VBL Therapeutics Announces Plans to Establish New Manufacturing Facility
October 13 2016 - 9:04AM
VBL Therapeutics (NASDAQ:VBLT), today announced that it has
engaged in a long-term lease contract of a new stand-alone facility
in Modiin, Israel. The site will house VBL's local biological drugs
manufacturing facility, as the company plans ahead for potential
commercialization of VB-111.
The site design enables modular expansion of the
manufacturing capacity, to supply growing demand following
commercialization, while requiring only limited capital resources
in the immediate stage. The near-term investment is not expected to
materially impact VBL's cash position. The Company projects that
its current cash will suffice to support operations into 2019,
beyond the readout of the pivotal GLOBE trial, while supporting a
potential registration trial in ovarian cancer and the investment
in the new facility. In addition, VBL expects that the
establishment of the new facility will qualify for increased
governmental financial incentives.
“Securing this new facility in Modiin fits
strategically with our development plans and is an important step
as we advance multiple clinical trials and move closer to potential
commercialization of VB-111,” stated Dror Harats, Chief Executive
Officer of VBL Therapeutics.
The new facility will also include the company’s
headquarters, discovery research and clinical development. VBL
intends to operate and relocate to the new site in the second half
of 2017.
VBL said that
future commercial supply of VB-111 will likely involve
a complementary source of
supply, probably via a Contract Manufacturing
partner in North America, although those plans have not yet been
set.
About VBL 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, VB-111, is a
first-in-class, targeted anti-cancer gene-therapy agent that is
positioned to treat a wide range of solid tumors. VB-111 is
conveniently administered as an IV infusion once every two months.
It has been observed to be well-tolerated in >170 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. The mechanism of VB-111 combines blockade of tumor
vasculature with an anti-tumor immune response. This mechanism
retains activity regardless of baseline tumor mutations or the
identity of the pro-angiogenic factors secreted by the tumor.
VB-111 is currently being studied in a Phase 3 pivotal trial for
Recurrent Glioblastoma (rGBM). The trial is being conducted under
an FDA Special Protocol Assessment (SPA), and VB-111 has obtained
fast track and Orphan designations.
Forward Looking Statements This
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 clinical development of VB-111 and its
therapeutic potential and clinical results, including statements
related to the GLOBE study and our cash position and funding
requirements. 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 VB-111 in rGBM may not support approval of VB-111
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. 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
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