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Imuno BCG Moreau RJ
- Development stage
- Approved
- Lead developer
- Biofabri
- 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, Vaccines & Immunotherapeutics
- Administration
- Intravesical
01
Overview
Imuno BCG Moreau RJ is an intravesical formulation of the Bacillus Calmette–Guérin (BCG) Moreau Rio de Janeiro substrain of Mycobacterium bovis, developed as an immunotherapy for high‑risk non‑muscle‑invasive bladder cancer (NMIBC). It is based on the early BCG Moreau RJ substrain, which lacks certain virulence-associated lipids such as phthiocerol dimycocerosates (PDIM) and phenolic glycolipids (PGL), a feature associated with reduced reactogenicity and fewer adverse events compared with some later BCG substrains.[1] In NMIBC, intravesical instillation of BCG induces a local inflammatory response with recruitment of innate and adaptive immune cells, secretion of cytokines (including interferons and interleukins), and activation of tumor-specific cytotoxic T cells that collectively mediate antitumor effects within the bladder wall.[1] Imuno BCG Moreau RJ is being developed and supplied by Biofabri as a strain‑specific BCG bladder cancer vaccine to provide an additional BCG option during global BCG shortages, with a phase 3 ENCORE‑01 trial evaluating its efficacy and safety versus historical experience of other BCG strains in high‑risk NMIBC.[1][2][8]
- Brand names
- Imuno BCG Moreau RJ
- Other names
- BCG Moreau RJBCG Moreau Rio de JaneiroBCG bladder cancer vaccine
02
Targets
TLR2 (Toll-like Receptor 2)TLR4 (Toll-like receptor 4)
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