VBL Therapeutics Announces Publication of Positive New Data on its Lecinoxoid Drug Candidates for the Treatment of Renal Fibrosis

  • These data, together with positive preclinical NASH data previously presented, support the potential of VBL’s lecinoxoid pipeline
  • Recently granted US patent provides patent protection for lecinoxoids treatment of fibrosis until at least November 2035 and supports potential partnering opportunities

TEL AVIV, Israel, Aug. 30, 2018 (GLOBE NEWSWIRE) -- 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.

Michael Rice
LifeSci Advisors, LLC
(646) 597-6979