ArticleCancer immunology, immunotherapy : CII2026
Preclinical evaluation of rBCG-h12: an engineered Bacillus Calmette-Guérin with an enhanced activity against bladder and pancreatic cancers.
Article in Cancer immunology, immunotherapy : CII, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundIntravesical Bacillus Calmette-Guérin (BCG) therapy has been the standard treatment for preventing recurrence of non-muscle-invasive bladder cancer (NMIBC) for over four decades. Although maintenance BCG therapy improves recurrence-free survival in intermediate- and high-risk NMIBC patients, its long treatment duration, toxicity, and limited efficacy - particularly in carcinoma in situ -necessitate the development of improved therapeutic alternatives. rBCG-h12 is a recombinant BCG strain engineered to enhance immunogenicity. This study evaluated its ability to augment macrophage activation and antitumor responses.
methodsThe safety of intravesical rBCG-h12 was evaluated in NOD/SCID and C57BL/6 mice through four weekly instillations. Body weight, survival, urine hematuria, and organ histopathology were monitored. Antitumor efficacy was tested using an orthotopic NMIBC transplant model. Immune microenvironment changes were analyzed by detecting macrophage and T cell markers. The systemic antitumor potential of rBCG-h12 was further evaluated via intramuscular injection in pancreatic cancer transplant and K-Ras
resultsIntravesical rBCG-h12 was well tolerated, with no observed mortality, weight loss, hematuria, or organ pathology. Compared with conventional BCG, rBCG-h12 more effectively suppressed bladder tumor growth, prolonged survival, and mitigated cachexia. Mechanistically, rBCG-h12 decreased CD206
conclusionsrBCG-h12 exhibited superior antitumor efficacy and safety compared with BCG. By suppressing M2-macrophages and promoting Th1 immune activation, rBCG-h12 shows promise as a next-generation BCG-based immunotherapy for both bladder and pancreatic cancers.
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