The OVAL Phase 3 potential-registration study of VB-111 in ovarian cancer continues as planned towards the important interim analysis in 1Q 2020
VB-111 clinical program expands to include U.S. NCI-sponsored study in colon cancer and investigator-sponsored trial in rGBMMOSPD2 program for inflammation: Proprietary monoclonal antibodies for inflammation demonstrate potential for MS, RA and NASH; Pre-IND submission for lead candidate VB-601 expected 2Q 2020. New data were accepted for presentation at the International Liver Congress (ILC 2020) and Digestive Disease Week® (DDW) conferencesMOSPD2 program for cancer: Bi-specific antibodies are in development for oncology; New data were accepted to a late breaking abstract session at AACR$37 million in cash and cash equivalents at year-end 2019, sufficient to fund operations into 3Q 2021Conference Call and Webcast at 8:30am Eastern Time TodayTEL AVIV, Israel, March 19, 2020 (GLOBE NEWSWIRE) — VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the year ended December 31, 2019, and provided a corporate update.“We are excited to advance our clinical program for VB-111 in ovarian cancer towards an important interim analysis, while collaborating with the National Cancer Institute and top US neuro-oncology centers in externally-sponsored studies of VB-111 for colon cancer and recurrent GBM,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics.  “The ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer continues to enroll patients as planned and we expect the readout from an important interim analysis by the end of the first quarter. VBL made significant advancement during 2019 on all fronts.  We now look forward to 2020 as a potential turn around year for the company, with three parallel clinical trials for VB-111 and upcoming results from our MOSPD2 programs for inflammation and oncology.”Amos Ron, Chief Financial Officer of VBL Therapeutics stated, “We had more than $37 million in cash, cash equivalents and restricted bank deposits at December 31, 2019.  This is expected to provide us with sufficient resources to continue to develop VB-111 and other product candidates and to fund our operating expenses and capital expenditure requirements into the third quarter of 2021.”Fourth Quarter and Key Corporate Highlights:VB-111 program in ovarian cancer – The OVAL Phase 3 potential-registration study of VB-111 in ovarian cancer continues as planned towards the important interim analysis in 1Q 2020. This analysis will focus on CA-125 response rate, which will be analyzed according to GCIG strict criteria in 60 evaluable patients. The data will help to inform whether the positive outcome observed with VB-111 in the Phase 2 study in ovarian cancer is being replicated in the OVAL Phase 3 trial.Results from a Phase 1/2 clinical trial of VB-111 in the treatment of patients with recurrent platinum resistant ovarian cancer were presented at the 2019 American Society of Clinical Oncology (ASCO) annual meeting. Data demonstrated a median overall survival (OS) of 498 days in the VB-111 therapeutic-dose arm, versus 172.5 days in the low-dose arm (p=0.03). 58% of evaluable patients treated with the therapeutic dose of VB-111 had a GCIG CA-125 response. In comparison, in the AURELIA trial, the GCIG CA-125 response rate was 31.8% with bevacizumab and chemotherapy, and only 11.6% with chemotherapy alone.VB-111 for colon cancer – In February 2020, we announced the launch of a Phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo^®), an immune checkpoint inhibitor, in the treatment of metastatic colorectal cancer, under a Cooperative Research and Development Agreement (CRADA) between VBL and the U.S. National Cancer Institute (NCI). NCI will serve as the IND sponsor for this study (ClinicalTrials.gov Identifier: NCT04166383).VB-111 program in recurrent glioblastoma (rGBM) – VBL announced the publication of clinical data from the Phase 2 and GLOBE Phase 3 studies of VB-111 in rGBM in two manuscripts published in December 2019 in the peer-reviewed journal Neuro-Oncology, the official journal of the Society for Neuro-Oncology.Study results attribute the contradictory outcomes between the Phase 2 and Phase 3 trials to the lack of VB-111 monotherapy priming in the GLOBE Phase 3 study, providing clinical, mechanistic and radiographic support for this hypothesis.With the understanding that study regimen may be a key factor for VB-111 activity in rGBM, a new study, under U.S. IND sponsorship by Dana-Farber Cancer Institute, in collaboration with a group of leading U.S. neuro-oncology investigators, will assess neo-adjuvant and adjuvant treatment with VB-111 in rGBM patients undergoing a second surgery. Launch of this study is expected in the first half of 2020.VB-111 GMP Facility – VBL’s new gene therapy pharmaceutical grade manufacturing facility in Modiin, Israel, was certified by the European Union (EU) Qualified Person (QP) as being in compliance with EU Good Manufacturing Practices (GMP). The facility has also been certified by the Israeli Ministry of Health as being in compliance with the Israeli law and regulations of GMP.  