VBI and Columbia partner against glioblastoma

CAMBRIDGE, Mass.—VBI Vaccines Inc. has 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. 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.

A growing body of research has demonstrated that GBM tumors are particularly susceptible to infection by cytomegalovirus (CMV), with over 90 percent of GBM tumors expressing CMV antigens. 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.

"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.

Brain tumors affect over 30,000 Americans annually, and they have remained one of the most difficult of cancers to treat. Recognizing that there remains an unmet need for advancing the treatment of these diseases, Columbia University in collaboration with New York–Presbyterian Hospital established an integrated Brain Tumor Center in 2005. The goal of the Center is to apply the world-renowned research resources of the Neurological Institute of New York and Columbia University to improving the outcome for patients who have malignant brain tumors. The Brain Tumor Center now sees approximately 300 new patients annually from the United States and abroad. It integrates all aspects of patient care in a multidisciplinary clinical setting that draws upon the expertise of neuro-oncologists, neurosurgeons, radiation oncologists, psychiatrists, neuropathologists, nurse practitioners, and social workers who work together to tailor diagnosis and therapy to an individual patient's needs. Combined with the Center’s clinical activities are extensive research efforts that range from basic laboratory research to better understand how the most common brain tumors develop and grow to applied laboratory research to develop and test new treatments for the most common types of brain tumors to clinical trials of novel therapies in patients. The Center has pioneered the development of several novel treatments as well as experimental models of brain tumors that are supported by grants from the National Institutes of Health.

VBI Vaccines Inc. is a biopharmaceutical company developing novel technologies that seek to expand vaccine protection in large underserved markets. VBI's eVLP vaccine platform allows for the design of enveloped ("e") virus-like particle ("VLP") vaccines that closely mimic the target virus. VBI's lead eVLP asset is a prophylactic cytomegalovirus (CMV) vaccine; VBI has initiated work for GMP manufacturing of its CMV candidate for use in formal preclinical and Phase 1 trials. VBI's second platform is a thermostable technology that enables the development of vaccines and biologics that can withstand storage or shipment at constantly fluctuating temperatures. VBI has completed proof of concept thermostability studies on a number of vaccine and biologic targets. VBI is headquartered in Cambridge, MA with research facilities in Ottawa, Canada.