NEW YORK – Cambridge, Massachusetts-based biopharmaceutical company Vigeo Therapeutics today announced that it has begun clinically testing its first-in-class small peptide drug, VT1021, in its Phase Ib/II clinical trials.
In a statement today, the company announced that it has dosed its first patients in the dose-expansion phase of the study. The ongoing clinical studies will evaluate VT1021 for safety and tolerability in a tissue agnostic group of patients with high CD36 expressing tumors, as well as in specific tumor types, including ovarian cancer, pancreatic cancer, triple-negative breast cancer, and glioblastoma. The five cohorts will enroll 15 patients each for a total of 75 patients.
VT1021 is designed to reprogram the tumor immune microenvironment (TIME) and block tumor growth and progression by way of triggering production of the anti-tumorigenic protein, thrombospondin-1 (Tsp-1). The naturally occurring Tsp-1 reprograms the TIME so that it is an inhospitable environment, inhibiting the tumor's growth.
"As opposed to targeting only one receptor, like CD47, VT1021 exploits multiple antitumor mechanisms that contribute to tumor cell death and immune response enhancement," Vigeo's interim CMO Lou Vaickus said in a statement. "This approach may be beneficial as a monotherapy as well as in combination with other agents, particularly in the classic 'cold' tumor environment."
In pre-clinical studies, VT1021 demonstrated the ability to cause tumor regression in animal models at both primary and metastatic sites. Then, in the dose-escalation phase of VT1021's Phase I trial, the drug demonstrated safety and tolerability. Now, through the expansion phase of the trial, the company aims to validate the drug's safety profile in patients across these four specific tumor types, as well as the CD36-expressing tumor-agnostic group. The company is anticipating an interim readout of the trial's results in the second half of 2020.
"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," Vigeo CEO Jing Watnick said in a statement, adding that the company plans to also begin studying VT1021 in combination with chemotherapies and anti-PD-1 antibodies.