On November 22, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that additional biomarker data from the Phase 1/2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were presented at the 27th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), on Friday, November 18, 2022 (Press release, VBI Vaccines, NOV 22, 2022, View Source [SID1234624354]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In the study arms that assessed high-dose VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF):
● Two (2) partial tumor responses (PR) were observed in patients – one patient with a PR remained on treatment protocol for more than 28 months, reaching survival of at least 32 months as of November 1, 2022
● An additional five (5) patients demonstrated stable disease for a sustained period of time
● All tumor responders (n=7) 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
New data from extensive biomarker panels continue to suggest that normal baseline CD4+/CD8+ T cell ratios, along with boosting of cytomegalovirus (CMV) gB specific antibody responses, were correlated with tumor and clinical responses. Six out of seven tumor responders (n=16) had normal baseline CD4+/CD8+ ratios, and all seven tumor responders saw boosting of gB antibodies after treatment with VBI-1901. Higher peak frequencies of CMV antigen-specific CD4+ T cells were observed in patients with tumor responses compared to non-responders, suggesting significant function of CD4+ T cells in controlling tumor growth.
"In an effort to better help address the significant unmet need for patients with recurrent GBM, a particularly devastating cancer, we continue to analyze comprehensive biomarker data from this Phase 1/2a study to identify potentially predictive correlates of response to treatment," said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. "We were pleased to see that the previously identified CD4+/CD8+ T cell ratio, a measure of immunological fitness, was associated with tumor responses and encouraging overall survival benefit compared to historical controls. We plan to incorporate this learning into the enrollment eligibility criteria in the next stage of development to help enrich for potential VBI-1901 responders. We look forward to initiating randomized, controlled evaluation of VBI-1901 in the recurrent setting in early 2023."
This dataset continues to build upon data first shared at ASCO (Free ASCO Whitepaper) 2021, which resulted in Fast Track Designation granted by the U.S. Food and Drug Administration (FDA) in June 2021. The data have subsequently been updated at the World Vaccine & Immunotherapy Congress in December 2021 and at ASCO (Free ASCO Whitepaper) 2022.
About VBI-1901 and GBM
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. 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.