OVERVIEW

VBL Therapeutics (Nasdaq: VBLT) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer

The lead product candidate from our oncology programVB-111, is a first-in class targeted anti-cancer gene-therapy based agent that is positioned to treat a wide range of solid tumors.   

Safe and Convenient:

VB-111 is given through a simple IV infusion once every two months.  So far, VB-111 demonstrated efficacy signal in three Phase 2 studies – in rGBM, Ovarian cancer and Thyroid cancer.  VB-111 was safe and well-tolerated in over 200 cancer patients. It has potential for combination therapy with other drugs.

Mechanism:

VB-111 (ofranergene obadenovec) is a unique biologic agent that uses a dual mechanism to target solid tumors. Based on a non-integrating, non-replicating, Adeno 5 vector, ofranergene obadenovec utilizes VBL’s proprietary Vascular Targeting System (VTS™) to target the tumor vasculature for cancer therapy. Unlike anti-VEGF or TKIs, ofranergene obadenovec does not aim to block a specific pro-angiogenic pathway; instead, it uses an angiogenesis-specific sensor (VBL’s PPE-1-3x proprietary promoter) to specifically induce cell death in angiogenic endothelial cells in the tumor milieu. This mechanism retains activity regardless of baseline tumor mutations or the identity of the pro-angiogenic factors secreted by the tumor and shows efficacy even after failure of prior treatment with other anti-angiogenics. Moreover, ofranergene obadenovec induces specific anti-tumor immune response, which is accompanied by recruitment of CD8 T-cells and apoptosis of tumor cells.

Regulatory Status:

We have obtained fast track designation for VB-111 in the United States for prolongation of survival in patients with glioblastoma that has recurred following a treatment with standard chemotherapy and radiation. We have also received orphan drug designation in both the United States and Europe.

Clinical Trials Status:

GBM:  VBL’s pivotal Phase 3 GLOBE study in rGBM, comparing VB-111 in combination with Avastin to Avastin alone, is currently being conducted in the US, Canada and Israel.  Enrollment in the study, 256 patients in total, was completed in December 2016, five months ahead of schedule.  The study is proceeding under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA), with full endorsement by the Canadian Brain Tumor Consortium (CBTC). The company expects top-line results from the full dataset in early 2018.

Ovarian Cancer:  VBL is planning to launch a Phase 3 pivotal study in platinum-resistant Ovarian Cancer in the fourth quarter of 2017.

Lung Cancer:  VBL is planning to launch an exploratory study of VB-111 in combination with a checkpoint inhibitor in the first quarter of 2018.