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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 CEO Jeff Baxter and CSO David E. Anderson, Ph.D., will participate in analyst-led fireside chats at two upcoming investor conferences. The Jefferies Virtual Healthcare Conference is set for June 3, 2021, at 1 PM ET. The Raymond James Human Health Innovation Conference will follow on June 23, 2021, at 12 PM ET. Live webcasts will be available on VBI's website, where replays will also be archived post-event. VBI focuses on immunology-based therapies for infectious diseases and cancers.
VBI Vaccines Inc. (Nasdaq: VBIV) announced the drawdown of a $12 million second tranche from a debt financing facility with K2 HealthVentures, increasing the total potential funding to $52 million. The second tranche was upsized from the original $10 million due to the achievement of significant clinical milestones, including positive survival data from Phase 2a for VBI-1901 in glioblastoma and proof-of-concept for VBI-2601 in chronic hepatitis B. Two additional tranches of $10 million each are available upon meeting specific conditions.
VBI Vaccines Inc. (Nasdaq: VBIV) announced expanded tumor response and overall survival data from the Phase 2a portion of its ongoing Phase 1/2a study for VBI-1901, a cancer vaccine targeting recurrent glioblastoma (GBM). At the 2021 ASCO Annual Meeting, data revealed a 6-month overall survival (OS) rate of 80% and 89% in two study arms. Notably, historical controls show ~60% OS at 6 months for GBM. The e-poster presentation by Dr. Patrick Y. Wen will provide insights into this promising therapy's potential in a challenging treatment landscape.
VBI Vaccines (Nasdaq: VBIV) announced that results from its pivotal Phase 3 study, PROTECT, for its 3-antigen hepatitis B vaccine were published in The Lancet Infectious Diseases. The study showed a seroprotection rate of 91.4% for VBI's vaccine compared to 76.5% for Engerix-B® at Day 196, and it exceeded pre-set margins for statistical superiority, especially in adults over 45 years. The safety profile was consistent with previous studies, indicating no new safety risks. Regulatory submissions in North America and Europe are ongoing.
VBI Vaccines reported Q1 2021 financial results with notable developments in its pipeline, focusing on hepatitis B, COVID-19, and glioblastoma. The company raised $22.1 million through share issuance, enhancing its cash position to $133.6 million. Revenue decreased to $0.3 million due to reduced R&D services from collaborations. R&D expenses rose to $6.8 million, attributed to COVID-19 vaccine programs. Net loss increased to $17.6 million, with a loss per share of $0.07. Key upcoming milestones include regulatory reviews and clinical data releases throughout 2021.
VBI Vaccines Inc. (Nasdaq: VBIV) has announced the acceptance of two abstracts for presentation at the Canadian Liver Meeting 2021 regarding its Phase 3 program for a 3-antigen prophylactic hepatitis B vaccine. The oral presentation, scheduled for May 4, will be led by VBI’s Chief Medical Officer, Francisco Diaz-Mitoma, discussing superior seroprotection rates of the vaccine. The second abstract will be showcased in the poster gallery. VBI's vaccine, commercially available in Israel, targets hepatitis B, a disease affecting over 290 million globally.
VBI Vaccines Inc. (Nasdaq: VBIV) announced the submission of preclinical data for its enveloped virus-like particle (eVLP) vaccine candidate, VBI-2902, for peer review. The data shows that VBI-2902, expressing a modified SARS-CoV-2 spike protein, elicited a potent neutralizing antibody response and provided significant protection in hamster models infected with COVID-19. Initial Phase 1/2 study in Canada has commenced, with results expected by Q2 2021. The vaccine demonstrates robustness at few doses and without ultra-cold chain requirements.
VBI Vaccines Inc. (Nasdaq: VBIV) announced that CEO Jeff Baxter and CSO David E. Anderson, Ph.D., will present on their coronavirus vaccine candidates at a virtual biotech investor summit on April 28, 2021, at 1:30 PM ET. The event, titled 'Over the Hump: Vaccine Strategies and Preparedness in a Variant World,' will be moderated by National Securities’ Senior Biotechnology Analyst, Cosme Ordonez, M.D., Ph.D. Attendees can access a live webcast and a replay will be available on VBI’s investor webpage.
VBI Vaccines Inc. (Nasdaq: VBIV) announced that its abstract from the PROTECT study, assessing its 3-antigen hepatitis B vaccine, has been accepted for oral presentation at the NFID 2021 Annual Conference on Vaccinology Research. The presentation, titled Higher seroprotection rates (SPR), will take place on April 27, 2021. VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine approved in Israel, and the Phase 3 study aims to demonstrate superior immunogenicity and safety compared to existing vaccines, addressing a significant global health threat.
Brii Biosciences, Vir Biotechnology, and VBI Vaccines have commenced a Phase 2 clinical trial for BRII-835 (VIR-2218) and BRII-179 (VBI-2601) aimed at treating chronic hepatitis B virus (HBV) infection. This landmark trial investigates the combination of an siRNA targeting HBV and an HBV immunotherapeutic, marking the first clinical evaluation of this dual-action approach. The study is multi-centered across several countries in Asia and Oceania, focusing on safety and efficacy. Leading experts express optimism about achieving a functional cure for HBV through this innovative combination.
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