VBL Therapeutics (Nasdaq:VBLT) today announced new preclinical data
indicating that treatment with ofranergene obadenovec (VB-111)
augments the anti-tumor activity of a PD-L1 blocker in lung cancer
and melanoma models. The data will be presented tomorrow, May 12,
in a poster session at the 20th Annual Meeting of the American
Society of Gene & Cell Therapy (ASGCT), taking place in
Washington, DC.
Immunotherapy with checkpoint inhibitors demonstrates remarkable
efficacy in several cancers; yet, only a low percentage of patients
seem to benefit from this class of treatment when given as a
monotherapy. Several studies have shown that response rates are
increased when checkpoint blockade is combined with other
anti-cancer treatments. VB-111 is a biologic agent that is being
currently studied in a Phase 3 clinical trial for recurrent
glioblastoma (rGBM). VB-111 specifically targets angiogenic
endothelial cells and promotes antitumor immune response. In the
study to be presented at ASGCT, VB-111 was evaluated in combination
with an anti-PD-L1 checkpoint inhibitor in lung and melanoma cancer
models, indications for which PD-1 blockers are already
marketed.
VBL's data show that treatment with either VB-111 or anti-PD-L1
reduced tumor burden in mice induced with Lewis lung carcinoma
(LLC), by 42% and 51% versus saline control, respectively;
however, the combination of both agents resulted in an amplified
effect (67% reduction versus control; p≤0.001), and similar results
were seen in a melanoma model. In addition, treatment with VB-111
and anti-PD-L1 enhanced infiltration of CD8+ cells to lung
tumors. A copy of the poster will be available on VBL’s
website, beginning May 12.
"An important observation from our pre-clinical data in the LLC
model was that the combination of VB-111 at a dose of 109 viral
particles (VPs)/mouse, which is equivalent to the human therapeutic
dose, with a PD-L1 blocker, yielded a tumor burden reduction
similar to treatment with 1011 VPs/mouse, a 100-fold higher dose,"
said Eyal Breitbart, Ph.D., Vice President of Research and
Operations at VBL. "Therefore, a combination with a checkpoint
inhibitor may achieve much better anti-tumor activity than VB-111
alone,” added Dr. Breitbart.
VB-111 is currently studied in the pivotal Phase 3 GLOBE trial
in rGBM, comparing VB-111 in combination with Avastin®
(bevacizumab) to Avastin alone, which is being conducted in
the US, Canada and Israel. Enrollment in the study, 256
patients in total, was completed earlier this year, five months
ahead of schedule. The study is proceeding under a Special
Protocol Assessment (SPA) granted by the FDA, with full endorsement
by the Canadian Brain Tumor Consortium (CBTC). The Company expects
to report interim data from the GLOBE trial in Q3-2017, with
top-line results from the full dataset expected to be available in
early 2018.
VBL plans to launch a Phase 3 study for VB-111 in combination
with chemotherapy for platinum-resistant ovarian cancer in the
second half of 2017. Launch of an exploratory clinical study on
VB-111 in combination with a checkpoint inhibitor in lung cancer is
also expected by year-end 2017.
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 regarding the clinical
development of ofranergene obadenovec (VB-111), including our
expectations regarding the timing of results from the GLOBE study,
our plans for our Phase 3 study of VB-111 in platinum-resistant
ovarian cancer, our plans for an exploratory clinical study of
VB-111 in combination with a checkpoint inhibitor in lung cancer,
and the therapeutic potential of, and clinical results for, VB-111.
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.
Avastin® (bevacizumab) is a registered trademark of
Genentech Inc.
INVESTOR CONTACT:
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
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