VBL Therapeutics (NASDAQ:VBLT), today announced top-line
results from its exploratory Phase 2 study of VB-111 (ofranergene
obadenovec) in patients with advanced, differentiated thyroid
cancer. As previously announced, this trial met its primary
endpoint, which was defined as 25% progression-free survival at 6
months (PFS-6), in heavily-pretreated patients with late-stage
disease. A dose-dependent response was seen, with 35% of patients
reaching PFS-6 in the therapeutic dose cohort, versus 25% in a
low-dose cohort. Given this positive clinical response, the Company
continued to follow patients for overall survival (OS) data, which
was not a primary endpoint. Although the trial included a small
number of patients and was not powered to show OS differences, the
new data show a dose-response and evidence of an overall survival
benefit in the cohort of patients treated with multiple therapeutic
doses of VB-111, compared to patients who received a single low
dose of VB-111 (mOS 761 days versus 469 days; p=0.096). Only
one patient remained alive in the low-dose cohort, compared to a
tail of about 50% in the high dose group.
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“The appearance of dose-dependent superior overall
survival provides encouragement, especially given that this trial
enrolled patients with late-stage disease whose tumors were
resistant to multiple lines of previous therapies,” said Keith
C. Bible, MD, PhD, Professor of Oncology, Division of Medical
Oncology, Department of Oncology, and Endocrine Malignancies
Disease Oriented Group, Mayo Clinic Cancer
Center, and Primary Investigator for this trial.
“This is the third indication in which we have seen
profound clinical responses and evidence of an overall survival
benefit with VB-111,” said Dror Harats, MD, Chief Executive Officer
of VBL Therapeutics. “Following our Phase 2 OS data in recurrent
GBM and platinum-resistant ovarian cancer, this trial, which
evaluated VB-111 as monotherapy, reinforces the potential of VB-111
and its unique mechanism of action, for multiple solid tumor
indications. We are continuing to focus on completion of our
clinical program, and potentially commercialization, of VB-111 for
rGBM, and to advance our ovarian cancer clinical program.
Based on the current data, we may expand our program to
additional indications, such as thyroid cancer, either
independently in the future, or earlier in collaboration with a
strategic partner," added Prof. Harats.
The open-label dose-escalating study enrolled
patients with advanced, recently-progressive, differentiated
thyroid cancer that is unresponsive to radioactive iodine, in two
cohorts. The majority of patients had tumors which had failed on
several therapeutic lines, including tyrosine kinase inhibitors,
prior to enrollment. In the first cohort twelve patients received a
single intravenous infusion of VB-111 at a low 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. The company previously reported that 35%
of patients in the therapeutic dose cohort (n=17) met the primary
endpoint of 6-month progression-free survival using Response
Evaluation Criteria in Solid Tumors (RECIST), compared to 25% of
patients in the low dose cohort. PFS at 12 months was 25% in the
VB-111 high dose cohort, versus 0% in the low dose cohort.
Continued follow-up now indicates further survival benefit for the
multiple-dose therapeutic cohort, with median OS of 761 versus 469
in the low-dose cohort (p=0.096). VB-111 was well-tolerated
in this study, with no signs of clinically significant safety
issues.
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 and an estimated 1,850 annual deaths as a
result of the disease. 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.
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 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, 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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