Stablepharma and AFT Move to Expand Fridge-Free Vaccine Distribution Following Positive Clinical Data
Potential agreement follows positive clinical and stability data, supporting rollout in UK, Canada, Australia and New Zealand.
Stablepharma Limited, specialists in thermostable formulations, today announced the signing of a Letter of Intent (LOI) with AFT Pharmaceuticals (NZX: AFT; ASX: AFP) regarding the proposed distribution of SPVX02, their lead fridge-free tetanus-diphtheria (Td) vaccine candidate, across the UK, Canada, Australia and New Zealand, with the option to extend into Singapore and Hong Kong. This marks a key step towards the removal of cold-chain constraints from vaccine logistics and administration across major international markets.
The LOI establishes the framework for a proposed long-form distribution agreement under which AFT Pharmaceuticals would hold exclusive distribution rights in the agreed territories, subject to final contract and customary conditions.
SPVX02 is the world’s first fridge-free Td vaccine to reach this stage of development and is currently advancing towards pivotal Phase 2b clinical trials. Phase 1 clinical data demonstrated that the vaccine is safe and well tolerated, with immunogenicity similar to the originator refrigerated vaccine 28 days after the administration of a single dose. Stablepharma has generated stability data showing that SPVX02 remains stable at 30°C for 24 months, enabling a 36-month shelf life label for storage up to 30°C for clinical study supply. This robust dataset validates the company’s thermostable reformulation approach.
Stablepharma has further demonstrated GMP production at scale, supporting the progression of SPVX02 from clinical development towards commercial supply.
Stablepharma’s proprietary StablevaX® platform enables vaccines such as SPVX02 (tetanus-diphtheria) and SPVX07 (hepatitis B) to be reformulated into lyophilised, dry vaccines designed to remain stable at 30°C from point of manufacture through to end of expiry date, without altering the API or compromising clinical performance. By removing the need for refrigerated storage and transport entirely, StablevaX® enables temperature sensitive medicines to be distributed through standard supply chains.
Özgür Tuncer, CEO & Executive Director of Stablepharma, said: “This is an important commercial milestone and a further step towards bringing SPVX02 to populations across major international markets. Our ground-breaking clinical and stability data demonstrate that vaccines can be reformulated into fridge-free formats without compromising safety or efficacy. Together with AFT Pharmaceuticals, we are working to translate that innovation into real-world impact, reducing reliance on the global cold-chain and improving access to essential vaccines at scale.”
The proposed distribution agreement builds on the companies’ broader strategic partnership announced in January 2026, which focused on developing a portfolio of fridge-free sterile injectables targeting anti-infective and oncology markets valued at over USD 6 billion.
Hartley Atkinson, Founder and Managing Director of AFT Pharmaceuticals, said: “We are pleased to expand our collaboration with Stablepharma through this proposed distribution agreement. The clinical progress of SPVX02, combined with its thermostable profile, represents a meaningful opportunity to simplify vaccine delivery and reduce logistical barriers across our markets. This aligns closely with AFT’s focus on innovation and improving access to medicines that make a tangible difference to patients.”
Under the proposed arrangement, Stablepharma will continue to lead development, while AFT Pharmaceuticals will be responsible for commercial distribution within the agreed territories. The parties intend to work collaboratively to progress clinical, regulatory and commercial milestones ahead of launch.
The announcement reflects increasing momentum behind fridge-free pharmaceuticals as healthcare providers seek more resilient, scalable and sustainable approaches to vaccine and medicines delivery. By removing dependence on the global cold-chain, Stablepharma aims to support more efficient supply chains and broaden access to essential healthcare worldwide.