TEL AVIV, Israel, April 02, 2020 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced that following the positive interim analysis in the OVAL study, its Japanese licensee NanoCarrier Co., Ltd. (TSE Mothers: 4571), intends to extend the ongoing global Phase 3 OVAL clinical trial in ovarian cancer to patients in Japan. NanoCarrier will be responsible for all required operations and expenses related to the study in Japan. VBL and NanoCarrier Co. Ltd. signed an exclusive license agreement in 2017 for the development, commercialization, and supply of VB-111 in Japan. There are more than 10,000 women diagnosed with ovarian cancer in Japan with more than 5,000 associated deaths annually. Therefore, opening clinical sites in Japan will enable to expedite the OVAL trial globally as well as the potential registration of the VB-111 in Japan upon positive outcome.
The Data Safety Monitoring Committee (DSMC) overseeing OVAL recently conducted a preplanned interim analysis and recommended that the study continue. The DSMC made its decision after reviewing un-blinded data and assessing CA-125 response, measured according to the GCIG criteria. The analysis met the interim pre-specified efficacy criterion of an absolute percentage advantage of 10% or higher CA-125 response rate for the VB-111 treatment arm in the first 60 enrolled subjects evaluable for CA-125 analysis.
“We are very pleased that NanoCarrier has chosen to develop VB-111 in ovarian cancer in Japan,” said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. “The extension of the OVAL study into Japan will open up another avenue of patient recruitment and may accelerate commercialization of VB-111 in this important market”.
In the previously reported Phase 2 study of VB-111 in platinum resistant ovarian cancer, 58% of the patients treated with VB-111 and paclitaxel demonstrated a CA-125 response. Those patients with a CA-125 response demonstrated a median overall survival of 808 days, versus 351 days for those patients without CA-125 response.
VBLT received an up-front payment of $15 million from NanoCarrier Co. Ltd, at the time the agreement was signed and is entitled to receive more than $100 million in development and commercial milestone payments. If VB-111 is approved, VBL will alsoreceive tiered royalties on net sales in the high-teens.
VBL retains rights to VB-111 in the rest of the world.
About the OVAL study OVAL is an international Phase 3 randomized pivotal potential registration clinical trial that is comparing a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer. The study was designed to enroll approximately 400 patients. Its primary endpoint is overall survival. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. For more information, refer to ClinicalTrials.gov identifier NCT03398655.
About VB-111 (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. VB-111 is a unique biologic agent that uses a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970).
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.
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 may include, but are not limited to, statements regarding our programs, including VB-111, 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, 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. In particular, the DSMC recommendation that the OVAL trial proceed is not assurance that the trial will meet its primary endpoint of overall survival once completed. 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, 2019, 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
