February 9, 2015
VBL Therapeutics to Present Preclinical Data at Keystone Symposium on Liver Metabolism and Nonalcoholic Fatty Liver Disease
Presentation to Reveal First Preclinical Data for Lead Lecinoxoid VB-201 in Non-Alcoholic Steatohepatitis and Liver Fibrosis
TEL AVIV, ISRAEL, February 9, 2015 — VBL Therapeutics (NASDAQ: VBLT), a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory disease, today announced that Eyal Breitbart, Ph.D., Vice President of Research and Operations of VBL, will present preclinical results evaluating the Company’s lead Lecinoxoid candidate, VB-201, for the treatment of non-alcoholic steatohepatitis (NASH) and liver fibrosis, in an oral presentation at the Keystone Symposium on Liver Metabolism and Nonalcoholic Fatty Liver Disease (NAFLD), taking place on March 22 – 27, 2015 in Whistler, British Columbia, Canada. The reported data will include preclinical results in mice with NASH and liver fibrosis, and will assess key measures of efficacy related to inflammation and fibrosis.
With a novel mechanism of action designed to mimic naturally occurring oxidized phospholipids with anti-inflammatory properties, VB-201 has the potential to address a range of chronic, immune-inflammatory and inflammatory-derived diseases. VBL recently completed two Phase 2 studies evaluating the efficacy of lead Lecinoxoid compound, VB-201, for the treatment of psoriasis and ulcerative colitis. Top line results from both studies are expected in the first quarter of 2015.
Fibrosis is a major pathological feature of many chronic autoimmune diseases and Toll-like receptors (TLRs) have been implicated as being a part of the underlying pathogenesis. Driven by the mechanism of action of VB-201, which inhibits the TLR2 and CD14/TLR4 complexes as well as monocyte migration, VBL explored VB-201 in a liver fibrosis model as proof of concept for additional target indications.
Details of the presentation are as follows:
Title: Oxidized-Phospholipid Small Molecule Inhibits Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis.
Presentation Time: WEDNESDAY, MARCH 25, 14:30 – 16:30, Workshop 2: NAFLD Therapeutics
Presenter: Eyal Breitbart, Ph.D., Vice President of Research and Operations, VBL Therapeutics
VB-201 is a proprietary, first-in-class, orally-available, disease-modifying medicine in development for the treatment of chronic immune-inflammatory diseases. VB-201 is the first product candidate to emerge from VBL’s proprietary Lecinoxoid platform technology, which comprises a family of orally administered small molecules designed to modulate the body’s inflammatory response by harnessing the ability of oxidized phospholipids to regulate and attenuate key immune-inflammatory signaling. VB-201 offers the potential to deliver long-term maintenance therapies in a number of immune-inflammatory indications, with a favorable safety profile.
VB-201 has completed several Phase 2 studies in patients with moderate-to-severe psoriasis and a sub-study in patients with cardiovascular risk, which achieved its primary endpoint, demonstrating a statistically significant reduction in vascular inflammation. Altogether, the compound has completed five clinical trials involving more than 400 subjects under U.S. IND applications. VB-201 has potential applicability across a range of inflammatory diseases, including atherosclerosis, psoriasis and inflammatory bowel diseases.
About the Lecinoxoid Platform:
VBL’s proprietary Lecinoxoid platform technology comprises a family of orally administered small molecules designed to modulate the body’s inflammatory response. Lecinoxoids are compounds that are structurally and functionally similar to naturally occurring molecules, known as oxidized phospholipids, which possess immune modulating anti-inflammatory properties, modified to enhance stability and activity. The Lecinoxoid platform technology seeks to harness the ability of oxidized phospholipids to regulate and attenuate key immune-inflammatory signaling.
Lecinoxoids have the potential to act on two specific mechanisms: the inhibition of cellular signaling cascades associated with the innate immune system, known as toll-like receptor signaling, and the inhibition of the migration of monocytes toward chemoattractants present in areas of inflammation.
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory diseases. VBL Therapeutics’ clinical pipeline is based on two distinct, proprietary platform technologies—an oncology program and an anti-inflammatory program—that leverage the body’s natural physiologic and genetic regulatory elements. The Company’s lead oncology product candidate, VB-111, is a gene-based biologic that is initially being developed for recurrent glioblastoma, or rGBM, an aggressive form of brain cancer. VB-111 has received orphan drug designation in both the United States and Europe and was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation. VBL Therapeutics expects to begin the pivotal Phase 3 trial for VB-111 in rGBM in the first half of 2015, under a special protocol assessment agreement granted by the FDA. VBL Therapeutics’ lead product candidate from its anti-inflammatory program, VB-201, is an oral small molecule which recently completed Phase 2 clinical trials for psoriasis and for ulcerative colitis, with top-line results expected in the first quarter of 2015.
Forward Looking Statements:
This press release contains forward-looking statements. 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. 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.
Stern Investor Relations, Inc.