Dr. Anderson will present data in animal models which highlights VBI-1901’s ability to stimulate innate immunity, in turn enhancing the ability to restimulate CMV-specific T-cell immunity. In a preclinical study, CMV+ Rhesus Macaques were given VBI-1901 combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), an adjuvant that recruits dendritic cells to the site of immunization and seeks to enhance immunity. After two doses, boosting of CMV-specific T-cell responses were seen in all animals, an observation consistent with other recent anti-CMV dendritic cell vaccine clinical studies against GBM where meaningful improvement in overall survival was observed.
“Broad evidence, both in preclinical research studies and in several human clinical trials, supports CMV as a cancer immunotherapeutic target and suggests that a CMV-based vaccine which can harness dendritic cells to re-stimulate CMV-specific T-cells has potential to confer positive clinical outcomes,” said Dr. Anderson. “Additionally, a growing body of research has demonstrated that multiple tumors, including GBM, are susceptible to infection by CMV and can thus be targeted with CMV-specific immunity. We are very encouraged by these preclinical data, which support the Phase 1/2a clinical trial the company expects to initiate soon.”
The FDA recently accepted VBI’s IND for VBI-1901. VBI expects to initiate enrollment in a multi-center Phase I/2a clinical study evaluating VBI-1901 in patients with recurrent GBM in the second half of 2017.
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.
To learn more about VBI’s GBM immunotherapy program, visit: http://www.vbivaccines.com/gbm/
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, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.