VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketed product is Sci-B-Vac®, a hepatitis B (“HBV”) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac is approved for use in Israel and ten other countries. VBI’s eVLP Platform technology allows for the development of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (“CMV”) and glioblastoma multiforme (“GBM”). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that allows vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.
Sci-B-Vac® is a licensed, third-generation hepatitis B vaccine that has demonstrated safety and efficacy in over 500,000 patients. Sci-B-Vac is currently approved for use in Israel and 14 other countries. In December 2017, VBI initiated patient dosing in a global, 15-month Phase 3 clinical program that, if successful, will allow the company to seek marketing authorization in the U.S., Europe, and Canada.
In contrast to some current hepatitis B vaccines, which contain only one surface antigen (the S antigen), Sci-B-Vac contains the S antigen and the pre-S1 and pre-S2 surface antigens. The composition of Sci-B-Vac may provide more opportunities for the immune system to respond with antibodies that can recognize one or more components of the hepatitis B virus (“HBV”).
According to the World Health Organization (“WHO”), globally, 240 million people are chronically infected with hepatitis B and more than 780,000 people die every year due to complications related to the virus, including cirrhosis and liver cancer. Learn more about Sci-B-Vac >>
- Mimics all three surface antigens of the hepatitis B virus.
- Offers high levels of anti-HBV antibodies and rapid onset of protection.
- Can be administered at lower doses than other currently available hepatitis B vaccines.
- Free of next-generation adjuvants.
- Produced in mammalian cells (CHO cells).
Competing Hepatitis B Vaccine
VBI’s eVLP Platform allows for the design of enveloped (“e”) virus-like particle (“VLP”) vaccines. eVLPs are designed to mimic the organization and conformation of viruses as they occur in nature, but without the viral genome, potentially yielding safer and more potent vaccine candidates.
Because of their structural similarity to viruses found in nature, vaccination with a target protein expressed in an eVLP is capable of imparting greater immunity than vaccination with the same recombinant target protein alone.1 Learn more >>
- “Third-generation” virus-like particle vaccines closely mimic the structure of target viruses.
- Potential preventative and therapeutic vaccine applications.
- Lead program is a vaccine to prevent cytomegalovirus (“CMV”) infection with strong preclinical proof of concept.2
- Exploring additional undisclosed eVLP candidates for development.
- Strong intellectual property estate.
Dr. David Anderson, VBI’s Chief Scientific Officer, discusses VBI’s unique approach to vaccine development.
Unlike first-generation and second-generation VLP approaches, which have yielded successful vaccines but can mean limited rational and flexible design potential, VBI’s eVLP Platform provides a stable foundation that mimics enveloped viruses and is suitable for a wide array of vaccine candidates.3
- Highly Immunogenic: Immune responses comparable to or better than natural infection by closely mimicking structure of target virus.4
- Customizable: Ability to rationally design a vaccine by including different antigens and controlling their relative expression.
- Safe: Unlike live-attenuated vaccines, VLPs cannot revert back to an infectious state.
- Commercially Viable: Manufactured and purified using scalable methods; demonstrated high yields and purity.5
Pipeline of eVLP-Derived Vaccine Candidates
Phase 1 (VBI-1501)
Phase 1/2a (VBI-1901)
CMV Vaccine Program
VBI is developing a prophylactic vaccine to prevent cytomegalovirus (“CMV”) infection. CMV is a leading cause of prenatal developmental delays. VBI has completed GMP manufacturing of its lead candidate for use in Phase I trials. VBI expects to evaluate safety, tolerability, and also immunological proof of concept in humans during Phase I trials by measuring CMV neutralizing antibodies in fibroblasts and epithelial cells. Learn more about VBI’s CMV Vaccine Candidate >>
Achieved and Anticipated Program Milestones
- Q2 2015: Initiated Formal Toxicology
- Q3 2015: Started GMP Clinical Batch
- Q1 2016: Complete Formal Toxicology and File IND
- H1 2016: Phase I Start
- Mid-Year 2017: Interim Readout
Market Need and Opportunity
CMV is a common virus that infects one in every two people in many developed countries.1 Most CMV infections are “silent,” meaning most people who are infected with CMV exhibit no signs or symptoms. However, CMV can cause serious disease in newborns when a mother is infected during pregnancy – this is known as congenital CMV infection.
