The World Health Organisation (WHO) estimates that up to 50 per cent of the world’s vaccine supply is wasted each year, in large part due to flaws in the cold chain.
A vaccine must follow an uninterrupted series of refrigerated processes, from production and storage to distribution and administration. Any break in the chain can significantly reduce the potency of a vaccine.
Stablepharma’s innovative StablevaX technology aims to overcome the flaws in the cold chain by eliminating it altogether.
Özgür Tuncer is CEO and executive director of Stablepharma. He has two decades of experience in the biopharmaceutical industry, including as global vice president at IQVIA and six years in the US with Pharmacia and Pfizer.
Tuncer was responsible for Pfizer’s entry into vaccines in 2006 via the acquisition of PowerMed.
He outlines Stablepharma’s ambitions.
“Our mission is to eliminate cold chain and take as many vaccines as possible out of the fridge so they can be distributed, stored and administered in room temperature conditions. And when we say ‘room temperature’ we’re talking about elevated temperatures we see in other parts of the world, so 45°c.”
Stablepharma believes it can achieve this thanks to its patented StablevaX technology which harnesses the Resurrection Plant.
The plant is adapted to desert life and can survive for years at a time without water. It hibernates by curling into a tight ball to protect itself until the rain returns, at which point, it is ‘resurrected.’
The plant’s secret lies in a sugar called trehalose. Stablepharma founder Dr Bruce Roser patented the process of using this sugar to achieve a state of suspended animation to stabalise vaccines within a sugar glass.
When water is drawn into a syringe, the vaccine, like the Resurrection Plant, is brought back to life.
Vaccines not reliant on the cold chain would be particularly beneficial in warmer countries within the developing world.
The Pfizer-BioNTech vaccine has to be stored in deep freezers at -70°c. It must then be kept refrigerated at 2°c – 8°c for up to five days to prevent degradation. Many countries simply to not have the technology or infrastructure to achieve this.
There are significant cost considerations to a fridge-free alternative, as Tuncer explains:
“Some countries can’t be paying US$20 a vaccine, because they need to vaccinate entire populations.
“One of the advantages of our technology is that it is relatively cost effective. We can apply it to many different vaccines. It would be as applicable in the Western world as in some other less developed countries.”
The cold chain is not just problematic for wastage, but for the environment, too.
Stablepharma estimates that the global cold chain costs about $400m a year to maintain.
“If we can eliminate the need for the cold chain, the process will be a lot greener in many ways and much more environmentally friendly,” Tuncer says.
Stablepharma currently has two programmes underway.
For the tetanus diphtheria (TD) programme, it has partnered with Bulgarian state-owned vaccine manufacturer, Bul Bio. Initial results from animal studies conducted so far show that StablevaX can keep the TD vaccine at 45°c for two months, without any impact on the potency of the vaccine. Stablepharma is now preparing to take it to the clinical trials stage.
Tuncer says: “It’s a long journey, because you have to do preclinical toxicity and meet a lot of regulatory requirements before you can move on to clinical trials.
“But the good news is that we only need around 40 people, rather than tens of thousands. We’re not creating a new vaccine, we’re essentially taking a vaccine that’s already registered and reformulating it.”
And with the Covid research, they’ve successfully taken the naked mRNA and kept it at 45°c for two months without any degradation. Quite an achievement as mRNA is quite fragile and unstable and can be lost if it’s removed from the fridge for just a couple of hours.
Stablepharma has now partnered with the University of Strathclyde.
“The team are world class in manufacturing lipid nanoparticles. So what we’re doing now is creating some vaccine analogues similar to the to the vaccines on the market and we’re trying to do them in a thermo-stable way,” Tuncer says.
“It’s not finalised yet and we’re also going to have some animal trials with the University to show that the vaccine is actually working as intended.”
Eventually, Stablepharma would like to introduce more programmes alongside the TD and Covid mRNA projects already underway. Tuncer thinks the StablevaX technology could be applied to more than 60 of the vaccines available today. But developing more programmes will rely on obtaining more resources and funding.
Stablepharma raised £2m within three weeks in a recent funding round. They’ve now set a Series A target of £10m. They also received Innovate UK funding from the government last year and were preparing to submit an EIC grand application to the EU at the time of our interview.
Stablepharma has aspirations beyond Covid. But the global pandemic has given a sense of urgency to its work.
The large-scale rollout of solutions like Stablevax could have lasting implications, with Ligia Noronha, director of the economy division at the United Nations Environment Programme (UNEP), saying last year: “The vaccination against COVID-19 is an inflection point that will determine how cold chains are handled on a global scale for the next two decades.”
“If we can just show the world that we can create a vaccine that’s thermo stable and it’s picked up by likes of Pfizer and Moderna – that would be a massive step for the world,” Tuncer says.
“But we don’t want to stop there. Covid is just a recent addition to our portfolio of infectious diseases, if you will. But there’s so much more that’s killing people all around the world.
“For me, the amazing part of this journey is that we feel like we’re working towards something very important which gives us a purpose and impact. We don’t see it as just as a company or a startup – we see it as a mission.”