VBI Vaccines Granted FDA Fast Track Designation for VBI-1901 for the Treatment of Recurrent GBM

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for VBI-1901, VBI’s cancer vaccine immunotherapeutic candidate for the treatment of recurrent glioblastoma (GBM) patients with first tumor recurrence. Fast Track Designation facilitates the development and expedites the review of new therapies to treat serious conditions and fill an unmet medical need.

“This Fast Track Designation provides additional medical validation and is a meaningful milestone for our development of VBI-1901 as we work to provide clinical benefit for patients who have few treatment options available today,” said Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer. “Building on the encouraging data seen to-date – including updated tumor responses and improvement in overall survival compared to historical controls as presented at ASCO – we look forward to working closely with the FDA as we progress this cancer vaccine immunotherapeutic candidate with the hope of improving outcomes for adults with recurrent GBM.”

About Fast Track Designation

The Fast Track program facilitates the expedited development and review of new drugs or biologics that are intended to: 1) treat serious or life-threatening conditions, and 2) demonstrate the potential to address unmet medical needs. A therapeutic that receives Fast Track Designation is eligible for some or all of the following: 1) more frequent meetings with FDA to discuss the development plan and data needed to support approval, 2) more frequent written communication from FDA relating to the design of the proposed clinical trials and use of biomarkers, 3) Accelerated Approval and Priority Review, if relevant criteria are met, and 4) Rolling Review, which means the company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, instead of waiting until all sections of the application are completed.

Fast Track Designation was granted to VBI-1901, adjuvanted with granulocyte macrophage colony-stimulating factor (GM-CSF), for the treatment of first-recurrent GBM.

ASCO 2021 Poster - Phase 2a Tumor Response Data and Overall Survival (OS) Data Update

The e-poster presentation highlighted patient-specific tumor response data and improvement in overall survival (OS) compared to historical controls across both arms:

• 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
  • 2 partial responses (≥ 50% tumor reduction) and 2 stable disease observations – 40% disease control rate

• Study arm 2 : VBI-1901 + GSK’s AS01_B adjuvant system¹
  • 6-month OS : 89% (n=8/9) – 12-month OS not yet reached
  • 5 stable disease observations – 50% disease control rate

With few options for recurrent GBM patients, historical control data have demonstrated overall survival to be ~60% at 6-months and ~30% at 12-months after treatment with a monotherapy.²