VBL Therapeutics Announces Patient Dosing Initiated in Randomized, Controlled and Blinded Trial of VB-111 in Patients with Re...
March 01 2021 - 7:00AM
VBL Therapeutics (Nasdaq: VBLT) today announced that patient dosing
has been initiated in a Phase 2 clinical trial investigating
ofranergene obadenovec (VB-111) for the treatment of recurrent
glioblastoma multiforme (rGBM). The study is sponsored by
Dana-Farber Cancer Institute and is being conducted through a
collaboration between VBL and seven leading neuro-oncology medical
centers in the U.S.
“This new study builds upon our previous successful Phase 2
trial of VB-111 in recurrent glioblastoma (rGBM) while
incorporating lessons learned from the GLOBE study,” said Dror
Harats, M.D., Chief Executive Officer of VBL Therapeutics. “It will
use the same VB-111 treatment regimen that induced significant
survival benefit in our prior Phase 2 study, this time in patients
that go through a second tumor resection. I believe that our
perseverance could lead to renewed hope for rGBM patients who are
in desperate need of therapies that may change their disease course
and prolong life."
The Phase 2 study is enrolling patients with rGBM who are
scheduled to undergo a second surgery. VB-111 will be administered
either before and after surgery (neo-adjuvant and adjuvant therapy)
or after surgery only (adjuvant therapy) and each arm will be
compared to a standard of care control arm. In addition to
endpoints of progression-free survival (PFS) at 6 months and
overall survival (OS), collection of tumor specimens will allow
important analysis of the activity of VB-111 within the tumor and
will evaluate its effect on the immune system in this
immunologically `cold` tumor. Additional information about the new
VB-111 study can be found on ClinicalTrials.gov
(NCT04406272).
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 U.S. and Europe, and fast track
designation in the U.S. for prolongation of survival in patients
with rGBM. VB-111 successfully demonstrated proof-of-concept and
survival benefit in Phase 2 clinical trials in
radioiodine-refractory thyroid cancer (NCT01229865) 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
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