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

• 14 leading neuro-oncology centers are actively recruiting patients across the United States
• 2 new clinical sites were activated in March 2024, with a third site expected to come online in April
• Patient enrollment in Q1 2024 was double the enrollment rate observed in Q4 2023

Phase 1/2a Study Data Highlights – VBI-1901 10µg + GM-CSF Study Arms
(n=16)

• 44% disease control rate achieved (n=7/16) – disease control rate is defined as stable disease (SD) + partial tumor response (PR) + complete tumor response (CR)
• 2 partial responses (PR) were observed – 1 patient was on treatment for more than 28 months (2.33 years), surviving at least 40 months (3.33 years) as of August 1, 2023, with a maximum tumor reduction of 93% relative to baseline
• 5 additional patients demonstrated stable disease (SD) for a sustained period of time
• All patients with a tumor response (PR or SD) (n=7/16) reached a minimum survival of 12 months
• Median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care¹

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.²