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, 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). We are still performing analyses on the data from GLOBE study, which we intend to report later this year.
As a result of the failure of the GLOBE trial to meet its pre-determined endpoints, we have decided to put further development of VB-111 in rGBM on hold at this point. However, we still 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.
- 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.