VBI Vaccines Announces FDA Acceptance of Investigational New Drug Application for VBI-1901 to Treat Glioblastoma Multiforme

  • VBI-1901 is a novel immunotherapy developed using VBI’s eVLP technology
  • On track to initiate a Phase 1/2a clinical study in the second half of 2017

CAMBRIDGE, MA, USA I August 15, 2017 I VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug Application (IND) for VBI-1901, a novel immunotherapy targeting Glioblastoma Multiforme (GBM), one of the most common and aggressive malignant primary brain tumors in humans. The IND enables VBI to initiate a multi-center Phase 1/2a clinical study evaluating VBI-1901 in patients with recurrent GBM in the second half of this year.

VBI has leveraged its enveloped virus-like particle (eVLP) platform and expertise in immunology to develop a broadly active therapeutic vaccine that targets two highly immunogenic CMV antigens, gB and pp65, to direct a potent immune response against CMV infection. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including GBM. The vaccine candidate is combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), an adjuvant that mobilizes dendritic cell function and seeks to enhance productive immunity against tumors.

“A growing body of research has demonstrated that GBM tumors may be susceptible to infection by CMV, with over 90% of GBM tumors expressing CMV antigens,” said Jeff Baxter, president and CEO of VBI. “FDA clearance of this IND is a significant milestone for VBI as we expand our eVLP platform into immuno-oncology applications.”

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. 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.

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 that are consistently expressed on GBM tumor cells. Recent research has demonstrated that an anti-CMV dendritic cell vaccination regimen may extend overall survival in patients with GBM. Thus, effective targeting of CMV antigens may represent an attractive strategy for a GBM immunotherapy.

About VBI Vaccines Inc.

VBI Vaccines Inc. (VBI) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI's first marketed product is Sci-B-Vac™, a hepatitis B (HBV) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac is approved for use in Israel and 14 other countries. VBI's eVLP Platform technology allows for the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (CMV) and glioblastoma multiforme (GBM). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that enables vaccines and biologics to preserve stability, potency and safety. VBI is headquartered in Cambridge, Mass., with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.

SOURCE: VBI Vaccines

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