Drug intelligence / Profile preview

APS001F

Development stage
Phase 2
Lead developer
Anaeropharma Science
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, 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, Gene Therapies, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Intravenous
01

Overview

APS001F is an investigational live biotherapeutic product developed by Anaeropharma Science. [1] It consists of a genetically-enhanced strain of the anaerobic bacterium *Bifidobacterium longum*, which is designed to selectively target and kill solid tumors. [1, 2] This novel therapy leverages the hypoxic (low-oxygen) environment characteristic of solid tumor cores, where the intravenously administered APS001F can selectively colonize and proliferate. [1] The bacterium is engineered to express the enzyme cytosine deaminase (CD). [1, 2, 4] This enzyme locally converts a systemically administered, non-toxic prodrug, flucytosine (5-FC), into the potent cytotoxic chemotherapy agent 5-fluorouracil (5-FU) directly at the tumor site. [1, 2, 4] This tumor-specific production of 5-FU aims to achieve high intratumoral concentrations of the anticancer agent while minimizing systemic toxicity associated with conventional chemotherapy. [1, 4]

Other names
CD-expressing bifidobacterium APS001F
02

Targets

CD (Cluster of Differentiation antigens)

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