VBL Therapeutics Announces Data Safety Monitoring Committee Provides Green Light to Advance the OVAL Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer

Rhea-AI Summary

VBL Therapeutics (Nasdaq: VBLT) announced positive results from the independent Data Safety Monitoring Committee (DSMC) review of its OVAL Phase 3 study of VB-111 for recurrent ovarian cancer. The DSMC found no safety concerns and recommended the trial's continuation. The study, which aims to enroll 400 patients, has shown a response rate of 53% across both arms, with rates in the treatment arm exceeding 58%. The next DSMC review is anticipated in Q3 2021.

Positive

• DSMC found no safety issues and recommended continuation of the OVAL trial.
• Response rate in the treatment arm was at least 10% higher than in the control group, indicating potential efficacy.
• Trial enrollment is on track, with approximately 200 patients currently enrolled.

Negative

• No guarantees that the OVAL trial will meet its primary endpoint of overall survival.

TEL AVIV, Israel, Feb. 22, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today 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.

About the OVAL study (NCT03398655)
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.

About VB-111 (ofranergene obadenovec)
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.

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. For additional information visit: www.vblrx.com.

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, or that we will obtain positive results to support further development of this candidate. 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.

CONTACT:
Burns McClellan for VBL Therapeutics
Lee Roth (investors) / Ryo Imai (media)
lroth@burnsmc.com / rimai@burnsmc.com
+1-212-213-0006

FAQ

What are the results of the OVAL Phase 3 study for VBLT?

The OVAL study reported a 53% overall response rate, with the treatment arm showing at least a 10% higher response.

What did the DSMC find during the review of VB-111?

The DSMC found no safety concerns and recommended the trial to continue as planned.

When is the next DSMC review for VBL Therapeutics?

The next DSMC review is expected during the third quarter of 2021.

How many patients are enrolled in the OVAL study?

Approximately 200 patients have been enrolled in the OVAL study.

What is the purpose of the OVAL study?

The OVAL study compares the efficacy of VB-111 combined with paclitaxel versus placebo plus paclitaxel in patients with platinum-resistant ovarian cancer.