On April 26, 2022 VBL Therapeutics (Nasdaq: VBLT), a late-clinical stage biotechnology company focused on developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ofra-vec (ofranergene obadenovec or VB-111) in combination with paclitaxel for the treatment of platinum-resistant ovarian cancer (Press release, VBL Therapeutics, APR 26, 2022, View Source [SID1234612970]).
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"We are pleased to receive FDA Fast Track designation for ofra-vec in platinum-resistant ovarian cancer. The Fast Track designation can facilitate the process towards potential registration and, importantly, may help expedite the time to market for ofra-vec, if approved," said Prof. Dror Harats, M.D., chief executive officer of VBL Therapeutics. "The readout of the progression free survival primary endpoint in the OVAL trial will be an important milestone for VBL in the second half of this year. We believe that, if positive, this will support a Biologics License Application submission to the FDA."
Ofra-vec is VBL Therapeutics’ investigational anti-cancer, gene-based agent in development to treat a wide range of solid tumors. The lead clinical program for ofra-vec is the OVAL Phase 3 registration-enabling trial in recurrent platinum-resistant ovarian cancer patients. VBL recently completed patient enrollment of 409 patients in this global trial being conducted at centers in the United States, Europe, Israel and Japan. In addition, the Independent Data Safety Monitoring Committee (DSMC) unanimously recommended to continue the trial as planned, following review of unblinded data from 370 randomized patients.
About the OVAL Trial
OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized, pivotal registration-enabling clinical trial comparing a combination of ofra-vec (ofranergene obadenovec or VB-111) and paclitaxel to placebo plus paclitaxel, in adult patients with recurrent platinum-resistant ovarian cancer. The OVAL trial has two primary endpoints: progression free survival (PFS) and overall survival (OS). Successfully meeting either primary endpoint has the potential to support a Biologics License Application (BLA). Meeting the PFS endpoint, with a top-line readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the U.S. Food and Drug Administration. A top-line readout of the OS primary endpoint is anticipated in 2023. OVAL is being conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies. For more information, refer to Clinicaltrials.gov NCT03398655.
About Ofra-Vec (ofranergene obadenovec; `VB-111`)
Ofra-vec is an investigational anti-cancer, gene-therapy agent in development to treat a wide range of solid tumors. Ofra-vec is a unique biologic agent designed to use a dual mechanism to target solid tumors. Its mechanism combines the blockade of tumor vasculature with an anti-tumor immune response. Ofra-vec is administered as an IV infusion once every 6-8 weeks. It has been observed in past clinical research to be generally 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 trials. Ofra-vec has received orphan designations for the treatment of ovarian cancer and for the treatment of glioma by the European Commission. The FDA granted ofra-vec orphan designation for the treatment of malignant glioma and fast track designation for the treatment of rGBM and the treatment of platinum-resistant ovarian cancer. Ofra-vec demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer (NCT01229865) and platinum-resistant ovarian cancer (NCT01711970).