The European regulatory environment of rna-based vaccines

A variety of different mRNA-based drugs are currently in development. This became possible, since major breakthroughs in RNA research during the last decades allowed impressive improvements of translation, stability and delivery of mRNA. This article focuses on antigen-encoding RNA-based vaccines that are either directed against tumors or pathogens. mRNA-encoded vaccines are developed both for preventive or therapeutic purposes. Most mRNA-based vaccines are directly administered to patients. Alternatively, primary autologous cells from cancer patients are modified ex vivo by the use of mRNA and then are adoptively transferred to patients. In the EU no regulatory guidelines presently exist t…

The regulatory landscape for actively personalized cancer immunotherapies

Evolution of the Regulatory Landscape for Immunomodulatory Compounds and Personalized Therapeutic Cancer Vaccines

The term cancer immunotherapy covers a huge range of different therapeutic interventions based on highly diverse medicinal products. Some immunotherapy products such as monoclonal antibodies have successfully been developed during the last years and contributed to major advances in cancer therapy. Development of cancer vaccines seemed to be more challenging. Nevertheless, some promising candidates are currently in late-stage clinical development, and one product (sipuleucel-T) was recently approved in the United States (USA) and in the European Union (EU). Additionally, cell therapy approaches based on adoptive lymphocyte transfer have recently come into focus due to surprisingly efficient …