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, but it did not meet its primary endpoint of OS in a Phase 3 for rGBM. VB-111 is currently being studied in a Phase 3 trial for ovarian 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 may retain activity regardless of baseline tumor mutations or the identity of the pro-angiogenic factors secreted by the tumor and may 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 also has received an Orphan Designation for the treatment of ovarian cancer by the European Medicines Agency (EMA). 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, enrolled 256 patients and was conducted in the US, Canada and Israel.  The study did not meet its primary endpoint of Overall Survival in rGBM.

Ovarian Cancer:  VBL launched a Phase 3 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.