VBL Therapeutics (NASDAQ:VBLT), announced today full results from
its exploratory Phase 2 study of VB-111 (ofranergene obadenovec) in
patients with advanced, differentiated thyroid cancer. The data
will be presented today by Dror Harats, M.D., CEO of VBL
Therapeutics, at the Federation of the Israel Societies for
Experimental Biology (FISEB) conference in Eilat, Israel.
The primary endpoint of the trial, defined as
6-month progression-free-survival (PFS-6) of 25%, was met with a
dose response. Forty-seven percent (47%; 8/17) of patients in the
therapeutic-dose cohort reached PFS-6, versus 25% (4/12) in the
sub-therapeutic cohort, both groups meeting the primary endpoint.
Reduction in tumor measurement after the first dose was seen in 44%
(7/16) of patients in the therapeutic-dose cohort, compared to 9%
(1/11) in the sub-therapeutic-dose cohort. An overall survival
benefit was seen with a tail of more than 40% at 3.7 years for the
therapeutic-dose cohort (mOS 684 days). This is similar to
historical data for pazopanib* (Votrient®), a tyrosine kinase
inhibitor; however, most patients in the VB-111 study had tumors
that previously had progressed on pazopanib or other kinase
inhibitors.
"We are encouraged to see dose-dependent responses
and an overall survival benefit with VB-111 monotherapy, in thyroid
cancer patients with end-stage disease whose tumors had not
responded to multiple lines of therapies, including kinase
inhibitors," said Dr. Dror Harats, CEO. "This trial, together
with our Phase 2 trials showing promise for VB-111 in
recurrent glioblastoma and platinum-resistant ovarian cancer, point
to the potential therapeutic application of VB-111 across multiple
solid tumors. We look forward to advancing VB-111 towards
commercialization, through our ongoing Phase 3 pivotal GLOBE trial
in rGBM and our planned Phase 3 trial in ovarian cancer," added Dr.
Harats.
The open-label dose-escalating study enrolled
patients with advanced, recently-progressive, differentiated
thyroid cancer that was unresponsive to radioactive iodine, in two
cohorts. Most patients had tumors that had not responded to
multiple therapies prior to enrollment, including radiation and
kinase inhibitors. In the first cohort, thirteen patients received
a single intravenous infusion of VB-111 at a sub-therapeutic dose
of 3X1012 viral particles (VPs). The second cohort included
seventeen patients, who received VB-111 at a therapeutic dose of
1013 VPs every two months until disease progression. One
patient proceeded from a single low dose to receive later multiple
high doses at progression and was included in both groups (for PFS
only). VB-111 was well-tolerated in this study, with no signs of
clinically significant safety issues.
About the Federation of the Israel
Societies for Experimental Biology (FISEB)ILANIT/FISEB is
a federation of 31 Israeli societies of experimental biology.
ILANIT’s conference is held every three years in Eilat, with
attendance by researchers and students. This year’s conference,
taking place February 20-23, is the culmination of the most
exciting research performed in Israel in many disciplines. For more
information, refer to http://fiseb.org/.
About Thyroid Cancer Thyroid
cancer occurs in the thyroid gland, a hormone-producing organ at
the base of the neck that regulates heart rate, blood pressure,
body temperature and weight. According to the National Cancer
Institute, there are an estimated 535,000 people currently living
with thyroid cancer in the United States, with an estimated 60,000
new cases each year. The type of treatment depends on the cancer
cell type, tumor size and severity of the disease. First-line
treatment is surgical removal of the thyroid gland, and is
recommended for most patients. Treatment with radioactive iodine
after surgery to destroy any remaining thyroid tissue may be
recommended for more advanced disease. If radioactive iodine is
ineffective, other treatments are prescribed, such tyrosine kinase
inhibitors and systemic chemotherapy. However, if such treatments
are unsuccessful, the therapeutic
options for patients are currently very limited.
There are an estimated 1,850 annual deaths in the U.S. as a result
of the disease. This subset of patients has an unmet need for novel
therapeutic options.
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).
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 efficacy 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 2x 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 and provided
evidence of disease stabilization and a positive safety
profile. 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.
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. 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.
* Lancet Oncol 2010; 11:
962–72
INVESTOR CONTACT:
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
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