UK Company, Stablepharma Ltd, enters Phase 1 Clinical Trials with world-first Fridge-Free Tetanus & Diphtheria Vaccine

LONDON, April 29, 2025 (GLOBE NEWSWIRE) -- Following MHRA approval, Stablepharma Ltd has commenced a Phase 1 clinical trial with its lead candidate, fridge-free tetanus and diphtheria vaccine, SPVX02. The Phase 1, first-in-human clinical trial led by Professor Saul Faust, is being conducted at the National Institute for Health and Care Research (NIHR) at Southampton Clinical Research Facility.

Stablepharma’s pioneering science has progressed into the clinical trial stage thanks to funding from shareholders and the UK Government, including Innovate UK and the NIHR. The first participant was dosed in the trial on the 15^th April 2025 and is expected to be completed in Q3 2025.

Stablepharma’s next-generation technology platform StablevaX™ reformulates existing and new vaccines and biologicals into thermostable products that do not require cold storage such as refrigeration or freezing, thus eliminating the need for cold chain.

This award-winning innovation tackles major global issues which include the distribution, storage, wastage, and CO2 emissions linked to the transportation of temperature-sensitive products. The World Health Organization reports that over 50% of vaccines are wasted each year due to cold chain failures, highlighting the significant impact StablevaX™ will have in improving vaccine access and reducing waste worldwide.

Dr Karen O’Hanlon, CDO at Stablepharma who is leading the phase 1 trial with Professor Faust, said, "Our team have worked tirelessly to reach the start of this phase 1 trial with SPVX02 - it marks a pivotal moment for Stablepharma, as we advance into the clinical development phase with the world’s first fridge-free Td vaccine, a groundbreaking innovation in vaccine technology.”

The team has demonstrated that SPVX02 remains stable and fully potent after three cycles of extreme temperature fluctuations, ranging from -20°C to +40°C. These findings underscore the resilience of StablevaX™ technology and its ability to effectively thermostabilise vaccines while maintaining vaccine efficacy. While most vaccines need constant refrigeration between 2-8°C, some biologics require storage at -20°C, making StablevaX™ a game-changer in addressing the challenges of maintaining product potency without any reliance on strict temperature controls. "We are very pleased that a room temperature (up to 30°C) shelf life of 18 months has been approved for the current clinical batch of SPVX02, manufactured in collaboration with our partner CDMO Thermo Fisher Scientific, for the phase 1 study,” added Dr O’Hanlon.

Özgür Tuncer, CEO & Executive Director commented, "This phase 1 clinical trial is an important step towards launching the world’s first fridge-free Tetanus & Diphtheria vaccine (SPVX02) by 2027. We have shown that our StablevaX™ technology can be manufactured under commercially scalable GMP conditions, enabling us to scale-up the manufacturing process to provide millions of doses per year without the need for the global cold chain. Our ambition is to create a ‘new era’ in vaccines by reducing reliance on the cold chain.”

Stablepharma was one of five UK companies awarded the €2.5 million grant through the European Innovation Council (EIC) Accelerator program. The grant recognises the company’s cutting-edge fridge-free pharmaceutical technology, which meets EIC’s rigorous criteria for excellence, impact, and risk management.

Stablepharma’s R&D team have identified 60 temperature-sensitive vaccines that could benefit from the company’s StablevaX™ technology. The company is actively partnering with global vaccine manufacturers, academic institutions, and NGOs to accelerate the development of its pipeline of thermostable products, aiming to improve vaccine accessibility and reduce storage-related challenges worldwide.

Stablepharma’s projects align with their commitment to positively impact global health, reduce wastage and ensure equitable access of vaccines.

About Stablepharma Ltd:
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.

StablevaX™ technology can be manufactured under scalable GMP conditions, enabling scale-up of the manufacturing process to provide millions of doses annually.

Press Contact: Laura Murphy
Head of PR & Communications
Stablepharma Ltd
M:+ 44 (0) 7789 850837
E: lmurphy@stablepharma.com
www.stablepharma.com

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