The hepatitis B infection continues to be a worldwide problem with 240 million people chronically infected. VBI Vaccines have the ability to advance late-stage. Phase 3 studies of its third-generation hepatitis B vaccine candidate - Sci-B-Vac®.  What makes Sci-B-Vac a 3rd generation vaccine, and how is it differentiated from the earlier-generation vaccines for HBV?  What unmet need are you working to address with the development of Sci-B-Vac? 

To our knowledge, Sci-B-Vac is the only commercially available vaccine that includes all three surface antigens of the Hepatitis B virus – the pre-S1, pre-S2, and the S antigens.  It is also adjuvanted with alum, an adjuvant used in FDA-approved vaccines, including some hepatitis B vaccines that have been safely administered to millions of newborn children.  The inclusion of all 3 antigens, notably the pre-S1 and pre-S2 antigens, and the mammalian cell derivation, rather than yeast derivation, drive a robust immune response.

Seroprotection rates with some older-generation HBV vaccines decline in both the elderly and in the immuno-compromised populations.  In head - to - head comparative trials, Sci-B-Vac® consistently achieved higher rates of seroprotection earlier in adult populations compared to the vaccines in the control arms, which were licensed hepatitis B vaccines.  This existing data, and data from the ongoing Phase 3 studies expected to read out mid-year 2019, could support the use of Sci-B-Vac in those adult populations that are not sufficiently protected by older-generation hepatitis B vaccines.

There are only a few small vaccine biotech companies – you more often see vaccine development from either large pharmaceutical companies or NGOs.  VBI is developing a pipeline of vaccine candidates using a proprietary enveloped virus-like particle (eVLP) technology to target unmet need in both infectious disease and immuno-oncology.  What is it about these vaccines that are particularly attractive to VBI?

Prevention is always better than a cure.  Our next generation of vaccines is designed to address some of the biggest unmet needs in both infectious disease and in immuno-oncology.  The eVLP platform represents a novel approach to designing vaccines based on protein structures that closely mimic the structure of viruses as they occur in nature, but without the viral genome, potentially yielding safer and more immunogenic vaccines. eVLPs are highly customizable, which allow VBI to design both preventative and therapeutic vaccine candidates.  In addition to Sci-B-Vac, VBI is advancing a preventative cytomegalovirus candidate, targeting a leading cause of birth defects, that recently produced positive, final Phase 1 data, and a therapeutic candidate to treat recurrent glioblastoma, brain cancer, which is currently in a phase 1/2a study.

Where do you see the field of vaccines in 5 years, and what role do you hope to play in improving human health and preventing disease?

Vaccines are essentially a way to harness the body’s natural immune response to fight disease. In addition to the prevention of infectious diseases, we see a broad expansion of vaccines as therapeutic approaches to targeting both infectious disease and immuno-oncology targets.  Immunology is a growing field of scientific study, and VBI is well-positioned to be a leader in the development of those next-generation vaccines.