Aura Biosciences’ ocular melanoma treatment receives fast track designation
AU-011, an investigational, first-in-class targeted therapy for ocular melanoma treatment, was granted fast track designation by the FDA, according to a press release from Aura Biosciences.
In addition, at Wills Eye Hospital, the first patient was enrolled and dosed in a phase 1b trial of the treatment, which is designed to target and selectively destroy cancer cells using viral nanoparticle conjugates.
Through the designation, the company can have frequent FDA interactions during the drug development process, and the treatment will receive priority review of its new drug application.
“Patients with ocular melanoma currently have few treatment options available that can effectively destroy tumor cells while still preserving vision,” Carol Shields, MD, co-director of the Ocular Oncology Service at Wills Eye Hospital, said in the release. “Aura’s trial is an important step in understanding the potential of AU-011 as a safe and novel therapeutic option to improve the outlook for these patients.”
Investigators are focusing on two dose levels of AU-011 in small to medium primary ocular melanoma and will enroll up to 12 adult patients at Wills Eye and other oncology centers, the release said.