Under their existing agreement, BioCina had already helped GPN to manufacture the candidate Gamma-PN for a phase 1 trial to protect from infections by the bacterium Streptococcus pneumoniae. The expansion will see BioCina scaling up the production process for phase 2 development worldwide.
According to the World Health Organization (WHO), pneumococcal diseases are a big public health menace and kill around one million children every year. While infections can be treated with antibiotics like penicillin, antimicrobial-resistant strains of S. pneumoniae are becoming increasingly prevalent, making vaccines ever more important.
While there are pneumococcal vaccines already in use, the WHO says that they are designed to protect against up to 23 serotypes, which account for 90% of invasive pneumococcal infections in industrialized countries.
In contrast GPN’s vaccine candidate is designed to protect against all serotypes of S. pneumoniae, which number around 100. This is because the engineered strain of S. pneumoniae in the vaccine expresses surface proteins that are common to all serotypes. In contrast, current vaccines express surface carbohydrates which are specific to different serotypes.
"We are extremely proud that GPN Vaccines has asked us to further scale-up the production of Gamma-PN, which has the potential to protect so many lives against a broad range of serotypes not covered by any current vaccines," said BioCina CEO Mark Womack, in a public statement.
The phase 1 trial of Gamma-PN completed its recruitment of 117 healthy volunteers in August 2023. The company said it would then collect the final blood samples from the participants and assess their immune responses to the vaccine compared to placebo or an existing pneumococcal vaccine.
In a case study report of its past work with GPN, BioCina explains that it took the lead candidate from preclinical development to clinical-stage manufacturing within ten months. The company says that the process to generate Gamma-PN is not commonly used among CDMOs specialized in microbial manufacturing and that one of the most important processes optimized by the CDMO was the filtration processes in the downstream process.
In April 2023, BioCina was awarded $5.0 million AUD ($3.2 million) in grants from the Australian Federal Government’s Medical Research Future Fund (MRFF) Grants scheme to finance the development of technology that improves the manufacturing of mRNA vaccines. Last year, the company also established a 300 L manufacturing suite to produce plasmid DNA for use in RNA therapeutics and cell and gene therapies.
