VBI Vaccines Stock

VBI Vaccines Inc. (VBI) operates as a commercial stage biopharmaceutical company.

Through the company’s innovative approach to virus-like particles (‘VLPs’), including a proprietary enveloped VLP (‘eVLP’) platform technology, the company develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. The company is committed to targeting and overcoming significant infectious diseases, including hepatitis B (‘HBV’), COVID-19 and coronaviruses, and cytomegalovirus (‘CMV’), as well as aggressive cancers, including glioblastoma (‘GBM’).

Product Pipeline

The company’s pipeline is consisted of vaccine and immunotherapeutic programs developed by virus-like particle technologies to target two distinct, but often related, disease areas - infectious disease and oncology. The company prioritizes the development of programs for disease targets that are challenging, underserved, and where the human immune system, when powered and stimulated appropriately, can be a formidable opponent.

The company’s eVLP platform technology expands the list of potentially viable target indications for VLPs by providing a stable core (Gag Protein) and lipid bilayer (the ‘envelope’). It is a flexible platform that enables the synthetic manufacture of an ‘enveloped’ VLP, or ‘eVLP’, which looks structurally and morphologically similar to the virus, with no infectious material.

The company’s product pipeline includes an approved vaccine and multiple late- and early-stage investigational programs. The investigational programs are in various stages of clinical development and the scientific information included about these therapeutics is preliminary and investigative. The investigational programs have not been approved by the United States Food and Drug Administration (‘FDA’), European Medicines Agency (‘EMA’), the United Kingdom Medicines and Healthcare products Regulatory Agency (‘MHRA’), Health Canada, or any other health authority and no conclusion can or should be drawn regarding the safety or efficacy of these investigational programs.

In addition to the company’s existing pipeline programs, the company may seek to in-license clinical-stage vaccines or vaccine-related technologies that complement the company’s pipeline, as well as technologies that may supplement the company’s efforts in both immuno-oncology and infectious disease.

Marketed Product

PreHevbrio [Hepatitis B Vaccine (Recombinant)]

PreHevbrio [Hepatitis B Vaccine (Recombinant)] was approved by the FDA on November 30, 2021, for the prevention of infection caused by all known subtypes of HBV in adults aged 18 years and older. PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S. On February 23, 2022, following discussion at the CDC’s ACIP meeting, PreHevbrio joined the list of recommended products for prophylactic adult vaccination against HBV infection. The inclusion of PreHevbrio in the ACIP recommendation was reflected in a CDC publication on April 1, 2022 and was a notable milestone as many insurance plans and institutions require an ACIP recommendation before a vaccine can be reimbursed or is made available to patients. Additionally, PreHevbrio was included in the 2023 annual update of the CDC Adult Immunization Schedule, as detailed in the CDC publication on February 10, 2023. VBI launched PreHevbrio in the U.S. at the end of the first quarter of 2022, and revenue generation began in the second quarter of 2022.

Commercial and regulatory activity for VBI’s 3-antigen HBV vaccine outside of the U.S. include:

EU: On May 2, 2022, the company announced that the European Commission (the ‘EC’) granted Marketing Authorization for PreHevbri [Hepatitis B Vaccine (Recombinant, Adsorbed)]. The European Commission’s centralized marketing authorization is valid in all EU Member States as well as in the EEA countries (Iceland, Liechtenstein, and Norway). On September 8, 2022, the company announced a partnership with Valneva SE (‘Valneva’) for the marketing and distribution of PreHevbri in select European markets, initially including the U.K., Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands. As part of this partnership, VBI expects PreHevbri will be available in certain European countries beginning in the first half of 2023.

The U.K.: On June 1, 2022, the company announced that the MHRA granted marketing authorization for PreHevbri [Hepatitis B Vaccine (Recombinant, Adsorbed)]. This follows the EC centralized marketing authorization received in May 2022 and was conducted as part of the EC Decision Reliance Procedures (‘ECDRP’). VBI expects to make PreHevbri available in the U.K. in the first half of 2023 as part of the partnership with Valneva.

