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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 the appointment of Vaughn B. Himes, Ph.D., as a member of its Board of Directors. Dr. Himes, with over 30 years in biotechnology, has a strong background in strategy and change management, significantly contributing to the launch of products worth over $2 billion. His expertise in chemistry, manufacturing, and controls (CMC) positions VBI to enhance its operations and product pipeline, particularly for its hepatitis B vaccine, PreHevbrio™. Dr. Himes' previous experience at Seagen Inc. includes overseeing the successful transition from R&D to commercial launch of key products. VBI aims to leverage Dr. Himes' insights to advance its clinical candidates and strengthen its market presence.
VBI Vaccines Inc. (Nasdaq: VBIV) is intensifying its focus on combating hepatitis B (HBV) through its FDA-approved vaccine PreHevbrio™ and the development of immunotherapeutic candidate VBI-2601. Key strategies include a planned 30-35% reduction in workforce and operating expenses, aimed to enhance financial efficiency. Additionally, a 1-for-30 reverse stock split is set to take effect on April 12, 2023, to meet Nasdaq listing requirements, reducing outstanding shares significantly. The CEO emphasized the commitment to public health and increasing vaccine utilization in the U.S.
VBI Vaccines Inc. (Nasdaq: VBIV) reported a successful year in 2022, focusing on its hepatitis B vaccine, PreHevbrio, which yielded $0.9 million in net sales post-launch. Recent partnerships have set the stage for broader access in the U.S., Europe, and Canada. Pipeline progress includes ongoing Phase II studies for HBV treatments and anticipated clinical data for glioblastoma and COVID-19 vaccines. Financial results show a net loss of $113.3 million for the year, attributed to increased operational costs. VBI aims to manage expenses while advancing significant medical solutions, reflecting its commitment to public health needs.
VBI Vaccines Inc. (Nasdaq: VBIV) will host a fireside chat on February 28, 2023, at 1:00 PM ET, featuring CEO Jeff Baxter and Chief Scientific Officer David E. Anderson discussing the company's hepatitis B portfolio. The discussion will focus on VBI-2601, a novel immunotherapeutic candidate for chronic HBV treatment, and PreHevbrio™, the only 3-antigen HBV vaccine approved in multiple regions, including the U.S. and Europe. The event can be accessed live on VBI's website. Hepatitis B affects over 290 million people globally, leading to severe liver complications and approximately 900,000 deaths annually.
VBI Vaccines Inc. (NASDAQ: VBIV) has released interim data from a Phase 2 study evaluating the combination of VBI-2601 (BRII-179) and BRII-835 in chronic hepatitis B patients. The combination was well-tolerated and showed stronger anti-HBsAg-specific immune responses compared to BRII-835 alone. Notably, two participants achieved undetectable HBsAg levels by Week 40, demonstrating promising efficacy. The data will be presented at the APASL 2023 Conference in Taipei, Taiwan, on February 18, 2023. VBI's Chief Medical Officer expressed optimism about the potential of this combination therapy as part of a functional cure for HBV.
VBI Vaccines Inc. (Nasdaq: VBIV) announces that Health Canada has approved PreHevbrio, a 3-antigen hepatitis B vaccine, for active immunization in adults. This marks the fourth regulatory approval for PreHevbrio, which is designed to prevent all known hepatitis B virus subtypes and potentially hepatitis D as well. The approval is based on positive results from pivotal Phase 3 studies, PROTECT and CONSTANT, indicating higher seroprotection rates compared to a single-antigen vaccine. The company aims to enhance public health initiatives in Canada.
VBI Vaccines (NASDAQ: VBIV) and the Coalition for Epidemic Preparedness Innovations (CEPI) are expanding their partnership to develop multivalent coronavirus vaccines targeting COVID-19 and future variants. This initiative utilizes VBI's enveloped virus-like particle (eVLP) technology, which aims to offer broad protection against multiple coronavirus variants and potential new strains. CEPI has committed up to US$33 million for the development of these vaccines, contributing to VBI's ongoing vaccine program, VBI-2900. The project emphasizes equitable access for at-risk populations worldwide.