
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    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
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    CD8 positive
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    belzupacap sarotalocan (AU-011)
    6ms
    A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer (clinicaltrials.gov)
    P1, N=19, Recruiting, Aura Biosciences | Trial completion date: Feb 2024 --> Jul 2024 | Trial primary completion date: Dec 2023 --> May 2024
    Trial completion date • Trial primary completion date
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    belzupacap sarotalocan (AU-011)
    10ms
    Phase 2 Trial of Belzupacap Sarotalocan (Bel-Sar, AU-011), aTargeted Therapy for Choroidal Melanoma via Suprachoroidal Administration, (ASRS 2023)
    No abstract available
    P2 data
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    belzupacap sarotalocan (AU-011)
    11ms
    Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma (clinicaltrials.gov)
    P2, N=22, Active, not recruiting, Aura Biosciences | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> May 2025 | Trial primary completion date: Sep 2023 --> May 2024
    Enrollment closed • Trial completion date • Trial primary completion date
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    belzupacap sarotalocan (AU-011)
    11ms
    Immune checkpoint inhibition combined with targeted therapy using a novel virus-like drug conjugate induces complete responses in a murine model of local and distant tumors. (PubMed, Cancer Immunol Immunother)
    Finally, we show that AU-011 and anti-PD-L1/anti-LAG-3 antibody treatment was an optimal combination in an abscopal model, inducing complete responses in approximately 75% of animals. Our data show the feasibility of combining AU-011 with PD-L1 and LAG-3 antibodies for the treatment of primary and distant tumors.
    Preclinical • Journal • Checkpoint inhibition
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    belzupacap sarotalocan (AU-011)
    11ms
    In Vitro Testing of the Virus-Like Drug Conjugate Belzupacap Sarotalocan (AU-011) on Uveal Melanoma Suggests BAP1-Related Immunostimulatory Capacity. (PubMed, Invest Ophthalmol Vis Sci)
    The in vitro cytotoxicity was accompanied by exposure of DAMPs (HSP90 and CRT), suggesting AU-011 may contribute to the development of systemic immunity and be a suitable candidate for combination with immunotherapy in vivo. AU-011 treatment was more effective against BAP1-positive cell lines, with a lower EC50 and higher CRT exposure.
    Preclinical • Journal
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    BAP1 (BRCA1 Associated Protein 1) • CALR (Calreticulin) • HSP90AA1 (Heat Shock Protein 90 Alpha Family Class A Member 1Heat Shock Protein 90 Alpha Family Class A Member 1)
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    BAP1 negative
    |
    belzupacap sarotalocan (AU-011)
    11ms
    A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in NMIBC (clinicaltrials.gov)
    P1, N=23, Recruiting, Aura Biosciences | Trial completion date: Aug 2023 --> Feb 2024 | Trial primary completion date: Jun 2023 --> Dec 2023
    Trial completion date • Trial primary completion date
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    belzupacap sarotalocan (AU-011)