Data Safety Monitoring Committee Green Lights Ovarian Cancer Study

VBL Therapeutics announced the results of the independent Data Safety Monitoring Committee (DSMC) pre-planned review of the ongoing OVAL Phase 3 registration enabling study of VB-111 in recurrent ovarian cancer. The committee found no safety issues with the trial and recommended its continuation as planned.

"This review continues the trend of encouraging reviews that have taken place since the clinical trial began," said Prof. Dror Harats, Chief Executive Officer of VBL Therapeutics. "The trial continues to enroll on track in the US, Europe and Israel. We look forward to the next DSMC review during the third quarter of 2021, followed by completion of enrollment at the end of 2021 or in early 2022.”

In March 2020, the Company announced results of the first interim analysis in the OVAL study, which reviewed unblinded data and assessed CA-125 response, measured according to the GCIG criteria, in the first 60 enrolled subjects evaluable for CA-125 analysis. The overall response rate across both arms was 53%. The response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) was at least 10% higher than in the control, i.e., 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate was 69%. According to the Company update on November 16, 2020, a high response rate of >50% in the total evaluable patient population was maintained with approximately 200 patients enrolled.

OVAL is an international Phase 3 randomized pivotal registration enabling clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer. The study is planned to enroll 400 patients. 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.

VB-111 is an investigational 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.