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 https://thermofisher.com 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. https://stablepharma.com/new-data-shows-stablevax-td-stable-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) https://www.bulbio.com/en.html. “Worldwide, 75 million women and their babies remain unprotected against maternal and neonatal tetanus?’. ‘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 https://boydconsultants.com/ 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.
See more stories here.