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daretabart + temozolomide + irinotecan
- Development stage
- Unknown
- Lead developer
- Essential Pharma
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
- Administration
- Intravenous, Oral
01
Overview
Daretabart (hu1418K322A) in combination with temozolomide and irinotecan is an investigational chemo-immunotherapy regimen being developed by Renaissance Pharma for the treatment of relapsed or refractory high-risk neuroblastoma in pediatric and young adult patients. Daretabart is a humanized monoclonal antibody that targets the GD2 disialoganglioside, a cell surface antigen highly expressed on neuroblastoma cells. It incorporates a K322A point mutation in the Fc region designed to reduce complement-mediated toxicity while maintaining potent antibody-dependent cell-mediated cytotoxicity (ADCC). The regimen combines this immunotherapy with temozolomide, an oral alkylating agent that induces DNA damage, and irinotecan, a topoisomerase I inhibitor that prevents DNA repair. This combination is currently being evaluated in the Phase 2/3 SHINE clinical trial.
- Other names
- daretabart + temozolomide + irinotecan
02
Targets
TOP1 (DNA Topoisomerase I)DNAGD2FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)
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