Following Positive Interim Analysis, VB-111 Global Study in Ovarian Cancer to Extend to Japan via Collaboration with NanoCarrier

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 also receive 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.