VBI Vaccines Announces Development of a Novel Glioblastoma Immunotherapy Candidate

VBI Vaccines Inc.

("VBI") today announced that it has applied its eVLP Platform in the development of a novel therapeutic vaccine candidate for glioblastoma multiforme ("Glioblastoma" or "GBM"). Columbia University's Brain Tumor Center is performing research to evaluate VBI's GBM immunotherapy candidate in ex vivo studies using GBM patient samples. 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.1 The current standard of care for 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 sixteen months.2 A growing body of research has demonstrated that GBM tumors are particularly susceptible to infection by cytomegalovirus ("CMV"), with over 90% of GBM tumors expressing CMV antigens.3 In addition, recent research has demonstrated that dendritic cell priming combined with dendritic cell vaccination against CMV can extend overall survival in patients with glioblastoma.4 "Recent advances in this field are promising, but there is still need for improved CMV vaccination approaches for GBM," said Dr. David E. Anderson, Ph.D., VBI's Chief Scientific Officer. "Our eVLP approach has allowed for the efficient delivery of multiple CMV antigens, and in the case of GBM, we believe could be capable of mobilizing a broad and robust anti-tumor immune response against GBM. Further, we have demonstrated the ability to manufacture eVLP-derived vaccine candidates with yields and purity that are expected to be suitable for production at a commercial scale." VBI is seeking to leverage its eVLP Platform and its expertise in CMV to develop a therapeutic vaccine candidate that has been designed to direct an immune response against glycoprotein B and pp65, two CMV antigens that are highly immunogenic targets during natural infection. The vaccine candidate includes an adjuvant that mobilizes dendritic function and enhances Th1-type immunity. VBI is evaluating the ability of its vaccine candidate to stimulate CD4+ and CD8+ T cell responses in peripheral blood mononuclear cells ("PBMCs") harvested from healthy patients and patients with GBM; CD4+ and CD8+ immune responses are critical to efficacious anti-tumor immunity. VBI will also monitor several biomarkers predictive of clinical efficacy. Columbia University's Brain Tumor Center, a world-class academic environment for the treatment of neurological diseases, combines exceptional patient care with innovative research and cutting edge technology. More than 400 patients undergo surgery for brain tumors at Columbia each year, making it one of the preeminent brain tumor centers in the U.S.5 To learn more about VBI's GBM Immunotherapy Program, visit: http://www.vbivaccines.com/gbm/