CLINICAL TRIALS

VB-111: Targeting Cancer


VBL’s lead product candidate from our oncology program, VB-111, is a targeted anti-cancer gene-based biologic agent that we are developing for solid tumor indications, with clinical trials in rGBM, ovarian cancer and thyroid cancer.

VB-111 is administered systemically and is both tissue- and condition-specific, allowing for targeted and limited gene expression in endothelial cells, the thin layer of cells that lines the interior surface of blood vessels undergoing angiogenesis.

Following the successful completion of a Phase 1/2 clinical trial, VB-111 has been advanced into tumor specific, repeat-dose trials including:  

  • Recurrent Glioblastoma (rGBM) – Following successful Phase 2 study, VB-111 was advanced to a Phase 3 trial in rGBM. GLOBE was a controlled, double-arm, open-label Phase 3 study designed to evaluate our therapeutic candidate VB-111 in combination with bevacizumab (also known as Avastin) in patients with recurrent glioblastoma.  Top-line results show that the study did not meet its pre-specified primary endpoint of overall survival (OS). No new safety concerns associated with VB-111 have been identified in the GLOBE study. The Company plan to conduct an in-depth analysis in order to better understand the outcome of the study and the potential activity of VB-111 in rGBM. We do not think that the results in rGBM will necessarily have implications on the prospects for VB-111 in other tumor types.
  • Ovarian cancerVBL completed a Phase 1/2 clinical trial in recurrent ovarian cancer, which combined VB-111 therapy with paclitaxel, a common chemotherapeutic agent used to treat ovarian cancer, to evaluate safety and efficacy in this indication. OVAL, our Phase 3 study of VB-111 in platinum-resistant Ovarian Cancer was launched in December 2017. The OVAL study is comparing VB-111 therapy in combination with paclitaxel, to paclitaxel alone.
  • Differentiated Thyroid cancer – VBL conducted an open-label Phase 2 clinical trial to evaluate safety and efficacy of VB-111 in advanced, recently progressive differentiated thyroid cancer that is unresponsive to radioactive iodine.