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MO-03
- Development stage
- Phase 2
- Lead developer
- Osel
- 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
MO-03 is an orally administered live biotherapeutic product (LBP) developed by Osel Inc. as a high-potency capsule formulation of the *Clostridium butyricum* MIYAIRI 588 (CBM588) strain. Specifically designed for oncology applications, MO-03 is intended for use in combination with standard-of-care immune checkpoint inhibitors to treat advanced and metastatic renal cell carcinoma (mRCC). The drug works by modulating the human gut microbiome to enhance the clinical efficacy of immuno-oncology regimens. *Clostridium butyricum* is a spore-forming anaerobe that produces short-chain fatty acids (SCFAs), primarily butyric acid, which serves as an energy source for the intestinal epithelium and exerts immunomodulatory effects that support antitumor activity. MO-03 is currently being evaluated in a pivotal Phase 3 trial, representing the first microbiome-based oral therapy to reach this stage of clinical development in oncology.
- Brand names
- Miyarisan
- Other names
- CBM588CBM-588CBM 588Clostridium butyricum MIYAIRI 588
02
Targets
15-LOX (Lysyl Oxidase)CD8A (CD8 alpha/beta Coreceptor)RORγtFFAR4 (Free fatty acid receptor 4)TLR4 (Toll-like receptor 4)TNFRSF10A (Death receptor 4)
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