VBL Therapeutics Announces Peer-reviewed Publication of Positive Results of Pre-specified Interim Analysis of OVAL, a Phase 3...
March 04 2021 - 7:00AM
VBL Therapeutics (Nasdaq: VBLT) today announced the online
publication of positive results of the pre-specified interim
analysis of the OVAL study, a Phase 3 registration enabling study
of VB-111 (ofranergene obadenovec) in recurrent platinum-resistant
ovarian cancer. The analysis showed a CA-125 GCIG response rate of
58% or higher in evaluable patients in the VB-111 treatment arm.
Based on the results of the interim analysis, the Data and Safety
Monitoring Committee (DSMC) recommended continuing the trial as
planned. The results were published online in the international
peer reviewed journal Gynecologic Oncology
(https://doi.org/10.1016/j.ygyno.2021.02.014).
“The goal of this interim analysis was to get a
signal of drug activity, using CA-125 as a validated biomarker,”
said Bradley J. Monk, M.D., FACOG, FACS, Arizona Oncology (US
Oncology Network), University of Arizona College of Medicine,
Creighton University School of Medicine, Head of the OVAL steering
committee and author on the manuscript. “The intention was to
reduce the risk of a negative trial and increase the chance of
success. New and novel approaches that have the potential to
significantly extend progression free survival or survival are
eminently required in platinum-resistant ovarian cancer. VB-111,
with its very unique mechanism of action, could be one of those
novel approaches and I look forward to the progress of the OVAL
trial, which is well designed to test this hypothesis.”
The article reported results of the pre-specified
interim analysis in the OVAL study, which reviewed unblinded data
and assessed CA-125 response, measured according to the GCIG
criteria, in the first 60 enrolled subjects evaluable for CA-125
analysis. Based on the overall response rate in the first 60
patients across both arms of 53%, and assuming balanced
randomization and an absolute advantage of 10% or higher to the
VB-111 arm, the response rate in the treatment arm (VB-111 in
addition to weekly paclitaxel) was calculated to be 58% or higher.
In patients who had post-dosing fever, which is a marker for VB-111
treatment, the response rate was 69%. The futility rule
determined for this analysis was that the response rate of VB-111
must be greater than the response rate of placebo by at least 10%
in order to continue the study. This rule was successfully met.
“We believe VB-111’s unique dual
mechanism of action has the potential to prolong life and possibly
turn certain cancers into manageable chronic diseases,” said Dror
Harats, M.D., Chief Executive Officer of VBL Therapeutics. “The
encouraging trajectory of the OVAL trial, not only as reported in
this paper but also based on the pre-specified DSMC reviews, makes
us hopeful that VB-111 may have a meaningful impact on ovarian
cancer.”
About the OVAL study
(NCT03398655)OVAL is an international
Phase 3 randomized pivotal registration enabling clinical trial
that compares a combination of VB-111 and paclitaxel to placebo
plus paclitaxel, in patients with platinum-resistant ovarian
cancer. The study is planned to enroll approximately 400 patients.
OVAL is conducted in collaboration with the GOG Foundation,
Inc., an independent international non-profit organization with the
purpose of promoting excellence in the quality and integrity of
clinical and basic scientific research in the field of gynecologic
malignancies.
About VB-111
(ofranergene
obadenovec)VB-111 is an
investigational first-in-class, targeted anti-cancer gene-therapy
agent that is being developed to treat a wide range of solid
tumors. VB-111 is a unique biologic agent that uses a dual
mechanism to target solid tumors. Its mechanism combines blockade
of tumor vasculature with an anti-tumor immune response. VB-111 is
administered as an IV infusion once every 6-8 weeks. It has been
observed to be well-tolerated in >300 cancer patients and
demonstrated activity signals in an “all comers” Phase 1 trial as
well as in three tumor-specific Phase 2 studies. VB-111 has
received an Orphan Designation for the treatment of ovarian cancer
from the European Commission. VB-111 has also received orphan
drug designation in both the US and Europe, and fast track
designation in the US for prolongation of survival in patients with
rGBM. VB-111 demonstrated proof-of-concept and survival benefit in
Phase 2 clinical trials in radioiodine-refractory thyroid cancer
and recurrent platinum-resistant ovarian cancer (NCT01711970).
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 areas of unmet
need in cancer and immune/inflammatory indications. VBL has
developed three platform technologies: a gene-therapy based
technology for targeting newly formed blood vessels with focus on
cancer, an antibody-based technology targeting MOSPD2 for
anti-inflammatory and immuno-oncology applications, and the
Lecinoxoids, a family of small-molecules for immune-related
indications. VBL’s lead oncology product candidate, ofranergene
obadenovec (VB-111), is an investigational, first-in-class,
targeted anti-cancer gene-therapy agent that is being developed to
treat a wide range of solid tumors. VB-111 is currently being
studied in a VBL-sponsored Phase 3 potential registration trial for
platinum-resistant ovarian cancer.
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 may include, but are
not limited to, statements regarding our programs, including
VB-111, including their clinical development, 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, the
risk that historical clinical trial results may not be predictive
of future trial results, that our financial resources do not last
for as long as anticipated, and that we may not realize the
expected benefits of our intellectual property protection. In
particular, the DSMC recommendation that the OVAL trial proceed is
not assurance that the trial will meet its primary endpoint of
overall survival once completed, or that we will obtain positive
results to support further development of this candidate. A
further list and description of these risks, uncertainties and
other risks can be found in our 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,
2019, and subsequent filings with the SEC. 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.
CONTACT:Burns McClellan
for VBL TherapeuticsLee Roth (investors) / Ryo Imai
(media)lroth@burnsmc.com / rimai@burnsmc.com+1-212-213-0006
Vascular Biogenics (NASDAQ:VBLT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Vascular Biogenics (NASDAQ:VBLT)
Historical Stock Chart
From Sep 2023 to Sep 2024