Stablepharma and BB-NCIPD Ltd (Bul Bio) to develop a fridge-free Tetanus mono vaccine

Stablepharma Ltd, the Fridge-free Vaccine Company and BB-NCIPD Ltd (Bul Bio) European vaccine manufacturer, have signed a second agreement for the exclusive bulk supply and commercialisation of the Tetanus vaccine (SPVX06). This agreement follows a similar arrangement with Bul Bio for the Tetanus diphtheria vaccine (SPVX02) in September 2022.

“As a result of this strategic partnership we will be jointly developing the world’s first ‘fridge free’ Tetanus diphtheria (SPVX02) and Tetanus (SPVX06) vaccines’, said Özgür Tuncer, CEO & Executive Director of Stablepharma. ‘We have exclusive rights to manufacture and distribute globally, and Stablepharma will own the global marketing authorisation, registration and sales of the fridge-free vaccines”.

Stablepharma also has in place a manufacturing agreement with Thermo Fisher Scientific [NYSE:TMO] for the GMP manufacture of both SPVX02 and SPVX06 vaccines. Stablepharma’s technology platform, StablevaX™ converts existing approved vaccines to a fridge-free status. By creating pre-dosed and stable vaccines, it ensures safe, efficient and waste-free delivery without the need for the cold chain.

Recent animal potency challenge test results demonstrated that the tetanus component of the StablevaXTM-Td vaccine remains thermostable and as potent as the reference vaccine, after exposure to +45°C for 12 months.

“Our relationship with Stablepharma continues to progress with this second agreement for the Tetanus vaccine’ said Roumen Kofinov, MD, General Manager of BB-NCIPD Ltd (Bul Bio). ‘Worldwide, 75 million women and their babies remain unprotected against maternal and neonatal tetanus₁’. ‘With this statistic in mind, I am convinced that together with Stablepharma, we are paving the way forward and fulfilling the guidelines of WHO to bring thermostable, fridge-free vaccines to mankind”.

Stablepharma is working closely with partners Boyds Consultants to pursue the regulatory requirements for the reformulated Tetanus diphtheria vaccine (SPVX02). “This is another milestone towards achieving our vision of making fridge-free vaccines a reality and accessible to everyone, everywhere’, added Özgür. ‘We will continue to work with of BB-NCIPD Ltd (Bul Bio) and Boyds Consultants in progressing both SPVX02 and SPVX06”.

“Our R&D team have identified up to 60 vaccine candidates that could be suitable for StablevaX™ technology to dramatically enhance the performance of existing and new vaccines’, said Nick Child, VP & Co-Founder of Stablepharma. ‘By eliminating the need for the cold-chain, our product pipeline could result in substantial health economic savings and reduce the impact of the cold chain’s current CO2 emissions”.

There are currently no fridge-free Tetanus or Diphtheria vaccine solutions on the marketplace.
₁. Center for Disease Control and Prevention CDC24/7: Saving Lives, Protecting People™