Aura Biosciences Receives Fast Track Designation for Bladder Cancer Candidate

Aura Biosciences’s investigational drug belzupacap sarotalocan (AU-011) has received a Fast Track designation from the FDA as a potential treatment for patients with non-muscle invasive bladder cancer.

AU-011 is a virus-like drug conjugate derived from the human papillomavirus. It is the company’s first investigational virus-like drug conjugate. There are currently no approved targeted therapies for non-muscle invasive bladder cancer.

The company plans on investigating the drug in this indication through a phase 1 clinical trial that is expected to begin later this year.