On June 15, 2021 VBL Therapeutics (Nasdaq: VBLT) reported an update on its ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer (Press release, VBL Therapeutics, JUN 15, 2021, View Source [SID1234584020]).
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The Company was notified by the U.S Food and Drug Administration (FDA) that clearance of new VB-111 batches for use in the U.S. is currently pending the completion of a technical review by the Chemistry, Manufacturing, and Controls (CMC) group, which is evaluating the comparability of VB-111 manufacturing between different source sites. Until new batches are cleared, the Company anticipates a temporary shortage of study drug supply for the U.S. Accordingly, recruitment of new patients in the U.S. will be temporarily paused. Treatment will continue as usual for all U.S. patients currently enrolled. To-date, the study has enrolled approximately 75% of the planned 400-patients.
"Our team is working to provide the requested information to the FDA as quickly as possible," said Dror Harats, M.D., CEO of VBL Therapeutics. "Since receipt of the notification, we have submitted some of the requested information, and are preparing the remaining documentation, which we believe can be completed and submitted to the agency in the next two to three months. We do not expect a material change to our data readout timelines. We are in regular contact with the FDA and taking the steps necessary to minimize disruption to the trial in the U.S."
VBL recently amended the primary endpoint of OVAL based upon requested changes by the Company that were reviewed by the FDA. OVAL now includes a second, separate primary endpoint, of progression free survival (PFS), in addition to the original primary endpoint of the trial, overall survival (OS). Successfully meeting either primary endpoint is expected to be sufficient to support BLA submission.
About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal registration enabling clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies.
About VB-111 (ofranergene obadenovec)
VB-111 is an investigational anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that is designed to use a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the US and Europe, and fast track designation in the US, for prolongation of survival in patients with recurrent glioblastoma. VB-111 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970)