Changes for page Vascular Biogenics

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--= Paragraph 1 =
++= Overview =
--==== Overview ====
--
  Vascular Biogenics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. The company conduct business under the name VBL Therapeutics. Vascular Biogenics was incorporated in Israel on January 27, 2000 as a company limited by shares under the name Medicard Ltd. In January 2003, the company changed its name to Vascular Biogenics Ltd. The company's program is based on its proprietary Vascular Targeting System, or VTS, platform technology, which utilizes genetically targeted therapy to destroy newly formed, or angiogenic, blood vessels, and which the company believe will allow it to develop product candidates for multiple oncology indications.
  The company's lead product candidate, VB-111 (ofranergene obadenovec), is a gene-based biologic that Vascular Biogenics is developing for solid tumor indications, and which Vascular Biogenics has advanced to programs for recurrent glioblastoma, or rGBM, an aggressive form of brain cancer, ovarian cancer and thyroid cancer. Vascular Biogenics has obtained fast track designation for VB-111 in the United States for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation. Vascular Biogenics has also received orphan drug designation for GBM in both the United States and Europe. VB-111 has also received an orphan designation for the treatment of ovarian cancer by the European Medicines Agency. In September 2015, the company reported complete results from its Phase 2 trial of VB-111 in rGBM, demonstrating a statistically-significant benefit in overall survival and favorable response rate in patients treated with VB-111 in combination with bevacizumab. The company's pivotal Phase 3 GLOBE study in rGBM began in August 2015 and was comparing a combination of VB-111 and bevacizumab to bevacizumab alone. The study, which enrolled a total of 256 patients in the US, Canada and Israel was conducted under a special protocol assessment, or SPA, agreement with the U.S. Food and Drug Administration, or FDA, with full endorsement by the Canadian Brain Tumor Consortium (CBTC). On March 8, 2018, the company announced top-line results from the GLOBE study, which showed that the study did not meet its pre-specified primary endpoint of overall survival (OS). No new safety concerns associated with VB-111 have been identified in the GLOBE study. Once the company receive the full and final data set, the company will conduct an in-depth analysis in order to better understand the outcome of the GLOBE study and the potential activity of VB-111 in rGBM. The company do not think that results of the GLOBE study in rGBM will necessarily have implications on the prospects for VB-111 in other tumor types. The company's OVAL phase 3 potential registration study of VB-111 in platinum resistant ovarian cancer was launched in December 2017 and is conducted in collaboration with the GOG Foundation, Inc., a leading organization for research excellence in the field of gynecologic malignancies.
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  The company previously manufactured clinical quantities of VB-111 at its facility in Or-Yehuda, Israel and through a third party in the United States. In October 2017, the company announced the opening of its new gene therapy manufacturing plant in Modiin, Israel. This plant can be the first commercial facility for production of VB-111 if it receives regulatory approval. On the longer term, the company intend to have more than one manufacturing site for VB-111, if regulatory approved.
--==== Product Candidates and Technology ====
++= Product Candidates and Technology =
  The following table summarizes the status of pipeline:
  [[image:https://www.sec.gov/Archives/edgar/data/1603207/000149315218003377/image_002.jpg]]
--===== VTS Platform =====
++== VTS Platform ==
  **Overview**
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  The company's VTS platform technology enables systemic administration of gene therapy to either destroy or promote angiogenic blood vessels. Beyond VB-111, Vascular Biogenics has generated additional product candidates which utilize the same vector and promoter as in VB-111, yet comprise alternative functional transgenes. VB-511 is an anti-angiogenic candidate, while VB-211 and VB-411 are pro-angiogenic candidates that may be employed for ischemic conditions like peripheral vascular disease. All three candidates have demonstrated pre-clinical efficacy and are ready for toxicology. The company may pursue further development of VB-511 internally, but the company aim to partner-out the pro-angiogenic candidates.
--**Lecinoxoid Platform Technology**
++== Lecinoxoid Platform Technology ==
  The company'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 company believe that Lecinoxoids hold significant promise in their ability to treat a range of chronic immune-based inflammatory diseases.
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  The company intend to continue research and development activities in the oncology field to strengthen the pipeline of its anti-cancer drug candidates. In this regard, the company believe that Vascular Biogenics has identified a novel tumor-related target, MOSPD2, that may be used as a marker for selective targeting of several types of tumors. In January 2017, a manuscript published by VBL disclosed that MOSPD2, a protein with a previously unknown function, regulates cell migration in human monocytes. While this first manuscript focused on the importance of MOSPD2 in immune cells, research conducted by VBL has explored the relevance of MOSPD2 in motility and metastasis of tumor cells. These oncology-related data were presented at the American Association of Cancer research (AACR) conference in April 2017. The company believe that targeting of MOSPD2 may have several therapeutic applications, including inhibition of monocyte migration in chronic inflammatory conditions, inhibition of tumor cell metastases and targeting of MOSPD2-expressing tumor cells. Vascular Biogenics is developing its VB-600 series of pipeline candidates towards these applications. The company expect to present additional findings related to its MOSPD2 program for cancer in the second quarter of 2018.
