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Vigil + irinotecan + temozolomide
- Development stage
- Unknown
- Lead developer
- Gradalis
- Modality
- Dendritic Cell Vaccines → Immune Effector Cells → Other Cell Types → Cell Therapies, Small Molecules
- Administration
- Autologous Intradermal Or Intratumoral (Vigil), Oral (temozolomide, Irinotecan May Also Be Oral Or Intravenous), Intravenous (irinotecan)
01
Overview
This is an investigational **combination regimen** comprised of three agents: - **Vigil**: an autologous tumor cell immunotherapy, specifically a bi-shRNA furin and GM-CSF–augmented genetically modified autologous tumor cell vaccine designed to enhance immune response against the patient's tumor; - **Irinotecan**: a small molecule topoisomerase I inhibitor that interferes with DNA replication and transcription, causing cancer cell death; - **Temozolomide**: an oral alkylating agent that induces DNA methylation leading to tumor cell apoptosis. The regimen is being investigated as a treatment for relapsed or refractory Ewing's sarcoma, particularly in children and adolescents, with initial clinical development by Gradalis. Vigil is manufactured from an individual patient's tumor and administered in combination with standard chemotherapy (irinotecan and temozolomide) to potentially improve time to progression and survival compared to chemotherapy alone.
- Other names
- Vigil plus irinotecan and temozolomideVigil + Tem/Iri
02
Targets
CSF2R (Granulocyte-macrophage colony-stimulating factor receptor)FurinTOP1 (DNA Topoisomerase I)DNA
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