VBL Therapeutics Celebrates Opening of its New Gene Therapy Manufacturing Plant and Company Headquarters
The Modiin facility is the first commercial-scale gene therapy manufacturing facility in
“Having a manufacturing facility in place is an important step as we make preparations for potential regulatory approval and commercialization of VB-111,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “Manufacturing has often been a limiting factor for BLA approvals, including for breakthrough products, and we believe the opening of this facility, together with the upcoming completion of our ongoing pivotal trial in recurrent glioblastoma (rGBM), should keep us on track for a timely submission of our BLA.”
Minister of Economy of Israel Mr.
On hand for the facility’s ribbon cutting ceremony were more than 150 guests from around the world, including governmental & municipal officials, local organizations and various Company stakeholders.
The investment in the facility is included in the Company's budget and was also supported by the
VBL's new headquarters and facility are located in
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. In addition, 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 recurrent GBM, 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 providing evidence of 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. Ofranergene obadenovec has also received orphan drug status by the EMA for treatment of ovarian cancer.
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 Company’s facility in Modiin,
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Matt Middleman, M.D.
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