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VBL Therapeutics Celebrates Opening of its New Gene Therapy Manufacturing Plant and Company HeadquartersTEL AVIV, Israel, Oct. 23, 2017 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT) announced today the opening of its new gene therapy manufacturing plant in Modiin, Israel. This plant will be the commercial facility for production of the Company’s lead product candidate, ofranergene obadenovec (VB-111), if approved. The Modiin facility is the first commercial-scale gene therapy manufacturing facility in Israel and currently one of the largest gene-therapy designated ones in the world (20,000 sq. ft.). It is capable of manufacturing in large-scale capacity of 1,000 liters and is scalable to 2,000 liters. “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.” Ben Shapiro, M.D., Chairman of VBL Therapeutics, added, "The inauguration of the new facility represents a major milestone for VBL. Investing in the appropriate infrastructure is critical as we complete the necessary pre-launch activities for VB-111 and evolve from a small biotech enterprise into an integrated biopharma company." Minister of Economy of Israel Mr. Eli Cohen said, "The establishment of VBL's innovative manufacturing facility for cancer therapy in Israel, is evidence of breakthrough and pioneering Israeli innovation and of the governmental policy to encourage Research and Development companies to establish their production activities in Israel, alongside other global innovative companies. The support of the Israel Innovation Authority of the Ministry of Economy in the amount of $22M over the years was essential for promoting this unique project. We will continue to support innovative companies that choose to develop and retain their activities in Israel." 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 Israel Innovation Authority, which has provided meaningful governmental grants to the project over the years. VBL expects that its current cash will fund the Company's operating expenses and capital expenditure requirements into 2019. VBL's new headquarters and facility are located in 8 Hasatat Street, Modiin, Israel. About Ofranergene Obadenovec (VB-111) 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. About VBL Forward Looking Statements INVESTOR CONTACT: MEDIA CONTACT: |