VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, announced today that it has completed a pre-Investigational New Drug (“IND”) meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the Phase III clinical program for Sci-B-Vac®, VBI’s third-generation hepatitis B vaccine. Sci-B-Vac® is currently approved for use in Israel and 14 other countries worldwide.
Based on the regulatory feedback from its meeting with the FDA, VBI can confirm that the initial IND for Sci-B-Vac® will not require any additional clinical studies to support its pivotal, global Phase III clinical program. VBI plans to submit the IND in the second half of 2017, together with the Clinical Trial Applications (“CTAs”) for Europe and Canada.“The successful completion of our pre-IND meeting with the FDA is a significant milestone in the development of Sci-B-Vac®. Following similar positive discussions with the European Medicines Agency and Health Canada, we now have a strong indication from all three regulatory agencies that Sci-B-Vac® is Phase III-ready in the U.S., Europe, and Canada,” said Jeff Baxter, VBI’s President and CEO. “VBI is now in the process of preparing a Phase III IND for the U.S., and CTAs for Europe and Canada, with submission planned in the second half of 2017. Additional details about the global Phase III clinical program will be available at the time the IND and CTA submissions are made.”
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 currently licensed second-generation hepatitis B vaccines, which contain only one surface antigen (the small S antigen), Sci-B-Vac® contains the S antigen and the larger pre-S1 and pre-S2 surface antigens. The composition of Sci-B-Vac® may prove more effective and safe, meeting an unmet medical need in individuals that do not respond optimally to second-generation hepatitis B vaccines.
To learn more about Sci-B-Vac®, visit: https://www.vbivaccines.com/sci-b-vac/