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rBCG-LTAK63 is a recombinant Bacillus Calmette-Guérin (BCG) strain engineered to express the genetically detoxified A subunit of the heat-labile toxin (LTAK63) from enterotoxigenic *Escherichia coli*. Developed by the Butantan Institute, it is designed as an enhanced immunotherapeutic candidate for non-muscle invasive bladder cancer (NMIBC) and a vaccine candidate for tuberculosis. The LTAK63 subunit acts as a mucosal adjuvant, significantly boosting the activation of dendritic cells, CD4+ T cells, and CD8+ T cells compared to conventional BCG. In bladder cancer models, it remodels the tumor microenvironment by increasing pro-inflammatory cytokine production (IFN-γ, TNF-α, IL-17) and reducing the frequency of immunosuppressive regulatory T cells (Tregs), leading to superior tumor growth control and improved survival.
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