CellGENTherapies

Neoantigen-targeted dendritic cell vaccination in lung cancer patients induces long-lived T cells exhibiting the full differentiation spectrum

Ingels J. et al. Cell Reports Medicine 2024

Here, we report the results of a first-in-human clinical trial in which we explored the potential of an autologous DC vaccine targeting neoantigens as adjuvant therapy in early-stage resected NSCLC patients. The primary endpoint of the trial was safety. Secondary endpoints were feasibility, immunogenicity, and relapse-free survival.

• An important challenge of Neo-mDC therapy is the extensive coordination required between the different actors and processes (i.e., next-generation sequencing [NGS], immunopeptidomics, bioinformatic analyses, production of the plasmid template, good manufacturing practice [GMP] production of RNA, apheresis of the patient, and finally GMP production of the cell therapy product) in order to streamline the overall production process and time.
• In the present trial, fully functional, neoantigen-loaded, monocyte-derived DCs were generated in only 4days, which is associated with reduced costs compared to classical 7/8-day DCs due to fewer operator interventions, less consumables, and less occupation time of ultrapure, class B clean rooms dedicated to aseptic processing.
• Further reduction of costs may be achieved by using fully automated, closed cell-culture systems, of which several platforms are currently being developed and actively explored for chimeric antigen receptor (CAR)-T cell production. The introduction of these systems will enable further reduction in operator interventions and reduce the need for class B clean rooms.

Preclinical toxicological assessment of an α-galactosylceramide-adjuvanted mRNA cancer vaccine in Wistar Han rats and domestic pigs

Meulewaeter S. et al. Mol Ther Methods Clin Dev 2025

In this study, a preclinical toxicological assessment of an α-galactosylceramide-adjuvanted mRNA cancer vaccine in Wistar Han rats and domestic pigs was conducted as a critical step in advancing toward the phase 1 clinical testing of Galsome-NEO.