VBI Vaccines Inc. (NASDAQ: VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that David Anderson, Ph.D., Chief Scientific Officer, will present the poster, “CMV gB/pp65 eVLPs Formulated with GM-CSF as a Therapeutic Vaccine Against Recurrent Glioblastoma (GBM),” at the 7th International Congenital Cytomegalovirus (CMV) Conference & 17th International CMV Workshop to be held April 7 – 11, 2019, in Birmingham, Alabama.

Dr. Anderson’s presentation will provide an overview of VBI-1901, an immuno-therapeutic developed using VBI’s proprietary enveloped virus-like particle (eVLP) technology platform. VBI-1901 targets CMV as a foreign viral antigen, which has the potential to harness and re-stimulate pre-existing CMV immunity to clear CMV-associated tumors. The poster presentation will also provide an overview of the ongoing Phase 1/2a clinical study evaluating VBI-1901 for the treatment of recurrent glioblastoma (GBM), a CMV-associated tumor.

Poster Session Presentation Details
  • Title: CMV gB/pp65 eVLPs Formulated with GM-CSF as a Therapeutic Vaccine Against Recurrent Glioblastoma (GBM)
  • Poster Number: 7.04
  • Event: 7th International Congenital CMV Conference & 17th International CMV Workshop
  • Date: Tuesday, April 9, 2019
  • Time: 11:55 AM – 1:55 PM CDT
  • Event Website: http://www.cmv2019.org
About 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 up to 28 patients with recurrent GBM:

VBI-1901 is administered intradermally and is adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), a potent adjuvant that mobilizes dendritic cell function. Patients in both phases of the study will receive vaccine every four weeks until tumor progression.

  • Part A: Dose-escalation phase to define the safety, tolerability, and optimal therapeutic dose level of VBI-1901 in recurrent GBM patients. This phase enrolled 18 patients across three dose cohorts.
  • Part B: A subsequent extension of the optimal therapeutic dose level, as defined in the dose escalation phase based on safety and immunogenicity data. This phase is expected to enroll an expanded cohort of 10 additional patients.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.