Alcyomics Limited Public Funding

Osteoarthritis (OA) is a painful and disabling disease of the joints. It principally affects the hands, hips and knees and is very common in most countries. It is estimated that over 250 million people have osteoarthritis which has a significant impact on global economies and healthcare systems. Osteoarthritis is the most common form of arthritis in the UK, (around 8.75 million) affecting around a third of people aged 45 and over. Within the next 10 years, the number of people with osteoarthritis is predicted to rise substantially as we are living longer and cases of obesity, which is linked to osteoarthritis, are also increasing. Currently, most treatments for osteoarthritis are restricted to pain relief. There are no drugs on the market that can reverse the disease or even halt its progression. Ultimately, most patients require a total joint replacement. Since osteoarthritis is a complex disease, involving many different types of cells and tissues in the joint, finding and testing new drugs to treat osteoarthritis is very complex as it is difficult to replicate osteoarthritis in the laboratory. Our project will advance a developed model of osteoarthritis to include nerve cells in order to assess novel pain-relieving drugs, vital for the control of the disease, assess the effectiveness of drugs in treating the disease and aid in the replacement of animal testing for new osteoarthritis therapies. The tissues within the model represent different parts of a human joint, bone and cartilage which will be "printed" with nerve cells, producing the 3D model of osteoarthritis. Compounds will activate the disease process, including neural activation and drugs will be introduced to evaluate their ability to stop or reverse osteoarthritis and pain sensitisation. Our model will advance the identification of effective osteoarthritis drugs, improving significantly on existing laboratory tests and current small animal models.

Osteoarthritis is a painful and disabling disease of the joints. It principally affects the hands, hips and knees and is very common in most countries. It is estimated that over 250 million people across the world have osteoarthritis which has a significant impact on global economies and healthcare systems. Osteoarthritis is the most common form of arthritis in the UK, (around 8.75 million) affecting around a third of people aged 45 and over. Within the next 10 years, the number of people with osteoarthritis is predicted to rise substantially as we are living longer and cases of obesity, which is linked to osteoarthritis, are also increasing. Currently, most treatments for osteoarthritis are restricted to pain relief. There are no drugs on the market that can reverse the disease or even halt its progression. Ultimately, patients require a total joint replacement, if such an operation is possible. This is mainly because osteoarthritis is a complex disease, often of unknown origin, involving many different types of cells and tissues in the joint. Finding and testing new drugs to treat osteoarthritis is very difficult as it is hard to replicate these disease conditions in laboratory test systems. Our project will advance a model of osteoarthritis that we have been developing over the last four years, to assess the effectiveness of drugs in treating the disease and aid in the replacement of animal testing for new osteoarthritis therapies. The tissues constituting the model are representative of different parts of a human joint, bone and cartilage. In this application, we will further develop this model to include nerve cells in order to assess novel pain-relieving drugs, vital for the control of the disease. The bone and cartilage will be "printed" with nerve cells, in order to produce the 3D models. A range of compounds will be used to activate the disease process, including neural activation, and drugs will then be introduced to evaluate their ability to stop or reverse osteoarthritis and pain sensitisation. Our models will speed up the process of identifying effective anti-osteoarthritis drugs, improving significantly on existing laboratory tests and small animal models.

Alcyomics has developed unique non-animal non-artificial human skin explant assays (Skimune & Skimune3D) which can test for safety and efficacy of novel drugs and compounds including cosmetics. Skimune and Skimune 3D have been developed by using human skin, tissue and blood therefore giving a human response to the compounds rather than, the currently used, animal models. Alcyomics innovative assays enable the products of the pharmaceutical, chemical and cosmetic industries to reach the clinic and/or the market place quicker by early assessment of their safety profiles. Alcyomics has recently improved their service offering by the aid of Innovate UK funding by developing Skimune3D in a 96 well format. The 96 well format allows for high throughput screening saving clients both money and time and Skimune3D enables multiple dose testing and information on patient drug dosage prior to clinical trial. In this current project we aim to further exploit this model by bioprinting Skimune3D and validate the bioprinted model for safety testing, therefore creating a more standardised service offering. Alcyomics will also work with Axol Ltd to incorporate nerve cells into the model in order to enable safety testing for neural toxicity. In summary this project will increase Alcyomics' service offering and in roads into new global markets and product development.

