VBI Vaccines Begins Enrolling Patients in a Phase I Trial of its Preventative Cytomegalovirus Vaccine Candidate

June 23, 2016 | Cytomegalovirus ("CMV"), Press Releases

VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (“VBI”) has received a No Objection Letter from Health Canada, providing clearance to begin enrolling Canadian participants in a Phase I clinical study to evaluate VBI’s preventative cytomegalovirus (“CMV”) vaccine candidate in humans.

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.¹ CMV affects more live births than Down syndrome or fetal alcohol syndrome,² making it a key public health priority and a strong candidate for recommended universal vaccination and reimbursement.³

“Congenital CMV infection is a leading cause of serious birth defects in the U.S. and globally,” said Jeff Baxter, VBI’s President and CEO. “Each year, thousands of newborns and their families are impacted by this devastating disease. We believe that developing a vaccine to prevent CMV offers the best chance of substantially eliminating congenital CMV infection and the resulting birth defects; advancing our vaccine candidate into a human clinical trial is a significant step forward in this effort.”

The Phase I study is designed to assess the safety and tolerability of VBI’s eVLP Platform-derived cytomegalovirus vaccine candidate in approximately 125 healthy CMV-seronegative adults. The study will also measure levels of vaccine-induced CMV neutralizing antibodies that may prevent CMV infection.

“While safety and tolerability are our primary endpoints, we will also measure the immune response generated by our CMV vaccine candidate, and compare it to persons with naturally acquired CMV immunity,” said Dr. David E. Anderson, VBI’s Chief Scientific Officer. “Naturally acquired CMV immunity may provide up to 90% protection from congenital CMV transmission,⁴ providing a benchmark for our Phase I study that could allow for human immunological proof of concept at an early stage of clinical development.”

Study participants will be split into five groups that will receive three varying doses of VBI’s adjuvanted vaccine candidate, an unadjuvanted version of the vaccine candidate, or a placebo control, at zero, two, and six months. The study is expected to last 20 months with an interim readout anticipated in H1 2017 following administration of the second vaccination. Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, will be made available at ClinicalTrials.gov.

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References

http://www.cdc.gov/cmv/trends-stats.html
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
Adler, et al. Immunity Induced by Primary Cytomegalovirus Infection Protects Against Secondary Infection Among Women of Childbearing Age. Journal of Infectious Disease, 1995; 171:26

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.

VBI Vaccines Begins Enrolling Patients in a Phase I Trial of its Preventative Cytomegalovirus Vaccine Candidate

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