Public Funding for Phico Therapeutics Limited

Awaiting

no public description

"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."

Phico is developing a novel antibacterial technology called SASPject, that can be targeted to selected harmful bacteria. SASPject is not affected by antibiotic resistance mechanisms and works by disabling bacterial DNA in a way that bacteria cannot avoid. This project will enable Phico to complete the pre-clinical development of SASPject PT3 targeted to Pseudomonas aeruginosa (Pa). Intrinsically resistant to many antibiotics, Pa caused ~40M days of hospital therapy in 2010 due to a wide range of infections. In this 18 month project Phico will extend efficacy data to determine the best dosing strategy in humans. Phico will also develop a manufacturing process to 15L and then transfer the process to a contract manufacturer who will scale up to a 50L GMP-ready process and produce material for a safety study. A lyophilisation process will also be developed. The safety study conducted during this project will provide sufficient data to support a clinical trial application, making SASPject PT3 ready to test in a Phase I trial.

Antibiotic resistance is a global healthcare crisis. There are now bacteria which are resistant to every marketed antibiotic and these are spreading around the world (HPA, 2011). The World Health Organisation’s World Health Day in 2011 “Antibiotic resistance – no action today no cure tomorrow” shows development of novel antibiotics that can treat resistant bacteria is desperately needed. Phico Therapeutics has developed a novel antibiotic technology called SASPject, which has the potential to treat any bacterial infection including those caused by the most antibiotic resistant bacteria. SASPject’s active ingredient, SASP, works in a way that means bacteria cannot become immune. The technology also has the unique, characteristic of limiting the spread of existing antibiotic resistance. Hence it could address the urgent medical need for novel treatments against multi-drug resistant bacteria. SASPject technology targets harmful bacteria selectively. For example, Phico has taken its first product, targeted against MRSA for nasal use, successfully through a phase I clinical trial demonstrating a good safety profile. Phico now plans to develop products for systemic use targeted to those multi-drug resistant bacteria responsible for some of the most serious and life threatening infections. This SMART project will underpin Phico’s strategic development by producing a detailed and in depth analysis of the markets for various possible SASPject products. This will allow prioritisation of product development and clinical trial design. Phico Therapeutics is a young biotechnology company with a novel and powerful antibacterial platform technology. Based at Babraham Research Campus, it employs 16 staff, including 9 post-doctoral scientists. The project outcomes will also support a significant round of investment raising in 2013 to enable Phico to take further anti-bacterial products through early clinical trials and ultimately, via pharmaceutical partnerships, to market.