VBL Therapeutics Announces Publication of Positive New Data on its Lecinoxoid Drug Candidates for the Treatment of Renal Fibr...
August 30 2018 - 07:00AM
VBL Therapeutics (Nasdaq:VBLT) today announced the publication of a
paper in the journal Basic and Clinical Pharmacology and
Toxicology. The paper, titled “Lecinoxoids for Renal Inflammation
and Fibrosis,” describes the role of the Company’s lead lecinoxoid
drug candidates, VB-201 and VB-703, in inhibiting toll-like
receptor activation and monocyte migration in a model of focal
segmental glomerulosclerosis (FSGS), thereby slowing kidney
function decline.
The recently granted U.S. Patent No. 10,022,388, entitled
"Oxidized Lipids and Treatment or Prevention of Fibrosis", provides
VBL with intellectual property protection for the use of Phase-2
ready candidate VB-201, and additional lecinoxoid candidates, for
treatment of fibrosis until November 2035, before potential
extensions.
“We had previously reported positive preclinical data suggesting
that VB-201 and VB-703 reduced inflammation and fibrosis in models
of nonalcoholic steatohepatitis (NASH) without affecting lipid
profile or steatosis,” said Eyal Breitbart, PhD, VP Research and
Operations at VBL Therapeutics. “This new paper discusses the
potential of lecinoxoids in treating renal fibrosis, a form of
chronic kidney disease (CKD), by targeting TLR2/4 activation and
monocyte migration. Renal fibrosis can result in end stage renal
disease, a major health and economic burden globally. We believe
these latest observations support continued development of our
novel portfolio of lecinoxoid drug candidates, and showcase the
potential of our anti-inflammatory pipeline.”
FSGS is a scarring process associated with chronic low-grade
inflammation ascribed to toll-like receptor (TLR) activation and
monocyte migration. The efficacy of lecinoxoid treatment on FSGS
development was explored using a 5/6 nephrectomy rat model.
Seven-weeks of treatment with lecinoxoids significantly reduced the
albumin/creatinine ratio and the percent of damaged glomeruli and
glomerular sclerosis. VB-703 attenuated the expression of
fibrosis hallmark genes collagen, fibronectin (FN), and
transforming growth factor β (TGF-β) in kidneys and improved the
albumin/creatinine ratio with higher efficacy than did VB-201, but
only VB-201 significantly reduced the number of glomerular and
interstitial monocytes. These results indicate that treatment with
TLR2/4 antagonizing lecinoxoids is sufficient to significantly
inhibit FSGS. Moreover, these data demonstrate that targeting
TLR2/4 and/or monocyte migration directly affect the priming phase
of fibrosis and may consequently alter disease progression.
For a copy of the paper, please visit:
https://www.ncbi.nlm.nih.gov/pubmed/30125459
About VBL's Lecinoxoid Platform:
VBL Therapeutics has developed the lecinoxoids, a novel class of
orally-available anti-inflammatory small molecules. Lecinoxoids
mimic the structure of native phospholipid molecules that regulate
the inflammatory process in vivo; however, Lecinoxoids are
synthesized chemically in a manner that increases their stability
and ability to target specific receptors. Lecinoxoids act through
two specific mechanisms: (1) The inhibition of the Toll-like
receptor (TLR) signaling by the TLR2 and CD14/TLR4 complexes –
inflammatory pathways implicated in various inflammatory diseases;
and (2) the inhibition of the migration of monocytes toward
chemo-attractants present in areas of inflammation. By modulating
innate immunity, the controller of the immune system, Lecinoxoids
can potentially target a spectrum of immune-inflammatory diseases
including cardiovascular diseases, NASH/Liver fibrosis, renal
fibrosis and others. The lead drug from the lecinoxoids platform,
VB-201, is an oral small molecule that has been administered to
more than 600 patients, across eight trials and was observed to be
relatively safe. In an exploratory Phase 2 trial, using a PET CT
VB-201 has demonstrated significant reduction of atherosclerosis
vascular inflammation, meeting the primary endpoint of the
sub-study. VB-201 did not meet the primary endpoint in Phase 2
clinical trials for psoriasis and for ulcerative colitis, however
it is Phase-2-ready and can be employed directly in clinical
trials. Beyond VB-201, VBL has developed 2nd and 3rd generation
structurally-related chemical compounds, which we believe offer
greater pharmacological efficacy and higher mechanistic selectivity
relative to VB-201 along with long patent term. The company has
observed promising preclinical results in NASH and renal fibrosis
models in some molecules, such as VB-201 and VB-703.
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 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
>300 cancer patients and demonstrated 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 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 Lecinoxoids candidates, 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, and the risk that
historical clinical trial results may not be predictive of future
trial results. 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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