TEL AVIV, Israel, April 25, 2017 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ: VBLT ), announced that new data on VB-111 will be presented at the upcoming American Society of Clinical Oncology (ASCO) 2017 Annual Meeting, to be held June 2-6 in Chicago, Illinois, as well as in the 20th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), to be held May 10-13 in Washington, DC.
Data from the Phase 2 clinical trial that investigated VB-111 in recurrent glioblastoma (rGBM) will be presented at ASCO, as detailed below:
| Title: | Treatment Through Progression with Ofranogene Obadenovec (VB-111), an Anti-Cancer Viral Therapy, Significantly Attenuates Tumor Growth in Recurrent GBM: Individual Phase 2 Patient Data | |
| Abstract: | 2055 | |
| Session Type: | Poster Session | |
| Session Title: | Central Nervous System Tumors | |
| Date: | June 5, 2017 | |
| Time: | 1:15 – 4:45 Central Time | |
| Location: | Hall A | |
| Poster Board: | #297 | |
| Presenter: | Andrew Jacob Brenner, MD, Ph.D., The University of Texas Health Science Center at San Antonio, et al. |
Previously announced data from this Phase 2 clinical trial showed prolongation of overall survival in rGBM patients treated with a combination of VB-111 and Avastin ® (bevacizumab) compared to limited exposure to VB-111 and to historical controls. This poster at ASCO will feature data on individual patients who were enrolled in this trial.
In addition, preclinical data demonstrating that VB-111 augments the anti-tumor activity of PD-L1 blockade will be presented at the ASGCT, as detailed below:
| Title : | Vascular targeting viral therapy augments PD-L1 checkpoint blockade anti-tumor activity | |
| Session Date/Time: | Friday, May 12, 2017 5:45 PM - 7:45 PM | |
| Session title: | Cancer-Immunotherapy, Cancer Vaccines III | |
| Room: | Exhibit Hall A & B South | |
| Abstract number: | 585 |
About Ofranergene Obadenovec (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.
Ofranergene obadenovec completed a Phase 2 study in rGBM, which showed a statistically significant improvement in overall survival in patients treated with ofranergene obadenovec through progression, compared to either patients treated with ofranergene obadenovec followed by bevacizumab alone, or to historical bevacizumab data. In a Phase 2 trial for recurrent platinum-resistant ovarian cancer, ofranergene obadenovec demonstrated a statistically significant increase in overall survival and 60% durable response rate (as measured by reduction in CA-125), approximately twice the historical response with bevacizumab plus chemotherapy in ovarian cancer. In a Phase 2 study in recurrent, iodine-resistant differentiated thyroid cancer, ofranergene obadenovec met the primary endpoint demonstrating disease stabilization with a positive safety profile, along with a dose-response and evidence of an overall survival benefit. Ofranergene obadenovec has received Fast Track Designation for recurrent glioblastoma in the U.S. and orphan drug status for glioblastoma in both the U.S. and EU.
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, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is positioned to treat a wide range of solid tumors. It is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >200 cancer patients and we have observed its efficacy signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a Phase 3 pivotal trial for recurrent Glioblastoma, conducted under an FDA Special Protocol Assessment (SPA).
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 the clinical development of ofranergene obadenovec (VB-111), including our expectations regarding the timing of results from the GLOBE study, and its therapeutic potential and clinical results. 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 ofranergene obadenovec (VB-111) in rGBM may not support approval of ofranergene obadenovec 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.
Avastin ® (bevacizumab) is a registered trademark of Genentech Inc.
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