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.
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).
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.
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.
P1, N=116, Active, not recruiting, Vigeo Therapeutics, Inc. | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Dec 2022 --> Jan 2024
over 1 year ago
Trial completion date • Trial primary completion date • Metastases
|
BRCA (Breast cancer early onset) • CD36 (thrombospondin receptor)
P1, N=116, Active, not recruiting, Vigeo Therapeutics, Inc. | Trial completion date: Mar 2022 --> Jun 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
over 2 years ago
Trial completion date • Trial primary completion date
|
BRCA (Breast cancer early onset) • CD36 (thrombospondin receptor)
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.
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.
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