Locate Bio Limited Public Funding

The UK has invested for many years in the science of regenerative medicine. This field is delivering on its promise to repair human tissues. Given the UK's strong position in the science that underpins this area we should also aim to develop a world-leading industry that exports regenerative medicines across the world. This project aims to demonstrate that the UK can lead in the manufacture of one class of these medicines, called regenerative matrices. These products are materials that are used by surgeons to regenerative tissue after implantation in patients. The manufacturing of these products shares some processes with those used for the pharmaceutical industry but there is a need for innovation. Locate Bio is focusing on developing regenerative matrices for the treatment of patients with lower back pain (LBP). LBP is the leading cause of disability in the UK and most countries in the world. A major cause of LBP is disc degenerative disease where the shock absorber made of cartilage between the bony vertebrae of the spine lose their structure. The surgical treatment of disc degenerative disease is very expensive and patients can encounter long-term side-effects. Locate Bio's first product lowers the cost and risk of these treatments. Most of the expertise for manufacturing of these products lies outside of the UK. Under this SMART Award, Locate Bio will develop the manufacturing processes for regenerative matrices to lay the foundations for product launches in China, USA, UK and the EU.

This project aims to develop a new surgical product that will cure diabetic patients of a specific type of severe back pain. When the backbone is damaged or deteriorates due to disease and aging, chronic pain can result due to a loss of elasticity and protection in the disc structure. One clincial treatment that is offered is to fuse the affected segments of the backbone to restrict movement and stop the pain. This fusion requires the surgeon to implant a material close to the main back bone. The material encourages new bone to form, and that bone creates a permanent bridge that stabilises the backbone in one specific segment. The most common treatment option is to move living bone from the patient's own hip into the area next to the backbone. This is called autografting. This is a very successful procedure for most patients but is far less successful for patients with diabetes (both insulin dependent and independent). The process appears to be less successful for diabetics because the bone tissue forming stem cells are less active. Our company has technologies to overcome these problems. The product is called CellFuse and it includes a method of priming the stem cells to grow faster and to create bone more quickly. This is combined with a simple to use adminsitration system that ensures these primed cells stay at the site of action. We will aim to prove that our new concept works for diabetic patient cells and within 2 years we will be ready for clinical trials in humans using a medicine manufactured in the UK.

Emerging cell therapies have vast potential in the treatment of currently incurable diseases; the potential market for cell-based therapies being over 100 million patients in the US alone. Some of the main targets include heart disease, diabetes, neurodegenerative diseases, musculoskeletal disorders, spinal cord injury, stroke, autoimmune diseases and trauma. A current barrier to success is inefficienct clinical administration of these therapies to the patient. This is due to underdeveloped methods for presenting the cells that results in the majority of them dying or migrating away soon after injection. This project aims to redresss this issue by creating purpose-built delivery vehicles that provide protective environments and solidify upon injection; thus improving the survival, localisation, and clinical effectiveness of cell therapy. In this programme of work, we will demonstrate these concepts within clinically-relevant preclinical models. Finance Summary Table – How to complete this sectionmmary

Our rapid increase in the understanding of the biology underlying many bodily repair processes has led to new perspectives in the design and use of materials to address disease or injury. For restorative stem cells to fully participate in tissue regeneration they need to be packaged in a delivery material that provides an optimal environment for them to function. This project will commercially develop a multi-functional tissue matrix that precisely locates an array of regenerative signals to service the requirements of tissue regeneration.The technology will be first directed towards bone repair applications, where earlier materials-based approaches are insufficient to heal large defects and in cases where more potent stimuli are required (e.g. for non-healing bone fractures and some spinal surgeries). The flexibility of the technology means that combinations of healing signals can be introdued into the matrix to make it more efficient and yield greater quantities of regenerated tissue. Further, a biologically-complex, highly active product can be produced with a low-cost formulation due to the re-purposing of existing, market-approved constituents.

Emerging cell therapies have vast potential in the treatment of currently incurable diseases; the potential market for cell-based therapies is over 100 million patients in the US alone. Some of the main targets include heart disease, diabetes, neurodegenerative diseases, musculoskeletal disorders, spinal cord injury, stroke, autoimmune diseases and trauma. A current barrier to success is inefficient clinical administration of these therapies to the patient. This is due to underdeveloped methods for presenting the cells that results in the majority of them dying or migrating away soon after injection. This project aims to redress this issue by creating purpose-built delivery vehicles that provide protective environments and solidify upon injection; thus improving the survival, localisation, and clinical effectiveness of cell therapies.

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