VBI Vaccines Provides Update on its Congenital CMV Phase I Clinical Study

May 2, 2017 | Cytomegalovirus ("CMV"), Press Releases

VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (“VBI”) today provided an update on its cytomegalovirus (“CMV”) Phase I clinical study, which is assessing the safety and tolerability of VBI’s vaccine candidate to prevent congenital CMV infection. Congenital CMV infection is a leading cause of birth defects, affecting more live births than Down syndrome or fetal alcohol syndrome, making it a key public health priority.

Upon review of all safety data up to one month after second immunizations in VBI’s prophylactic CMV Phase I clinical study, the Data and Safety Monitoring Board (“DSMB”) unanimously recommended the continuation of the study without modification. No safety signals have been detected, suggesting VBI’s CMV vaccine candidate is safe and well-tolerated.

Additionally, all participants in the study have now successfully received the third and final immunization in the series. Further vaccine immunogenicity and safety follow-up are ongoing.

An interim safety and immunogenicity report, based on blood samples collected from participants one month post-second vaccination, is expected mid-year 2017.

About the Phase I Clinical Study Design

The Phase I study is designed to assess the safety and tolerability of VBI’s CMV vaccine candidate in approximately 125 healthy CMV-negative adults. The study will also determine the vaccine immunogenicity by measuring levels of vaccine-induced CMV neutralizing antibodies, which may prevent CMV infection.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT02826798.

About the Data and Safety Monitoring Board

The DSMB was formed with key opinion leaders, a statistician, and experts in safety in clinical studies of this nature. The board is an arms-length committee that monitors the clinical study to assess safety data at various time points during the clinical study, and to recommend to VBI whether to continue, modify, or stop the study.

About CMV

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 retardation. CMV affects more live births than Down syndrome or fetal alcohol syndrome, making it a key public health priority and a strong candidate for recommended universal vaccination and reimbursement.

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.