RUTI® in combination with BCG Therapy Show Encouraging Outcomes in Bladder Cancer

Archivel Farma is delighted to anounce the outcome of RUTIVAC study in Bladder Cancer. The RUTI ® vaccine, developed and produced in-house by Archivel Farma, was tested in a phase I trial involving 40 patients with high-risk non-muscle-invasive bladder cancer at Hospital Universitari Germans Trias i Pujol. Administered prior to standard BCG therapy, RUTI ® enhanced the immune response, reducing tumor recurrence and progression, and improving patient survival over five years. The vaccine generated stronger CD4⁺ and CD8⁺ T-cell responses and increased cytokine production, without promoting immunosuppressive T-regulatory cells. Importantly, RUTI ® was well tolerated with only mild injection-site reactions. These promising results, published in European Urology, suggest that RUTI ® could enhance the current standard of care for bladder cancer, paving the way for larger trials to confirm its clinical benefits. Read in https://doi.org/10.1016/j.eururo.2025.08.014 Archivel Farma has been both, sponsor and RUTI ® supplier for this study. We extend our sincere thanks and congratulations to our partners, IrsiCaixa and the Germans Trias i Pujol Research Institute (IGTP), for their dedication and excellent work. 20/10/2025

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