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

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the first patients have been dosed in the randomized, controlled Phase 2b study of VBI’s cancer vaccine immunotherapeutic candidate, VBI-1901, in patients with first recurrent glioblastoma (rGBM). The study will assess the safety, tolerability, tumor response rates, and survival following treatment with VBI-1901, as a monotherapy, at 10 leading neuro-oncology centers across the United States.

Andrew B. Lassman, M.D., Chief of Neuro-Oncology at Columbia University Vagelos College of Physicians and Surgeons, Associate Director for Clinical Trials at the NCI-designated Herbert Irving Comprehensive Cancer Center, and principal investigator of the study, commented, “Based on the pre-clinical and clinical data seen in earlier stages of this study, I look forward to demonstrating the potential value of VBI-1901, relative to current standard of care, in my patients in this next phase of clinical development, with the hope to provide meaningful benefit against a brain tumor that is notoriously aggressive with a high mortality rate.”

Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, commented, “Median overall survival in the recurrent GBM setting is just eight months, making any advancement in patient care critical. As we work to offer new hope to the patients, family members, and caretakers who are battling this devastating and historically treatment-resistant brain tumor, we are excited to kick-off this next phase of development for VBI-1901.”

In the Phase 1/2a study of VBI-1901 in the rGBM setting, extensive biomarker panels suggested normal baseline CD4+/CD8+ T-cell ratios, which is a measure of immunological fitness, along with boosting of cytomegalovirus (CMV) gB specific antibody responses were correlated with tumor and clinical responses. These learnings have been incorporated into patient enrollment eligibility criteria for the Phase 2b study to help identify patient populations that may be more likely to respond to treatment with VBI-1901.

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-care²

Phase 2b Study Design