Drug intelligence / Profile preview

E. coli Nissle ΔclbP

Development stage
Preclinical
Lead developer
Ardeypharm
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
Administration
Oral
01

Overview

E. coli Nissle ΔclbP is a genetically modified version of the probiotic strain *Escherichia coli* Nissle 1917 (EcN). The modification involves the deletion of the *clbP* gene, which encodes a peptidase essential for the maturation of colibactin, a genotoxic secondary metabolite produced by the *pks* genomic island. While wild-type EcN is widely used for gastrointestinal disorders, its potential to induce DNA double-strand breaks via colibactin has raised safety concerns regarding long-term use and colorectal cancer risk. The ΔclbP variant retains the probiotic benefits of the parent strain—such as competitive exclusion of pathogens, enhancement of intestinal barrier function, and immunomodulation—while eliminating genotoxicity. This strain serves as a safer chassis for the development of engineered live biotherapeutic products (LBPs) designed to deliver therapeutic payloads to the gut.

Other names
Escherichia coli strain Nissle 1917 clbP deletion mutantclbP-deficient E. coli Nissle 1917
02

Targets

TNFA (Tumor necrosis factor alpha (soluble))IL10 (Interleukin-10)OCLN (Occludin)

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