Benzinga | Jun 8, 2021 10:38AM EDT

VBI Vaccines' Brain Cancer Immunotherapy Gets FDA Fast Track Review; Announces Updated Tumor Response, Overall Survival Data

* The FDA has granted Fast Track Designation for VBI Vaccines Inc's (NASDAQ:VBIV) VBI-1901, its cancer vaccine immunotherapeutic candidate to treat recurrent glioblastoma (GBM) patients with first tumor recurrence.

* The company also announced the most recent tumor response and overall survival (OS) data from the Phase 1/2a study at the American Society of Clinical Oncology Annual Meeting.

* Study arm 1: VBI-1901 + granulocyte-macrophage colony-stimulating factor (GM-CSF) 6-month and 12-month OS : 80% (n=8/10) and 60% (n=6/10), respectively. Two partial responses and two stable disease observations -- 40% disease control rate.

* Study arm 2: VBI-1901 + GlaxoSmithKline plc's (NYSE: GSK) AS01B adjuvant system. 6-month OS : 89% (n=8/9) -- 12-month OS not yet reached. 5 stable disease observations -- 50% disease control rate. Historical control data have demonstrated overall survival to be ~60% at 6-months and ~30% at 12-months after treatment with a monotherapy.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: VBIV shares are up 4.1% at $3.61 during the market session on the last check Tuesday.