VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (“VBI”) is scheduled to present at the 10th Vaccine Congress on Monday, September 5, 2016 at 12:45 PM CEST (6:45 AM ET). The event is being held at the NH Grand Hotel Krasnapolsky in Amsterdam, the Netherlands.
During the presentation, eVLP Delivery of an Optimized Form of CMV gB Antigen for Prophylactic Vaccination against Congenital CMV, Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, will summarize recent developments in the company’s cytomegalovirus (“CMV”) vaccine program, including new data that demonstrates the desirable properties of VBI’s eVLP Platform.
VBI’s eVLP Platform allows for the design of enveloped (“e”) virus-like particle (“VLP”) vaccines. eVLPs are an innovative new class of vaccines that closely mimic the target virus to elicit a potent immune response. Because of their structural similarity to viruses found in nature, vaccination with a target protein expressed in an eVLP may be capable of imparting greater immunity than vaccination with the same recombinant target protein alone1.
New data from a preclinical study, conducted over a twelve-month time period, demonstrates that prior exposure to eVLPs does not impact the kinetics or potency of subsequent eVLP vaccinations.
“This new data shows that there is a potent immune response to the target CMV antigen being presented by the eVLP, but very little immune response to the eVLP itself,” said Dr. Diaz-Mitoma. “This is important because a strong immune reaction to the eVLP might lead to rapid clearance by the immune system, potentially impacting the effectiveness of subsequent vaccinations. We are encouraged by this data, which supports the use of multiple dose regimens of eVLP vaccines.”
VBI’s lead eVLP is a preventative CMV vaccine candidate. VBI is conducting a Phase I clinical study to assess the safety and tolerability of its CMV vaccine candidate in 125 healthy CMV-negative adults. The study will also measure levels of vaccine-induced CMV neutralizing antibodies that may prevent CMV infection. The study is expected to last 20 months with preliminary results anticipated in the first half of 2017.
CMV can cause serious disease in newborns when a mother is infected during pregnancy. Each year, approximately 5,000 U.S. infants will develop permanent problems due to CMV, which can include deafness, blindness, and mental retardation2. CMV affects more live births than Down syndrome or fetal alcohol syndrome3, making it a key public health priority and a strong candidate for recommended universal vaccination and reimbursement4.
- Event: 10th Vaccine Congress
- Date: Monday, September 5, 2016
- Time: 12:45 PM CEST (6:45 AM ET)
- Location: The NH Grand Hotel Krasnapolsky in Amsterdam, the Netherlands
- Event Website: http://www.vaccinecongress.com/
- Kirchmeier M, Fluckiger AC, Soare C, et al. Enveloped virus-like particle expression of human cytomegalovirus glycoprotein B antigen induces antibodies with potent and broad neutralizing activity. Clin Vaccine Immunol. 2014;21(2):174-80.
- Cannon, M. J., and K. F. Davis. 2005. Washing our hands of the congenital cytomegalovirus disease epidemic. BMC Public Health 5:70
- Stratton KR et al, Committee to Study Priorities for Vaccine Development, Inst. of Med.; Washington, DC
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 (“e”) virus-like particle (“VLP”) 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 allows 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.
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “believe”, “may”, “plan”, “potentially”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements. Such forward-looking statements included, but are not limited to: the capability of an eVLP to impact immunity, the impact of an eVLP on vaccination effectiveness and design parameters and measurement levels of the Phase I study.
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