Development stage: Application for marketing authorization under review (EU) / in preparation (US)
Antibody-based treatment for children with neuroblastoma
APN311 is a monoclonal chimeric antibody produced in CHO cells targeting the GD2 antigen on neuroblastoma cells. It is investigated in several late-stage clinical trials against neuroblastoma (a rare childhood cancer), with more than 700 patients having received treatment to date. Apeiron has recently filed its application for marketing authorization in the EU and is preparing an application for the US. The project has received Orphan Drug designations from the EMA and the US-FDA plus Fast Track designation from the US-FDA.
Publications relating to APN311
Ladenstein et al. Ch14.18 antibody produced in CHO cells in relapsed or refractory Stage 4 neuroblastoma patients: a SIOPEN Phase 1 study. MAbs. 2013 Sep-Oct;5(5):801-9.
Zeng et al. Anti-neuroblastoma effect of ch14.18 antibody produced in CHO cells is mediated by NK-cells in mice. Molecular Immunology 42 (2005) 1311–1319.