VBI Vaccines Inc. 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 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. 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: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 first quarter 2024 was double the enrollment rate observed in fourth quarter 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-care. 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.