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    DRUG:

    ITI-3000

    i
    Other names: ITI-3000
    Company:
    HLB Bio Group
    Drug class:
    Immunostimulant
    Related drugs:
    8ms
    LAMP1 targeting of the large T antigen of Merkel cell polyomavirus results in potent CD4 T cell responses and tumor inhibition. (PubMed, Front Immunol)
    These findings strongly suggest that in pre-clinical studies, DNA vaccination with ITI-3000, using the UNITE™ platform, enhances CD4 T cell responses to MCPyV-LT that result in significant anti-tumor immune responses. These data support the initiation of a first-in-human (FIH) Phase 1 open-label study to evaluate the safety, tolerability, and immunogenicity of ITI-3000 in patients with polyomavirus-positive MCC (NCT05422781).
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • LAMP1 (Lysosomal Associated Membrane Protein 1)
    |
    ITI-3000
    10ms
    Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC) (clinicaltrials.gov)
    P1, N=6, Completed, Immunomic Therapeutics, Inc. | Recruiting --> Completed
    Trial completion
    |
    ITI-3000
    2years
    LAMP1 targeting of the large T antigen of Merkel cell polyomavirus elicits potent CD4+ T cell responses, tumor inhibition, and provides rationale for first-in-human trial (AACR 2022)
    In pre-clinical studies, vaccination with LTS220A-UNITETM (ITI-3000) induced antigen-specific CD4+ T cells that were sufficient to delay tumor growth, and this effect was dependent on their ability to produce IFNγ...The primary objectives will be safety and tolerability, observing dose-limiting toxicities, serious adverse events, standard clinical assessments, and safety laboratory parameters. Immunogenicity of the vaccine will be measured by peripheral blood assessments of T cell activation using ELISpot and flow cytometry assays.
    P1 data
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • LAMP1 (Lysosomal Associated Membrane Protein 1)
    |
    ITI-3000