VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (“VBI”) announced today that the Biologics and Genetic Therapies Directorate ("BGTD") of Health Canada expressed its general support and acceptance of the company’s development path for its Sci-B-Vac® vaccine, a prophylactic vaccine against hepatitis B, in a pre-Clinical Trial Application (“CTA”) meeting. A complete CTA must be filed with and approved by BGTD, and all conditions of BGTD must be met, prior to the initiation of a clinical program in Canada.
Given the extensive manufacturing data, licensed clinical efficacy and safety experience of Sci-B-Vac®, BGTD agreed in principle with the overall development strategy of VBI. In addition, BGTD agreed that the proposed Phase III program would satisfy the regulatory requirements for marketing authorization in Canada, supporting the indication for active immunization against hepatitis B in adults. Sci-B-Vac® fills a significant gap in an unmet medical need to protect against hepatitis B, especially in older individuals who may not be protected with currently licensed hepatitis B vaccines.
“We are delighted that Health Canada has expressed its support of the Sci-B-Vac® Phase III program in Canada,” said Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer. “This feedback is encouraging and enables us to submit the formal CTA to Health Canada in the first half of 2017. It also further validates the positive feedback VBI received last month from the European Medicines Agency (“EMA”).”
VBI is seeking evaluation and approval from the U.S. Food and Drug Administration (“FDA”), the BGTD, and the EMA for the pivotal Sci-B-Vac® global Phase III clinical studies. VBI plans to provide additional information about the clinical studies upon completion of discussions with these regulatory agencies.
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 prove more immunogenic in subjects that currently do not respond optimally to second-generation vaccines.
To learn more about Sci-B-Vac®, visit: https://www.vbivaccines.com/sci-b-vac/