Why is Stabilitech’s technology so revolutionary?
Vaccines are transported around the world in what’s called the ‘cold chain’, meaning each vaccine is kept at between 2-8°Cright up until a doctor takes it out of the fridge to administer it. However, 50% of the world’s vaccines are lost because of thermal excursions, meaning that they go out of temperature range at some point during the transportation and storage process. That’s a huge loss. When I first invested in the company back in 2006, our founder and Chief Scientific Officer, DrJeff Drew, had developed technology to make vaccines completely thermally stable at room temperature. We went straight to big pharma with the tech, convinced that they would reformulate their existing vaccines but it turned out they wouldn’t for a few reasons, including the difficulty of getting regulatory approval and the significant expense involved. We realised that we would need to become the master of our own destiny by developing our own vaccines.
What does the process of developing a new vaccine look like?
Vaccines are tested for dose-ranging, safety and effectiveness in three phases: during Phase One, you give the vaccine or a placebo to fifty healthy volunteers and in Phase Two you repeat the process with 250 people. Phase Three is almost identical to phase two but on a much larger scale. The entire process is very expensive. Fortunately for us, Innovate UK had a grant open for developing a range of new vaccines and we won a contract to produce a candidate vaccine for Zika.
How does Stabilitech’s oral vaccine work?
Using a harmless adenovirus as a carrier and removing two genes to stop it multiplying, we then insert a gene from a target virus (such as the now-infamous spike DNA that stick out of the COVID-19 ball). We also add another gene, which enables the spike to be reproduced. When it goes inside your cell, it delivers the DNA into the nucleus, triggering your body to produce billions of copies of that spike protein. In turn, your immune system will start to produce antibodies. Where the antibodies develop depends on where you put it. If we put it into your arm, you’d get a systemic immune response. If we put it into your gut, you get a mucosal immune response.
A benefit of oral vaccines is that you have 250 sqm of surface area in your gut, so you can have millions of cells per infectious particle. When you inject a vaccine into your arm, you end up with millions of virus particles in a tiny area. Because of this, we use 1000 times less vaccine than injections. My view is that we’re going to create the world’s best immunity for giving both systemic and mucosal immunity. I want us to become the Google of vaccines.
What difference does a systemic versus a mucosal immune response make?
Different viruses behave in different ways: you catch COVID-19 through the mucosal cells in your nose, throat, mouth and eyes and it remains there, rather than going systemic. On the other hand, when you catch Zika via a mosquito bite it goes into your blood and so is systemic.
While this may seem technical, it’s important: I believe the mucosal immunity makes our vaccine potentially the most powerful for COVID-19 of any company anywhere in the world. By taking the vaccine orally, the adenovirus moves from the mucosal cells in your gut into your lungs, mouth and eyes, triggering an IgA response. When a vaccine is injected into your arm, you get an IgG response. An IgG response is less powerful; it neutralises the virus as it enters your bloodstream, but it won’t prevent you catching it, whereas the IgA response prevents you catching it all together.
Why is temperature control so important in an oral vaccine?
Without being temporally controlled, a capsule would die before it got to your gut – hence why most vaccines are injected into your arm. With our technology, if we put 100,000 infectious particles into a capsule, all 100,000 of those will reach your gut.
What stage are you at with your COVID-19 vaccine?
We’ve manufactured our COVID vaccine already – in fact, I have one with me right here! We sent it off to New Zealand to be manufactured for our PhaseOne clinical trial. If all goes to plan, the trial should start in mid-November.
Why has there been so little change in the way vaccinations are developed and administered?
Vaccines have been the forgotten part of biotech for many years because we’ve being doing quite well so far! It’s been over 100 years since Spanish flu, the previous serious pandemic. However, I think that everyone’s view on vaccines is going to change moving forward. This is a huge opportunity; we are right in the centre of a perfect storm. Regulators are being very supportive, there is public funding available and there is a global need that is going to catapult us forward.
How do you think the healthcare sector needs to evolve in the wake of COVID-19?
I think we have to break the stranglehold that big pharma has over our lives and start to consider vaccinations as we do all other technology: what’s the next best thing we can create to meet our needs? As people, we should be demanding more in terms of immunity and not just accepting the minimum.
For more information about Stabilitech, please visit their website.