Public Funding for Glialign Limited

Peripheral Nerve Injury (PNI) is seen in 2-5% of trauma cases, affecting around 1 million people in Europe and the US every year. Of these, 600,000 will have surgery but only 50% will regain function and many are in continuous pain. In the USA, trauma PNI leads to 8.5M restricted activity days and 5M bed/disability days p.a. Upper extremity paralysis affects 360,000 in the US and 300,000 in Europe. Up to 50% have autografts (140 -- 180,000 procedures in the US) but lack of suitable donor tissue or surgeon availability will limit autograft numbers. The construction of living artificial nerve tissue containing therapeutic cells provides promise for the repair of nerve injuries where current clinical options are limited to autografting or the use of non-living scaffolds. Engineered Neural Tissue (EngNT) has been developed at UCL and is being commercialised by the spin out company Glialign Ltd. It comprises columns of aligned human therapeutic cells in an aligned collagen matrix, resembling natural nerve graft tissue. It is constructed using a three-step process of cellular self-alignment in tethered collagen gels, followed by stabilisation through a fluid removal step to make a sheet of material, followed by a final assembly stage to roll the sheet into a cylindrical construct. Engagement with industry partners and the Cell and Gene Therapy Catapult (CGTC) has been supported by Innovate-UK and investment funds, suitable sources of clinical grade therapeutic cells and materials have been established, preclinical proof of concept studies have shown promising results in animal models, and the translational pathway for developing EngNT as an Advanced Therapy Medicinal Product (ATMP) has been explored in detail. The project seeks to progress the development of this novel engineered living nerve growth guide, designated "EngNT" - which is intended as an off-the-shelf nerve tissue replacement, primarily for peripheral nerve repair. Work will develop GMP small scale manufacturing processes for the nerve conduit and sheath and produce demonstration lots to make the process ready for subsequent manufacture of clinical lots for use in patients. Commercial scale up processes and regulatory requirements will also be explored in order to expedite the clinical development of the fully commercialised EngNT product.

Peripheral nerve injury is debilitating, causing loss of feeling and movement and in some cases long-term pain. Nerves can be repaired surgically to enable regeneration to occur, but often the injury results in a large gap which needs to be bridged. Currently the best way to repair large gaps is to use a nerve graft, which involves taking a healthy nerve section from elsewhere in the patient's body, which is limited in terms of the amount of tissue available and which causes additional loss of function at the donor site. Glialign is a new company set up to develop a solution to this problem. Our approach combines tissue engineering technology with therapeutic cells in order to build living replacement nerve tissue which mimics the structure and function of a natural nerve graft (Engineered Neural Tissue, EngNT). By using cells and materials that are safe to implant into any person without immune rejection, EngNT has the potential to be an 'off the shelf' product, immediately available for nerve repair whenever and wherever it is required. This project will evaluate the clinical and commercial feasibility of the technology through preclinical testing and development of a strong business case, leading to future regulatory and manufacturing development and clinical trials.