VBL Therapeutics Announces Modiin Production Facility Received a GMP Compliance Certificate Following EU QP Audit
July 22 2019 - 8:00AM
VBL Therapeutics (Nasdaq: 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.
About VBLVascular 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.
INVESTOR CONTACT:Michael RiceLifeSci Advisors,
LLC(646) 597-6979
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