Canada: On December 8, 2022, the company announced that Health Canada approved PreHevbrio [3-antigen Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of HBV in adults aged 18 years and older. VBI expects to make PreHevbrio available in Canada in 2023.

Israel: Approved and commercially available under the brand name Sci-B-Vac.

Prophylactic Investigational Candidates

VBI-2900: Coronavirus Vaccine Program (VBI-2901, VBI-2902, VBI-2905)

In response to the ongoing SARS-CoV-2 (COVID-19) pandemic, VBI initiated development of a prophylactic coronavirus vaccine program. Coronaviruses are enveloped viruses by nature which make them a prime target for VBI’s flexible eVLP platform technology.

On August 26, 2020, the company announced data from three pre-clinical studies conducted to enable selection of optimized clinical candidates for the company’s coronavirus vaccine program. As a result of these studies, VBI selected two vaccine candidates with the intention of bringing forward candidates that add meaningful clinical and medical benefit to those already approved: VBI-2901, a multivalent coronavirus vaccine candidate expressing the SARS-CoV-2, SARS, and MERS spike proteins; and VBI-2902, a monovalent vaccine candidate expressing an optimized ‘prefusion’ form of the SARS-CoV-2 spike protein.

In March 2021, a Phase I study of VBI-2902 was initiated and on June 29, 2021, the company announced initial positive data from the Phase Ia portion of this study that evaluated one- and two-dose regimens of 5µg of VBI-2902 in 61 healthy adults aged 18-54 years. After two doses, VBI-2902 induced neutralization titers in 100% of participants, with 4.3x higher geometric mean titer (‘GMT’) than that of the convalescent serum panel (n=25), and peak antibody binding GMT of 1:4,047. VBI-2902 was also well tolerated with no safety signals observed.

In response to the increased circulation of SARS-CoV-2 variants, the Phase Ib portion of the Phase I study was initiated in September 2021 to assess VBI-2905, the company’s eVLP vaccine candidate directed against the SARS-CoV-2 Beta variant. On April 5, 2022, the company announced new data from the Phase Ib study (n=53). A single-dose booster of VBI-2905 increased the geometric mean titer (‘GMT’) of neutralizing antibodies directed against the Beta variant 3.8-fold, at day 28, in participants who had previously received two-doses of an mRNA vaccine (ancestral strain) – approximately 2-fold increases were also seen at day 28 in antibody GMTs against both the ancestral and delta variant. New preclinical data announced at the same time showed that against a panel of coronavirus variants in mice, reactivity was seen with VBI-2902 against all variants, including the ancestral strain, Delta, Beta, Omicron, Lambda, and RaTG13 (a bat coronavirus that is distant to circulating human strains). In this same panel, VBI-2901 was able to elicit an even stronger response against all variants tested – as the strains became more divergent from the ancestral strain, VBI-2901 elicited a greater difference in GMT from VBI-2902, ranging from 2.5-fold higher against the ancestral strain to 9.0-fold higher against the bat coronavirus. Additionally, a validated pseudoparticle neutralization assay (‘PNA’) benchmarked against the WHO reference standard demonstrated that VBI-2902 elicited neutralizing antibody responses of 176 IU50/mL in its Phase Ia study – this international standard measure would predict a greater than 90% efficacy, with two internationally approved vaccines estimated to have 90% efficacy at 83 and 140 IU50/mL (Gilbert, PB, 2021).

The clinical and preclinical data for all three candidates continue to support the potential of the eVLP platform against coronaviruses. On September 29, 2022, the company initiated the first clinical study of VBI’s multivalent coronavirus candidate, VBI-2901, designed to increase breadth of protection against COVID-19 and related coronaviruses. Interim data from this study are expected mid-year 2023.

