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Company Overview
VBI Vaccines Inc. is a biopharmaceutical company dedicated to developing innovative vaccine technologies designed to broaden protection across underserved markets. Utilizing an advanced enveloped virus-like particle (eVLP) platform and state-of-the-art thermostable technology, the company aims to address fundamental challenges in vaccine design and distribution. Headquartered in Cambridge, MA with research facilities in Ottawa, Canada, VBI Vaccines operates at the intersection of cutting-edge biotechnology and practical medical solutions, establishing itself as a notable contender in the highly specialized field of vaccine development.
Innovative Vaccine Technologies
The cornerstone of VBI Vaccines’ approach lies in its proprietary eVLP technology. This platform facilitates the design of vaccines that closely mimic the structure of the target virus, thereby prompting a comprehensive and natural immune response. With the lead asset focused on a prophylactic cytomegalovirus (CMV) vaccine, the company exemplifies the integration of advanced molecular biology with immunological insights. Additionally, its investment in thermostable technology is a response to the persistent challenges posed by vaccine storage and transportation. This technology enhances the resilience of vaccines and biologics against temperature fluctuations, ensuring stability and efficacy without constant reliance on traditional cold-chain logistics.
Market and Industry Landscape
Operating within the expansive realm of biopharmaceutical research, VBI Vaccines Inc. is positioned in a competitive yet rapidly evolving segment of the healthcare industry. As demand for reliable and robust vaccine technologies grows, particularly in regions with limited access to sophisticated storage infrastructure, the company’s dual technological focus serves a critical role. The combination of the eVLP platform with thermostability addresses both the scientific and logistical problems typically encountered in vaccine rollout. This positions VBI Vaccines to potentially make inroads into markets that have traditionally been constrained by issues of vaccine distribution and temperature control.
Research and Business Strategy
VBI Vaccines Inc. sustains its research-driven approach through a comprehensive strategy that integrates early clinical explorations with robust manufacturing development. The initiation of cGMP manufacturing processes for its CMV candidate underscores a commitment to rigorous standards and prepares the pathway for formal preclinical and phase I trials. Rather than relying on broad market catchlines, the company’s strategy is built on careful, science-backed progress through developmental phases, ensuring that each step meets high standards of quality and efficacy inherent in biopharmaceutical R&D.
Competitive Position and Differentiators
Within the complex ecosystem of vaccine development, competition is significant and multifaceted. VBI Vaccines distinguishes itself through its unique blend of technologies. The eVLP platform not only simulates the native virus more accurately but provides a customizable framework that can be adapted for various pathogens. Meanwhile, the thermostable technology uniquely positions the company to solve one of the vaccine distribution’s nagging logistical challenges: the reliance on cold-chain infrastructure. These dual attributes allow VBI Vaccines to stand apart in a field where many competitors are locked into more conventional methods of vaccine development that do not adequately address the critical stability concerns faced by many healthcare providers worldwide.
Commitment to Scientific Excellence and Market Significance
At its core, VBI Vaccines Inc. is driven by scientific inquiry and a commitment to harnessing innovation to improve public health outcomes. The company’s research undertakings are a testament to its expertise in virology and immunology, applying rigorous scientific methods to solve real-world challenges. The adoption of next-generation vaccine platforms and temperature-resilient formulations ensures that VBI is not only addressing current healthcare needs but is also setting new benchmarks in vaccine development. Investors and industry professionals can view the company as a focused entity that leverages deep scientific expertise to traverse the complexities of vaccine innovation, with each technological breakthrough reinforcing its potential to impact global health significantly.
Operational Excellence and Development Infrastructure
The geographically diversified research presence—spanning Cambridge, MA and Ottawa, Canada—enables VBI Vaccines to tap into varied pools of scientific talent and advanced laboratory capabilities. This strategic arrangement enhances its research and development infrastructure, ensuring that the practical application of its dual technologies is supported by robust experimental and manufacturing setups. The company’s operational model demonstrates a well-integrated approach that combines breakthrough science with pragmatic execution, which is crucial for the demanding nature of biopharmaceutical product development.
Understanding the Business Model
VBI Vaccines Inc. does not solely rely on blockbuster product launches; rather, its business model capitalizes on the integration of specialized research, the validation of novel technologies, and the progressive scaling of manufacturing capabilities. This methodical approach enhances its potential to forge strategic partnerships with stakeholders in the healthcare industry, including research institutions, regulatory bodies, and healthcare providers. Through careful adherence to cGMP standards and a focus on scientific transparency, the company fosters an environment of trust and credibility. Each stage of its developmental pipeline is marked by rigorous scientific validation, which not only builds a robust operational framework but also cultivates an enduring reputation among industry experts and investors alike.
In summary, VBI Vaccines Inc. represents a confluence of innovative science and practical application. With its advanced eVLP technology that mimics target viruses to trigger effective immune responses and its pioneering thermostable techniques that address critical distribution challenges, the company is uniquely poised within its sector. While its ongoing research and development initiatives continue to progress through early trial phases, the firm’s comprehensive approach to solving widespread healthcare challenges elevates its standing within the competitive biopharmaceutical landscape.
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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