Drug intelligence / Profile preview

dinutuximab beta + modified N7 regimen

Development stage
Preclinical
Lead developer
Recordati
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous
01

Overview

**Dinutuximab beta + modified N7 regimen** is an investigational chemoimmunotherapy combination regimen evaluated for the induction treatment of high-risk neuroblastoma (HR-NB) in pediatric patients. The regimen pairs the anti-GD2 chimeric monoclonal antibody dinutuximab beta with a modified version of the SIOPEN N7 induction chemotherapy protocol (which includes cyclophosphamide, doxorubicin, vincristine, cisplatin, and etoposide), alongside granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) and low-dose interleukin-2 (IL-2, aldesleukin). Dinutuximab beta targets the disialoganglioside GD2 expressed on neuroblastoma cells, inducing antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), while the chemotherapy backbone provides cytotoxic tumor reduction. This combination has been evaluated in pilot clinical studies, demonstrating encouraging end-of-induction response rates and a manageable safety profile, though it remains an off-label or investigational regimen.

Other names
dinutuximab beta + modified MSKCC/COG N7 protocoldinutuximab beta + modified MSKCC/COG N7 regimendinutuximab beta + modified N7dinutuximab beta + modified N7 protocoldinutuximab beta + modified SIOPEN N7 protocoldinutuximab beta + modified SIOPEN N7 regimen
02

Targets

DNATOP2A (DNA topoisomerase II)GD2CSF2R (Granulocyte-macrophage colony-stimulating factor receptor)IL-2R (Interleukin-2/interleukin-15 receptor complex)TUBB (Tubulin (alpha and beta subunits))

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