98.8% of Patients Seroprotected at Two Months Following Second Dose of Sci-B-Vac(TM)
CAMBRIDGE, MASSACHUSETTS--(Marketwired - Nov. 14, 2016) - VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) ("VBI")
today reported interim results from an ongoing Phase IV postmarketing study to evaluate Sci-B-Vac™, VBI's licensed third-generation hepatitis B vaccine, in healthy
adults.
In its interim analysis, Sci-B-Vac™ was found to be well-tolerated and demonstrated rapid onset of protection against the
hepatitis B virus ("HBV"). Seroprotection rates, the percent of patients who produced an antibody response capable of preventing
an infection, were as follows:
- 91.9% of study participants were seroprotected at Month 2, one month after receiving a second dose of Sci-B-Vac™.
- 98.8% of participants were seroprotected at Month 3, two months after receiving a second dose of Sci-B-Vac™, and prior to
receiving a third dose.
"These interim results further demonstrate that Sci-B-Vac™ can safely and reliably be used to prevent HBV infection," said Dr.
Francisco Diaz-Mitoma, M.D., Ph.D., VBI's Chief Medical Officer. "In addition, the results add to a growing body of evidence that
suggests persons receiving Sci-B-Vac™ may develop seroprotection against HBV after receiving just two doses of the vaccine."
"We are also in the process of eliciting feedback on our late-stage clinical development plan from European and North American
regulatory bodies," said Jeff Baxter, VBI's President and CEO. "This encouraging data adds to our excitement about the potential
of Sci-B-Vac™ to protect against HBV infection in major global markets."
This Phase IV study is for routine quality control purposes and to support the existing licensure of Sci-B-Vac™ in Israel. The
study is further designed to validate VBI's new in-house reference standard vaccine for routine quality control purposes, in
accordance with the European Pharmacopeia and Israeli Ministry of Health guidelines. The study also seeks to characterize the
safety and immunogenicity of Sci-B-Vac™ to further support planned pivotal clinical trials in Europe and North America. VBI will
continue to gather and analyze study data, with final results anticipated in the second half of 2017.
Study Design
This Phase IV study is an open label, single arm, single center clinical study now underway in Israel. VBI enrolled 88
healthy, HBV-seronegative males and females between 20 and 40 years of age. Study participants were vaccinated three times with
10 micrograms/ml of Sci-B-Vac™ at zero, one, and six months.
The primary endpoint is seroprotection rate. Successful seroprotection against HBV infection is defined by rate and by an
anti-HBV surface antibody (anti-HBs) titer of ≥ 10 mIU/ml following immunization.
About Sci-B-Vac™
Sci-B-Vac™ is a licensed third-generation hepatitis B vaccine that has demonstrated safety and efficacy in over 300,000
patients. Sci-B-Vac™ is currently approved for use in Israel and in 14 other countries. In contrast to second-generation
hepatitis B vaccines, which contain only one surface antigen (the S antigen), Sci-B-Vac™ contains the S antigen and the pre-S1
and pre-S2 surface antigens. The composition of Sci-B-Vac™ may provide more opportunities for the immune system to respond with
antibodies that can recognize one or more components of the hepatitis B virus.
To learn more about Sci-B-Vac™, visit: https://www.vbivaccines.com/sci-b-vac/
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 ("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.
Cautionary Statement on Forward-looking Information
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", "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 include, but are not limited to, the design, purpose and
implementation of the study, timing for receipt of results of the study, and the potential effects of Sci-B-Vac™.
Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful
development and/or commercialization of the company's products, including the receipt of necessary regulatory approvals; general
economic conditions; that the parties' respective businesses are able to operate as anticipated without interruptions;
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include: the failure to successfully develop or commercialize the company's products; adverse changes in general economic
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Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking
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or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by
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