VBI Vaccines to Present New Preclinical Data for its GBM Immunotherapy, VBI-1901, at The Immuno-Oncology Summit
- IND-enabling data, including restimulation of CMV-specific T-cell immunity in Rhesus Macaques - Mechanistic data demonstrating
VBI-1901 stimulates innate immunity - Data presentation Wednesday, Aug. 30
CAMBRIDGE, MASSACHUSETTS--(Marketwired - Aug. 28, 2017) - VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) (VBI)
today announced that David Anderson, Ph.D., Chief Scientific Officer of VBI, will present new preclinical data demonstrating the
mechanism by which VBI-1901 stimulates CMV-specific immunity in monkeys at The Immuno-Oncology Summit in Boston on Wednesday,
Aug. 30, 2017. VBI-1901 is a novel immunotherapy developed using VBI's eVLP technology to target CMV-positive (CMV+) tumors,
including glioblastoma multiforme (GBM), the company's lead immuno-oncology program.
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.
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forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of
1995 and are forward-looking information within the meaning of Canadian securities laws (collectively "forward-looking
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information currently available to management. Actual results could differ materially from those contemplated by the
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products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the
development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential
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and other factors, including risks and uncertainties with respect to the company, is set forth in the Company's filings with the
Securities and Exchange Commission and the Canadian securities authorities, including its Annual Report on Form 10-K filed with
the Securities and Exchange Commission on March 20, 2017, and filed with the Canadian security authorities at sedar.com on March
24, 2017, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. The company disclaims any intention
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except as required by law.