Innovative Therapy with a Nanostructured Complex and Monoamine Oxidase-A Inhibitor for Bacillus Calmette-Guérin-Unresponsive Non-Muscle Invasive Bladder Cancer.

• Grant number: 25/12383-9
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: May 01, 2026
• End date: January 31, 2027
• Field of knowledge: Biological Sciences - Morphology - Anatomy
• Principal Investigator: Gabriela de Oliveira
• Grantee: Gabriela de Oliveira

Abstract

The project proposes the development and preclinical validation of ImmunoClor, a novel intravesical nanoimmunotherapy designed for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC)-a challenging clinical condition associated with high recurrence rates, limited therapeutic options, and significant deterioration in patient quality of life. ImmunoClor consists of a nanostructured inorganic complex (CIN-1) combined with a selective monoamine oxidase-A inhibitor (MAO-Ai). This formulation operates through a dual and synergistic mechanism of action: (i) modulation of the tumor microenvironment by reversing the immunosuppressive polarization of macrophages and stimulating cytotoxic T lymphocytes; and (ii) inhibition of oxidative and metabolic pathways associated with tumor immune evasion, thereby promoting programmed cell death. The therapeutic strategy aims to restore antitumor immunity in a localized, safe, and effective manner. The development plan comprises five technical-scientific axes designed to advance the formulation's technology readiness level (TRL) from TRL 3 to TRL 4: (1) comprehensive physicochemical characterization; (2) in vitro functional evaluation in tumor cells; (3) toxicological studies in murine models; (4) assessment of antitumor and immunological efficacy in an NMIBC animal model; and (5) therapeutic benchmarking against the current gold-standard treatment (BCG). ImmunoClor represents a first-in-class, low-cost, and scalable national innovation developed by AETER Biotech Ltda., a spin-off from the University of Campinas (UNICAMP) dedicated to oncology-focused technological innovation. The platform has broad freedom to operate and strong international patentability potential, supported by a formal know-how agreement with the university. This project addresses a critical gap in the healthcare system-marked by the global shortage of BCG and the inaccessibility of systemic therapies-by offering a viable alternative for both the Brazilian Unified Health System (SUS) and the private sector. It is estimated that over 5,000 patients per year in Brazil could benefit from this new therapeutic approach. The successful completion of Phase 1 will enable the consolidation of a robust technical-regulatory dossier, the filing of strategic patents, and the structuring of the next clinical and industrial development phase. (AU)