Development of Manufacturing Process of Engineered-Phage for IV administration in P.aeruginosa infections

"Phico is a biotechnology company developing a novel platform technology, SASPject, to treat infections, particularly those due to antibiotic resistant bacteria. Phico is developing an intravenous SASPject, PT3.8 targeted against Pseudomonas aeruginosa which causes 10% of all hospital infections and is a major cause of hospital acquired and ventilator associated pneumonia where it causes a very high rate of mortality. There are globally limited options for manufacturing novel engineered-biologicals, particularly phage-based, such as SASPject, resulting in significant barriers to the development of these drugs, ultimately limiting patient options for treatment. To address this need, outside of this grant Phico is developing its own internal Good Manufacturing Practice (GMP) capabilities for process optimisation and manufacture of future SASPject platform products in the UK. The grant objectives are: \*Optimise the development of the manufacturing process for PT3.8 to increase the yield, thereby ensuring commercially viable cost of goods, and develop a purification method that ensures the product is fit for intravenous use in humans. \*Scale up and provision of a 15L engineering batch of material for GLP-toxicology studies, exemplifying Phico's facility, thereby supporting its GMP accreditation As well as underpinning and optimizing manufacture of Phico's first intravenous product, this project will form the foundation for exemplifing the UK's first GMP manufacturing capability suitable for GMP manufacturing of bacteriophage-based therapeutics which will ultimately support production of the Phase 1 and later clinical batches for PT3.8 clinical development. This will ensure future manufacturing capacity and sustainability for Phico's lead product and future product pipeline, providing a solution to the major barrier to fulfilling Phico's pipeline manufacturing requirements. Longer-term, Phico plans to make its manufacturing capabilities available for rental to other biotechnology companies when not in use by Phico, enabling other companies to conduct manufacturing in the UK, retaining knowledge of manufacturing processes in-house and in the UK. Phico will work with two collaborators on the grant: The Clinical Trial Company will provide a Qualified Person to set up and oversee the Quality Assurance system to support PT3.8 manufacture, oversee and release the engineering batch of PT3.8 ensuring it will ultimately underpin a Phase 1 batch for approval by the UK's Medicines and Healthcare products Regulatory Agency (MHRA); Second collaborator, GE Healthcare UK Ltd have a Manufacture of Investigational Medicinal Product Licence in the UK for manufacture of medicines and will be providing advice and guidance throughout the project."