Aura Biosciences Inc ((AURA)) announced an update on their ongoing clinical study.
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Aura Biosciences Inc. is conducting a Phase 1, open-label trial titled ‘A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer.’ The study aims to assess the feasibility and safety of AU-011, a treatment for bladder cancer, using focal injections with or without laser application. This research is significant as it explores new treatment avenues for patients with non-muscle-invasive bladder cancer (NMIBC) who are unresponsive or intolerant to BCG therapy.
The intervention being tested is Belzupacap Sarotalocan (AU-011), administered intratumorally and intramurally. The study also explores the combination of AU-011 with laser application to enhance treatment efficacy.
The study follows a non-randomized, sequential intervention model with no masking, focusing primarily on treatment. This design allows researchers to evaluate the direct effects of AU-011 on bladder cancer.
The study began on July 20, 2022, and is currently recruiting participants. The latest update was submitted on September 29, 2025. These dates are crucial as they indicate the study’s progress and ongoing data collection.
This clinical update could positively influence Aura Biosciences’ stock performance by showcasing their commitment to innovative cancer treatments. It may also affect investor sentiment positively, given the potential for AU-011 to address unmet needs in bladder cancer treatment. Competitors in the oncology sector may watch closely as this study progresses.
The study is ongoing, and further details are available on the ClinicalTrials portal.