Aura Biosciences, Inc. (AURA) has announced positive preliminary findings from its ongoing Phase 1 clinical trial evaluating bel-sar (AU-011) for the treatment of non-muscle-invasive bladder cancer (NMIBC). The trial, currently enrolling 13 patients, is designed to assess the safety and feasibility of both bel-sar alone and bel-sar with light activation.
The results, which were released on Thursday, are particularly promising for patients receiving bel-sar with light activation. In this group (n=8), four out of five patients with low-grade disease demonstrated a complete response, meaning no tumor cells were detected after histopathological evaluation. Moreover, two out of three patients with high-grade disease showed visually observable tumor shrinkage during cystoscopy.
These early findings are significant, as they demonstrate clinical activity as early as seven days after a single low dose of bel-sar with light activation. This rapid response, combined with the observed immune-oncology effect (marked CD8+ T-cell infiltration), could potentially translate into a durable treatment benefit for patients.
“A potentially differentiating aspect of this novel treatment is the rapid tumor response accompanied by an immune-oncology effect such as a marked CD8+ T-cell infiltration observed in just a matter of days with a single low dose. We believe this could have the potential to translate into a durable response,” stated Sabine Brookman-May, Senior Vice President, Therapeutic Area Head Urologic Oncology of Aura Biosciences.
In terms of safety, bel-sar has shown a favorable profile in the trial. As of September 9th, the data cut-off date, bel-sar was well-tolerated in 12 patients, with less than 10% experiencing Grade 1 adverse events and no Grade 2 or higher drug-related adverse events reported. Notably, no serious adverse events have been reported.
The positive preliminary results from this Phase 1 trial have fueled optimism for bel-sar’s potential as a new treatment option for NMIBC. Aura Biosciences is now actively preparing for a Phase 2 trial to further investigate bel-sar’s clinical activity and the durability of its effects in patients.
AURA stock surged by 18.85% to $12.23 during after-hours trading on Thursday following the announcement of these positive results.