VBL Therapeutics Provides Update on Long-Term Survival in Phase 2 Trials of Patients with Multiple Tumor Types
June 19 2017 - 8:00AM
VBL Therapeutics (Nasdaq:VBLT) provided an update on the long term
status and survival of patients from three completed Phase 2
trials, which investigated the company’s lead candidate, VB-111,
respectively in recurrent glioblastoma (rGBM), recurrent
platinum-resistant ovarian cancer and radioiodine refractory
differentiated thyroid cancer. All three trials had previously
shown signals of an overall survival benefit for VB-111. The
company has continued to follow the survival of patients from these
trials.
“We are pleased to report that in all three indications over 50%
of patients have achieved long term survival following treatment
with VB-111 as detailed below. Each of these Phase 2 trials
enrolled difficult to treat patients for whom prior treatments had
failed,” said Prof. Dror Harats, CEO of VBL Therapeutics. "In
addition, we continue to follow patients from our Phase 1 studies,
who responded to VB-111 and have now survived for more than 5
years, although they were end-stage patients whose tumors had
previously progressed in spite of several lines of therapy. We are
now conducting pivotal trials with the goal of investigating these
survival benefits and providing data to support regulatory approval
and commercialization of VB-111. Our GLOBE pivotal trial in
rGBM has completed enrollment and we expect top line data from the
full dataset becoming available in early 2018. We expect
patient enrollment in our planned Phase 3 OVAL study in ovarian
cancer to begin in the second half of 2017. In addition, we plan to
launch a combination study of VB-111 with a checkpoint inhibitor in
lung cancer by year-end 2017.”
Summary of Data
- rGBM: In the Phase 2 study in rGBM patients,
12 months survival was 54% in patients who were treated with VB-111
through progression, including an rGBM patient who remains alive
with complete response after 38 months, compared to 23% of patients
who had limited exposure of a therapeutic dose of VB-111. According
to a meta-analysis, the 12 months survival on Avastin™
(bevacizumab) is only 24%.
- Ovarian Cancer: In the Phase 2 study in
recurrent platinum-resistant and refractory ovarian cancer, 53% of
patients treated with a therapeutic dose of VB-111 in combination
with paclitaxel were alive at 15 months, some of whom remain alive
and are on active follow up. No patients in the sub-therapeutic
dose were alive at the 15-month timepoint.
- Thyroid Cancer: In the Phase 2 study in
radioiodine refractory differentiated thyroid cancer, 53% of those
who received multiple therapeutic doses of VB-111 were alive at 24
months, compared to 33% of those who received a single,
sub-therapeutic dose of VB-111. 35% of patients on the therapeutic
dose cohort remain alive at 39 to 46 months.
VBL's presentation at BIO will take place tomorrow at 11.45am
PDT in the San Diego Convention Center. A webcast of the live
presentation can be viewed here:
http://www.veracast.com/webcasts/bio/internationalconvention2017/17205139583.cfm.
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. Clinical data indicate that continuous exposure to
VB-111 can lead to attenuation of tumor growth and to tumor
shrinkage, which can translate to survival benefit.
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 planned OVAL study and other intended studies, and VB-111’s
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, 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.
INVESTOR CONTACT:
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
MEDIA CONTACT:
Matt Middleman
LifeSci Public Relations
(646) 627-8384
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