VBI Vaccines Inc. (NASDAQ: VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the company’s abstract titled, “Trivalent hepatitis B (HepB) vaccine yields superior seroprotection rates in adults: results from the phase 3 double-blind, randomized study comparing immunogenicity and safety of a 3-Dose regimen of Sci-B-Vac® and Engerix B® (PROTECT),” has been selected for a late-breaker oral presentation at IDWeek 2019™, in Washington, D.C., on Friday, October 4, 2019.
Joanne Langley, M.D., Professor of Pediatrics and Community Health and Epidemiology, CIHR-GSK Chair in Pediatric Vaccinology, Dalhousie University, and Head of the Division of Infectious Disease, IWK Health Centre, and principal investigator of the PROTECT study, will deliver the oral presentation. Dr. Langley will discuss the top-line data from the PROTECT study, a pivotal Phase 3 study designed to evaluate the efficacy and safety of a 10µg dose of Sci-B-Vac®, VBI’s trivalent hepatitis B vaccine, compared with a 20µg dose of the comparator vaccine, Engerix-B®. Notably, Dr. Langley will highlight the two successfully-met co-primary endpoints and detailed seroprotection data in key patient subgroups, including by age group, gender, diabetic status, body mass index, and smoking status.
- Abstract #: 717615
- Session: 184 – Late Breaker Oral Abstract Session 2
- Location: Walter E. Washington Convention Center, Room 209 ABC
- Date: Friday, October 4, 2019
- Time: 2:35 – 2:45 PM ET
- Event Website: https://idweek.org
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 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 Securities and Exchange Commission and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2019, and filed with the Canadian security authorities at sedar.com on February 25, 2019, 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.