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VBI Vaccines Inc. (NASDAQ: VBIV) is a leading biopharmaceutical company focused on developing next-generation vaccines to meet unmet needs in infectious diseases and immuno-oncology. Headquartered in Cambridge, MA, with research facilities in Ottawa, Canada, VBI is at the forefront of vaccine innovation with two primary platforms.
The first platform, Enveloped Virus-Like Particle (eVLP), enables the design of vaccines that closely mimic the target virus, enhancing their effectiveness. The company's lead eVLP asset is a prophylactic cytomegalovirus (CMV) vaccine, currently advancing with GMP manufacturing for formal preclinical and Phase I trials.
The second platform is a thermostable technology allowing vaccines and biologics to withstand fluctuating temperatures during storage and transport. VBI has completed proof-of-concept thermostability studies on several vaccine and biologic targets, highlighting this platform's potential to improve global vaccine distribution.
VBI's commercial product, Sci-B-Vac, is a hepatitis B (HBV) vaccine approved for adults, children, and newborns. The company's innovations are designed to address significant gaps in the vaccine market, particularly in underserved areas.
Recent achievements include the initiation of GMP manufacturing for its CMV vaccine candidate and successful proof-of-concept studies for its thermostable technology. VBI continues to be a pivotal player in the biopharmaceutical field, dedicated to advancing public health through cutting-edge vaccine solutions.
VBI Vaccines Inc. (Nasdaq: VBIV) announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for a 3-antigen prophylactic hepatitis B vaccine. This marks a significant milestone for VBI in increasing access to its vaccine, which targets all known hepatitis B virus subtypes in adults. The MAA is based on data from two Phase 3 studies, PROTECT and CONSTANT. Hepatitis B affects over 290 million people globally and poses a significant health risk, leading to many deaths each year. The vaccine is already commercially available in Israel as Sci-B-Vac®.
VBI Vaccines Inc. (Nasdaq: VBIV) announced a fireside chat on December 8, 2020, focusing on its hepatitis B portfolio. The discussion will feature analyst Steven Seedhouse from Raymond James & Associates, highlighting two key candidates: the 3-antigen prophylactic HBV vaccine, Sci-B-Vac®, and VBI-2601, an immunotherapeutic for chronic HBV. With over 290 million global HBV infections leading to significant mortality, VBI's developments aim to address this public health threat. The chat will be accessible via the company's website, with a replay available afterward.
VBI Vaccines Inc. (Nasdaq: VBIV) announced the submission of a Biologics License Application (BLA) for its 3-antigen hepatitis B vaccine to the FDA. This vaccine aims to prevent infections from all known hepatitis B virus subtypes in adults, addressing a significant public health threat in the U.S., where approximately 2.2 million individuals are chronically infected. The vaccine is already commercially available in Israel as Sci-B-Vac® and has completed a Phase 3 clinical program. VBI aims for regulatory approvals in the U.S., Europe, and Canada.
VBI Vaccines Inc. (Nasdaq: VBIV) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its 3-antigen prophylactic hepatitis B vaccine. This vaccine aims to prevent infections from all known hepatitis B virus subtypes in adults. CEO Jeff Baxter highlighted the MAA submission as a significant milestone, with plans for a Biologics License Application (BLA) submission to the FDA in the near future. Hepatitis B, a major global health threat, affects over 290 million people and causes significant morbidity and mortality.
VBI Vaccines Inc. (Nasdaq: VBIV) has announced positive interim results from a Phase 1b/2a study of VBI-2601 (BRII-179) for chronic hepatitis B. In the study, 67% and 78% of patients showed T cell responses in low-dose unadjuvanted and adjuvanted groups, respectively. Antibody responses were seen in 60% and 67% of evaluable patients in the respective groups. The study, involving 46 patients, demonstrated good tolerability without safety signals. Future studies are planned to explore combinations with other therapies for a functional cure.
VBI Vaccines Inc. (Nasdaq: VBIV) announced its participation in the AASLD - The Liver Meeting® where it presented a pivotal Phase 3 study (PROTECT) on its hepatitis B vaccine, Sci-B-Vac®. The data showed that Sci-B-Vac had significantly higher seroprotection rates (SPR) and antibody levels compared to Engerix-B, especially in adults over 45 and those with comorbidities. Key findings included a 91.4% SPR for Sci-B-Vac versus 76.5% for Engerix-B, and a six-fold higher geometric mean concentration of antibodies across all adults. This data underscores the potential of Sci-B-Vac to address unmet medical needs.
VBI Vaccines Inc. (Nasdaq: VBIV) announced that its abstract showcasing data from the Phase 1/2a study of VBI-1901, a cancer vaccine candidate for recurrent glioblastoma, has been accepted for e-poster presentation at the Society for Neuro-Oncology's annual meeting on November 19-21, 2020. The study involves 38 patients and includes two phases: Phase 1 established the optimal dose of 10.0 µg, while Phase 2a evaluates the vaccine with different adjuvants. The poster will detail findings on a baseline biomarker associated with tumor responses.
VBI Vaccines Inc. (Nasdaq: VBIV) presented two abstracts at ID Week 2020™ showcasing data from the Phase 3 studies of its 3-antigen hepatitis B vaccine, Sci-B-Vac®. The PROTECT and CONSTANT studies demonstrated that Sci-B-Vac® induced significantly higher anti-HBs titers compared to the single-antigen Engerix-B vaccine, with results showing GMCs up to 7.5 times higher. Additionally, Sci-B-Vac® achieved seroprotection rates of 87.2%-100% in adults 18-45, highlighting its rapid immunogenicity. This innovative vaccine aims to address limitations in current HBV immunization protocols.
VBI Vaccines Inc. (Nasdaq: VBIV) will present its vaccine candidate VBI-2601 for hepatitis B during the H.C. Wainwright HBV Mini-Conference on October 20, 2020, from 2:00 PM to 2:30 PM ET. The event features CEO Jeff Baxter and Chief Scientific Officer David E. Anderson, Ph.D. Hepatitis B poses significant health risks, with over 290 million global infections and 780,000 annual deaths. VBI is advancing innovative vaccines, including the Sci-B-Vac® and VBI-2601 for chronic hepatitis B treatment. A webcast recording will be available on VBI's investors page.
VBI Vaccines Inc. (Nasdaq: VBIV) has announced that its abstract on the Phase 3 program of Sci-B-Vac®, a 3-antigen hepatitis B vaccine, was accepted for e-poster presentation at the AASLD – The Liver Meeting® on November 13, 2020. The presentation will detail the vaccine's superior seroprotection rates compared to mono-antigenic vaccines. With over 290 million global hepatitis B infections, the need for effective vaccines is critical. Sci-B-Vac® has shown safety and efficacy in over 750,000 patients and is already commercially available in Israel.
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