VBI Vaccines Announces Dosing of First Patients in Phase 2b Study of VBI-1901 in Recurrent GBM - Seite 2

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

For more information about the Phase 2b study, visit clinicaltrials.gov and reference trial identifier: NCT03382977.

About GBM and VBI-1901

Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 14,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers, including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other benefits.