These important steps are expected to support future commercialization of VB-111, if approved.MOSPD2 bi-specific mAbs for cancer – We are developing bi-specific antibodies designed to kill tumor cells, based on MOSPD2 as a novel target whose expression is induced in multiple tumors. We previously presented preclinical proof-of-concept for this approach using a BiTE antibody, and are currently advancing our lead bi-specific antibody candidate towards an IND filing. New data from this program were accepted for presentation in a late breaking abstract session at the 2020 American Association of Cancer Research (AACR) annual meeting.MOSPD2 mAb program for inflammation – VBL continues to advance the development of lead MOSPD2 antibodies for immune-inflammatory indications, with potential for MS, RA and NASH. The Company signed a service agreement with Thermo Fisher Scientific, one of the leading vendors in the antibody field, for production of lead candidate VB-601 for toxicology and clinical development. A pre-IND submission for VB-601 is expected in 2Q 2020. New data on MOSPD2 as a target for inflammatory digestive disorders were accepted for presentation at EASL’s annual International Liver Congress, ILC 2020, and Digestive Disease Week® (DDW) conferences later this year. Our abstract for DDW was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction.Lecinoxoids platform – VBL executed a strategic exclusive option to license agreement with one of the world-leading European animal health companies for the development of VBL’s proprietary anti-inflammatory molecule, VB-201, for veterinary use. VBL received an undisclosed up-front payment. Upon exercise of the license option, VBL expects to receive additional milestones and royalties, which have the potential to exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans.             Fiscal Year Ended December 31, 2019 Financial Results:Cash Position: At December 31, 2019, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposit of $37.0 million and working capital of $29.1 million. VBL expects that its cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into 3Q 2021.Revenues: Revenues related to VBL’s collaboration in Japan and with an animal health company amounted to $0.6 million in the year ended December 31, 2019. R&D Expenses: Research and development expenses, net, after government grants, for the year ended December 31, 2019, were approximately $15.5 million, compared to approximately $15.9 million in the same period in 2018.G&A Expenses: General, administrative and marketing expenses for the year ended December 31, 2019, were $4.9 million, compared to $5.6 million for the same period in 2018.Comprehensive Loss: VBL reported a net loss for year ended December 31, 2019, of $19.5 million, or ($0.54) per share, compared to a net loss of $20.4 million, or ($0.62) per share, in the year ended December 31, 2018. For further details on VBL’s financials, please refer to Form 20-F filed with the SEC.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 areas of unmet need in cancer and immune/inflammatory indications. VBL’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 6-8 weeks. VB-111 has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in a VBL-sponsored “all comers” phase 1 trial as well as in three VBL-sponsored tumor-specific phase 2 studies. VB-111 is currently being studied in a VBL-sponsored phase 3 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 of clinical trials and expected announcement of data, therapeutic potential and clinical results, and our financial position, operating results and cash runway. 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, that our financial resources do not last for as long as anticipated, 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 our 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, 2018, 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 Rice
LifeSci Advisors
[email protected]
(646) 597-6979
VASCULAR BIOGENICS LTD.STATEMENTS OF FINANCIAL POSITIONVASCULAR BIOGENICS LTD.
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