VBI Vaccines Inc (NASDAQ:VBIV) just announced that it has received positive feedback from an entity called the Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) regarding its lead hepatitis B asset. The company has gained a few percentage points on the back of the announcement, but as yet, markets are still to respond to the news.
The drug in question, called Sci-B-Vac, accounts for just one part of VBI's development pipeline. However, the implications of a succesfull development campaign for the asset in Europe and the US are considerable, and that's why this latest news is so important.
Here's a look at Sci-B-Vac as a drug, and what has happened to this point, and what's next.
As mentioned, the drug is targeting hepatitis B, and it is a type of preventative vaccine; that is, a vaccine administered before an infection develops in an attempt to prevent future infection.
There are two key things to note about this drug. First, it's approved already in fifteen countries. Second, there already exists numerous hepatitis B vaccines, but VBI's asset has numerous advantages of these alternatives.
The fact that it is already approved means that VBI has been able to gather a wealth of safety and efficacy data together ahead of its submission for regulatory approval in Europe and the US, and this serves to both reduce the cost burden associated with collecting submission supportive data, and improve the chances of said submissions picking up a regulatory green light in their respective regions. To date the drug has behind it an extensive safety and efficacy track record amassed from more than over 20 clinical studies in more than 4,000 children and adults, and more than 300,000 patients have been dosed globally. It's a standard of care vaccination in Israel, administered to children procedurally alongside other standard administration vaccines.
So why is it better than current alternatives, and further, why is a new version of a hepatitis B vaccine required?
Sci-b-Vac's advantage over current SOC in the space is rooted in immunogenicity. In the vaccination space, immunogenicity refers to the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human or animal. The higher the provoked response, the quicker the patient becomes immune to the target infection, and the longer the immunity lasts. As such, the higher the immunogenicity of a vaccine, the better it is. The provoked response is rooted in the similarity of the artificially introduced substance to the target infection. To put this another way, the more a vaccine looks like a virus, the better it is.
This is why (in the early days of vaccination) an actual fragment of a virus was used. In more recent times, drug makers artificially create the virus using synthetic antigens. VBI has taken this synthetic antigen method, and improved on it, y creating a vaccine that can express a range of different types of antigens. Most viruses (hepatitis B included) express a range of antigens. The more of these antigens a vaccine can express, the higher the immunogenicity of the vaccine, and therein lies Sci-B-Vac's advantage – it expresses more hepatitis B related antigens than any other hepatitis B vaccine.
That's why it's better – why is it needed?
There are a number of reasons, but the primary justification is rooted in the degradation of efficacy of currently approved standards in the space as a patient ages. Research has shown that the older a person gets the less effective the current hepatitis B vaccines are in creating immunity. These so called second-generation hepatitis B vaccines use an antigen called the S antigen to create an immunologic response in vaccine recipients. An age specific decline in efficacy starts at around age 40.
As such, research shows that there is a need to provide a better, more immunogenic hepatitis B vaccine option for aging populations. Couple this with an aging global population (and in turn, with the fact that nowadays, age 40 can hardly be considered advanced age) and there's more than enough justification for a new, increasingly effective entrant into the space.
What is the importance of the recent update?
As mentioned, the vaccine is already approved in 15 countries, including Israel, but the real market potential for Sci-B-Vac lies in the US and Europe. The recent announcement relates to the European submission – the CHMP is a subsidiary of the European Medicines Agency (EMA) – and the path is now in place to a phase III trial that will support regulatory submission. We expect news on a similar US route to hit press over the coming quarters.
When these markets approve the vaccine, it should serve to boost VBI's revenues, and provide the company with the cash it requires to fund its remaining pipeline. The technology used to create this third generation vaccine has also borne a number of development assets (a GBM oncology therapy, a CMV vaccine and an RSV vaccine being the current leads) and will need cash to fund the pushing of these assets towards commercialization.
With a recent financing injecting $23.6 million into the VBI's balance sheet from renowned biotechnology fund Perceptive Advisors, the company has cash on hand to fund its regulatory and development commitments through early 2018.