VBL Therapeutics Resumes U.S. Enrollment In Phase 3 Trial On Ovarian Cancer

(RTTNews) - VBL Therapeutics (VBLT) said Monday that it will resume immediately enrollment of new patients in VB-111 studies in the Unites States.

The move comes following authorization by the U.S. Food and Drug Administration Chemistry, Manufacturing and Controls (CMC) Group to use new batches of ofranergene obadenovec (VB-111) produced in VBL's commercial-scale GMP Modiin, Israel facility in clinical studies in the United States.

VBL was notified in June by the FDA that clearance of new VB-111 batches for clinical use in the United States was pending the completion of a technical review by the CMC group, which focused on the comparability of VB-111 manufacturing between different source sites.

VBL said it had submitted the requested data and documentation to the FDA in early August and the FDA has now provided clearance for VBL to use new batches of VB-111 produced in its commercial-scale facility located in Modiin, Israel. VBL has sufficient FDA-cleared batches and will resume patient recruitment in the OVAL trial in the United States.

The OVAL trial, which evaluates VB-111 in ovarian cancer, is planned to enroll about 400 patients globally and nearly 80% of patients have already been recruited.

VB-111 is an investigational anti-cancer gene-therapy agent in development to treat a wide range of solid tumors. VB-111 is administered as an IV infusion once every 6-8 weeks.

The OVAL trial has two primary endpoints: progression free survival (PFS) and overall survival. Meeting the PFS endpoint, with a readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the FDA, compared to original projections based on the readout of the overall survival primary endpoint that remains anticipated in 2023.

OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized pivotal registration-enabling clinical trial comparing a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer.