title: Translation of genomics-guided RNA-based personalised cancer vaccines: towards the bedside.
abstract: Cancer is a disease caused by DNA mutations. Cancer therapies targeting defined functional mutations have shown clinical benefit. However, as 95% of the mutations in a tumour are unique to that single patient and only a small number of mutations are shared between patients, the addressed medical need is modest. A rapidly determined patient-specific tumour mutation pattern combined with a flexible mutation-targeting drug platform could generate a mutation-targeting individualised therapy, which would benefit each single patient. Next-generation sequencing enables the rapid identification of somatic mutations in individual tumours (the mutanome). Immunoinformatics enables predictions of mutation immunogenicity. Mutation-targeting RNA-based vaccines can be rapidly and affordably synthesised as custom GMP drug products. Integration of these cutting-edge technologies into a clinically applicable process holds the promise of a disruptive innovation benefiting cancer patients. Here, we describe our translation of the individualised RNA-based cancer vaccine concept into clinic trials.
authors.affiliation: 1] TRON gGmbH-Translational Oncology at Johannes Gutenberg-University Medical Center gGmbH, Langenbeckstr 1, Building 708, 55131 Mainz, Germany [2] BioNTech AG, Hölderlinstr 8, 55131 Mainz, Germany.
authors.forename: V
authors.initials: V
authors.lastname: Boisguérin
authors.affiliation: TRON gGmbH-Translational Oncology at Johannes Gutenberg-University Medical Center gGmbH, Langenbeckstr 1, Building 708, 55131 Mainz, Germany.
authors.forename: J C
authors.initials: JC
authors.lastname: Castle
authors.affiliation: TRON gGmbH-Translational Oncology at Johannes Gutenberg-University Medical Center gGmbH, Langenbeckstr 1, Building 708, 55131 Mainz, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Loewer
authors.affiliation: TRON gGmbH-Translational Oncology at Johannes Gutenberg-University Medical Center gGmbH, Langenbeckstr 1, Building 708, 55131 Mainz, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Diekmann
authors.affiliation: 1] TRON gGmbH-Translational Oncology at Johannes Gutenberg-University Medical Center gGmbH, Langenbeckstr 1, Building 708, 55131 Mainz, Germany [2] BioNTech AG, Hölderlinstr 8, 55131 Mainz, Germany [3] TheraCode GmbH, Hölderlinstr 8, 55131 Mainz, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Mueller
authors.affiliation: 1] TRON gGmbH-Translational Oncology at Johannes Gutenberg-University Medical Center gGmbH, Langenbeckstr 1, Building 708, 55131 Mainz, Germany [2] Ribological GmbH, Hölderlinstr 8, 55130 Mainz, Germany.
authors.forename: C M
authors.initials: CM
authors.lastname: Britten
authors.affiliation: TRON gGmbH-Translational Oncology at Johannes Gutenberg-University Medical Center gGmbH, Langenbeckstr 1, Building 708, 55131 Mainz, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Kreiter
authors.affiliation: 1] University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany [2] Ganymed Pharmaceuticals AG, Freiligrathstraße 12, 55131 Mainz, Germany.
authors.forename: Ö
authors.initials: Ö
authors.lastname: Türeci
authors.affiliation: 1] TRON gGmbH-Translational Oncology at Johannes Gutenberg-University Medical Center gGmbH, Langenbeckstr 1, Building 708, 55131 Mainz, Germany [2] BioNTech AG, Hölderlinstr 8, 55131 Mainz, Germany [3] University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Sahin
mesh_terms: D019496:Cancer Vaccines / Q000235:genetics*; D004353:Drug Evaluation, Preclinical; D006801:Humans; D009154:Mutation; D057285:Precision Medicine; D012334:RNA, Neoplasm / Q000235:genetics*; D057170:Translational Research, Biomedical
chemical_list: D019496:Cancer Vaccines; D012334:RNA, Neoplasm