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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. (VBIV) reported its Q2 2022 financial results, highlighting a cash position of $82.4 million. Revenue increased to $0.3 million from $0.1 million year-over-year, primarily due to the U.S. launch of its HBV vaccine, PreHevbrio. However, the company faced a net loss of $45.7 million and net loss per share of $0.18, impacted by a $21.9 million foreign exchange loss. VBI continues to advance its pipeline, with new clinical studies in GBM and COVID-19 vaccines expected to start soon.
VBI Vaccines Inc. (Nasdaq: VBIV) announced the appointment of John Dillman as Chief Commercial Officer. With a strong background in commercial strategy, Dillman will oversee VBI's sales and operations for its 3-Antigen Hepatitis B Vaccine, PreHevbrio™, collaborating closely with Syneos Health. His prior experience includes 17 years at Sanofi Pasteur, where he managed over $3 billion in annual sales. VBI aims to advance public health and address unmet medical needs while focusing on upcoming milestones across its development pipeline.
VBI Vaccines (NASDAQ: VBIV) presented new findings from the pivotal Phase 3 PROTECT study at The International Liver Congress™ 2022. The analysis revealed that participants vaccinated with VBI's 3-antigen hepatitis B vaccine had significantly better immune responses compared to those who received the single-antigen vaccine Engerix-B. Specifically, the 3-antigen vaccine achieved an 88.1% seroprotection rate versus 72.4% for Engerix-B. Additionally, 72.9% of the 3-antigen vaccine recipients retained higher anti-HBs titers after 2.5 years, underscoring its potential as a crucial public health intervention against hepatitis B.
VBI Vaccines Inc. (NASDAQ: VBIV) announced the results of its annual general meeting held on June 22, 2022, where 69.52% of common shares were represented. All eight nominated directors, including Steven Gillis and Linda Bain, were elected with varying approval percentages. Significant approvals included setting the director count at eight and appointing EisnerAmper LLP as the independent accounting firm for the upcoming year. Detailed voting results can be found in VBI's SEC and SEDAR filings.
VBI Vaccines Inc. announced that the FDA granted Orphan Drug Designation for VBI-1901, an immunotherapeutic vaccine for glioblastoma (GBM). This designation underscores the urgent need for new therapies, with an estimated 14,000 new GBM cases annually in the U.S. VBI plans to initiate a randomized clinical study in Q3 2022 to support an accelerated approval application. The company continues to report strong tumor response data and overall survival improvements based on Phase 2a study results. This designation allows for potential tax credits and marketing exclusivity.
VBI Vaccines Inc. (Nasdaq: VBIV) announced that its President and CEO, Jeff Baxter, will participate in an analyst-led fireside chat at the Jefferies Healthcare Conference on June 8, 2022, from 1:30-1:55 PM ET. The event will be available via a live webcast on VBI's website, with a replay accessible afterward. VBI is focused on developing innovative vaccine candidates leveraging its enveloped virus-like particle platform to tackle infectious diseases and cancers. The company has operations in Cambridge, Ottawa, and Rehovot.
VBI Vaccines Inc. recently presented new data from the Phase 2a study of its cancer vaccine candidate, VBI-1901, at the ASCO Annual Meeting on June 5, 2022. The study focuses on recurrent glioblastoma (GBM) and shows a significant improvement in overall survival compared to historical controls. Median overall survival was reported at approximately 12.9 months and 14.6 months for different study arms, with an 18-month overall survival rate of 25% and 40%, respectively. One patient has sustained a 93% tumor reduction for over six months. Upcoming studies are planned for Q3 and Q4 2022.
VBI Vaccines Inc. has received marketing authorization from the UK Medicines and Healthcare Products Regulatory Agency for PreHevbri™, the only approved 3-antigen hepatitis B vaccine for adults in the UK. This follows the European Commission's marketing authorization granted in April 2022. PreHevbri is expected to be available in the UK in early 2023, targeting a significant infectious disease with over 290 million people infected globally. VBI's CEO expressed optimism about the vaccine's potential impact based on favorable Phase 3 study results.
VBI Vaccines Inc. (Nasdaq: VBIV) announced that an abstract on the long-term immune response data from its 3-antigen hepatitis B vaccine will be presented at The International Liver Congress™ 2022, set for June 22-26, 2022. The presentation is scheduled for June 26, 2022, at 10:00 AM BST, led by Timo Vesikari, M.D. The company’s hepatitis B vaccine is notable for being the only 3-antigen vaccine approved in the EU, US, and Israel, designed to significantly combat a global health threat that affects over 290 million people worldwide.
VBI Vaccines Inc. presented a health economics and outcomes research (HEOR) poster comparing its 3-antigen hepatitis B vaccine, PreHevbrio™, to a single-antigen vaccine, Engerix-B®, at the ISPOR 2022 conference. The study focused on the cost-effectiveness of these vaccines in U.S. adults. PreHevbrio™ is notable as the only 3-antigen hepatitis B vaccine and is approved in the U.S., EU, and Israel, targeting over 290 million people infected globally with HBV. This research underscores VBI's commitment to advancing vaccine solutions amidst significant health challenges posed by hepatitis B.