--==== Intellectual Property ====
++== Intellectual Property ==
  The company's success depends, at least in part, on its ability to protect its proprietary technology and intellectual property, and to operate without infringing or violating the proprietary rights of others. The company rely on a combination of patent, trademark, trade secret and copyright laws, know- how, intellectual property licenses and other contractual rights, including confidentiality and invention assignment agreements to protect its intellectual property rights.
--==== Patents ====
++== Patents ==
  As of January 28, 2018, the company had 178 granted patents and 39 applications pending worldwide for its oncology program and VTS platform technology and 110 granted patents and 30 patent applications pending worldwide for its anti-inflammatory program and Lecinoxoid family of compounds. The company's lead VTS asset, VB-111, is covered by US granted patent extending to 2033 before any extensions. The company's lead Lecinoxoid, VB-201, is protected by US granted composition-of-matter patent extending to 2027 before any extensions. In addition, Vascular Biogenics has pending patent applications covering use of VB-201, VB-703 and additional Lecinoxoid for NASH and fibrosis indications that may extend, if granted, to the 2030s. For MOSPD2, there are 2 applications pending worldwide.
--==== Trademarks ====
++== Trademarks ==
  The company rely on trade names, trademarks and service marks to protect its name brands. The company's registered trademarks in several countries include the following: “VTS,” “VASCULAR TARGETING SYSTEMS,” “VBL,” “V VBL THERAPEUTICS & Design,” “VASCULAR BIOGENICS,” “VASCULAR THERAPEUTICS” and “GLOBE & Design.”
--==== Trade Secrets and Confidential Information ====
++== Trade Secrets and Confidential Information ==
  In addition to patented technology, the company rely on its unpatented proprietary technology, trade secrets, processes and know-how. The company rely on, among other things, confidentiality and invention assignment agreements to protect its proprietary know-how and other intellectual property that may not be patentable, or that the company believe is best protected by means that do not require public disclosure. For example, the company require its employees to execute confidentiality agreements in connection with their employment relationships with it, and to disclose and assign to it inventions conceived in connection with their services to it. However, there can be no assurance that these agreements will be enforceable or that they will provide it with adequate protection.
  The company may be unable to obtain, maintain and protect the intellectual property rights necessary to conduct its business, and may be subject to claims that the company infringe or otherwise violate the intellectual property rights of others, which could materially harm its business. For a more comprehensive summary of the risks related to its intellectual property, see “Risk Factors.”
--==== Sales and Marketing ====
++= Sales and Marketing =
  Vascular Biogenics has not yet established sales, marketing or product distribution operations because its lead candidates are still in early clinical development.
--==== Manufacturing ====
++= Manufacturing =
  The company generally perform process development for its drug substance candidates and manufacture quantities of its drug candidates necessary to conduct pre-clinical studies and clinical trials of its drug candidates. The company rely on third-party manufacturers to produce bulk drug substance required for its clinical trials and expect to continue to rely on third parties to manufacture clinical trial drug supplies for the foreseeable future. The company also contract with additional third parties for the formulating, labeling, packaging, storage and distribution of the final drug products.
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  In October 2017, the company announced the opening of its new gene therapy manufacturing plant in Modiin, Israel. This plant will be the commercial facility for production of the Company’s lead product candidate, ofranergene obadenovec (VB-111), if approved. The site design enables modular expansion of the manufacturing capacity, to supply growing demand following commercialization. The Modiin facility shall also enable it to comply with the restrictions of the Research Law and its undertaking to the OCS that an essential portion of its VB-111 production, and in any event not less than the majority of VB-111 production, will remain in Israel. The investment in the facility is included in the Company’s budget and was also supported by the Israel Innovation Authority. VBL expects that its current cash will fund the Company’s operating expenses and capital expenditure requirements through 2020.
--==== Employees ====
++= Employees =
  As of March 1, 2018, the company employed 37 employees, including 30 in research and development, and 7 in general and administrative positions, and of which 14 employees have either MDs or PhDs. All of its employees are located in Israel. The company believe its employee relations are good.
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  None of its employees currently work under any collective bargaining agreements.
--==== Property ====
++= Property =
  The company's corporate headquarters and research facilities are currently located in Modi’in, Israel, where the company lease an aggregate of approximately 21,500 square feet of office and laboratory space, pursuant to a lease agreement that expires in June 2023. This facility additionally houses its clinical development, clinical operations, regulatory and management functions, as well as its local biological drugs manufacturing facility.
++
++= References =