VBI Vaccines Inc. (Nasdaq:VBIV) (“VBI”) today will present new data supporting its glioblastoma (“Glioblastoma” or “GBM”) cancer immunotherapy program at the Keystone Symposia Cancer Vaccines Conference taking place in Whistler, British Columbia, Canada. Keystone Symposia are peer-reviewed conferences that attract contributors from academia and industry.

During the poster presentation, CMV gB/pp65 eVLPs Formulated with GM-CSF as a Therapeutic Vaccine against GBM, Dr. David E. Anderson, VBI’s Chief Scientific Officer, will summarize recent progress in VBI’s development of a therapeutic glioblastoma vaccine, including new manufacturing characterization data that confirms the high purity and quality of VBI’s vaccine candidate.

“We are encouraged by our preclinical data and by the quality of the vaccine candidate now being manufactured at a GMP-compliant facility,” said Dr. Anderson. “We expect that purity measurements will meet regulatory requirements for clinical evaluation. We are planning to have a pre-IND meeting with the FDA in the first half of 2016 to discuss our plans to evaluate the vaccine in glioblastoma patients.”

GBM Program Highlights

  • Promising results obtained through a collaboration with the Columbia University Brain Tumor Center.
    • Ex vivo studies demonstrated the vaccine candidate’s ability to induce desired anti-tumor immunity in peripheral blood mononuclear cells (“PBMCs”) obtained from healthy subjects and patients with GBM.
    • The vaccine candidate stimulated strong T-cell immunity, including both CD4+ and CD8+ T cell responses.
    • The vaccine candidate elicited secretion of IFN-γ and CCL3, key biomarkers associated with positive clinical outcomes.
  • In vivo data confirm the vaccine candidate’s ability to induce desired CD4+ and CD8+ T cell responses in mice; additional animal studies are planned to determine optimal dosing and formulation properties.
  • Pilot (10L) scale production is underway at a GMP-compliant facility; characterization data confirms the high quality of the vaccine candidate, which is expected to meet all regulatory requirements.
  • A pre-IND meeting with the U.S. FDA is currently sought for H1 2016.

GBM Program Background

Glioblastoma 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.3 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, with median patient survival of less than 16 months.4

Targeted immunotherapy may provide a promising adjunct or alternative to conventional GBM treatment. Immunotherapy is a fundamentally different way of treating cancer that stimulates the patient’s immune system to resume its attack on tumors. While conventional therapies are non-specific and may damage surrounding normal tissues, targeted immunotherapy may offer a highly specific and potentially long-lasting treatment approach that leverages the immune system to protect against cancer.

Developing a broadly applicable GBM immunotherapy requires the identification of antigens, used to direct the immune response, that are consistently expressed on tumor cells. A growing body of research has demonstrated that GBM tumors are susceptible to infection by cytomegalovirus (“CMV”), with over 90% of GBM tumors expressing CMV antigens.5 In addition, recent research has demonstrated that an anti-CMV dendritic cell vaccination regimen can extend overall survival in patients with glioblastoma.6 Thus, effective targeting of CMV antigens may represent an attractive strategy for a GBM immunotherapy.

VBI seeks to leverage its enveloped virus-like particle (“eVLP”) Platform and its expertise in anti-CMV immunity to develop a bivalent therapeutic vaccine candidate designed to direct an immune response against gB and pp65, two CMV antigens that are highly immunogenic targets during natural infection. The vaccine candidate includes granulocyte-macrophage colony-stimulating factor (“GM-CSF”), an adjuvant that mobilizes dendritic function and enhances Th1-type immunity.7

To learn more about VBI’s GBM Immunotherapy Program, visit: https://www.vbivaccines.com/gbm/