EASYGEN · EASY workflow integration for GENe therapy

More than 20 million new patients world-wide are diagnosed with cancer every year, and prediction for 2050 foresee over 35 million cancer cases, reflecting the population ageing and growth with a tremendous burden on the health care system. A global WHO survey with 115 participating countries has shown, that only 39% can cover basic cancer care management, financed as core health service. This reveals significant global inequities between high GNP and low- and middle-income countries, which is also reflected in country-specific cancer patient outcomes. Hence, there is a strong need for emerging technologies, that democratize access to cancer treatment, reduce the disparities in cancer care, and significantly reduce the burden on the healthcare workforce. Chimeric Antigen Receptor T-cells are considered as cutting-edge treatment for cancer, but currently only for hematologic malignancies. And although the efficacy is very promising the number of European patients having access to CAR-T treatment is still very limited due to high costs and complex manufacturing and logistic processes. The public private partnerhsip EASYGEN will develop an automated, modular point-of-care cell- and gene-therapy platform, that will allow for the first time hospital on-site CAR-T manufacturing. Designed as a closed, modular, one-stop solution, the device aims to reduce manufacturing time significantly to less than 24 hours and treatment costs by 50%. In a user-centric, co-creation approach, the device will be holistically integrated in a standard hospital workflow, hence empowering healthcare systems to provide CAR-T treatment in any standard hospital setting, capable of conducting leukapheresis. Its modular set-up will ensure adaptability to different ATMPs including solid tumours. Therewith, EASYGEN will initiate a paradigm shift in the CAR-T market, paving the way to a greater democratized cancer treatment access and improving the patient’s quality of life and overall outcome.