VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that its abstract highlighting data from Part B of the ongoing Phase 1/2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) was accepted for e-poster presentation at the 25th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), taking place November 19-21, 2020.Poster # CTIM-07

  • Title: Identification of a baseline biomarker associated with tumor responses in a Phase 1/2a trial of a therapeutic CMV vaccine against recurrent glioblastoma (GBM)
  • Session: Clinical trials: Immunologic
  • Presenter: Andrew B. Lassman, M.D., Chief of Neuro-oncology at Columbia University Irving Medical Center and Associate Director for Clinical Infrastructure at Herbert Irving Comprehensive Cancer Center, and principal investigator of the ongoing Phase 1/2a study
  • Date: Available November 19-21, 2020

Title: Higher hepatitis B antibody titers induced in all adults vaccinated with a 3-antigen hepatitis B (HBV) vaccine, compared to a single-antigen HBV vaccine: results from two pivotal phase 3 double-blind, randomized studies (PROTECT and CONSTANT)

Joanne Langley, M.D., Professor of Pediatrics and Community Health and Epidemiology, CIHR-GSK Chair in Pediatric Vaccinology, Dalhousie University, and Head of the Division of Infectious Disease, IWK Health Centre, and principal investigator of the PROTECT study delivered the poster presentation.

  • Title: Identification of a baseline biomarker associated with tumor responses in a Phase 1/2a trial of a therapeutic CMV vaccine against recurrent glioblastoma (GBM)
  • Session: Clinical trials: Immunologic
  • Presenter: Andrew B. Lassman, M.D., Chief of Neuro-oncology at Columbia University Irving Medical Center and Associate Director for Clinical Infrastructure at Herbert Irving Comprehensive Cancer Center, and principal investigator of the ongoing Phase 1/2a study
  • Date: Available November 19-21, 2020

Download e-Poster PresentationAbout the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in 38 patients with recurrent GBM:

  • Phase 1 (Part A)
    • Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences
    • This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg
  • Phase 2a (Part B)
    • Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase
    • This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01B adjuvant system as immunomodulatory adjuvants
    • Enrollment of the 10 patients in the GM-CSF arm and the 10 patients in the AS01B arm are complete

VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with the AS01B adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

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, 12,000 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 is exceptionally lethal.