VBI Vaccines Reports Rapid Seroprotection Results from an Interim Analysis of a Phase IV Postmarketing Study of its Sci-B-Vac® Hepatitis B Vaccine

November 14, 2016 | Press Releases, Sci-B-Vac®

98.8% of Patients Seroprotected at Two Months Following Second Dose of Sci-B-Vac®

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

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VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
VBI Investor and Media Contact

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Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: info@vbivaccines.com
VBI Cautionary Statement on Forward-looking Information

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Certain statements in this press release that are forward-looking and not statements of historical fact are 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 statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential 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 products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 5, 2020, and filed with the Canadian security authorities at sedar.com on March 5, 2020, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.