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:  

  • Ovarian cancer – VBL 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.  Our OVAL phase 3 potential registration study of VB-111 in platinum resistant ovarian cancer is conducted in collaboration with the GOG Foundation, Inc., a leading organization for research excellence in the field of gynecologic malignancies. OVAL has been designed to enroll up to 350 adult patients at approximately 70 clinical sites in the United States and Israel. The OVAL study is comparing VB-111 therapy in combination with paclitaxel, to paclitaxel alone.
  • Recurrent Glioblastoma (rGBM) – Following successful Phase 2 study in rGBM, 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.  In March 2018, we announced top-line results from the GLOBE study, which showed that the study did not meet its pre-specified primary endpoint of overall survival (OS) or the secondary endpoint of progression-free survival (PFS). The full study data were presented at the 2018 Society for Neuro-Oncology Annual Meeting by Dr. Timothy Cloughesy, MD, Professor of Clinical Neurology and Director of the Neuro-Oncology Program, UCLA School of Medicine and principal investigator of the GLOBE trial.
    • Thorough analyses of the baseline risk factors of the Phase 2 and the Phase 3 treatment groups did not reveal any differences. Therefore, patient selection or different patient populations could not explain the difference between the results of the two studies. The only significant change between the Phase 2 and Phase 3 treatment cohorts was in the treatment regimen – the regimen for Phase 2 trial included `priming` with VB-111 whereas the regimen for GLOBE trial did not. 
    • Data suggest that concomitant treatment with bevacizumab may have a negative effect on VB-111 activity. The Company believe that priming with VB-111 without bevacizumab may be critical for the immune and vascular-disruptive/anti-angiogenic mechanism of VB-111 in rGBM. 
    • We believe in the biological activity of VB-111 as seen in our Phase 1 and Phase 2 trials, and do not think that results of the particular GLOBE study that investigated VB-111 in combination with bevacizumab in rGBM, will necessarily have implications on the prospects for VB-111 in other tumor types, in different patients populations, or in different regimens. 
    • The company is currently evaluating the path forward of VB-111 in rGBM, including the option of an investigator-initiated clinical trial.
  • Differentiated Thyroid cancer – VBL conducted a successful 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. Currently, VBL does not have an active clinical trial in Thyroid Cancer.