Pharma collaboration targets first fridge-free vaccine for Tetanus diphtheria

The world’s first fridge free vaccine for Tetanus diphtheria (Td) is being developed in a collaboration between biotech Stablepharma and manufacturer BB-NCIPD (Bul Bio).  

The companies will develop a thermally stable version of the Td vaccine using Stablepharma’s StablevaX formulation and device, which removes the need for cold chain storage and transportation of applicable drug products.

The global demand for the Td vaccine has been driven by the World Health Organisation’s recommendation for moving away from a sole Tetanus vaccine to the Td combination product. 

“We have established a strategic R&D partnership, alongside a statement of intention for the future development and commercialisation of the StablevaX Td product – this is an excellent and exciting opportunity for both parties,” said Stablepharma’s managing director and co-founder, Nick Child

“This is a timely and opportune moment to partner and progress this R&D programme with an innovative vaccine stabilisation company. We look forward to working with the team at Stablepharma,” said Dr. Roumen Kofinov, general manager of BB-NCIPD.

The collaboration will see BB-NCIPD provide Stablepharma with its bulk Tetadif vaccine which will then be converted to the StablevaX formulation to produce a thermally stable version.

“We have developed a positive working relationship with BB-NCIPD over the last year and have been working on signing an R&D and commercialisation deal with BB-NCIPD, so we are very pleased. Tetanus & Diphtheria containing vaccines market is expected to reach $7bn by 2027 and Bul Bio is one of the five WHO PQ’ed suppliers of the Td vaccine globally. Our aim is to produce the world’s first fridge free Td vaccine,” added Stablepharma’s Board director and head of Strategy, Ozgur Tuncer.

In-vivo animal trials using the StablevaX products are planned and will be run using vaccine batches that have been stored at 45°C. The trial’s aim is to prove that the StablevaX version of the standard Td vaccine will be as effective as the standard fresh vaccine.

An Innovate UK grant awarded in November 2020 will be used to finance pre-clinical trials for the StablevaX vaccine and potentially progress the programme to human clinical trials.