Drug intelligence / Profile preview

APS001F + flucytosine

Development stage
Unknown
Lead developer
Anaeropharma Science
Modality
Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Small Molecules
Administration
Intravenous (APS001F), Oral (flucytosine)
01

Overview

APS001F + flucytosine is a **combination drug** comprising a living recombinant strain of *Bifidobacterium longum* (APS001F) engineered to express **cytosine deaminase** and the prodrug **flucytosine (5-FC)**. APS001F is administered intravenously, where it localizes to hypoxic regions of solid tumors and produces cytosine deaminase. When flucytosine is given orally, this enzyme converts it locally within the tumor into **5-fluorouracil (5-FU)**, a cytotoxic agent that inhibits tumor growth. This approach is designed to maximize tumor-specific delivery of 5-FU while limiting systemic exposure and toxicity. Preclinical and early clinical trials suggest direct antitumor and local immunomodulatory effects, with development focused on advanced solid tumors[1][3][4][5][7].

Other names
APS001F/5-FCflucytosine5-FC
02

Targets

yCD (Cytosine deaminase (Saccharomyces cerevisiae))TS (Thymidylate synthase)CD (Cluster of Differentiation antigens)Neuraminidase

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