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 targeted anti-cancer gene-therapy based agent that is positioned to potentially treat a wide range of solid tumors.   

VB-111 is given through a simple IV infusion once every two months.  So far, VB-111 showed activity in three Phase 2 studies – in rGBM, Ovarian cancer and Thyroid cancer.  VB-111 was well-tolerated in over 300 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 activity 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 Background:

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. VB-111 is an investigational product.

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 in 1Q2018.

Ovarian Cancer:  VBL launched a Phase 3 pivotal registration trial, OVAL, in platinum-resistant ovarian cancer in December 2017. The OVAL study will be conducted in collaboration with the GOG Foundation, Inc., a leading organization for research excellence in the field of gynecologic malignancies.

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.