The VBI-2900 program is supported by a partnership with the Coalition for Epidemic Preparedness Innovations (‘CEPI’ and the partnership, the ‘CEPI Funding Agreement’); a partnership with the Strategic Innovation Fund (‘SIF’), established by the Government of Canada; and a collaboration with the NRC. On December 6, 2022, the company and CEPI announced that the company expanded the scope of the CEPI Funding Agreement to advance the development of multivalent coronavirus vaccines that could be deployed against COVID-19, as well as a future ‘Coronavirus X’.

VBI-1501: Prophylactic CMV Vaccine Candidate

The company’s prophylactic CMV vaccine candidate uses the eVLP platform to express a modified form of the CMV glycoprotein B (‘gB’) antigen and is adjuvanted with alum, an adjuvant used in FDA-approved products.

Following the successful completion of the Phase I study in May 2018, and positive discussions with Health Canada, the company announced plans for a Phase II clinical study evaluating VBI-1501 on December 20, 2018. The company received similarly positive guidance from the FDA in July 2019. The Phase II study is expected to assess the safety and immunogenicity of dosages of VBI-1501 up to 20µg with alum. The company is evaluating the timing of the Phase II study.

Therapeutic Investigational Candidates

VBI-2601: HBV Immunotherapeutic Candidate

VBI-2601 (BRII-179) is the company’s novel, recombinant, protein-based immunotherapeutic candidate in development for the treatment of chronic HBV infection. VBI-2601 is formulated to induce broad immunity against HBV, including T-cell immunity which plays an important role in controlling HBV infection.

On April 12, 2021, and June 23, 2021, the company announced data from the completed Phase Ib/IIa clinical study in patients with chronic HBV infection, which was conducted by the company’s partner Brii Biosciences Limited (‘Brii Bio’). The study was a randomized, controlled study designed to assess the safety, tolerability, antiviral and immunologic activity of VBI-2601. The study was a two-part, dose-escalation study assessing different dose levels of VBI-2601 with and without an immunomodulatory adjuvant, conducted at multiple study sites in New Zealand, Australia, Thailand, South Korea, Hong Kong Special Administrative Region of China, and China.

The data from the Phase Ib/IIa for 33 evaluable patients across all study arms suggested: VBI-2601 was well tolerated at all dose levels with and without the adjuvant with no significant adverse events identified; VBI-2601 induced both B cell (antibody) and T cell responses in chronically-infected HBV patients; VBI-2601 induced restimulation of T cell responses to HBV surface antigens, including S, Pre-S1, and Pre-S2, in greater than 50% of the evaluable patients compared to no detectable response in the control arm; the T cell responses and antibody responses were comparable across the 20µg and 40µg unadjuvanted study arms; and T cell response rates between the adjuvanted and unadjuvanted cohorts were also comparable. Based on the acceptable safety profile and vaccine-induced adaptive immune responses seen in this study, VBI-2601 (BRII-179) advanced to Phase II studies.

On April 21, 2021, the company announced that the first patient had been dosed in a Phase II clinical study evaluating VBI-2601 in combination with BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (‘siRNA’) targeting HBV, for the treatment of chronic HBV infection. The multi-center, randomized, open-label study is designed to evaluate the safety and efficacy of this combination with and without interferon-alpha as a co-adjuvant. The study is being conducted at clinical sites in Australia, Taiwan, Hong Kong Special Administrative Region of China, South Korea, New Zealand, Singapore, and Thailand. VBI’s partner, Brii Bio, is the study sponsor.

On February 15, 2023, the company announced interim data from the Phase II combination study. The data, which was featured in an oral presentation at the 32nd Conference of the Asian Pacific Association for the Study of the Liver (‘APASL’) on February 18, 2023, demonstrated that the combination therapy was generally well-tolerated, restored strong anti-HBsAg antibody responses, and led to improved HBsAg-specific T-cell responses, when compared to BRII-835 alone.

Additional data from the study are expected to be announced later this year.

