VBL Drops After FDA Withholds Clearance for New Cancer Treatment Batches

 VBL Therapeutics Ltd. shares were down 16% to $2.26 Tuesday after the company said it was notified by the Food and Drug Administration that clearance of new VB-111 batches for use in the U.S. is currently pending the completion of a technical review evaluating the comparability of VB-111 manufacturing between different source sites.

The company's Phase 3 study is investigating ofranergene obadenovec, or VB-111, for the treatment of platinum-resistant ovarian cancer.

Until new batches are cleared, VBL expects a temporary shortage of study drug supply for the U.S.

Accordingly, recruitment of new patients in the U.S. will be temporarily paused, it said. Treatment will continue as usual for all U.S. patients currently enrolled. To date, the study has enrolled 75% of the planned 400 patients.

VBL recently amended the primary endpoint of the study based on requested changes by the company that were reviewed by the FDA. The study now includes a second, separate primary endpoint of progression free survival, in addition to the original primary endpoint of the trial, overall survival. Successfully meeting either primary endpoint is expected to be sufficient to support BLA submission.

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