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.

VBL Therapeutics’ pivotal Phase 3 GLOBE trial of VB-111 in rGBM is ongoing under a special protocol assessment granted by the FDA. Enrollment has been completed in December 2016. The trial is conducted in the US, Canada and Israel.