VBI Vaccines (Nasdaq:VBIV), GlaxoSmithKline PLC (NYSE:GSK) – 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.

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