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    DRUG:

    VT1021

    i
    Other names: VT1021, VT-1021, VT 1021
    Company:
    Vigeo Therap
    Drug class:
    CD36 stimulant, TSP1 stimulant
    Related drugs:
    6ms
    Phase 1 dose expansion and biomarker study assessing first-in-class tumor microenvironment modulator VT1021 in patients with advanced solid tumors. (PubMed, Commun Med (Lond))
    VT1021 is safe and well-tolerated in patients with solid tumors in a phase I expansion study. VT1021 has advanced to a phase II/III clinical study in glioblastoma (NCT03970447).
    P1 data • Journal • Metastases
    |
    THBS1 (Thrombospondin 1)
    |
    VT1021
    10ms
    First-in-human phase I dose escalation trial of the first-in-class tumor microenvironment modulator VT1021 in advanced solid tumors. (PubMed, Commun Med (Lond))
    VT1021 is safe and well-tolerated across all doses tested. RP2D has been selected for future clinical studies. PR and SD with tumor shrinkage are observed in multiple patients underscoring the single-agent potential of VT1021. Expansion studies in GBM, pancreatic cancer and other solid tumors at the RP2D have been completed and results will be communicated in a separate report.
    P1 data • Journal • Metastases
    |
    CD36 (thrombospondin receptor) • THBS1 (Thrombospondin 1)
    |
    THBS1 expression
    |
    VT1021
    12ms
    GBM AGILE: A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (clinicaltrials.gov)
    P2/3, N=1030, Recruiting, Global Coalition for Adaptive Research
    Trial completion date • Trial primary completion date
    |
    IDH wild-type
    |
    temozolomide • Stivarga (regorafenib) • lomustine • VT1021 • Hepacid (pegargiminase) • paxalisib (GDC-0084) • dianhydrogalactitol (VAL-083) • troriluzole (BHV-4157)
    over1year
    The Role of CD36 in Cancer Progression and Its Value as a Therapeutic Target. (PubMed, Cells)
    We will also review existing approaches to targeting CD36 in pre-clinical studies, as well as discuss the only CD36-targeting drug to advance to late-stage clinical trials, VT1021. Given the roles of CD36 in the etiology of metabolic disorders, such as atherosclerosis, diabetes, and non-alcoholic fatty liver disease, the clinical implications of CD36-targeted therapy are wide-reaching, even beyond cancer.
    Review • Journal
    |
    CD36 (thrombospondin receptor)
    |
    VT1021
    over1year
    Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=116, Active, not recruiting, Vigeo Therapeutics, Inc. | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Dec 2022 --> Jan 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    BRCA (Breast cancer early onset) • CD36 (thrombospondin receptor)
    |
    BRCA mutation
    |
    VT1021
    over2years
    Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=116, Active, not recruiting, Vigeo Therapeutics, Inc. | Trial completion date: Mar 2022 --> Jun 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
    Trial completion date • Trial primary completion date
    |
    BRCA (Breast cancer early onset) • CD36 (thrombospondin receptor)
    |
    BRCA mutation
    |
    VT1021
    almost3years
    Clinical efficacy and biomarker assessment of VT1021, a CD36/CD47 dual-targeting agent, in recurrent glioblastoma (SNO 2021)
    In conclusion, VT1021 demonstrates promising single-agent clinical activity in rGBM, particularly in subjects with high expression levels of CD36 and CD47. Additional clinical studies have been planned to further investigate the efficacy of VT1021 in rGBM and other solid tumor indications.
    Clinical
    |
    CD47 (CD47 Molecule) • CD36 (thrombospondin receptor)
    |
    VT1021
    3years
    Development of Thrombospondin-1 as a clinical pharmacodynamic biomarker for VT1021, a first-in-class therapeutic agent that reprograms the tumor microenvironment. (SITC 2021)
    For subjects with pancreatic cancer, Tsp-1 protein induction in PBMCs is a potential prognostic biomarker. The predictive/prognostic utility coupled with the ability to measure levels in peripheral blood makes Tsp-1 a powerful biomarker to assess and predict clinical response to VT1021.
    Clinical • PK/PD data
    |
    CD36 (thrombospondin receptor) • THBS1 (Thrombospondin 1) • ITGAM (Integrin, alpha M)
    |
    VT1021
    3years
    Clinical update of VT1021, a first-in-class CD36 and CD47 targeting immunomodulating agent, in subjects with pancreatic cancer and other solid tumors stratified by novel biomarkers (SITC 2021)
    Based on these findings, the DH expression of CD36/CD47 could be a useful predictive biomarker to stratify subjects for inclusion in future trials in pancreatic cancer, and in other solid tumor indications. Trial Registration NCT03364400
    Clinical
    |
    CD8 (cluster of differentiation 8) • CD47 (CD47 Molecule) • CD36 (thrombospondin receptor) • THBS1 (Thrombospondin 1)
    |
    VT1021
    over3years
    Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=116, Active, not recruiting, Vigeo Therapeutics, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Mar 2022 | Trial primary completion date: Sep 2020 --> Dec 2021
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date
    |
    BRCA (Breast cancer early onset) • CD36 (thrombospondin receptor)
    |
    BRCA mutation
    |
    VT1021
    over4years
    Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=105, Recruiting, Vigeo Therapeutics, Inc. | N=70 --> 105 | Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Sep 2019 --> Sep 2020
    Clinical • Enrollment change • Trial completion date • Trial primary completion date
    |
    BRCA (Breast cancer early onset) • CD36 (thrombospondin receptor)
    |
    BRCA mutation
    |
    VT1021