VBL resumes patient enrollment

 The stock price of VBL Therapeutics (NASDAQ: VBLT) increased by over 10% pre-market. Investors are responding positively to VBL Therapeutics announcing the enrollment of new patients in VB-111 studies in the U.S. will resume immediately following authorization by the U.S. Food and Drug Administration (FDA) 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 U.S.

A couple of months ago, VBL was notified by the FDA that clearance of new VB-111 batches for clinical use in the U.S. 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. And VBL prepared and 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 Israel. Plus VBL has sufficient FDA-cleared batches and will resume patient recruitment in the OVAL trial in the United States.

The OVAL trial evaluating VB-111 in ovarian cancer is planned to enroll about 400 patients globally and nearly 80% of patients have already been recruited. And the trial has 2 primary endpoints: progression free survival (PFS) and overall survival (OS). Achieving either primary endpoint has the potential to support a biologics license application (BLA). And 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 OS primary endpoint that remains anticipated in 2023.

https://pulse2.com/vbl-therapeutics-nasdaq-vblt-stock-over-10-increase-pre-market-explanation/