VBI Vaccines (NASDAQ: VBIV) (“VBI”) this morning said it has received positive scientific advice regarding its European development path for its Sci-B-Vac™ vaccine from the European Medical Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). In its letter, the CHMP stated its support of VBI’s proposed plan to proceed to the phase III clinical studies of Sci-B-Vac™, and agreed that the product information and data from ongoing studies supports the phase III clinical studies and VBI’s planned filing of a market authorization application. The company is also evaluating plans for the pivotal phase III clinical studies with the U.S. Food and Drug Administration (FDA) and Health Canada. “We are encouraged by the feedback received by the CHMP at EMA, and believe VBI is now well-positioned to advance its pivotal studies in Europe to obtain registration and licensure of Sci-B-Vac,” VBI Chief Medical Officer Francisco Diaz-Mitoma, M.D., Ph.D. stated in the news release.
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About VBI Vaccines Inc.
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 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 allows for 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 and glioblastoma multiforme. VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that allows 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. To learn more visit www.vbivaccines.com.
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