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 has been investigated in several late-stage clinical trials against neuroblastoma (a rare childhood cancer), with more than 1.000 patients having received treatment to date. In May 2017, Apeiron has received marketing authorization for treatment of neuroblastoma in the EU.

The project (present trade name 'Dinutuximab beta Eusa') has been licensed to EUSA Pharma for worldwide marketing and sales in September 2016. Eusa presently is preparing a BLA for the US to be submitted in 2018.

 

 Video of antibody mediated destruction of tumor cells via human effector functions (complement and effector cells)

 

Publications relating to APN311

 ASCO 2015 Poster - Loibner et al.

 ASCO 2015 Poster 1 - Lode et al.

 ASCO 2015 Poster 2 - Lode et al.

 ASCO 2015 Poster - Takahashi et al.

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.