10085294Manufacturing scale up of Clickmers, a novel class of therapeutic moleculesClosedCollaborative R&DInnovate UKAcross the developed world populations are rapidly aging leading to increasing prevalence of cancer, chronic disease, and dementia. Novel and more effective therapies are required for healthy aging. APIS recently acquired Clickmer technology and now has ambitious plans to develop Clickmers as innovative new drugs to tackle major health challenges including breast cancer. Clickmers are short DNA sequences that can be chemically changed to improve their ability to bind proteins. Compared to existing aptamer solutions, whose DNA backbone cannot be changed, this means that there are higher chances of selecting a Clickmer to bind the disease-causing protein of interest. Additionally, compared to antibodies, Clickmers provide opportunity for highly consistent, lower cost, animal-free production. This in turn has positive impact by lowering treatment costs and improving accessibility of treatment across society. With these advantages, Clickmers are therefore attractive for targeting disease-causing proteins for which antibodies, small molecules, or aptamers have failed. APIS plans to bring multiple Clickmer products to market by selling custom Clickmers to Pharma and APIS' own drug development, initially in the area of breast cancer. With approximately 2 million new cases per year, breast cancer is the most common cancer in women. APIS seek to treat highly aggressive breast cancer. With big Pharma facing patent expiry for blockbuster drugs, there is a trend towards increased deals to fill innovation gaps in their drug pipelines. Selling custom Clickmers to Pharma can provide an attractive new approach to drug development. APIS forecast that these products will bring both short-term and long-term revenues, in turn providing company growth and job creation. Currently the quantity of Clickmer that can be manufactured at APIS is not high enough to support further drug development studies. There is therefore a critical business need to increase the scale at which Clickmers can be manufactured to enable these studies. Our main focus is to optimise the manufacturing process and to introduce quality controls to ensure high-quality, reliable supply of Clickmers. With safety of future drugs in mind, we will investigate and monitor levels of purity and impurities in the manufactured Clickmers. In summary, APIS' long-term vision is to disrupt the current approach to targeting disease-causing proteins. Clickmers provide a highly flexible process for selecting a Clickmer with desirable interaction properties and for highly consistent, lower cost manufacturing. This project will enable Clickmers to be produced in sufficient quantity to further their development as drugs of the future.