VBL Presents New Data on Potential of VB-111 to Stimulate the Immune System and Drive Immune Cells to Infiltrate Tumor Microe...
March 19 2019 - 7:00AM
VBL Therapeutics (Nasdaq: VBLT), today announced the presentation
of human data indicating that the viral anti-cancer investigational
therapy VB-111 has potential to stimulate the immune system to
induce a strong and durable response against ovarian tumors.
Administration of VB-111 was associated with an infiltration of
immune cells within the tumor, which was followed by tumor necrosis
and sustained clinical response. VBL's study entitled “VB-111, an
anti-cancer gene therapy, induces immunotherapeutic effect in
platinum resistant ovarian cancer” was presented last evening at
the SGO 50th Annual Meeting on Women's Cancer at the Hawaii
Convention Center in Honolulu, Hawaii. The presentation was
delivered by Dr. Ronnie Shapira-Frommer from Sheba Medical Center,
Tel Aviv and Dr. Richard Penson from Massachusetts General
Hospital, Boston.
Ofranergene obadenovec (VB-111) is a targeted
anti-cancer investigational gene therapy with a dual mechanism:
disruption of the tumor vasculature and induction of an anti-tumor
directed immune response. In a Phase 2 clinical trial, VB-111 in
combination with chemotherapy (paclitaxel) prolonged survival in
patients with recurrent platinum resistant ovarian cancer (median
OS 498 days for therapeutic dose VB-111 + paclitaxel combination
therapy, compared to 172 days for low dose VB-111 + paclitaxel
(p=0.03)). OVAL, VBL's ongoing pivotal Phase 3 trial, is designed
to repeat the successful Phase 2 protocol, with the primary
endpoint of improvement in overall survival. An interim analysis of
the OVAL study is expected at year-end 2019.
"Cancer cells utilize various mechanisms to
proliferate and survive, including silencing of, and escape from,
the immune system. We believe that treatment strategies should
therefore aim both to target the cancer cells and to stimulate the
immune system to attack the tumor," said Dror Harats, M.D., Chief
Executive Officer of VBL Therapeutics. "While we initially designed
VB-111 as anti-tumor therapy targeting tumor blood supply, it is
now evident that VB-111 can also drive immune cells into
immunologically `cold` tumors turning the tumors ‘hot,` enabling
the immune system to fight the tumor. These clinical findings
provide encouraging evidence of the therapeutic potential of
VB-111, as we continue to advance our clinical program in ovarian
cancer and additional indications."
For a link to VBL's poster at the SGO 50th
Annual Meeting on Women's Cancer refer to: SGO Poster
About Ofranergene Obadenovec (VB-111)VB-111, a
potential first-in-class anticancer therapeutic candidate, is the
Company’s lead oncology product currently being studied in the OVAL
potential-registration Phase 3 pivotal trial for ovarian cancer
(ClinicalTrials.gov Identifier: NCT03398655). VB-111 has
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. In addition, VB-111 successfully demonstrated
proof-of-concept and survival benefit in Phase 2 clinical trials in
radioiodine-refractory thyroid cancer and recurrent
platinum-resistant ovarian cancer (NCT01711970). VB-111 has
received an Orphan Designation for the treatment of ovarian cancer
from the European Commission.
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
being developed 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 >300 cancer
patients and demonstrated activity 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 potential
registration trial for platinum-resistant ovarian cancer.
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 our programs, including VB-111,
including their clinical development, such as the timing thereof,
therapeutic potential and clinical results, and the scope and
protection of our intellectual property rights. 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, and that we may not realize the expected benefits of our
intellectual property protection. 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, 2017, 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.
INVESTOR CONTACT:Michael RiceLifeSci Advisors,
LLC(646) 597-6979
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