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    DRUG:

    IGV-001

    i
    Other names: IGV-001
    Associations

    News

    Trials
    Company:
    Imvax
    Drug class:
    IGF-1R inhibitor, Immunostimulant
    Related drugs:
    Associations

    News

    Trials
    6ms
    A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma (clinicaltrials.gov)
    P2, N=93, Active, not recruiting, Imvax | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    temozolomide • IGV-001
    8ms
    A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma (clinicaltrials.gov)
    P2, N=93, Recruiting, Imvax | Phase classification: P2b --> P2
    Phase classification
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    temozolomide • IGV-001
    1year
    Additional results from a phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma. (SNO 2023)
    The neutrophil:lymphocyte (N:L) ratio emerged as a potential marker of good response that will be explored further in the ongoing Phase 2b study. Overall, these data support the ongoing Phase 2b randomized study designed to assess the efficacy and safety of IGV-001 in patients with ndGBM.
    Clinical • P1 data
    |
    IGV-001
    over1year
    A biologic-device combination product delivering tumor-derived antigens elicits immunogenic cell death-associated immune responses against glioblastoma. (PubMed, J Immunother Cancer)
    These results support treatment with IGV-001 to induce clinically relevant ICD-driven anticancer immune responses in patients with GBM.
    Journal
    |
    HMGB1 (High Mobility Group Box 1) • CALR (Calreticulin)
    |
    IGV-001
    over1year
    IGV-001: A Biologic-device Combination Product to Elicit Immunogenic Cell Death-associated Immune Responses Against Glioblastoma (FCI 2023)
    The lead product, IGV001, was evaluated in newly diagnosed glioblastoma (GBM) patients in a phase 1b study. Sequencing the T cell receptor Vβ CDR3 region in 8 clinical samples showed that clonal expansion in peripheral blood between 28d postIGV-001 and timepoints 90-150d positively correlated with OS (Spearman r=0.88, p<0.01). Key cytokines were found to be predictive of patient outcome via machine learning classification.
    Cynviloq (paclitaxel polymeric micelle formulation) • IGV-001
    over2years
    Machine learning algorithm identifies key serum cytokines associated with evidence of clinical activity in patients treated with personalized immunotherapeutic platform (IGV-00) (AACR 2022)
    A classification model has been developed to predict long-term “good” vs. short-term “poor” outcomes of IGV-001-treated patients. In particular, we identified IL-8, IL-6 and IL-17A as key immune correlates of patient outcome as early as d14 post-treatment and sustained beyond standard of care treatment.
    Clinical
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL10 (Interleukin 10) • IL17A (Interleukin 17A) • IL13 (Interleukin 13) • IL15 (Interleukin 15) • IL1B (Interleukin 1, beta) • IL5 (Interleukin 5)
    |
    IGV-001
    over2years
    Personalized immunotherapeutic platform with evidence of clinical activity in glioblastoma (IGV-001) protects mice against other lethal solid tumor challenges (AACR 2022)
    BDC containing saline or 1x106 IMV-001-treated tumor cells (hereon IOV-001 and IHV-001, respectively) were implanted in flanks of C57BL/6 mice and explanted 48 h later, as per glioblastoma clinical protocol. These data support the antitumor activity of this novel immunotherapeutic platform in multiple cancers beyond glioblastoma. Results suggest that efficacy is associated with a systemic immunological response, resulting in generation of Th1 antitumor cytotoxic T cells. Future studies are seeking to resolve the factors triggering good v. poor responses using phenotypic evaluation of T cell activation/exhaustion markers and Th1/Th2 cytokine production.
    Preclinical • PD(L)-1 Biomarker • IO biomarker
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    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD4 (CD4 Molecule)
    |
    IGV-001 • IHV-001 • IOV-001
    3years
    A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma - the ImmuneSense Study (clinicaltrials.gov)
    P2b, N=93, Not yet recruiting, Imvax | Trial primary completion date: Jun 2022 --> Jun 2023
    Clinical • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    temozolomide • IGV-001