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    DRUG:

    SGT-53

    i
    Other names: SGT-53, p53-gene-therapy, TfRscFv-Liposome-p53 Complex, Synerlip p53
    Associations

    News

    Trials
    Company:
    SynerGene Therap
    Drug class:
    p53 stimulant
    Related drugs:
    Associations

    News

    Trials
    2years
    A Novel P53 Nanomedicine Reduces Immunosuppression and Augments Anti-PD-1 Therapy for Non-Small Cell Lung Cancer in Syngeneic Mouse Models. (PubMed, Cells)
    Our data indicate that SGT-53 can restore effective immune responses against lung cancer cells by reducing immuno-suppressive cells (M2 macrophages and regulatory T cells) and by downregulating immunosuppressive molecules (e.g., galectin-1, a negative regulator of T cell activation and survival) while increasing activity of cytotoxic T cells. These results suggest that combining SGT-53 with anti-PD-1 immunotherapy could increase the fraction of lung cancer patients that responds to anti-PD-1 therapy and support evaluation of this combination particularly in patients with ICI-resistant lung cancers.
    Preclinical • Journal
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    TP53 (Tumor protein P53) • LGALS1 (Galectin 1)
    |
    SGT-53
    2years
    SGT-53, Carboplatin, and Pembrolizumab for the Treatment of Metastatic Triple Negative Inflammatory Breast Cancer (clinicaltrials.gov)
    P1; Trial completion date: Sep 2026 --> Nov 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Sep 2025 --> Nov 2022
    Trial completion date • Trial primary completion date • Trial withdrawal • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • carboplatin • SGT-53
    over2years
    TP53 Gene Therapy as a Potential Treatment for Patients with COVID-19. (PubMed, Viruses)
    We herein summarize the rationale for repurposing SGT-53 as a therapy for infection by SARS-CoV-2, the pathogen responsible for the COVID-19 pandemic. Because p53 regulation was found to play a crucial role in different infection stages of a wide variety of viruses, it is rational to believe that restoring p53 function based on SGT-53 treatment may lead to beneficial therapeutic outcomes for infectious disease at large including heretofore unknown viral pathogens that may emerge in the future.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 expression
    |
    SGT-53
    almost3years
    SGT-53 in Children With Recurrent or Progressive CNS Malignancies (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, SynerGene Therapeutics, Inc. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • MDM2 (E3 ubiquitin protein ligase) • CDKN1A (Cyclin-dependent kinase inhibitor 1A)
    |
    ATRX mutation • MDM2 mutation
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    Avastin (bevacizumab) • temozolomide • irinotecan • Onivyde (nanoliposomal irinotecan) • SGT-53
    3years
    SGT-53, Carboplatin, and Pembrolizumab for the Treatment of Metastatic Triple Negative Inflammatory Breast Cancer (clinicaltrials.gov)
    P1; N=9; Not yet recruiting; Sponsor:Northwestern University
    New P1 trial • Clinical • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • carboplatin • SGT-53
    over3years
    [VIRTUAL] A phase II trial combining tumor-targeting TP53 gene therapy with gemcitabine/nab-paclitaxel as a second-line treatment for metastatic pancreatic cancer. (ASCO 2021)
    Our data suggest a clinically meaningful benefit of adding SGT-53 to GEM/ABX particularly for second-line PAC patients, most of whom had failed prior FFX treatment.
    Clinical • P2 data
    |
    TP53 (Tumor protein P53) • CA 19-9 (Cancer antigen 19-9)
    |
    gemcitabine • albumin-bound paclitaxel • SGT-53
    4years
    SGT-53 in Children With Recurrent or Progressive CNS Malignancies (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, SynerGene Therapeutics, Inc. | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • MDM2 (E3 ubiquitin protein ligase) • CDKN1A (Cyclin-dependent kinase inhibitor 1A)
    |
    ATRX mutation • MDM2 mutation
    |
    Avastin (bevacizumab) • temozolomide • irinotecan • Onivyde (nanoliposomal irinotecan) • SGT-53