FDA Grants Fast Track Status to Belzupacap Sarotalocan for NMIBC

The FDA has granted fast track designation to belzupacap sarotalocan (AU-011), for the treatment of patients with non-muscle invasive bladder cancer, according to an announcement by Aura Biosciences, Inc.¹

“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, in a press release.

Belzupacap sarotalocan a first-in-class virus-like drug conjugate (VDC) therapy. In preclinical in vivo models, the agent was shown to have a direct cytotoxic effect on tumor cells and lead to long-term anti-tumor immunity. When used in combination with immune checkpoint inhibitors, the activity of belzupacap sarotalocan was enhanced.2 With an FDA fast track designation, review of applications for belzupacap sarotalocan will be expedited. The designation is designed to bring therapies forward that have the ability to fill an unmet medical need.

A phase 1 study of belzupacap sarotalocan is planned to launch in the second half of 2022, and data will from the study will be announcement in 2022. In the study, investigators will assess the drug’s safety early proof of mechanism, assess distribution, local necrosis, and evidence of immune activation.

“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, 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.”

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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. News release. June 30, 2022. Accessed July 8, 2022.}