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 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.
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
positioned 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 we have observed its efficacy 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
Phase 3 pivotal trial for recurrent Glioblastoma, conducted under
an FDA Special Protocol Assessment (SPA).
Forward Looking StatementsThis 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, Israel, clinical development of ofranergene
obadenovec (VB-111), including our expectations regarding the
timing of results from the Phase 3 study, and its therapeutic
potential and clinical results. These forward-looking statements
are not promises or guarantees and involve substantial risks and
uncertainties. Among the factors that could cause actual results to
differ materially from those described or projected herein include
uncertainties associated generally with research and development,
clinical trials and related regulatory reviews and approvals, and
the risk that historical clinical trial results may not be
predictive of future trial results. In particular, results from our
pivotal Phase 3 clinical trial of ofranergene obadenovec (VB-111)
in recurrent GBM may not support approval of ofranergene obadenovec
for marketing in the United States, notwithstanding the positive
results seen in prior clinical experience. A further list and
description of these risks, uncertainties and other risks can be
found in the Company’s regulatory filings with the U.S. Securities
and Exchange Commission, including in our annual report on Form
20-F for the year ended December 31, 2016. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
VBL Therapeutics undertakes no obligation to update or revise the
information contained in this press release, whether as a result of
new information, future events or circumstances or otherwise.
INVESTOR CONTACT:Michael RiceLifeSci Advisors,
LLC(646) 597-6979
MEDIA CONTACT:Matt Middleman, M.D.LifeSci
Public Relationsmatt@lifescipublicrelations.com(646) 627-8384
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