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/
VBI Vaccines Inc. (“VBI”) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketed product is Sci-B-Vac™, a hepatitis B (“HBV”) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac™ is approved for use in Israel and 14 other countries. VBI’s eVLP Platform technology enables the development of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (“CMV”) and glioblastoma multiforme (“GBM”). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that enables vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements, including statements regarding: plans for Phase 3 clinical studies, the provision of additional information about clinical studies, the potential effects of Sci-B-Vac™, and the timeline for the submission of the IND.
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