Aura Biosciences gets FDA fast track status for belzupacap sarotalocan

Aura Biosciences has secured fast track designation for belzupacap sarotalocan (AU-011) from the US Food and Drug Administration (FDA) for the treatment of non-muscle invasive bladder cancer (NMIBC).

Belzupacap sarotalocan is the first virus-like drug conjugate (VDC) being developed by the American biotech company for various oncology indications.

Dr. Mark De Rosch — Aura Biosciences Chief Operating Officer and Head of Regulatory Affairs said: “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.”

Aura Biosciences said that a planned phase 1 clinical trial of belzupacap sarotalocan in non-muscle invasive bladder cancer will assess the safety and early proof of mechanism, evaluate local necrosis, distribution, and evidence of immune activation.

The clinical stage biotech company is likely to begin the phase 1 trial in the latter half of this year. Initial data from the phase 1 clinical trial of belzupacap sarotalocan is expected to come out next year.

Dr. Cadmus Rich – Aura Biosciences Chief Medical Officer and Head of research and development said: “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.

“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.”