Aura Biosciences receives FDA fast track designation for belzupacap sarotalocan (AU-011) for the treatment of non-muscle invasive bladder cancer

Aura Biosciences

30 June 2022 - Aura Biosciences today announced that the U.S. FDA has granted fast track designation for belzupacap sarotalocan (AU-011), Aura’s first virus-like drug conjugate product candidate, for the treatment of non-muscle invasive bladder cancer.

Aura’s planned Phase 1 clinical trial with belzupacap sarotalocan in this indication will evaluate the safety and early proof of mechanism, assess distribution, local necrosis and evidence of immune activation. Aura expects to initiate the trial in the second half of 2022, with initial Phase 1 data expected in 2023.

Read Aura Biosciences press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Fast track