FDA grants Fast Track designation to novel therapy for NMIBC


Aura Biosciences reported in a news release that the FDA has granted its Fast Track designation to belzupacap sarotalocan (AU-011) for the treatment of patients with non–muscle invasive bladder cancer (NMIBC).1

Investigators plan to assess the agent’s safety profile, mechanisms of action, distribution, local necrosis, and proof of immune activation in a phase 1 clinical trial in the aforementioned patient population. The trial is set to begin in the second half of 2022, with initial findings anticipated in 2023.

“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,” Mark De Rosch, PhD, FRAPS, chief operating officer and head of regulatory affairs at Aura, said in a press release.

Belzupacap sarotalocan is a virus-like drug conjugate that consists of a virus-like particle conjugated with an anticancer agent. It was selectively designed to seek out and eliminate cancer cells as well as encourage immune system activation and potentially yield prolonged antitumor immunity.

The fast track designation was designed to allow for the development of therapeutics in areas with significant unmet need and hasten the review process. If supported by clinical findings, belzupacap sarotalocan could be eligible for priority review in NMIBC. The agent has also previously received fast track designation and orphan drug designation by the FDA for chorodial melanoma, in which belzupacap sarotalocan is currently being assessed in a phase 2 trial (NCT04417530).

“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,” Cadmus Rich, MD, chief medical officer and Head of R&D at Aura, said in a press release. “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.”

The phase 2 trial assessing the agent in primary indeterminate lesions and small choroidal melanoma has an estimated enrollment of 58 patients and will feature up to 7 experimental cohorts. The primary end point is tumor thickness growth rate over 52 weeks, with secondary end points including time to reach composite end point, time to reach disease progression, and change from baseline best corrected visual acuity at 52 weeks.


1. Aura Biosciences receives FDA fast track designation for belzupacap sarotalocan (AU-011) for the treatment of non-muscle invasive bladder cancer. News release. Aura Biosciences. June 30, 2022. Accessed July 1, 2022. https://bwnews.pr/3yAoEPt

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