Aura Biosciences' Bladder Cancer Candidate Demonstrates Tumor Shrinkage In Patients With High-Grade Disease

Core Insights - Aura Biosciences, Inc. has revealed early data from a Phase 1 trial of bel-sar (AU011) for non-muscle-invasive bladder cancer (NMIBC) [1] - The trial includes 13 patients, focusing on the safety and feasibility of bel-sar alone and with light activation [1][2] Trial Details - The primary endpoints are to evaluate the safety and feasibility of local administration of bel-sar alone (n=5) and with light activation (n=8) [1] - Secondary endpoints include assessing biological activity and immune-mediated changes in the tumor microenvironment [2] Clinical Outcomes - In the group receiving bel-sar with light activation (n=8), 4 out of 5 patients with low-grade disease showed a complete response with no tumor cells remaining [2] - Among patients with high-grade disease, 2 out of 3 demonstrated visual tumor shrinkage [2] - Clinical activity was detectable as soon as seven days after a single low dose of bel-sar with light activation [2] Immune Response - A notable aspect of this treatment is the rapid tumor response and marked CD8+ T-cell infiltration observed within days of treatment [3] - This rapid response may indicate potential for a durable effect [3] Safety Profile - As of the data cut-off on September 9, bel-sar was well-tolerated, with less than 10% of patients reporting Grade 1 adverse events and no Grade 2 or higher events [3] - No serious adverse events have been reported [3] Market Reaction - Following the announcement, AURA stock increased by 18.85%, trading at $12.23 in after-hours trading [4]