Aura Biosciences Inc. said the U.S. Food and Drug Administration has granted Fast Track designation for belzupacap sarotalocan AU-011 for the treatment of non-muscle invasive bladder cancer.
The company said its planned Phase 1 clinical trial with belzupacap sarotalocan, a virus-like drug conjugate product candidate, would 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.
Fast Track designation is an FDA process designed to facilitate the development of products that address high unmet medical needs and may expedite the review of drugs intended to treat serious or life-threatening diseases.
Belzupacap sarotalocan has also been previously granted Fast Track and Orphan Drug designations by the FDA for the treatment of choroidal melanoma and is currently in Phase 2 clinical development in this indication.
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