VBL Therapeutics Announces Addition of Progression Free Survival as a Second Primary Endpoint in OVAL, a Phase 3 Registration...
June 03 2021 - 7:00AM
VBL Therapeutics (Nasdaq: VBLT) today announced a primary endpoint
amendment in the OVAL Phase 3 registration-enabling study of
VB-111. The clinical trial amendment included a second, separate
primary endpoint, of progression free survival (PFS), in addition
to the original primary endpoint of the trial, overall survival
(OS). Based upon the changes that were reviewed by the U.S. Food
and Drug Administration (FDA), successfully meeting either primary
endpoint is expected to be sufficient to support BLA submission.
Successful meeting of the PFS endpoint, with a readout anticipated
in 2022, could accelerate BLA submission by approximately one year
compared to original projections based on the readout of the OS
primary endpoint that remains anticipated in 2023. The OVAL study
amendment, along with an update on the number of patients enrolled,
which as of April 30, 2021, exceeded 260 patients, will be
presented tomorrow as part of a virtual Clinical Trial in Progress
poster presentation at the 2021 ASCO Annual Meeting.
“The addition of PFS as a second independent
primary endpoint has several very important implications on the
OVAL study,” said Bradley Monk, M.D., FACS, FACOG, Arizona
Oncology (U.S. Oncology Network), and Chair of the OVAL Study
Steering Committee. “First, it de-risks the study, as it provides
two options for study success. Second, it should accelerate the
time to clinical readout and to potential approval, as PFS data are
expected during 2022. Third, keeping OS as a primary endpoint
preserves the opportunity of differentiating VB-111 from current
ovarian cancer treatments, which were approved based on PFS data
and have not as yet shown an OS benefit.”
Title: Clinical Trial in
Progress: Pivotal Study of VB-111 Combined with Paclitaxel vs.
Paclitaxel for Treatment of Platinum-Resistant Ovarian Cancer
(OVAL, VB-111-701/GOG-3018)Authors: Arend, R.C.,
et al.Session: Gynecologic CancerSession
type: Poster SessionAbstract: 5599
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 field
of gynecologic malignancies.
About VB-111
(ofranergene obadenovec)VB-111
is an investigational 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 is designed to use 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 recurrent glioblastoma. 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
Therapeutics 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 Therapeutics’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
Therapeutics-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 VBL Therapeutics’s programs, including VB-111,
and 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 financial resources do not last for as long as
anticipated, and that VBL Therapeutics may not realize the expected
benefits of its intellectual property protection. In particular,
the addition of progression free survival as a primary endpoint in
the OVAL trial is not assurance that the trial will meet either of
its primary endpoints, that it will do so within any particular
timeframe, or that VBL Therapeutics 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 VBL Therapeutics’s regulatory filings with
the U.S. Securities and Exchange Commission, including in its
annual report on Form 20-F for the year ended December 31,
2020, 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
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