On April 2, 2020 VBL Therapeutics (Nasdaq: VBLT) reported 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 (Press release, VBL Therapeutics, APR 2, 2020, View Source [SID1234556105]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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).