Stabilitech Biopharma – creating thermally stable vaccines
In a small town in West Sussex some amazing technology is being developed. Based on a business park just outside Burgess Hill, Stabilitech is working on a novel delivery mechanism for vaccines and might just have a possible Covid-19 vaccine. Human trials for this start next month.
We were fortunate to have Chair, Wayne Channon, come and present at a recent Yellowstone Advisory webinar to explain just what the company is doing and we were not disappointed. Stabilitech have developed a technology which enables vaccines to maintain their stability through a broad range of temperatures.
At the start of the process, the RNA from the SARS-CoV-2 virus is sequenced. A small segment of the RNA is selected and converted to DNA which is inserted into an Adenovirus-5 viral vector as a cargo. The genes that make the virus multiply are removed and a promoter is added which enables copies of the DNA to be made. A sugar solution is then added, and this combination is then freeze-dried and then crushed to create a powder. The powder is packaged into an acid resistant capsule which is able to safely travel through the stomach’s 37C temperature without loss of efficacy. The patented technology works by displacing water from the hydration shell of the viral capsid, replacing the electrostatic interactions but ensuring that the viral capsids maintain the correct conformation to remain infectious. In nature it’s a bit like the Arizona cacti that survive through periods of drought and then reinvigorating themselves when they come into contact with water.
From the stomach the capsule moves into the small intestine and dissolves. The infectious particles infect the gut cells and once infected the nucleic DNA of these mucosal cells will make millions of copies of the cargo. The immune system sees these cargo proteins and makes the relevant antibodies. These cargos go both into blood cells and into mucosal cells giving both systemic and mucosal immunity.
The company is currently developing a vaccine for Covid-19. Tests are about to start in humans in phase 1 and phase 2 trials. If this is successful, Stabilitech will move onto a larger clinical trial towards the end of the year. It is likely that this later trial will take place outside of the UK in a country where Covid-19 is still more prevalent in the community.
Wayne believes that it could be as short as 6 months from starting clinical trials to get approval from regulatory authorities which compares very favourable to traditional vaccine development.
This thermally stable vaccine has many advantages: it provides both systemic and mucosal immunity, the time to immunity is only 2-3 weeks, capsules can be self-administered with no need for clinicians and no refrigeration required in the logistics chain. The capsules could even be posted out in the mail!
It is really great to see such ground-breaking technology developed here in the UK. I’m sure with all the development work going on we will be hearing plenty more from Stabilitech in the future. Interestingly, Covid-19 is just one of many vaccines where Stabilitech can apply their technology, so watch this space.