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    DRUG:

    AV-GBM-1

    i
    Other names: Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens, AV-GBM-1
    Company:
    AiVita Biomedical
    Drug class:
    Immunostimulant
    Related drugs:
    1year
    AV-GBM-1 vs Control as Adjunctive Therapy Following Surgery and RT/TMZ in Newly Diagnosed GBM (clinicaltrials.gov)
    P3, N=672, Not yet recruiting, Aivita Biomedical, Inc. | Trial completion date: Mar 2027 --> Mar 2029 | Trial primary completion date: Mar 2026 --> Mar 2028
    Trial completion date • Trial primary completion date • Surgery
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    temozolomide • AV-GBM-1
    over1year
    Phase 2 study of AV-GBM-1 (a tumor-initiating cell targeted dendritic cell vaccine) in newly diagnosed Glioblastoma patients: safety and efficacy assessment. (PubMed, J Exp Clin Cancer Res)
    AV-GBM-1 was reliably manufactured. Treatment was well-tolerated, but there were numerous treatment-emergent central nervous system AEs. mPFS was longer than historical benchmarks, though no mOS improvement was noted.
    P2 data • Clinical Trial,Phase II • Journal
    |
    CSF2 (Colony stimulating factor 2)
    |
    temozolomide • AV-GBM-1
    over2years
    PHASE II TRIAL OF VACCINE IMMUNOTHERAPY IN PRIMARY GLIOBLASTOMA: ADJUNCTIVE AUTOLOGOUS DENDRITIC CELLS PULSED WITH LYSATE FROM IRRADIATED SELF-RENEWING AUTOLOGOUS TUMOR CELLS (AV-GBM-1) (SNO 2021)
    feasibility, safety, and PFS were encouraging. A phase III trial is in development. Clinicaltrials.gov NCT03400917.
    P2 data • IO biomarker
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • CSF2 (Colony stimulating factor 2) • FGF (Fibroblast Growth Factor) • LCN2 (Lipocalin-2) • IL4 (Interleukin 4)
    |
    AV-GBM-1
    over2years
    AV-GBM-1 vs Control as Adjunctive Therapy After RT/TMZ for Newly Diagnosed GBM (clinicaltrials.gov)
    P3, N=726, Not yet recruiting, Aivita Biomedical, Inc.
    Clinical • New P3 trial
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    AV-GBM-1