VBL Therapeutics Announces Peer-reviewed Publication of Positive Results of Pre-specified Interim Analysis of OVAL, a Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer

Rhea-AI Summary

VBL Therapeutics (Nasdaq: VBLT) announced promising results from the interim analysis of the OVAL study, a Phase 3 trial evaluating VB-111 in patients with recurrent platinum-resistant ovarian cancer. The analysis revealed a CA-125 response rate of at least 58% in the VB-111 treatment arm, exceeding the required 10% advantage over placebo. The Data and Safety Monitoring Committee has recommended the continuation of the trial. The trial aims to enroll around 400 patients, and VB-111 is a novel gene therapy with potential to significantly improve treatment outcomes.

Positive

• CA-125 response rate in VB-111 arm is at least 58%.
• Trial continuation recommended by the Data and Safety Monitoring Committee.
• VB-111 is a first-in-class gene therapy with a unique dual mechanism of action.

Negative

• Uncertainty remains regarding the trial's primary endpoint of overall survival.
• Historical clinical trial results may not guarantee future success.

• Analysis shows a CA-125 response of at least 58% in the VB-111 treatment arm
• Published online in Gynecologic Oncology

TEL AVIV, Israel, March 04, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced the online publication of positive results of the pre-specified interim analysis of the OVAL study, a Phase 3 registration enabling study of VB-111 (ofranergene obadenovec) in recurrent platinum-resistant ovarian cancer. The analysis showed a CA-125 GCIG response rate of 58% or higher in evaluable patients in the VB-111 treatment arm. Based on the results of the interim analysis, the Data and Safety Monitoring Committee (DSMC) recommended continuing the trial as planned. The results were published online in the international peer reviewed journal Gynecologic Oncology (https://doi.org/10.1016/j.ygyno.2021.02.014).

“The goal of this interim analysis was to get a signal of drug activity, using CA-125 as a validated biomarker,” said Bradley J. Monk, M.D., FACOG, FACS, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Head of the OVAL steering committee and author on the manuscript. “The intention was to reduce the risk of a negative trial and increase the chance of success. New and novel approaches that have the potential to significantly extend progression free survival or survival are eminently required in platinum-resistant ovarian cancer. VB-111, with its very unique mechanism of action, could be one of those novel approaches and I look forward to the progress of the OVAL trial, which is well designed to test this hypothesis.”

The article reported results of the pre-specified 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. Based on the overall response rate in the first 60 patients across both arms of 53%, and assuming balanced randomization and an absolute advantage of 10% or higher to the VB-111 arm, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) was calculated to be 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate was 69%. The futility rule determined for this analysis was that the response rate of VB-111 must be greater than the response rate of placebo by at least 10% in order to continue the study. This rule was successfully met.

“We believe VB-111’s unique dual mechanism of action has the potential to prolong life and possibly turn certain cancers into manageable chronic diseases,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “The encouraging trajectory of the OVAL trial, not only as reported in this paper but also based on the pre-specified DSMC reviews, makes us hopeful that VB-111 may have a meaningful impact on ovarian cancer.”

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 approximately 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 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. VBL has developed three platform technologies: a gene-therapy based technology for targeting newly formed blood vessels with focus on cancer, an antibody-based technology targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the Lecinoxoids, a family of small-molecules for immune-related indications. VBL’s lead oncology product candidate, 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 currently being studied in a VBL-sponsored Phase 3 potential registration trial for platinum-resistant ovarian cancer.

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 study for VBLT as of March 2021?

The interim analysis showed a CA-125 response rate of at least 58% in the VB-111 treatment arm.

When is the next milestone for VBLT in the OVAL trial?

The trial is ongoing, with approximately 400 patients planned for enrollment.

What does the positive interim analysis mean for VBLT's stock?

The positive results could increase investor confidence in VBLT's pipeline and future market potential.

What are VB-111's mechanisms of action?

VB-111 utilizes a dual mechanism to target tumors by blocking tumor vasculature and enhancing the anti-tumor immune response.