On January 5, 2022, the company announced that the first patient was dosed in a second Phase IIa/IIb clinical study evaluating VBI-2601. This Phase II study assesses VBI-2601 as an add-on therapy to the standard-of-care in China nucleos(t)ide reverse transcriptase inhibitor (‘NRTI’) and pegylated interferon therapy (PEG-IFN-a,). Interim topline clinical data from part one of this Phase IIa/IIb clinical study is expected in the third quarter of 2023.

VBI-1901: Glioblastoma (GBM)

The company’s cancer vaccine immunotherapeutic program, VBI-1901, targets CMV proteins present in tumor cells. CMV is associated with a number of solid tumors, including GBM, breast cancer, and pediatric medulloblastoma.

In January 2018, the company initiated dosing in a two-part, multi-center, open-label Phase I/IIa clinical study of VBI-1901 in 38 patients with recurrent GBM. Phase I (Part A) of the study was a dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences. In December 2018, this phase completed enrollment of 18 patients across three dose cohorts, the highest of which (10 µg) was selected as the optimal dose level to test in the Phase IIa portion (Part B) of the study. Phase IIa of the study, which initiated enrollment in July 2019, is a two-arm study that enrolled 20 first-recurrent GBM patients to receive 10 µg of VBI-1901 in combination with either GM-CSF or GSK proprietary adjuvant system, AS01, as immunomodulatory adjuvants. AS01 is provided pursuant to a Clinical Collaboration and Support Study Agreement with GSK, which the company entered into on September 10, 2019. Enrollment of the 10 patients in the VBI-1901 with GM-CSF arm was completed in March 2020 and enrollment of the 10 patients in the VBI-1901 with AS01 arm was completed in October 2020.

On June 8, 2021, the company announced that the FDA granted Fast-Track Designation for VBI-1901 formulated with GM-CSF for the treatment of recurrent GBM patients with first tumor recurrence. The designation was granted based on data from the Phase I/IIa study.

On June 22, 2022, the company announced that the FDA granted Orphan Drug Designation for VBI-1901 for the treatment of GBM.

Based on the data seen to-date, as part of the next phase of development the company anticipates assessing VBI-1901 in randomized, controlled studies in both primary and recurrent GBM patients. In the recurrent setting, the company intends to expand the number of patients in the current trial and add a control arm, with the potential to support an accelerated approval application based on tumor response rates and improvement in overall survival. Subject to discussion with the FDA, the amended protocol is expected to initiate enrollment of additional patients in the second quarter of 2023.

On October 12, 2022, the company announced a collaboration with Agenus Inc. to evaluate VBI-1901 in combination with anti-PD-1 balstilimab in a Phase II study as part of the INSIGhT adaptive platform trial in patients with primary GBM. Subject to approval from regulatory bodies, the company expects enrollment to initiate in the VBI-1901 study arm in INSIGhT mid-year 2023.

Partnerships, Collaborations, and Licensing Agreements

The company’s focus is to develop and deliver vaccines and therapeutics that target significant infectious diseases and aggressive cancers. As part of this strategy, the company has entered into, and expect to enter into additional, partnerships, collaborations, and licensing agreements.

Partnership with Syneos Health (‘Syneos’)

On December 7, 2020, the company announced a partnership for the commercialization of the company’s 3-antigen HBV vaccine with Syneos, who was selected for their robust and innovative commercialization experience and deep vaccine expertise, including successful partnerships with leading vaccine manufacturers. VBI and Syneos began working together on the launch strategy in 2019 and expanded the relationship in 2020 to build the leadership team and field teams dedicated to VBI, incorporating full-service commercialization solutions. As part of this partnership, the company has fully-dedicated field team members across medical affairs, market access, and sales.

