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The clinical-stage biopharmaceutical company has announced the opening of a new gene therapy manufacturing facility in Modiin, Israel, which is anticipated to be the production site of the company’s lead cancer drug candidate.
On Oct. 23, 2017, VBL Therapeutics, a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of cancer treatments, announced the opening of a new gene therapy manufacturing facility in Modiin, Israel. The site will facilitate the production of the company’s lead cancer drug candidate, ofranergene obadenovec, if approved.
Ofranergene obadenovec is an anti-cancer, gene-therapy agent that uses a dual mechanism to target solid tumors. It is currently being studied in a Phase III trial for recurrent glioblastoma, conducted under FDA special protocol assessment. Additionally, the drug has received fast track designation for recurrent glioblastoma in the United States, as well as orphan drug status for glioblastoma in the US and European Union. The therapy has also received orphan drug status by European Medicines Agency for treatment of ovarian cancer.
According to the company, the new 20,000-ft2 facility is the first commercial-scale gene therapy manufacturing facility in Israel, and currently one of the largest gene-therapy designated sites in the world. Manufacturing capabilities include a large-scale capacity of 1000 L, and scalability up to 2000L.
“Having a manufacturing facility in place is an important step as we make preparations for potential regulatory approval and commercialization of [insert instead the actual product name within brackets],” said Dror Harats, MD, CEO of VBL Therapeutics, in a company press release. “Manufacturing has often been a limiting factor for biologics license application (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, should keep us on track for a timely submission of our BLA.”
"The inauguration of the new facility represents a major milestone for VBL,” said Ben Shapiro, MD, chairman of VBL Therapeutics, in the release. “Investing in the appropriate infrastructure is critical as we complete the necessary pre-launch activities for ofranergene obadenovec and evolve from a small biotech enterprise into an integrated biopharma company."
Source: VBL Therapeutics