TEL AVIV, Israel, July 22, 2019 (GLOBE NEWSWIRE) -- VBL Therapeutics (VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced that its new gene therapy manufacturing facility in Modiin, Israel, has been approved by a European Union (EU) Qualified Person (QP) as being in compliance with EU Good Manufacturing Practices (GMP).
“EU-GMP standards are very high, and having our Modiin manufacturing facility approved on its first audit not only represents the excellence VBL aspires to, but is also an important step in the regulatory process for our lead asset, VB-111, in Europe,” said Naamit Sher, Ph.D., VP Development and Regulatory, VBL Therapeutics. “VB-111 is currently being evaluated in the Phase 3 OVAL study in ovarian cancer. If approved for marketing in the EU, our facility could supply commercial product into that market.”
The Modiin facility is the first commercial-scale gene therapy manufacturing facility in Israel and currently one of the largest gene-therapy designated facilities 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. Construction of the facility was funded partially with the support of meaningful grants from the Israel Innovation Authority (IAA) of the Ministry of Economy.
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 being developed 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 >300 cancer patients and demonstrated activity 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 potential registration trial for platinum-resistant ovarian cancer.
LifeSci Advisors, LLC