VBI Vaccines (VBIV) Says Pre-IND Meeting with FDA Over VBI-1901 Complete; Fast-Track Designation Under Consideration

October 11, 2016 8:32 AM EDT
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VBI Vaccines Inc. (Nasdaq: VBIV) announced that it has completed a pre-IND meeting with the U.S. Food and Drug Administration ("FDA") to discuss the development plan for VBI-1901, VBI's glioblastoma multiforme ("Glioblastoma" or "GBM") immunotherapy candidate.

The FDA addressed VBI's questions related to preclinical data and planned clinical trial design and provided greater clarity on the requirements needed to file an IND to initiate a Phase I/IIa clinical trial in patients with GBM. VBI anticipates filing this IND in the first half of 2017. The FDA will consider a Fast Track designation for VBI-1901 at the time of the IND submission.

"We are encouraged by the productive discussions with the FDA," said Dr. David E. Anderson, VBI's Chief Scientific Officer. "Even with aggressive treatment, GBM is universally fatal, with median patient survival of less than 16 months. VBI-1901 may offer a novel approach to treating persons with glioblastoma. We believe that preclinical data supports the clinical advancement of VBI-1901 and we are currently undertaking IND-enabling next steps."

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(1). 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(2).

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 focus 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(3). In addition, recent research has demonstrated that an anti-CMV dendritic cell vaccination regimen can extend overall survival in patients with glioblastoma(4). Thus, effective targeting of CMV antigens may represent an attractive strategy for a GBM immunotherapy.

VBI has leveraged its eVLP Platform and its expertise in anti-CMV immunity to develop VBI-1901, a polyvalent 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(5).


(1) Dolecek TA, Propp JM, Stroup NE, et al. (2012) CBTRUS statistical
report: Primary brain and central nervous system tumors diagnosed in the
United States in 2005-2009. Neuro Oncol 14(suppl 5):v1-v49.
(2) Johnson DR, O'neill BP. Glioblastoma survival in the United States
before and during the temozolomide era. J Neurooncol. 2012;107(2):359-
64.
(3) Mitchell DA, Xie W, Schmittling R, et al. Sensitive detection of human
cytomegalovirus in tumors and peripheral blood of patients diagnosed
with glioblastoma. Neuro-oncology. 2008;10(1):10-8.
(4) Mitchell DA, Batich KA, Gunn MD, et al. Tetanus toxoid and CCL3 improve
dendritic cell vaccines in mice and glioblastoma patients. Nature.
2015;519(7543):366-9.
(5) Arellano M, Lonial S. Clinical uses of GM-CSF, a critical appraisal and
update. Biologics. 2008;2(1):13-27.

Preclinical Findings

In preclinical studies, VBI demonstrated that VBI-1901 stimulated immune responses critical to efficacious anti-tumor immunity. In studies conducted using peripheral blood mononuclear cells ("PBMCs"), harvested from healthy subjects and patients with GBM, VBI-1901 stimulated strong CD4+ and CD8+ T cell responses ex vivo, characterized by secretion of IFN-g and CCL3, key biomarkers associated with positive clinical outcomes.

In a mouse study, VBI-1901 induced desired anti-tumor immunity in vivo, expanding both CD4+ and CD8+ T cell responses. Additional preclinical animal studies are planned to determine optimal dosing and formulation properties.

Vaccine Candidate Manufacture and Next Steps

Pilot (50L) scale production of VBI-1901 is now underway at a GMP-compliant facility. VBI has employed electron microscopy to confirm the integrity of the polyvalent eVLPs, with positive interim results. Purity measurements are expected to meet regulatory requirements for clinical evaluation of VBI-1901. VBI anticipates filing an IND in the first half of 2017.

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



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