VBL Therapeutics Reports Full Phase 2 Data From Clinical Trial of VB-111 in Recurrent Glioblastoma (rGBM) at the ECC 2015 Conference, Meeting the Primary Endpoint of Statistically-Significant Increase in Overall Survival

TEL AVIV, Israel, Sept. 28, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), today announced full Phase 2 data on VB-111 in combination with Bevacizumab (Avastin™) in rGBM. Data were presented yesterday at the European Cancer Congress 2015, in Vienna, Austria by principal investigator Andrew J. Brenner, MD, PhD.

Data showed statistically significant overall survival benefit in patients treated with VB-111 continued with VB-111 in combination with Avastin™ upon disease progression (continuous exposure cohort), compared to patients treated with VB-111 followed by Avastin™ alone, upon disease progression (limited exposure cohort). Patients treated with continuous exposure of VB-111 had median overall survival (mOS) of 15 months, compared to mOS of 8 months in patients with limited VB-111 exposure (p=0.048). In addition, for the first time the company reported overall response rate (ORR) data of 29% (7/24) with 2 complete responders in the continuous exposure cohort, compared 9% (2/22) with no complete responders in the limited exposure cohort.

"The data from this multicenter study shows that VB-111 almost doubles the historical median overall survival for rGBM, with clear strengthening of the statistical significance along time, as the data further matured," said Yael Cohen, M.D., Vice President, Clinical Development of VBL Therapeutics.

"These numbers compare favorably to any current benchmark in rGBM and may change the treatment paradigm for rGBM patients," added principal investigator Andrew Brenner, MD, PhD, Clinical Investigator, Cancer Therapy and Research Center, University of Texas Health Science Center San Antonio.

Study results include 46 patients with rGBM treated with VB-111; upon disease progression, 23 patients were treated with VB-111 in combination with Avastin™, and 22 received Avastin™ alone. One patient, who achieved a complete response, is still stable on VB-111 alone at 22 months. The median number of bi-monthly VB-111 doses was 4 for the continuous exposure cohort versus 1 in the limited exposure cohort (average of 4.6 vs. 2.2, respectively). Continuous exposure to VB-111 demonstrated significant improvement in overall survival, with median overall survival of 15 months, compared to 8 months in patients on limited VB-111 exposure (p=0.048), meeting the primary endpoint of the trial. VB-111 also demonstrated a statistically significant improvement over the historical Avastin™ arm from the BELOB trial, which looked at efficacy of Avastin™, lomustine or a combination of both agents, and reported a median overall survival of eight months for Avastin™ in 50 patients with rGBM (p=0.005)1. Two complete responses and five partial responses were seen in the VB-111 continuous exposure cohort (n=24), compared to only two partial responses in VB-111 limited exposure cohort (n=22). VB-111 was found to be safe and well tolerated.

Study data also suggest that VB-111 may induce an immuno-therapeutic effect. Of the 46 patients who received VB-111, 25 patients experienced a fever post-dosing of VB-111 at least once, while 21 patients did not. Feverish patients demonstrated increased overall survival of 16 months, compared to non-feverish patients, who had a median overall survival of 8.5 months (p=0.03). This correlation between clinical efficacy and fever suggests that VB-111 may induce an immune response in patients and supports a role of the immune system as part of VB-111's mechanism of action. These findings strengthen VB-111 preclinical data, which showed an elevated immune response in tumors of VB-111-treated animals.

"We are very pleased that the full Phase 2 data show such a meaningful and statistically significant overall survival benefit for VB-111 in rGBM. Moreover, the favorable response rate and the complete response cases support our confidence in the potential of VB-111 as a treatment for rGBM and additional solid tumor indications," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. The company intends to share the data with the FDA in 1Q 2016.

VBL Therapeutics' recently-launched pivotal Phase 3 GLOBE trial of VB-111 in rGBM is ongoing under a special protocol assessment granted by the FDA. The study is led by Timothy Cloughesy, MD, Professor of Clinical Neurology and Director of the Neuro-Oncology Program, UCLA School of Medicine and is actively recruiting patients. The multicenter study will be conducted in the US, Canada and Israel and is expected to enroll 252 patients. The primary endpoint of the study is overall survival, with interim analysis expected at 91 events and full study report at 151 events.

A webcast of the VB-111 presentation at conference will be available under the conference website at http://www.europeancancercongress.org/Webcasts several days after the end of the congress.

Study Details:

The Phase 2 trial is a multi-center study designed to determine the safety, tolerability and efficacy of VB-111 in patients with rGBM. In the first stage of the study, patients were treated with VB-111 alone. Upon disease progression -- defined according to the Response Assessment in Neuro-Oncology (RANO) criteria as a worsening of the patient's cancer with an increase of at least 25% in the overall mass of measurable tumors, the appearance of new tumors, the worsening of non-measurable tumors since the beginning of treatment, a need for increased dose of corticosteroids, or clinical deterioration -- patients entered the second stage of the study, in which they received either Avastin™ alone as standard of care (limited exposure) or Avastin™ in combination with VB-111 (continuous exposure), in two consecutive cohorts. Interim results from this study were presented in conjunction with the American Society of Cancer Oncology (ASCO) Annual Meeting, May 29th-June 2nd, 2015.

About VB-111

VB-111 is a novel, intravenously-administered, targeted anti-angiogenic agent that utilizes VBL's proprietary Vascular Targeting System (VTS(TM)) to target endothelial cells in the tumor vasculature for cancer therapy. VB-111 contains a non-replicating adenovirus, a proprietary modified murine pre-proendothelin promoter (PPE-1-3x) and a Fas-Chimera transgene to angiogenic tumor blood vessels, leading to their apoptosis. VB-111 is the first agent based on transcriptional targeting of tumor endothelium to be assessed in a clinical trial.

VB-111 completed a Phase 1/2 "all-comers" clinical trial, which demonstrated multiple cases of objective tumor response and disease control and excellent safety and tolerability. VB-111 has Fast Track Designation for recurrent glioblastoma in the US and orphan drug status for glioblastoma in both the US and EU. Beyond GBM, VBL is also conducting early phase II studies in thyroid cancer and ovarian cancer.

About VBL

Vascular Biogenics Ltd., operating as VBL Therapeutics, is a late-stage clinical 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, is a gene-based biologic that is initially being developed for recurrent glioblastoma, or rGBM, an aggressive form of brain cancer. VB-111 has received orphan drug designation in both the United States and Europe and was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation. VBL Therapeutics' pivotal Phase 3 GLOBE trial of VB-111 in rGBM is ongoing under a special protocol assessment granted by the FDA.

Forward-Looking Statements

This press release contains forward-looking statements. 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 proposed 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 our current clinical trial. 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. 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.

1 Taal et al., Lancet Oncol. 2014 Aug;15(9):943-53.

CONTACT: INVESTOR CONTACT: Michael Rice, Founding Partner LifeSci Advisors, LLC 646-597-6979

Source: VBL Therapeutics