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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.
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