New Biomarker Data Supports Direct Link between VB-111’s Dual Mechanism of Action and its Clinical Effect on Overall Survival and Progression Free Survival in Recurrent Glioblastoma Multiforme Patients

TEL AVIV, Israel, Dec. 18, 2017 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq:VBLT), announced new biomarker data supporting the direct link between lead asset VB-111’s dual mechanism of action and clinical effect on overall survival (OS) and progression-free survival (PFS) in patients from the company’s Phase 2 trial of VB-111 (ofranergene obadenovec) in recurrent glioblastoma multiforme (rGBM). To date, VB-111 has demonstrated statistically significant proof-of-concept OS benefit across three indications – rGBM, platinum-resistant ovarian cancer and radio-iodine resistant thyroid cancer. Pivotal Phase 3 top-line data in rGBM are expected in the first quarter of 2018.

These new findings, which were recently presented in an oral presentation at the 22nd Annual Meeting of the Society for Neuro-Oncology (SNO), validate the direct relationship between VB-111’s novel dual immuno-oncology and vascular targeting mechanisms of action to overall survival, and show that molecular and radiographic biomarkers may serve as predictors of clinical benefit. For VBL's data see the following link.

“These promising biomarker data correlate increased tumor blood vessels and inflammatory markers with increased survival benefit. This understanding is a critical step in patient care and clinical decision-making as biomarkers have the potential to guide treatment and predict patient response and benefit from therapies,” stated Corinne Epperly, MD, MPH, U.S. chief operating officer at VBL Therapeutics.

Summary of Data

The purpose of this analysis was to characterize vascular imaging parameters and the release of immuno-stimulatory cytokines, and to explore their correlation with the survival benefit observed in this trial.

  • VB-111 demonstrated a significant improvement in PFS and OS in a Phase 2 trial in rGBM.
  • Febrile response to VB-111 treatment was an indicator of immune activation which was a predictor of increased OS.
  • Improved OS in VB-111-treated patients correlates with vascular imaging parameters.
  • Improved OS in VB-111 treated patients correlates with an immune-stimulatory cytokine response.
  • VB-111 promotes secretion of pro-inflammatory, anti-tumor immune mediators and reduces T-cell production of immuno-suppressing cytokines in a preclinical GBM model.

“Our latest analysis has further strengthened our understanding of the highly novel dual mechanism of action of VB-111,” said Dror Harats, MD, CEO of VBL Therapeutics. “We have shown that the survival benefits observed in our rGBM Phase 2 trial are tied to reduced tumor vascularity, which is consistent with what we know about the anti-angiogenic properties of VB-111. In addition, we have demonstrated that VB-111 is associated with fever and immune-mediated responses, including secretion of immune-stimulatory cytokines that correlate with OS as well. The dual mechanism of action is further supported by preclinical data identifying the cell populations and molecular signaling driving this immune anti-tumor response. The data also provide new potential biomarkers that may be useful for clinical analyses. Building upon this, we look forward to additional insights on VB-111 from our pivotal Phase 3 GLOBE trial in rGBM, from which we expect top-line data in the first quarter of 2018.”

About VB-111 (ofranergene obadenovec)
Lead candidate VB-111 is a first-in-class anticancer targeted gene therapy-based biologic that has demonstrated statistically significant long-term survival in patients and offers broad potential to treat a wide range of cancers. VB-111 harnesses natural processes in the body to target tumors by employing a dual mechanism – a proprietary anti-angiogenic gene therapy that leads to targeted elimination of the tumor’s blood supply, and a viral immuno-oncology mechanism that educates the immune system to fight the tumor. VB-111 is currently being studied in a Phase 3 pivotal trial for rGBM under a special protocol assessment (SPA) with the FDA. VBL expects shortly to start a Phase 3 study of VB-111 in ovarian cancer by year-end 2017 and intends to launch an exploratory Phase 1/2 study in NSCLC, in combination with a checkpoint inhibitor in the first quarter of 2018. VB-111 has demonstrated statistically significant OS and a PFS benefit in a Phase 2 trial in patients with rGBM. VB-111 has received Fast Track designation from the FDA in the US for significant prolongation of survival in patients with rGBM, and Orphan Drug designation for treatment of GBM in both the US and Europe. VB-111 has also received an Orphan Designation for the treatment of ovarian cancer by the European Medicines Agency (EMA). VB-111 is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >300 cancer patients and has demonstrated efficacy signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies.

About VBL
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s lead oncology product candidate, VB-111 (ofranergene obadenovec), is a first-in-class biologic agent that uses a dual mechanism to target solid tumors. It utilizes an angiogenesis-specific sensor (VBL's PPE-1-3x proprietary promoter) to specifically target the tumor vasculature, by induction of cell death in angiogenic endothelial cells in the tumor milieu. Moreover, it is an immune-stimulant that triggers a local anti-tumor immune response, which is accompanied by recruitment of CD8 T-cells and apoptosis of tumor cells.

Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding VB-111, including its clinical development, therapeutic potential and clinical results, including the expected timing of clinical results and the initiation of clinical trials. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. In particular, results from our pivotal Phase 3 clinical trial of VB-111 in rGBM may not support approval of VB-111 for marketing in the United States, notwithstanding the positive results seen in prior clinical experience. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the U.S. Securities and Exchange Commission, including in our annual report on Form 20-F for the year ended December 31, 2016. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Michael Rice
LifeSci Advisors
(646) 597-6979

Matt Middleman, M.D.
LifeSci Public Relations
(646) 627-8384