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TICE-strain BCG-Ludwig Institute for Cancer Research-transitional cell carcinoma
- Development stage
- Phase 1
- Lead developer
- Merck
- Modality
- Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Vaccines & Immunotherapeutics, Cytokines & Interferons → Recombinant Proteins and Enzymes
- Administration
- Intradermal
01
Overview
This investigational immunotherapy regimen, developed and studied by the Ludwig Institute for Cancer Research, consists of a combination of the NY-ESO-1 protein vaccine, TICE-strain Bacille Calmette-Guérin (BCG), and sargramostim (GM-CSF). NY-ESO-1 is a cancer-testis antigen that is highly expressed in transitional cell carcinomas (TCC) of the urothelium but absent in normal adult tissues, making it an ideal target for tumor-specific immunotherapy. In this regimen, TICE-strain BCG—a live-attenuated preparation of *Mycobacterium bovis*—and sargramostim—a recombinant human granulocyte-macrophage colony-stimulating factor—function as immunological adjuvants. They are intended to enhance the recruitment, maturation, and activation of antigen-presenting cells (such as dendritic cells), thereby priming a robust cytotoxic T-lymphocyte response against NY-ESO-1-expressing tumor cells. The therapy is primarily evaluated in patients who have undergone cystectomy or nephroureterectomy for high-risk transitional cell carcinoma to eliminate minimal residual disease and prevent cancer recurrence.
- Brand names
- TICE BCGLeukine
- Other names
- NY-ESO-1 protein + TICE-strain BCG + sargramostimNY-ESO-1 vaccine regimenNY-ESO1 vaccine regimenNY-ESO 1 vaccine regimenNY-ESO-1 protein + BCG + GM-CSF
02
Targets
CSF2R (Granulocyte-macrophage colony-stimulating factor receptor)TLR2 (Toll-like Receptor 2)TLR4 (Toll-like receptor 4)NY-ESO-1 (New york esophageal squamous cell carcinoma 1)
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