Transforming drug development with 3D retina models
Newcells Biotech Limited was awarded £1m to deliver their retinal model as a tool for toxicology studies under the CRACK IT challenge.
Newcells Biotech Limited, a team of internationally recognised experts in the building and application of complex models of human tissues for drug discovery, was awarded £1m to deliver their project, 3D hiPSC (human-induced pluripotent stem cells) derived laminated retinal model as a tool for toxicology studies under the CRACK IT: Retinal 3D challenge led by National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs)
Background
NC3Rs is a UK-based scientific organisation dedicated to replacing, refining and reducing the use of animals in research and testing, operating under the umbrella of the Medical Research Council (MRC), which forms part of UK Research and Innovation (UKRI).
CRACK IT was established with the support of Innovate UK in 2011 and is run using the Contracts for Innovation process (previously known as the Small Business Research Initiative or SBRI) with the support of Innovate UK’s Contracts for Innovation team.
Project overview
At the time, the development of drugs for eye disorders was growing expansively, with an increase in the marketplace for therapies targeting retinal disorders expected to grow to $14.8bn by 2022. However, there were no adequate in vitro models that could recapitulate the complex structure of the mature human retina. Newcells Biotech Ltd collaborated with Newcastle and Loughborough Universities, Sunderland Eye Infirmary and Asymptote to generate human induce pluripotent stem cells (hiPSC) to create 3D retinal organoids that closely modelled the structure and function of the human retina, enabling the replacement of animals in the discovery of new ophthalmic drugs.
Following the Evaluation Report of the, then known, Small Business Research Initiative, Newcells Biotech was featured as one of exemplar projects across a diverse portfolio of projects. Newcells Biotech’s project had developed a retina in vitro model, which was commercialised and on the market with contracts with multiple firms including Genentech in the USA. Newcells Biotech was also able to generate the Intellectual Property (IP) with Newcastle University, acquiring additional existing IP from the university, enhancing their competitiveness.
Outcomes and continued impact
Following the completion of the project we caught up with Newcells Biotech’s, CEO, Dr Mike Nicholds, to find out what impact the funding had on the company.
“The funding has driven the growth of Newcells Biotech, expanding revenue, the number of customers, the company’s geographical markets and diversification of the product offering. It has proven to have a positive impact on our customers by providing preclinical efficacy and safety data that optimises the design of animal and clinical studies. We have examples of customers using the model and data for candidate selection and to support in vitro characterisation. There are limited in vitro alternatives to this model meaning that customers must rely more on animal data, particularly on efficacy for indications such as retinopathies.
This project has resulted in the development of the human retina organoids in vitro model and a suite of assays, which is the basis of services and products that has driven revenue growth of over 50% per annum. The retina platform now accounts for >40% of the company’s total revenue, achieving a cumulative revenue into the company of over £5 in 3 years.”
The project has also resulted in an increase in staff, the formation of a retina team, that now counts 7 experts and a dedicated manufacturing team that ensures continuous supply of retinal organoids. The production processes have led to the company increasingly investing in automation to drive productivity and quality improvements.
This model is also contributing to the company remaining at the forefront of technology and expanding in growth markets such as gene therapy development. It is now an established tool used by companies developing gene therapies to test their therapies for safety and efficacy. Newcells Biotech has established business with companies globally (EU, US, Japan, Taiwan) that now benefit from using this model to acquire predictive data from a human-cell derived model prior to moving to clinical trials.
Newcells Biotech has established key collaboration with major pharma and biotech companies including the sponsors of the original Challenge project and continue to work closely with them on advancing the models capability and application.
– Dr Mike Nicholds, Newcells Biotech Limited