Chimeric Antigen Receptor (CAR) T-cell (CAR-T) therapy represents a revolutionary advance in cancer treatment. In this kind of treatment, T cells (a type of immune system cell) are taken from a patient’s blood and genetically engineered in the laboratory in such a way that they bind to specific proteins on the cancer cells and attack them. To this end, the gene for a special receptor (called a Chimeric Antigen Receptor) that binds to a certain protein on the patient’s cancer cells is inserted into the T cells. Millions of these lab-grown CAR-T cells are then given (back) to the patient by infusion. Ideally, the CAR T cells recognise and kill the cancer cells and continue to multiply in the patient’s body.
CAR T-cells have emerged as a key breakthrough, particularly in treating B-cell malignancies, with long-term remission and cure in previously end-stage patients. These unprecedented clinical responses have clearly transformed the clinical landscape, with several commercial CAR-T products being available as standard-of-care in EU countries.
However, the current commercial production paradigm by pharmaceutical companies poses significant challenges to rapid implementation. Specifically, products have long lead times, thereby, precluding severely ill patients from eligibility for this life-saving therapy.
Furthermore, centralised production poses challenges to rapid innovation and has a significant environmental impact with often inter-continental delivery. Moreover, such a centralised production of commercial CAR-T products has prohibitively high costs that strain the healthcare systems in Europe, even in the currently limited indication areas for which it is approved. Indeed, some countries do not include CAR-Ts in their public standard-of-care. Therefore, efforts currently focus on developing academic point-of-care (PoC) production, which is also the primary focus of InnoCAR-T.
