Aura Biosciences Gets Fast Track Designation for AU-011 Bladder Cancer Treatment
June 30 2022 - 7:44AM
Dow Jones News
By Chris Wack
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.
Aura shares were up 3%, to $12.95, in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
June 30, 2022 07:29 ET (11:29 GMT)
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