Drug intelligence / Profile preview

ONKO BCG

Development stage
Unknown
Lead developer
Synthaverse
Modality
Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Vaccines & Immunotherapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics
Administration
Intravesical
01

Overview

ONKO BCG is an intravesical live bacterial immunotherapy developed and manufactured by Synthaverse (formerly BIOMED-LUBLIN), utilizing the live attenuated **Moreau Polish substrain** of *Mycobacterium bovis* (Bacillus Calmette-Guérin). It is specifically indicated for the treatment of superficial, non-muscle invasive bladder cancer (NMIBC), including the treatment of carcinoma in situ and as adjuvant therapy to prevent tumor recurrence following transurethral resection of the bladder tumor (TURBT). The drug works by inducing a localized, non-specific immune response in the bladder wall. Upon administration, the BCG bacteria attach to the urothelium—often mediated by fibronectin—and are internalized by both immune and tumor cells. This process triggers a massive recruitment and activation of inflammatory cells, including macrophages, T-lymphocytes, and natural killer (NK) cells, and the release of various cytokines (such as IL-1, IL-2, IL-12, and TNF-alpha), which collectively lead to the destruction of residual malignant cells. ONKO BCG serves as a standard-of-care biologic alternative or supplement to intravesical chemotherapy for intermediate- and high-risk NMIBC.

Brand names
ONKO BCG 50ONKO BCG 100
Other names
BCG MoreauBCG Moreau Polish substrainBCG Moreau-LublinOnko BCG-Synthaverse

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