Extension For Impact Funding Our results to date have shown that within the general population there are responders, mild or non responders to the COVID-19 virus. This will allow us to identify those individuals who may respond well to a vaccine and those individuals that may need further, or additional, therapy for COVID-19. The extension for impact funding will allow us to validate these results on cohorts of asymptomatic or mildly effected individuals and those who acquired more severe disease. A pattern of molecules, cytokine/chemokines, or genes will be validated on COVID-19 patient samples and further aid in drug discovery and vaccine development.

"The Northern Alliance Advanced Therapies Treatment Centre (NAATTC) is a group of NHS hospitals and services. NAATTC has a wide geographical reach across Scotland and the North of England and is responsible for the health care of 15 million NHS patients. Advanced therapies are becoming increasingly available with a growing number of companies developing them both in the UK and worldwide. They are based on the administration of gene- and cell-based products in specialities such as haematology, autoimmunity, hepatology, cardiology and ophthalmology. They are thought to be more effective than existing treatments and provide treatments for diseases where currently no effective therapy exists. However most are still in clinical trials. Advanced therapies present significant challenges to healthcare providers compared with existing treatments. Addressing these challenges in the NHS will require development and dissemination of new skills for nurses, doctors, hospital pharmacists, NHS managers, and commissioners such as NHS England and the clinical commissioning groups (CCGs). It will also require changes in the way treatment is delivered. The changes required in the NHS can only be properly implemented through partnership with the companies that are developing and providing advanced therapies to the NHS. Manufacturers will need assistance with clinical trials to ensure optimal trial design, effective recruitment into clinical trials, and long term follow up of outcomes. The manufacturing and distributing processes are complex and it is critical that these systems are integrated effectively with those within the NHS. The NAATTC already has considerable experience of delivering advanced therapies and clinical trials and will use this experience to work with manufacturers (and their supply chains) to significantly increase their capacity to deliver advanced therapies effectively, safely, and seamlessly to patients within the NHS. It will identify gaps in our existing provision and develop solutions to narrow and eliminate the gaps. It will share the best practice that it develops to other ATTCs and to other NHS organisations. The outcomes will be to deliver these promising therapies to NHS patients and to make the NHS a global leader in their delivery, creating health and wealth for the UK."

Alcyomics have developed unique, non-animal, non-artificial human skin explant assays (Skimune™ and Skimune™3D) which can test for safety and efficacy of novel drugs and compounds, including cosmetics. Alcyomics assays enable the products of the pharmacuetical, chemical and cosmetics industries to reach the clinic and/or the market place, quicker by early assessment of their safety profiles. Alcyomics has recently improved their service offering by developing Skimune™ 3D, a new 3D human skin model for skin sensitisation which predicts adverse immune responses or allergy, as well as toxic profiles, of the compounds under test. The next stage of development involves improving the scalablility of this 3D skin model to increase capacity and further commercialisation. The project funding will be used to transform the existing model into a standard 96-well plate format, thereby increasing the number of drugs and novel compounds that can be tested and creating a platform that is amenable to future automation. The construction of this tool will involve novel, bespoke manufacturing processes and collaboration with another North East company (ReproCELL). Successful completion of this work will enable Alcyomics to increase the capacity of their drug testing operation for the toxicology and genotoxicity markets. This will provide a greater service provision and aid Alcyomics to achieve its objective to become a 'one-stop shop' for safety and efficacy profiling for the pharmaceutical, chemical and cosmetics industry globally. ReproCELL as distributor will also aid in increasing sales and marketing.

Awaiting Public Project Summary

Alcyomics Ltd, has developed a novel proof of concept human skin equivalent model (Skimune™-3D) from our current patented skin assay (Skimune™). Both assays use healthy volunteer blood and skin samples to assess drugs and compounds for adverse immune reactions. Our objective, using Launchpad funding is to make a reproducable manufacturable Skimune™-3D model with improved scalability and longevity. We will assess the longevity and reproducibility of the new model, using a panel of known positive and negative controls. Using robust protocols with release specifications for manufacture we will test at least ten independent Skimune™-3D batches. New SOPs and testing protocols for Skimune™-3D will be established and validated against the current Skimune™ whole skin assay. Our model is the first 3D skin model capable of assessing adverse immune responses. Working with our existing and NE Process Sector Cluster clients we will trial the new Skimune™-3D assays. We will also avail of the business and market support facilities the Launchpad can offer to access new customers in the Cluster and markets e.g. cosmetic safety testing, toxicology and stratified medicine.

To develop a novel 3D human skin equivalent model which will allow entry into new markets for skin sensation and detection of adverse immune responses to novel compounds and drugs.

Awaiting Public Project Summary