VBL Therapeutics Shares Drop As Pending Clearance Of New Batches Cancer Gene Therapy Hit Recruitment In Ovarian Cancer Trial

The FDA notified VBL Therapeutics Ltd VBLT that clearance of new VB-111 batches for use in the U.S. is currently pending, as review by the Chemistry, Manufacturing, and Controls (CMC) group is still ongoing.
VB-111 (ofranergene obadenovec) gene therapy for ovarian cancer.
Until new batches are cleared, the Company anticipates a temporary shortage of study drug supply for the U.S., and patient recruitment will be temporarily paused in OVAL Phase 3 study.
To date, the study has enrolled approximately 75% of the planned 400-patients.
VBL recently amended the primary endpoint of OVAL based on feedback from the FDA.
OVAL now includes a second, separate primary endpoint, progression-free survival, and the original primary endpoint of the trial, overall survival.
Successfully meeting either primary endpoint is expected to be sufficient to support BLA submission.
Price Action: VBLT shares are down 15.7% at $2.25 during the market session on the last check Tuesday.