Collaboration and License Agreement with Brii Bio

On December 4, 2018, the company entered into the License Agreement with Brii Bio, pursuant to which, among other things, subject to terms and conditions set forth in the License Agreement, amended on April 8, 2021:

The company and Brii Bio agreed to collaborate on the development of a HBV recombinant protein-based immunotherapeutic in China, Hong Kong, Taiwan and Macau (collectively, the ‘Licensed Territory’), and to conduct a Phase Ib/IIa collaboration clinical trial for the purpose of comparing VBI-2601, which is a recombinant protein-based immunotherapeutic developed by VBI for use in treating chronic HBV, with a novel composition developed jointly with Brii Bio (either being the ‘Licensed Product’);

The company granted Brii Bio an exclusive royalty-bearing license to perform studies, and regulatory and other activities, as may be required to obtain and maintain marketing approval for the Licensed Product, for the treatment of HBV in the Licensed Territory and to commercialize and promote the Licensed Product for the diagnosis and treatment of chronic HBV in the Licensed Territory; and

Brii Bio granted the company an exclusive royalty-free license under Brii Bio’s technology and Brii Bio’s interest in any joint technology developed during the collaboration to develop and commercialize the Licensed Product for the diagnosis and treatment of chronic HBV in the countries of the world other than the Licensed Territory.

On December 20, 2021, the company and Brii Bio further amended the License Agreement (the ‘Brii Second Amendment’) subject to the following additional terms and conditions:

The company and Brii Bio agreed to conduct an additional Phase II combination clinical trial of VBI-2601, both with and without IFN-a, and BRII-835 (VIR-2218) (‘Combo Clinical Trial’); and

Brii Bio granted the company a non-exclusive royalty free license under the Brii Bio technology arising from the data generated in the Combo Clinical Trial solely for use in the development, manufacture or commercialization of the Licensed Product in combination with an siRNA in the countries of the words other than the Licensed Territory.

Pursuant to the Brii Second Amendment and the initial development plan, Brii Bio shall fund all clinical trials for the Licensed Territory. The company and Brii Bio will jointly own all right, title and interest in the joint know-how development and the patents claiming joint inventions made pursuant to the Brii Second Amendment.

Collaboration Agreement with GSK

On September 10, 2019, the company entered into the Collaboration Agreement with GSK (the ‘GSK Collaboration Agreement’) pursuant to which the company agreed to investigate the use of GSK’s proprietary AS01 adjuvant in the company’s Phase I/IIa study of VBI-1901. As a result of the GSK Collaboration Agreement, the company added a second study arm to Part B of the study and announced enrollment of patients in the AS01B arm in March 2020.

Collaboration Agreement with the NRC

On March 31, 2020, the company announced a collaboration with the NRC, Canada’s largest federal research and development organization, to develop a coronavirus vaccine candidate. The collaboration combines VBI’s viral vaccine expertise, eVLP technology platform, and coronavirus antigens with the NRC’s uniquely designed SARS-CoV-2 antigens and assay development capabilities to select the most immunogenic vaccine candidate for further development.

On December 21, 2020, the company signed an amendment to the collaboration agreement with the NRC to broaden the scope of collaboration to include certain pre-clinical evaluations, bioprocess optimization, technology transfer, and the performance of additional scale up work.

On July 8, 2021, the company signed a second amendment to the collaboration agreement with the NRC to broaden the scope of the collaboration to include developing a vaccine against the Beta variant of SARS-CoV-2.

On August 27, 2021, the company signed a third amendment to the collaboration agreement with the NRC to further broaden the scope to include certain stable cell line work for the company’s vaccine candidate against the Beta variant of SARS-CoV-2.

On November 15, 2021, the company signed a fourth amendment to the collaboration agreement with the NRC to further broaden the scope for the company’s vaccine candidate against the Beta variant of SARS-CoV-2 to include additional animal studies and PRNT analysis.

On February 8, 2022, the company signed a fifth amendment to the collaboration agreement with the NRC to further broaden the scope to include additional assays of new variants against SARS-CoV-2.

On April 28, 2022, the company signed a sixth amendment to the collaboration agreement with the NRC to further broaden the scope to include generation and testing of stable pools of cells expressing SARS-CoV-2 spike protein.

