The Mutanome Engineered RNA Immuno-Therapy (MERIT) project aims to clinically translate and industrially validate a pioneering RNA-based immunotherapy approach to target the individual tumour antigen signature. MERIT focuses on previous inventions, fits into the overall business and innovation needs of the partners, and addresses triple-negative breast cancer patients with high medical need. The MERIT concept, including patents and potential products, was developed using EU FP6 funding. The innovative therapeutics will pave the way for generation of scientific knowledge and technologies and will stimulate the development of new products, tools, patents, and innovative marketable applications.The concept behind MERIT is to implement a highly innovative Next-Generation-Immunotherapy drug platform enabling Next–Generation-Sequencing-guided stratified medicine and clinical-grade individualized RNA vaccines. Every patient’s tumour expresses many shared tumour-specific antigens and bears a highly individual molecular “signature” comprising 10’s to 100’s of non-synonymous mutations, many of which are immunogenic. We will use clinical-grade RNA to produce a) a warehouse of therapeutic vaccines targeting shared antigens and b) custom therapeutic vaccines targeting patient-specific mutations. Upon success, partner BioNTech will move the therapeutics to advanced clinical trials and commercial applications for the benefit of triple negative breast cancer patients and other solid tumours.