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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 updates from its Phase 1b/2a study of VBI-2601 (BRII-179), targeting chronic hepatitis B infection. Involving 46 patients, the trial assessed safety and immune response, revealing VBI-2601 was well-tolerated, showing T cell responses in over 50% of patients. The next step includes a Phase 2 study in collaboration with Brii Biosciences, focusing on a combination approach targeting enhanced immune responses. The complete dataset will be presented at a future scientific conference.
VBI Vaccines Inc. (Nasdaq: VBIV) announced that CEO Jeff Baxter and CSO David E. Anderson, Ph.D., will speak at the Oppenheimer 31st Annual Healthcare Conference on March 17, 2021, at 10:40 AM ET. The session will be part of a fireside chat format and will last until 11:10 AM ET. A webcast of the presentation can be accessed here, with a recording available on the company's website afterward. VBI focuses on developing innovative vaccine candidates using its proprietary VLP platform to address significant infectious diseases and aggressive cancers.
VBI Vaccines Inc. (VBIV) has partnered with CEPI to advance its enveloped virus-like particle (eVLP) vaccine candidates for SARS-CoV-2 variants, including the B.1.351 variant. CEPI will provide up to $33 million to support the Phase 1 clinical development of VBI-2905, focusing on its pre-fusion spike protein. This endeavor will also facilitate preclinical expansions of additional multivalent candidates to enhance the vaccine's effectiveness against emerging variants. The partnership aims to make successful candidates available through the COVAX Facility.
VBI Vaccines Inc. (VBIV) has initiated enrollment for a Phase 1/2 clinical study of its COVID-19 vaccine candidate, VBI-2902, a monovalent enveloped virus-like particle (eVLP) vaccine. The study aims to evaluate the safety and immunogenicity of VBI-2902 in healthy adults aged 18-54, with initial data expected by the end of Q2 2021. VBI's efforts are supported by the Government of Canada's Strategic Innovation Fund, which has allocated up to CAD$56 million for this project. The trial involves a collaborative effort with the National Research Council of Canada.
VBI Vaccines (Nasdaq: VBIV) has initiated patient enrollment for its Phase 1/2 clinical study of VBI-2902, a COVID-19 vaccine candidate using a novel enveloped virus-like particle (eVLP) approach. The randomized, observer-blind study will assess safety and immunogenicity in up to 60 healthy adults. Funding support from Canada's Strategic Innovation Fund bolsters VBI's efforts to deliver effective COVID-19 solutions. Initial data is anticipated by the end of Q2 2021, with the Phase 2 study expanding to three age cohorts and additional sites in Canada.
VBI Vaccines (Nasdaq: VBIV) reported its financial results for Q4 and the full year 2020, highlighting significant advancements in its vaccine pipeline. The company introduced two new candidates for COVID-19 and is advancing its 3-antigen hepatitis B vaccine candidate, with applications submitted to the FDA and EMA. With $119.1 million in cash as of year-end 2020, VBI is well-positioned for upcoming milestones in 2021, including further clinical studies for its therapeutic vaccine candidates targeting chronic HBV and recurrent glioblastoma.
VBI Vaccines Inc. (Nasdaq: VBIV) announces participation in the Raymond James 42nd Annual Institutional Investors Conference on March 2, 2021. CEO Jeff Baxter and CSO David E. Anderson, Ph.D., will present from 4:40 PM to 5:20 PM ET. The event will highlight the company's innovative approach to vaccine development using virus-like particles to combat diseases such as hepatitis B and coronaviruses. A live webcast of the presentation will be available, with a recording accessible on the company's website afterward.
VBI Vaccines Inc. (Nasdaq: VBIV) announced that the FDA has accepted its Biologics License Application for a 3-antigen prophylactic hepatitis B vaccine. This vaccine targets all known hepatitis B virus subtypes in adults, with a PDUFA target date set for November 30, 2021. The BLA is backed by pivotal Phase 3 studies, PROTECT and CONSTANT, assessing the vaccine's efficacy and safety compared to Engerix-B®. Hepatitis B is a major global health threat, affecting over 290 million people, with significant mortality linked to the disease.
VBI Vaccines Inc. (Nasdaq: VBIV) announced progress on its coronavirus vaccine program, featuring two candidates: VBI-2901 (trivalent) and VBI-2902 (monovalent). Exciting preclinical results show VBI-2902 effectively prevents significant weight loss in infected hamsters and reduces lung inflammation. A Phase 1/2 clinical study for VBI-2902 is expected to start in Canada in Q1 2021, despite delays due to supply chain issues. The company received CAD$56 million from the Government of Canada to support these studies.
VBI Vaccines Inc. (Nasdaq: VBIV) announced the publication of positive results from a Phase 4 study of its 3-antigen hepatitis B vaccine, Sci-B-Vac®, in younger adults. The study, published in Vaccine, achieved a seroprotection rate of 98.8% at month 3, with 100% seroprotection by month 7. There were no safety concerns reported. VBI aims to expand access to this vaccine, which is important for the fight against hepatitis B, particularly for young adults like healthcare workers. The company is working with regulatory agencies for licensing outside Israel.