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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:
    10d
    AU-011-102: A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer (clinicaltrials.gov)
    P1, N=55, Recruiting, Aura Biosciences | Trial primary completion date: Dec 2026 --> Mar 2027
    Trial primary completion date
    |
    belzupacap sarotalocan (AU-011)
    21d
    CoMpass: A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma (clinicaltrials.gov)
    P3, N=100, Recruiting, Aura Biosciences | Trial completion date: Mar 2027 --> Aug 2028 | Trial primary completion date: Mar 2026 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    belzupacap sarotalocan (AU-011)
    2ms
    NMIBC: A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer (clinicaltrials.gov)
    P1, N=55, Recruiting, Aura Biosciences | N=21 --> 55 | Trial completion date: Jul 2024 --> Apr 2027 | Trial primary completion date: Jun 2024 --> Dec 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    belzupacap sarotalocan (AU-011)
    2ms
    AU-011-203: Suprachoroidal Administration in Subjects With Metastases to the Choroid (clinicaltrials.gov)
    P2, N=24, Recruiting, Aura Biosciences | Not yet recruiting --> Recruiting
    Enrollment open
    |
    belzupacap sarotalocan (AU-011)
    1year
    AU-011-203: Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, Aura Biosciences
    New P2 trial
    |
    belzupacap sarotalocan (AU-011)
    over1year
    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, Completed, Aura Biosciences | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Apr 2024
    Trial completion • Trial completion date
    |
    belzupacap sarotalocan (AU-011)
    almost2years
    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
    |
    belzupacap sarotalocan (AU-011)
    almost2years
    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
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    CD8 positive
    |
    belzupacap sarotalocan (AU-011)
    2years
    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
    |
    belzupacap sarotalocan (AU-011)
    over2years
    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
    |
    belzupacap sarotalocan (AU-011)
    over2years
    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
    |
    belzupacap sarotalocan (AU-011)