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engineered bacillus subtilis spores

Development stage
Preclinical
Lead developer
Creative Biolabs
Modality
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, Vaccines & Immunotherapeutics, 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, Cell Therapies, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Oral, Topical, Intranasal
01

Overview

Engineered Bacillus subtilis spores represent a versatile therapeutic platform technology rather than a single drug. Bacillus subtilis is a bacterium generally recognized as safe (GRAS) that can form highly robust endospores. These spores can be genetically engineered to function as delivery vehicles for a variety of therapeutic payloads. [1, 2, 27] The engineering process typically involves modifying the bacterium to express a specific protein, such as a vaccine antigen or a therapeutic peptide, on the spore's surface (spore display) or to secrete it after germination. [13, 25, 29] The exceptional resilience of these spores allows them to survive harsh conditions, such as the acidic environment of the stomach, enabling oral administration for gut-targeted therapies or mucosal vaccination. [4, 9, 25] They are also being investigated for topical applications, where the engineered bacteria can produce drugs directly on the skin. [5, 31] Upon reaching the target site, the spores can either elicit an immune response directly or germinate into metabolically active vegetative cells that produce the therapeutic agent in situ. [20, 25] This platform is being explored for a wide range of applications, including oral vaccines (e.g., for COVID-19), the delivery of therapeutic proteins for metabolic diseases, cancer immunotherapy, and as probiotics. [8, 16, 28, 35]

Other names
engineered Bacillus subtilis spores
02

Targets

MAGEA8 (Melanoma-associated antigen 8)

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