Drug intelligence / Profile preview

CRS-100

Development stage
Phase 1
Lead developer
Novartis
Modality
Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Vaccines & Immunotherapeutics
Administration
Intravenous
01

Overview

CRS-100 (formerly ANZ-100) is a live-attenuated strain of the bacterium *Listeria monocytogenes* (Lm) developed as a cancer immunotherapy. It is engineered using the LADD (Live, Attenuated, Double-Deleted) platform, which involves the deletion of the *actA* and *inlB* genes to significantly reduce virulence by preventing cell-to-cell spread and limiting the infection of hepatocytes. Despite these attenuations, the bacterium remains capable of being phagocytosed by antigen-presenting cells (APCs), where it escapes the phagosome and enters the cytosol. This process triggers potent innate immune signaling pathways, including the activation of Toll-like receptors (TLRs) and the STING pathway, which promotes the maturation of dendritic cells and the subsequent activation of tumor-specific CD4+ and CD8+ T-cell responses. CRS-100 was primarily investigated in Phase 1 clinical trials for the treatment of advanced carcinomas with liver metastases, serving as a foundational vector for subsequent antigen-specific Listeria-based vaccines.

Brand names
ANZ-100ANZ100ANZ 100
Other names
Live-attenuated Listeria monocytogenes
02

Targets

STING (Stimulator of interferon genes protein)NOD2 (Nucleotide-binding oligomerization domain-containing protein 2)TLR2 (Toll-like Receptor 2)TLR5

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