On February 28, 2023, the company signed a seventh amendment to the collaboration agreement with the NRC to extend the expiration date of the collaboration agreement to December 31, 2023.

Collaboration Agreement with the Agenus Inc. (‘Agenus’)

On October 12, 2022, the company entered into a Clinical Collaboration Agreement with Agenus Inc. pursuant to which the company will evaluate VBI-1901 in combination anti-PD-1 balstilimab in a Phase II study as part of the INSIGhT adaptive platform trial in patients first diagnosed with GBM. Subject to approval from regulatory bodies, the company expects enrollment to initiate in the VBI-1901 study arm in INSIGhT mid-year 2023.

Partnership with the CEPI

On March 9, 2021, the company announced a partnership with CEPI to develop eVLP vaccine candidates against SARS-COV-2 variants, including the Beta variant, also known as the B.1.351 variant and 501Y.V2, first identified in South Africa.

On December 6, 2022, the company and CEPI entered into an amendment to the CEPI Funding Agreement (the ‘CEPI Amendment’) to expand the scope of the CEPI Funding Agreement.

Suppliers

The company has identified the following parties as key suppliers of reagents, technology, or expertise, which impact its development plans with the company’s eVLP pipeline candidates:

UPMC is the owner of the eVLP vaccine platform intellectual property portfolio to which the company has an exclusive license. Under the terms of the ePixis License Agreement, as amended, the company is required to pay royalties for successful products developed using the intellectual property for as long as patent claims cover the period in a given jurisdiction. This patent portfolio has claims that are expected to remain in force until 2023 in the U.S., after which time the company is no longer obligated to compensate UPMC for the development of vaccines based on the UPMC intellectual property portfolio. After that time, the remaining patent protection of the CMV vaccine candidate will be based on patents and patent applications co-owned with UPMC which, if granted, would provide patent protection extending until 2032. The company is negotiating an agreement with UPMC to cover the CMV patents and patent applications.

The company has collaborated with NRC on various vaccine projects since 2004 and has a long history of successful partnerships, including several NRC-administered industrial research grants. The NRC developed a proprietary cell line (HEK-293-NRC) that the company is using for production of the company’s eVLP-based vaccine candidates. VBI Cda and the NRC have signed a research agreement that provides VBI Cda with access to NRC facilities and expertise for the advancement of the company’s vaccine candidate programs. Supplementary to such research agreement, the company negotiated terms for a non-exclusive license to the HEK-293-NRC cell line. Under these terms, the company was required to pay success-based milestone payments until the patents on the cell line expired in November of 2018. The company is collaborating with NRC to develop a coronavirus vaccine candidate. The collaboration combines the company’s viral vaccine expertise, eVLP technology platform, and coronavirus antigens with the NRC’s uniquely designed SARS-CoV-2 antigens and assay development capabilities to select the most immunogenic vaccine candidate for further development. The scope of collaboration includes certain pre-clinical evaluations, bioprocess optimization, technology transfer, and the performance of additional scale up work.

Catalent Biologics has manufactured clinical batches of the company’s CMV vaccine candidate and its GBM immunotherapeutic vaccine candidate pursuant to the terms of a GMP-Manufacturing Services Agreement dated September 26, 2014. Resilience Biotechnologies manufactures clinical batches of the company’s prophylactic coronavirus vaccine program and the company’s GBM immunotherapeutic vaccine candidate pursuant to the terms of a Master Service and Supply Agreement dated November 10, 2020.

Research and Development

The company’s research and development expenses were $15.5 million for the year ended December 31, 2022.

Intellectual Property

Patents

The company’s intellectual property portfolio includes 19 active patent families consisting of 196 fully owned or co-owned or exclusively licensed patents and patent applications. The highlights of the company’s patent portfolio include:

eVLP Vaccine Related Intellectual Property: The company has an exclusive license to a patent family that protect the eVLP vaccine platform and derivatives thereof. Among these patents are rights that were originally developed at the UPMC (now Sorbonne Universite), for which the company holds a world-wide exclusive license to the base technology for the design of an eVLP.

