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Aura Biosciences Receives FDA Fast Track Designation for Belzupacap Sarotalocan (AU-011) for the Treatment of Non-Muscle Invasive Bladder Cancer
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug
About this update from Aura Biosciences, Inc.
[{"type":"text","content":" CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for belzupacap sarotalocan (AU-011), Aura’s first VDC product candidate, for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).\n\n“We are pleased that belzupacap sarotalocan has been granted Fast Track designation. We believe that, given that NMIBC presents such a high unmet medical need, the opportunity for more frequent interactions with Division of Oncology at FDA and the potential for Priority Review will be valuable as we advance further into clinical development in patients with NMIBC,” said Dr. Mark De Rosch, Chief Operating Officer and Head of Regulatory Affairs of Aura.\n\n“NMIBC has no approved targeted therapies, and patients experience high levels of recurrence and progression, ultimately leading to cystectomy or the removal of the entire bladder,” said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura. “This milestone supports our goal to advance the development of belzupacap sarotalocan for patients with NMIBC in need of better and earlier targeted treatment options with the potential to help preserve the bladder.”\n\nAura’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.\n\nFast 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. Features of Fast Track designation include opportunities for more frequent interactions with the FDA review team and, if supported by clinical data, eligibility for Priority Review. 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.\n\nAbout Aura Biosciences\n\nAura B...