Each year, approximately 5,000 U.S. infants will develop permanent problems due to CMV, some of them severe, including deafness, blindness, and mental retardation.2 CMV affects more live births than Down Syndrome or Fetal Alcohol Syndrome,3 making it a key public health priority and a strong candidate for recommended universal vaccination among certain high-risk populations.4
The LPV Platform is a proprietary formulation and process that allows vaccines and biologics to preserve stability, potency, and safety. Many vaccines and biologics are highly sensitive to temperature and physical stress, and many must be stored between 4° C and 8° C to preserve their integrity. Without proper storage, exposure to elevated or freezing temperatures can lead to a loss in potency or reduced safety, limiting protective benefits or therapeutic effects.1 Learn more >>
- Long-lasting stability across a variety of conditions; demonstrated potency in multiple preclinical animal models, including non-human primates.2
- Suitable for a variety of vaccines and biologics; has been used to preserve stability and potency of several classes of vaccine antigens, including protein-based, monoclonal antibodies, whole-inactivated, and live-attenuated vaccines and viral vectors.3
- Successfully tested in a GMP-compliant production plant at pilot levels; data demonstrates product consistency across batches.4
- Novel, fully synthetic lipid combinations with well-established safety profiles; lipids reduce protein aggregation and reduce other process-related (sheer) stresses.5
With its partners, VBI seeks to develop a next-generation of vaccines and biologics which preserve stability and allow for consistently safe and effective administration in both established and emerging markets. If you are interested in learning more about our LPV Platform, please contact us.
Collaborations of Note
VBI has completed proof of concept studies on a number of vaccine and biologic targets that demonstrate the LPV Platform’s ability to preserve potency under stress conditions:
Proof of Concept Studies
Vaccines and biologics vary greatly in their ability to remain viable during handling, storage, and administration. The stability of a particular vaccine formulation depends on many factors including the type of antigen (active ingredient) and the presence of other vaccine components such as adjuvants, stabilizers, and preservatives.
One factor that is known to affects characteristics of all vaccines over time is temperature. Without a constant temperature in a very narrow range above freezing, many vaccines lose their potency, become ineffective, or can become hazardous. Currently, more than 90% of all vaccines require shipment in a temperature controlled supply chain or “cold chain”.10
Reliance on a cold chain increases vaccine costs by up to 20%11 and is a significant barrier to patient access in many emerging markets. In addition to maintaining the cold chain, there is a separate challenge of verifying any lapses in the chain to ensure the viability of the vaccine before it is administered, particularly in poor or remote areas.
- Kirchmeier et al. (2014). Enveloped Virus-Like Particle Expression of Human Cytomegalovirus Glycoprotein B Antigen Induces Antibodies with Potent and Broad Neutralizing Activity. Clinical and Vaccine Immunology, 174-180.
- VBI Studies: 15BC04, 15BC19, 15BC39
- VBI studies: 15BC04, 15BC19 (CMV); Garrone, P (2011) Sci Transl Med 3, 94ra71 (HCV); Szecsi, J (2006) Virol J 3, 70 (Flu)
- VBI Studies: 15BC04, 15BC19
- VBI Studies: 15CH19, 15CH38
CMV Vaccine Program
- Cannon, M. J., and K. F. Davis. 2005. Washing our hands of the congenital cytomegalovirus disease epidemic. BMC Public Health 5:70
- Stratton KR et al, Committee to Study Priorities for Vaccine Development, Inst. of Med.; Washington, DC
- CDC Vaccine Storage and Handling Recommendations and Guildelines (http://www.cdc.gov/vaccines/recs/storage/)
- VBI Studies: 12BC04, 12MK01, 12FE01, Undisclosed partner feasibility studies
- VBI Studies: 12BC04ABCDE, 07CH12, 07CH17, Undisclosed partner feasibility studies
- VBI Studies: 12BC04ACDE, Reports REP-IMM-034, REP-FORM-101
- VBI Studies: 07CH12, Undisclosed partner feasibility studies
- VBI Studies: 12BC04ACDE, Reports REP-IMM-034, REP-FORM-101
- VBI Studies: 07CH17
- VBI Studies: 07CH12
- VBI Studies: Undisclosed partner feasibility study
- Biopharma Cold Chain Sourcebook 2010
- World Health Organization (“WHO”)