VBL Therapeutics Awarded $2.5 Million Grant by the Israel Innovation Authority
June 08 2017 - 7:00AM
VBL Therapeutics (Nasdaq:VBLT) today announced that it has been
awarded a grant of 8.75 million New Israeli Shekels (approximately
$2.5 million) by the Israel Innovation Authority. The grant
will support clinical trials and development activities for
calendar year 2017. The Israel Innovation Authority, formerly
known as the Office of the Chief Scientist, which is responsible
for the country’s innovation policy, is an independent and
impartial public entity that operates for the benefit of the
Israeli innovation ecosystem and the country’s economy as a whole.
The funds will support the development of ofranergene
obadenovec (VB-111), a targeted anti-cancer gene-therapy agent
currently in development for recurrent glioblastoma (rGBM),
platinum-resistant ovarian cancer and other solid tumors.
"The Israel Innovation Authority’s support of the VB-111 program
provides validation for the potential of this drug to help patients
suffering from various types of cancer,” said Dror Harats, Chief
Executive Officer of VBL Therapeutics. “We believe this
non-dilutive grant for the VB-111 program underscores the
confidence that the Innovation Authority has in our technology and
its potential for commercialization. The continuous financial
support for the VB-111 program is an important contribution to our
ability to execute on our plans into 2019, as we prepare for the
commercialization of VB-111 and establish our new manufacturing
site.”
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. Moreover,
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 rGBM, 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 demonstrating
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.
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 >200 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 about our cash position
and resources, statements regarding the clinical development of
ofranergene obadenovec (VB-111), including our expectations
regarding the timing of results from the GLOBE 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 rGBM 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 Rice
LifeSci Advisors, LLC
(646) 597-6979
MEDIA CONTACT:
Matt Middleman
LifeSci Public Relations
(646) 627-8384
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