Stablepharma’s Fridge-Free Vaccine that Eliminates the Need for Cold Chain entering First-in-Human UK Clinical Trial.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Stablepharma to begin a Phase I clinical trial with SPVX02, an adult booster vaccine aimed at preventing tetanus and diphtheria (Td) infections. This approval marks a major milestone for Stablepharma as it moves into a clinical development pathway with the world’s first fridge-free Td vaccine, a groundbreaking development in vaccine technology.
“This is excellent news for Stablepharma as we get closer to the commercialisation of our first fridge-free vaccine, SPVX02”, said Ozgur Tuncer, CEO & Executive Director. “This approval is a direct result of the huge efforts by our Development Team, led by Dr Karen O’Hanlon and our clinical trial partners, including the University Hospital Southampton NHS Foundation Trust. I am proud to say that Stablepharma has reached another significant milestone in its journey as a clinical-stage biotechnology company”.
Stablepharma’s innovative technology platform, StablevaX™, transforms vaccines, therapeutics, and diagnostics into thermostable products that do not require refrigeration. This technology addresses a critical global challenge: the distribution, storage, and wastage issues associated with temperature-sensitive products reliant on the cold chain. Stablepharma’s technology was recognised earlier this month with a grant award of €2.5m from the European Innovation Council (EIC) Accelerator programme.
“This approval by the MHRA is very good news indeed”, said Dr Karen O’Hanlon, Chief Development Officer, who led the regulatory application process with her team at Stablepharma. “As part of the approvals received, we were delighted to note that the MHRA supported our proposed room temperature shelf life for SPVX02, which is in line with ICH and WHO guidelines, for the clinical trial batch of SPVX02. This GMP clinical trial batch, which was manufactured by Thermo Fisher Scientific, pharmaceutical and biotechnology services company, will be used in the phase I study”.
Stablepharma anticipates at least a 4-year shelf life for its commercial product following the success of recent stability studies. The studies highlight the impressive resilience of SPVX02, demonstrating its ability to maintain efficacy even under challenging environmental conditions, where the vaccine was exposed to temperature fluctuations ranging from -20°C to +40°C, underscoring its robustness.
The first-in-human trial of the vaccine is being conducted at the National Institute for Health and Care Research (NIHR) Southampton Clinical Research Facility at University Hospital Southampton. The study is being led by Professor Saul Faust, Director of the NIHR Southampton research facility and Dr O’Hanlon.
Professor Faust commented, “This innovation has tremendous potential for eradicating vaccine wastage and moving away from the need for the cold chain. This will have huge benefits that will ultimately provide greater safety and effectiveness for vaccines.”
The first participant will be dosed with the SPVX02 vaccine, in late March 2025.
About Stablepharma:
Stablepharma Ltd is a high-growth biotechnology company based in the UK and Spain, with the mission to reduce reliance on the pharmaceutical cold-chain. Stablepharma’s vision is to save lives, reduce global wastage and CO2 emissions by making fridge-free vaccines and pharmaceuticals a reality.
Stablepharma’s R&D team has identified up to 60 vaccine candidates that could be suitable for StablevaX™ technology. The company actively collaborates with global vaccine manufacturers, academic institutions and NGOs, to advance their pipeline of thermostable products.
StablevaX™ technology can be manufactured under scalable GMP conditions, enabling scale-up of the manufacturing process to provide millions of doses annually.