VBI Vaccines Presents Encouraging Early Tumor Response Data From Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma

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 David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will present early tumor response data from the ongoing Phase 2b study of VBI-1901, VBI’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (rGBM) at the World Vaccine Congress Washington at 1:10pm ET on April 3, 2024. The multi-center, randomized, controlled, open-label study has been designed to evaluate overall survival, tumor response rates, and safety and tolerability of VBI-1901 as a monotherapy in rGBM patients.

Dr. Anderson commented: “In recurrent GBM, tumors typically double or triple in size within six weeks, with no effective treatments available to improve survival. Early indications from this ongoing study suggest tumor growth behavior in-line with expectations for both the standard-of-care arm and the VBI-1901 arm, based on positive data seen from the Phase 1/2a study. While early, I am very excited by these results and hope to see the trends continue to confirm the results seen in earlier studies, where VBI-1901 improved median overall survival by ~5 months compared to historical controls – ~13 months vs. ~8 months¹ – and achieved a 44% DCR.”

Based on the data seen in the Phase 1/2a study of VBI-1901 in rGBM patients, the FDA granted Fast Track Designation in June 2021 and Orphan Drug Designation in June 2022.

Dr. Anderson’s presentation will be archived on the Events/Presentations page in the Investors section of VBI’s website.

Phase 2b Data Highlights
As of March 22, 2024, 17 patients have been randomized 1:1 to either the active, VBI-1901 treatment arm, or to the control, standard-of-care treatment arm (SoC).

• Active Study Arm: VBI-1901 + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
  • 9 patients have been randomized and 5 of those patients are currently evaluable for tumor response assessment (n=5)
  • 2 stable disease (SD) have been observed in the VBI-1901 arm to-date
  • 40% (n=2/5) early disease control rate achieved
• Control Study Arm: Standard-of-Care (SoC) Therapy – Carmustine or Lomustine
  • 8 patients have been randomized and 6 of those patients are currently evaluable for tumor response assessment (n=6)
  • No tumor responses have been observed in the SoC arm
  • 0% (n=0/6) disease control rate
  • All evaluable patients have experienced tumor progression and have been taken off study protocol

Phase 2b Patient Enrollment Update