CPI partners with ImmunoBiology Ltd to manufacture heat-stabilised Pneumococcal vaccine formulation

Pneumococcal diseases including meningitis, septicaemia and pneumonia are caused by the bacterium Streptococcus pneumoniae. Both the elderly and the very young are particularly vulnerable to these diseases and there are a reported 50 million annual cases amongst these populations globally, with a fatality rate of around 0.7%. There is clearly an unmet medical need for effective and affordable vaccination programmes.

ImmBio has developed a multi-antigen vaccine candidate, PnuBioVax, which provides broad protection against Pneumococcal diseases. In partnership with CPI, work is now underway to develop a heat-stable PnuBioVax formulation that removes the requirement for cold chain delivery. CPI will initially work on the evaluation of the current PnuBioVax formulation before refining an optimal formulation providing stability between 2 – 8 °C and higher. With a wealth of relevant expertise and technology, CPI has successfully completed previous projects optimising biopharmaceutical formulations.

PnuBioVax is composed of a well characterised mixture of proteins and, in contrast to other products on the market, delivers protection against Pneumococcal disease that is independent of serotype. A first-in-human trial in 2016 demonstrated that the vaccine was well tolerated and that an increase in the desired antibodies was observed. In parallel to ImmBio’s work with CPI, the company is also working towards efficacy studies in vulnerable populations. 

Enrique Tabares, CEO at ImmunoBiology Ltd, said: ​“The cold chain contributes to the high cost of biologics and there is a risk that sensitive vaccines may be wasted due to environmental shocks. We are therefore delighted to be working with CPI on the development of a heat-stabilised PnuBioVax formulation. This will be a fantastic step towards improving the accessibility of this exciting vaccine.”

Lucy Foley, Director of Biologics at CPI, said: ​“PnuBioVax has the potential to provide broad protection against very serious pneumococcal diseases and we are excited to be applying our biopharmaceutical expertise in order to help optimise the vaccine’s formulation. By leveraging our knowledge and experience in the development and production of biopharmaceuticals, we aim to significantly improve the vaccine’s transport and storage costs and also improve accessibility.”

This research is funded by the Department of Health and Social Care using UK Aid funding, is managed by the Engineering and Physical Sciences Research Council (EPSRC, grant number: EP/R013764/1) and delivered by the Future Vaccine Manufacturing Research Hub (FVMRH) at Imperial College London. The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health and Social Care.

The FVMRH is committed towards researching innovative and more cost-effective vaccines for populations in lower and middle-income countries (LMICs). The hub’s goal is to improve the way vaccines are manufactured, stabilised and stored in partnership with vaccine manufacturers in Italy, India, Vietnam, Bangladesh, Uganda and China, as well as translational research partners comprising of the National Institute for Biological Standards and Control (NIBSC), CPI and NHS Blood and Transplant.

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