Member spotlight: how Stablepharma is pioneering the world’s first fridge-free Td vaccine

Following a number of ‘firsts’ for Stablepharma during 2024, we spoke with Ozgur Tuncer, CEO and Executive Director about a year that has accelerated the commercialisation of the world’s first fridge-free vaccine, SPVX02, for the prevention of Tetanus and Diphtheria.

Ozgur also highlights some of the global challenges associated with the cold chain and talks about entering a ‘new era’ in vaccines.

Tell us about Stablepharma and your vision?

We are working to make temperature-sensitive vaccines and pharmaceuticals more accessible to everyone, everywhere in the world. I know that this may appear to be a little ambitious, however Stablepharma’s vision is to revolutionise the delivery of temperature-sensitive medicines, that require cold storage, by providing an ambient alternative. Given that most vaccines should typically be stored between 2-8°C, we believe that our StablevaX™ technology will be a game changer for the industry, for countries and governments where access to life-saving vaccines and pharmaceuticals is critical, and in addition, the cost and environmental impact of delivery logistics and refrigerated storage is high. So, this encompasses pretty much the entire world – as even developed countries have a responsibility to our planet! For instance, in Europe, only 30% of the vaccine costs are actual acquisition costs as 70% is associated with logistics and cold chain.

What do you consider Stablepharma's greatest achievement thus far?

I am excited to say that we have achieved a number of key milestones over the last three years, but 2024, and now entering 2025, seem to be a pivotal time for us. We have made real strides towards our first-in-human clinical trials for SPVX02, a fridge-free Tetanus and Diphtheria (Td) adult booster vaccine. Following the successful manufacture of our first GMP clinical trial batch, in partnership with Thermo Fisher Scientific and our recent MHRA approval, we have initiated our clinical trials at the National Institute for Health and Care Research (NIHR) Southampton Clinical Research Facility. The study is being led by Professor Saul Faust, Director of the research facility and Dr Karen O’Hanlon, our CDO. Trials will commence in early April 2025.

The MHRA approval marked a major milestone for Stablepharma as it moved us into a clinical development pathway with the world’s first fridge-free Td vaccine, that is not only feasible but scalable – a groundbreaking development in vaccine technology.

Towards the end of 2024, we won global recognition for our technology by the prestigious US Fierce Pharma ‘Biotech Innovation Award’, we also filed a new patent on our adjuvanted vaccines and we appointed our first Non-Executive Chairman, Dr Steven Chatfield. In early 2025 we were awarded the EIC Accelerator Grant of €2.5m by the European Innovation Council.  All in all, I have to say that it has been an exceptional time for our company!

What have been Stablepharma’s biggest challenges?

Without question, for a company of our size and means, trying to get the ear of Big Pharma has been our greatest challenge, even though we all recognise that the number of vaccines that are wasted each year, due to failures in the global cold chain, is an area of huge concern.

However, we have been experiencing a sea change over the last 14 months and have signed another partnership agreement for the commercialisation and distribution of our vaccines in Europe with AJ Vaccines of Denmark. This is in addition to our partnerships with BulBio and Thermo Fisher in the EU. Partnerships are key to advancing and broadening our portfolio of fridge-free products, which will ultimately help address public health risks through collaboration of research and development. Another key benefit of broadening our portfolio is that we can impact the considerable CO2 emissions associated with the global cold chain.

What is Stablepharma’s ambition?

Well, as I mentioned earlier, the enormous benefit of our StablevaX™ technology platform is that it reformulates and thermally stabilises existing, approved vaccines and pharmaceuticals, to fridge-free versions, which not only greatly increases the shelf life of the products but allows for strategic stockpiling, in temperatures of up to 40°C. Our ambition is to create a “new era” in vaccines, working with partners to reduce reliance on the cold chain and enable greater access and stockpiling. We are not just talking about countries with inadequate infrastructures to store refrigerated products, but also more broadly the entire world where the burden, cost and environmental impact is huge. We look at Stablepharma as “the dawn of New Vaccines”.

Why did you join BIA? 

Joining the BIA was an easy decision for Stablepharma, not only to participate in their excellent networking events but also to be part of an organisation that has the focus and lobbying power with relevant government bodies in the UK. It is always good to meet other technology and biotechnology companies within the life sciences space, as well as suppliers and specialists in our industry sector. BIA’s clear commitment to progressing and celebrating the successes of the UK life sciences sector for ultimately, better patient and population healthcare, is truly impressive. 

What excites you about the UK life sciences sector?

I have worked in other parts of the world including the US, but I think the UK is an ideal country to launch a new technology, particularly within the life sciences space. UK is home to very exciting, cutting-edge science, and very strong academic institutions and life sciences is a strategic industry for the UK Government. We have been well supported by the UK Government with grants such as Innovate UK and last year, were selected to be part of Innovate UK’s Scale Up Programme.

We must remember that there is little doubt that the UK stood out as a world leader during the COVID-19 pandemic. We are very lucky to have both Professor Sir Jonathan Van-Tam and Professor Saul Faust, OBE on our Advisory Board and Dr Steve Chatfield as our Non-Executive Chairman, as all of them were heavily involved in the Covid pandemic, as well as vaccine development and future pandemic preparedness.

If you could invite any scientist or entrepreneur to dinner, who would it be and why?

Although I am probably a bit late to do so, as a scientist, I would love to have dinner with Dr Anna Wessels Williams, who isolated a strain of diphtheria in 1894 which was used to develop the first diphtheria antitoxin and later a diphtheria vaccine. Diphtheria, of course, is now completely preventable, thanks to tetanus and diphtheria-containing vaccines. I would love to be able to tell her about the fridge-free version of our Td (Tetanus diphtheria) vaccine and hear more about her journey to making this significant invention.