Replies to post #2027 on Vascular Biogenics Ltd (VBLT)

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VBL Therapeutics jumps 12% after resuming U.S. enrollment in late-stage OVAL trial

Aug. 30, 2021 7:38 AM ETVascular Biogenics Ltd. (VBLT)

By: Mamta Mayani, SA News Editor1 Comment

VBL Therapeutics (NASDAQ:VBLT) gains 11.5% premarket after announcing that enrollment of new patients in VB-111 studies in U.S. will resume immediately following authorization by the FDA Chemistry, Manufacturing and Controls (CMC) Group to use new batches of ofranergene obadenovec (VB-111), its commercial-scale facility located in Modiin, Israel.

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

VBL has sufficient FDA-cleared batches and will resume patient recruitment in the OVAL trial in U.S.

The OVAL trial evaluating VB-111 in ovarian cancer is planned to enroll ~400 patients and nearly 80% of those have already been recruited.
The trial has two primary endpoints: progression free survival and overall survival.
Meeting the PFS endpoint, with a readout anticipated in H2 2022, could accelerate BLA submission by approx. one year.