VBI Vaccines Announces Poster Presentation at 2024 ASCO Annual Meeting Highlighting New Interim Phase 2b Data from VBI-1901 in Recurrent Glioblastoma Patients

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 new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

The presentation at ASCO will provide an update to the encouraging data previously shared at the World Vaccine Congress Washington in April, including additional data from those initially evaluable patients, as well as data from new patients who have since been randomized into the Phase 2b study.

Presentation Details

• Title: Randomized Phase 2b trial of a CMV vaccine immunotherapeutic candidate (VBI-1901) in recurrent glioblastomas
• Date: Saturday, June 1, 2024
• Poster Session: Central Nervous System Tumors
• Poster Session Time: 9:00 AM – 12:00 PM CDT

Phase 2b Study Design
Multi-center, randomized, controlled, open-label study in up to 60 patients with first recurrent GBM

• Patients will be randomized in a 1:1 ratio across two study arms:
  • Intradermal VBI-1901 + GM-CSF: 10 µg dose every 4 weeks until clinical disease progression
  • Monotherapy standard-of-care: either intravenous carmustine or oral lomustine, every 6 weeks until disease progression or intolerable toxicity
• Endpoints include:
  • Safety and tolerability
  • Overall survival (OS) – median and overall
  • Tumor response rate (TRR)
  • Progression-free survival (PFS)
  • Immunologic responses
  • Reduction in corticosteroid use relative to baseline
  • Change in quality of life compared to baseline

The U.S. Food and Drug Administration (FDA) has considered demonstration of a statistically significant improvement in overall survival relative to a randomized control arm to be clinically significant and has recognized this as criteria to support the approval of new oncology drugs.¹