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DRUG:

VT1021

i
Other names: VT1021, VT-1021, VT 1021
Company:
Vigeo Therap
Drug class:
CD36 stimulant, TSP1 stimulant
18d
Assessing CD36 and CD47 expression levels in solid tumor indications to stratify patients for VT1021 treatment. (PubMed, NPJ Precis Oncol)
We have developed VT1021 that induces the expression of thrombospondin-1 (TSP-1) in myeloid-derived suppressor cells (MDSCs) recruited to the tumor microenvironment (TME). Our studies identified CD36 and CD47 as dual biomarkers that can be used as patient stratifying tools and prognostic biomarkers for VT1021 treatment.
Journal
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CD47 (CD47 Molecule) • CD36 (thrombospondin receptor)
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VT1021
7ms
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
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THBS1 (Thrombospondin 1)
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VT1021
11ms
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
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CD36 (thrombospondin receptor) • THBS1 (Thrombospondin 1)
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THBS1 expression
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VT1021
1year
Trial completion date • Trial primary completion date
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IDH wild-type
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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
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CD36 (thrombospondin receptor)
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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
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BRCA (Breast cancer early onset) • CD36 (thrombospondin receptor)
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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
3years
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
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CD47 (CD47 Molecule) • CD36 (thrombospondin receptor)
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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
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CD36 (thrombospondin receptor) • THBS1 (Thrombospondin 1) • ITGAM (Integrin, alpha M)
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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
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CD8 (cluster of differentiation 8) • CD47 (CD47 Molecule) • CD36 (thrombospondin receptor) • THBS1 (Thrombospondin 1)
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VT1021
almost4years
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
almost5years
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
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BRCA (Breast cancer early onset) • CD36 (thrombospondin receptor)
|
BRCA mutation
|
VT1021