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Escherichia coli Nissle 1917 + PCSK9 nanobody
- Development stage
- Preclinical
- Lead developer
- Zhengzhou University
- Modality
- Nanobodies (VHH) → Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
- Administration
- Oral
01
Overview
Escherichia coli Nissle 1917 + PCSK9 nanobody is an engineered live biotherapeutic product consisting of the probiotic bacterium *Escherichia coli* Nissle 1917 (EcN) modified to express and secrete a high-affinity camelid-derived nanobody (VHH-B11) targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). Designed for oral administration, the engineered bacteria colonize the gastrointestinal tract and constitutively release the PCSK9 nanobody, which utilizes the NSP4 signal peptide for efficient extracellular secretion. The nanobody enters the systemic circulation and the liver, where it binds to circulating PCSK9. By neutralizing PCSK9, the drug prevents the degradation of hepatic low-density lipoprotein receptors (LDLR), thereby increasing the clearance of LDL cholesterol from the blood. This microbial delivery system aims to provide a cost-effective, needle-free alternative to monoclonal antibody injections for managing metabolic and cardiovascular diseases.
- Other names
- EcN/pUC19-tac-NSP4-PCSK9nbrecombinant engineered bacterium EcN/PCSK9nbengineered probiotic PCSK9nb
02
Targets
PCSK9 (Proprotein convertase subtilisin/kexin type 9)
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