On April 9, 2020 Vigeo Therapeutics, a clinical-stage biopharmaceutical company developing novel therapeutics to reprogram the tumor immune microenvironment (TIME), reported it has dosed the first patients in its Phase 1b/2 clinical trial evaluating its first in class lead candidate, VT1021, a small peptide with dual targeting activities of CD36 and CD47 (Press release, Vigeo Therapeutics, APR 9, 2020, View Source [SID1234556241]). The Phase 1b/2 study will enroll approximately 75 patients with 15 patients in each of five groups: ovarian cancer, pancreatic cancer, triple negative breast cancer, glioblastoma, and a tissue agnostic group of patients with high CD36 expressing tumors.
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Vigeo is developing therapies that target the TIME via induction of thrombospondin-1 (Tsp-1). Tsp-1 is a naturally occurring, potent anti-tumorigenic protein with a pleiotropic mechanism of action mediated by CD36 and CD47 that has been shown to reprogram the TIME and block tumor growth and progression.
The ongoing open-label, multicenter dose-expansion study (NCT03364400) is designed to evaluate efficacy and confirm the safety and tolerability of VT1021. The study evaluates VT1021 in four selected cancers that have high CD36 expressing tumors and in a group of patients who do not have one of the selected cancer types but nonetheless express high levels of CD36 based on tumor tissue staining.
"Advancing VT1021 in this study is a key milestone for Vigeo and we are excited to commence investigation of this promising agent in five patient groups in tumors that have a high expression of CD36," said Jing Watnick, Ph.D., President and Chief Executive Officer of Vigeo Therapeutics. "In addition to the indication expansion study, we plan to commence multiple combination studies to evaluate VT1021 in combination with chemotherapies and/or anti-PD-1 antibodies. We look forward to providing updates over the course of the study."
"The innovative and promising approach of VT1021 is to induce tumor microenvironment production of Tsp-1, which is a high affinity ligand of two key receptors with potent downstream antitumor activities, CD36 and CD47. As opposed to targeting only one receptor, like CD47, VT1021 exploits multiple antitumor mechanisms that contribute to tumor cell death and immune response enhancement," said Lou Vaickus, MD, FACP interim Chief Medical Officer of Vigeo. "This approach may be beneficial as a monotherapy as well as in combination with other agents, particularly in the classic "cold" tumor environment."
To-date, VT1021 has been shown to be safe and well tolerated with no serious drug related adverse events.
About VT1021
Vigeo’s lead molecule, VT1021, is a small peptide that reprograms the tumor immune microenvironment (TIME) by targeting CD36 and CD47 via Tsp-1 Induction, to stop tumor growth. Pre-clinical results have demonstrated that VT1021, when administered systemically, can cause tumor regression in animal models at both primary and metastatic sites. VT1021 is currently being evaluated in a Phase 1/2, open label, multicenter trial that assesses the drug’s safety, tolerability, and preliminary anti-tumor efficacy. The trial’s dose escalation phase has been completed and the expansion phase is underway. An interim readout is expected in the second half of 2020.