On Thursday, Aura Biosciences, Inc. (NASDAQ:AURA) revealed early data from an ongoing Phase 1 trial of bel-sar (AU-011) in patients with non-muscle-invasive bladder cancer (NMIBC).
To date, the trial includes 13 patients, with the primary endpoints of evaluating the safety and feasibility of local administration of bel-sar alone (n=5) and bel-sar with light activation (n=8).
Also Read: Aura Biosciences Touts Promising Data From Eye Cancer Candidate.
The secondary endpoints are to evaluate biological activity and immune-mediated changes in the tumor microenvironment (TME).
In patients receiving bel-sar with light activation (n=8), 4 out of 5 patients with low-grade disease demonstrated a clinically complete response with no tumor cells remaining on histopathological evaluation.
Two out of 3 patients with high-grade disease demonstrated visual tumor shrinkage observed on cystoscopy.
The data in these eight patients receiving bel-sar with light activation showed clinical activity detectable as soon as seven days after a single low dose of bel-sar with light activation.
“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. In parallel with expanding the ongoing Phase 1 trial, we are preparing for a Phase 2 trial to further evaluate bel-sar’s clinical activity and durability of response,” said Sabine Brookman-May, Senior Vice President, Therapeutic Area Head Urologic Oncology of Aura Biosciences.
In the safety analysis as of Sept. 9, data cut-off date (n=12), bel-sar was well-tolerated, with less than 10% of patients reporting Grade 1 and no Grade 2 or higher drug-related adverse events reported.
No serious adverse events have been reported.
Price Action: AURA stock traded 18.85% higher at $12.23 during after-hours trading on Thursday.
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