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    DRUG:

    VBI-1901

    i
    Other names: VBI-1901, GBM immunotherapy, eVLP vaccine, GBM eVLP, glioblastoma eVLP vaccine, VBI1901, VBI 1901
    Company:
    Brii Biosci, VBI Vaccines
    Drug class:
    Immunostimulant
    Related drugs:
    1year
    Peripheral Biomarker Analysis of T cell-mediated Collagen Remodeling Correlates with Tumor Responses in a Phase IIa trial of vaccine immunotherapeutic candidate (VBI-1901) (SNO 2023)
    The peripheral C4G biomarker targets granzyme-B-cleaved type IV collagen, which is associated with T cell infiltration and has previously been shown to potentially identify recurrent GBM patients responding to nivolumab and bevacizumab. Evaluating the balance of immune infiltration vs. tumor cell growth in patients with brain tumors is challenging and these data suggest a means of assessing this dynamic using a peripheral biomarker. These data may be particularly useful in discerning pseudoprogression associated with T cell infiltration from tumor progression.
    P2a data • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • CSF2 (Colony stimulating factor 2) • GZMB (Granzyme B)
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • VBI-1901
    over1year
    Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects (clinicaltrials.gov)
    P1/2, N=98, Recruiting, VBI Vaccines Inc. | Active, not recruiting --> Recruiting
    Enrollment open
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    lomustine • carmustine • VBI-1901
    over2years
    Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects (clinicaltrials.gov)
    P1/2, N=98, Active, not recruiting, VBI Vaccines Inc. | N=38 --> 98 | Trial completion date: Mar 2022 --> Aug 2025 | Trial primary completion date: Mar 2022 --> Jul 2025
    Enrollment change • Trial completion date • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • IFNG (Interferon, gamma)
    |
    lomustine • carmustine • VBI-1901
    3years
    Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects (clinicaltrials.gov)
    P1/2, N=38, Active, not recruiting, VBI Vaccines Inc. | Trial completion date: Jul 2021 --> Mar 2022 | Trial primary completion date: Oct 2020 --> Mar 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • IFNG (Interferon, gamma) • CSF2 (Colony stimulating factor 2)
    |
    VBI-1901
    over3years
    [VIRTUAL] Evaluation of GM-CSF and AS01B adjuvants in a phase I/IIa trial of a therapeutic CMV vaccine (VBI-1901) against recurrent glioblastoma (GBM). (ASCO 2021)
    These encouraging results from both arms of the trial justify further clinical evaluation in a randomized, controlled trial expected to begin later in 2021.
    Clinical • P1/2 data
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • CSF2 (Colony stimulating factor 2)
    |
    VBI-1901
    over3years
    Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects (clinicaltrials.gov)
    P1/2, N=38, Active, not recruiting, VBI Vaccines Inc. | Trial completion date: Nov 2020 --> Jun 2021
    Clinical • Trial completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • IFNG (Interferon, gamma) • CSF2 (Colony stimulating factor 2)
    |
    VBI-1901
    4years
    Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects (clinicaltrials.gov)
    P1/2, N=38, Active, not recruiting, VBI Vaccines Inc. | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • IFNG (Interferon, gamma) • CSF2 (Colony stimulating factor 2)
    |
    VBI-1901
    over4years
    [VIRTUAL] TCR and HLA analysis of patients in a phase I/IIa trial of a therapeutic CMV vaccine against recurrent glioblastoma (GBM) (ESMO 2020)
    Methods PBMC samples prior to treatment were available for 17 patients, with a variable number of additional samples obtained from each patient obtained, two weeks after each monthly treatment with VBI-1901...Funding: VBI Vaccines. Clinical trial identification: NCT03382977.
    Clinical • P1/2 data
    |
    IFNG (Interferon, gamma) • CSF2 (Colony stimulating factor 2)
    |
    VBI-1901
    5years
    Interim results of the extension phase of a Phase I/IIa trial of a therapeutic CMV vaccine against recurrent glioblastoma (GBM) (SNO 2019)
     Patients will be vaccinated monthly until clinical progression.  Tumor responses and associated immunological biomarkers will be presented, and are expected to include initial data for all 10 patients.
    P1/2 data • IO biomarker
    |
    IFNG (Interferon, gamma) • CSF2 (Colony stimulating factor 2)
    |
    VBI-1901