GBM Vaccine Immunotherapeutic Candidate Related Intellectual Property: The company owns or co-owns three patent families, which directly address the company’s GBM vaccine immunotherapeutic candidate. These patents and applications include claims to compositions of matter and methods of treating GBM patients.

CMV Vaccine Candidate Related Intellectual Property: The company owns or co-owns two patent families which directly address the company’s CMV vaccine candidate. These patents and patent applications include a composition of matter patent describing the CMV vaccine candidate, as well as a proprietary assay used to provide high-throughput screening of anti-CMV vaccine candidate responses.

HBV Immunotherapeutic Candidate Related Intellectual Property: The company owns or co-owns two patent families, which directly address the company’s HBV immunotherapeutic candidate. These patent applications include claims to compositions of matter and methods of treating HBV patients.

Coronavirus Vaccine Candidate Related Intellectual Property: The company owns or co-owns two patent families which directly addresses the company’s coronavirus vaccine candidates. These patent applications include claims to compositions of matter and methods of treating a subject at risk of COVID-19 infection.

Lipid Particle Vaccines (‘LPV’) Vaccine Related Intellectual Property: The company owns six patent families, which protect its LPV technology platform. These patents include the method for manufacturing an LPV so as to confer thermostability, the proprietary ratios of excipients and antigens that are required to give rise to a thermostable formulation, and specific parameters required to confer thermostability to several distinct classes of vaccine antigens and biologic proteins.

The company’s licensed patent family relating to virus-like particles has a patent whose term extends to 2023 in the U.S. The company’s most recently filed patent family will have a patent term that extends to 2041.

Trademarks

The company uses the PreHevbrio, PreHevbri, and Sci-B-Vac trademarks in connection with its 3-antigen HBV vaccine. These trademarks are registered in 12 countries. There are two pending marks in the U.S. and one pending mark in Norway. There is one registered European Community mark. The company also has a registration for the LPV mark in Canada.

Governmental Regulation and Product Approval

The manufacturing and marketing of the company’s products and product candidates and the company’s ongoing research and development activities are subject to extensive regulation by the FDA and comparable regulatory agencies of local, state, and foreign jurisdictions, such as Health Canada in Canada, the EMA in Europe, and the MHRA in the U.K.

The company relies on third parties for the production of clinical and commercial quantities of the company’s products in accordance with cGMP regulations.

The company is also subject to regulation by the Occupational Safety and Health Administration and federal, provincial and state environmental protection agencies and to regulation under the Toxic Substances Control Act.

Competition

The company faces general market competition from several subsectors of the vaccine development field, including large, multinational pharmaceutical companies, including Sanofi S.A. (‘Sanofi’), GSK, Merck, Janssen Pharmaceutical, Inc (‘Janssen’), Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Company Limited, and Pfizer, Inc. (‘Pfizer’); large and mid-size pharmaceutical companies and emerging biotechnology companies, including Dynavax, Novavax Inc., Moderna, Inc. (‘Moderna’), BioNTech SE, and Hookipa Biotech AG; and academic and not-for-profit vaccine researchers and developers, including the National Institutes of Health.

In the prophylactic HBV vaccine space, the company has several key competitors commercializing single-antigen HBV vaccines, including GSK, the manufacturer of Engerix-B and Twinrix; Merck, the manufacturer of Recombivax HB; and Dynavax, the manufacturer of Heplisav-B.

Within the CMV vaccine space, the company has several key competitors, some of whom are further advanced with their CMV vaccine development. Among these, Moderna’s CMV vaccine is in Phase III, and Hookipa Biotech AG CMV vaccine is in Phase II.

History

The company was formerly known as SciVac Therapeutics Inc. and changed its name to VBI Vaccines Inc. in 2016.