VBI Vaccines' Brain Cancer Immunotherapy Gets FDA Fast Track Review; Announces Updated Tumor Response, Overall Survival Data - VBI Vaccines (NASDAQ:VBIV), GSK (NYSE:GSK)

The FDA has granted Fast Track Designation for VBI Vaccines Inc's 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 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.