Positive Data from Phase 1 Trial of Bel-sar in Patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) Presented at the 40th Annual European Association of Urology Congress

Core Insights - Aura Biosciences announced positive data from a Phase 1 trial of bel-sar (AU-011) for patients with non-muscle invasive bladder cancer (NMIBC), indicating potential for a paradigm shift in treatment approaches [1][3] - The trial demonstrated clinical complete responses in patients with intermediate and high-risk NMIBC, with a favorable safety profile [1][4] Trial Design and Results - The trial included 15 patients, assessing safety and feasibility of bel-sar alone and with light activation, focusing on tumor necrosis and immune changes [2] - In the light-activated group, 4 out of 5 intermediate-risk patients showed clinical complete responses, while 1 out of 5 high-risk patients also responded positively [2][5] - Immune profiling indicated significant infiltration of cytotoxic T-cells and the formation of tertiary lymphoid structures, suggesting a robust anti-tumor immune response [6] Safety Profile - Bel-sar was well-tolerated, with drug-related Grade 1 adverse events reported in less than 10% of patients, and no serious adverse events noted [4] Future Development Plans - Aura will host a virtual investor event to discuss the Phase 1b/2 trial and future development plans for bel-sar [7][8] - The company aims to outline the potential of bel-sar as a new front-line treatment option for NMIBC, which could expand treatment options and improve patient outcomes [3][10]