VBI Vaccines Presents Additional Biomarker Data from Phase 1/2a Study of VBI-1901 in Recurrent GBM at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting

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 additional biomarker data from the Phase 1/2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) patients, were highlighted in a poster presentation at the 28^th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), held on Friday, November 17, 2023.

New proof-of-mechanism data demonstrated that vaccination with VBI-1901 was associated with T-cell activation capable of trafficking across the blood-brain barrier to the tumor microenvironment, an area which is known to be highly immunosuppressive and difficult to infiltrate. The additional peripheral biomarker data assessed levels of C4G – a protein fragment produced when cytotoxic T-cells, or killer T-cells, migrate into and throughout the tumor microenvironment – high baseline levels of which have been associated with longer overall survival in studies conducted in metastatic melanoma patients [Prakash et al., 2014].¹ After vaccination with VBI-1901 in the Phase 1/2a study in recurrent GBM patients, the data showed there were higher blood/plasma levels of C4G in patients who achieved partial tumor responses than in patients with stable or progressive disease. Additionally, higher levels of C4G after vaccination with VBI-1901 have been associated with longer progression-free survival.

“We are very pleased to share these significant mechanistic findings at SNO,” said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. “The GBM tumor microenvironment is notoriously immunosuppressive and difficult to penetrate, which is why most treatment needs to be administered intratumorally, and why there are currently so few effective treatment options for patients. We believe that these data continue to enrich the potential for VBI-1901 to have meaningful impact in recurrent and primary GBM, and we look forward to data from the next phases of development in each setting.”

Data Highlights from Phase 1/2a Study Data in Recurrent GBM Patients- 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 PRs 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 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-care²

Ongoing Phase 2b Study Design in Recurrent GBM Patients