VBL Therapeutics (NASDAQ:VBLT), provides corporate update and
reviews anticipated highlights for 2017.
- Following positive EOP2 meeting on VB-111 in ovarian cancer,
VBL plans to launch a Phase 3 trial of VB-111 in Ovarian Cancer
during the second half of 2017.
- Interim analysis in the GLOBE pivotal study is expected in
mid-2017, with top-line data expected in early 2018.
- VBL's novel immune-oncology target to be disclosed during 1H
2017
Dear Fellow Shareholders,
As we conclude 2016 and look forward to a busy year
for the Company in 2017, I wanted provide you with a review of VBL
Therapeutics' recent accomplishments and share the goals we have
set for the coming year.
VBL Therapeutics is a Phase 3 stage
biopharmaceutical company whose mission is to develop and
commercialize first-in-class treatments for cancer. We are starting
the new year in a strong position on all major fronts – clinical,
regulatory, scientific and financial.
Our major focus during 2016 was on advancing
clinical development of VB-111 (ofranergene obadenovec). VB-111 is
a unique biologic agent that uses a dual mechanism to target solid
tumors. Based on a non-integrating, non-replicating, Adeno 5
vector, VB-111 utilizes VBL's proprietary Vascular Targeting System
(VTS™) to target the tumor vasculature for cancer therapy. Unlike
anti-VEGF or TKIs, VB-111 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 efficacy even after failure of prior treatment
with other anti-angiogenics. Moreover, VB-111 induces specific
anti-tumor immune response, which is accompanied by recruitment of
CD8 T-cells and apoptosis of tumor cells.
We made excellent progress in 2016 with VB-111
across three Phase 2 studies for different oncology indications –
recurrent glioblastoma (rGBM), platinum-resistant ovarian cancer,
and radio-iodine resistant thyroid cancer.
VBL's Phase 2 study of VB-111 in rGBM met its
primary endpoint, almost doubling median Overall Survival (mOS). At
ASCO 2016, we presented additional clinical analyses that
demonstrate significant OS benefit in rGBM patients receiving
VB-111 through progression, compared with historical meta-analysis
data for the standard-of-care Avastin®. During 2016, we continued
to advance our GLOBE pivotal study in rGBM and were pleased to
announce that this study completed enrollment five months ahead of
our initial projection. Earlier in 2016 the independent Data Safety
Monitoring Committee (DSMC), which oversees this trial, recommended
that the study continue as planned following their scheduled
review.
In platinum-resistant Ovarian Cancer, we presented
data at ASCO 2016 demonstrating a significant increase in OS with
VB-111 given in combination with chemotherapy, along with 60%
durable CA-125 response rate. This is approximately 2x the
historical response with Avastin® plus chemotherapy in ovarian
cancer. In December 2016 we had an End-of-Phase 2 meeting with the
FDA to discuss the clinical path of VB-111 in Ovarian cancer. We
have agreement with the FDA on our clinical plan, to proceed
directly to a Phase 3 pivotal study in platinum-resistant patients,
with OS as the primary endpoint. We are excited to advance VB-111
for this orphan indication, in which current therapies often fail
to prolong patient survival, and plan to launch an Ovarian Cancer
pivotal study in the second half of 2017.
In recurrent Thyroid Cancer, we reported overall
survival data for VB-111 monotherapy in our Phase 2 study. The
study previously met its primary endpoint, demonstrating disease
stabilization and safety, along with a dose-response. The new data
showed evidence of an overall survival benefit for patients treated
with therapeutic dose of VB-111. We see these positive data as
additional proof-of-concept for VB-111 in a third type of advanced
solid tumor, particularly important for demonstrating potential
VB-111 efficacy even as monotherapy. We intend to present the full
data set from this trial during the first quarter of 2017.
Our primary focus continues to be advancement of VB-111 towards
commercialization in the rGBM and Ovarian Cancer indications.
In 2017, VBL anticipates a number of clinical
development value enhancing milestones. The GLOBE trial has the
potential to become a key inflection point for our company, as it
is a pivotal study in an orphan indication with a huge unmet need.
In addition to the successful operational efforts that allowed us
to complete enrollment ahead of schedule, we also recently received
FDA approval for adjustments in the protocol of the GLOBE trial
under the Special Protocol Assessment (SPA), related to the timing
of the interim and final analyses. We believe that these
adjustments will provide better powering and increase the
probability for a clearer efficacy signal. Given the
faster-than-projected recruitment pace during 2016 and the
completion of recruitment for the GLOBE study, we continue to
expect that the interim analysis will occur in mid-2017 and that
the top line data from the full dataset will be available in early
2018. In addition, we intend to launch a Phase 3 pivotal study in
platinum-resistant Ovarian Cancer during the second half of 2017
and are also exploring the launch of an exploratory clinical study
of VB-111 in combination with a checkpoint inhibitor.
As we plan ahead towards the potential
commercialization of VB-111, we expect to enhance our manufacturing
capabilities through operation of a new manufacturing facility in
Modiin, Israel. The new facility will also include the company’s
headquarters, discovery research and clinical development. We
signed a long-term lease contract last October and intend to
operate and relocate to the new site in the second half of
2017.
Additional potential milestones may emerge from
VBL's innovative pipeline. Our continuing research into the
mechanisms of cancer biology led us to identify a cell surface
protein which is involved in the motility of certain cancer cells
and immune cells. Serving as the basis for VBL's "VB-600" series,
our researchers have developed antibodies against this novel
target, which may have potential in clinical applications. We
intend to provide additional data about this target protein in
first half of 2017.
VBL's pipeline also includes the Lecinoxoids family
of anti-inflammatory small molecules. In 2016, we presented results
for the Phase-2-ready VB-201 drug candidate and the next-generation
molecule VB-703 for the treatment of non-alcoholic steatohepatitis
(NASH) and liver fibrosis. We are exploring strategic
collaborations that will advance the clinical and business
potential of the Lecinoxoids, as well as pre-clinical assets from
our VTS platform.
We begin 2017 with a solid financial position. In
2016, we successfully closed a $24 million registered direct
offering, which further strengthened our capital. We are
grateful for the support of existing and new investors and we now
expect to be able to fund the company into 2019, beyond the readout
of the GLOBE trial. In addition to the GLOBE trial, the
budgeted work plan includes the Phase 3 study in ovarian cancer,
the establishment of the new manufacturing site, an exploratory
clinical study of VB-111 in combination with CPIs and the next
stage of the preclinical development of our novel immune-oncology
target.
In closing, we are excited by the progress we made
in 2016 and by the promise of our technology as we actively advance
novel drug candidates through multiple programs from the
pre-clinical stage to a pivotal Phase 3 studies. I would like to
thank our excellent team for their dedication and hard work, our
board members for their guidance and contribution to the progress
of the company, and our shareholders for their support of our
strategy and potential. I look forward to another productive year
in 2017.
Sincerely
Dror Harats,
Chief Executive Officer
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, 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 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 ofranergene
obadenovec (VB-111) and its therapeutic potential, clinical trials
and clinical results, including the timing thereof, our other
pipeline candidates, our new Modiin facility and our cash position
and financial outlook. 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, 2015. 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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