Aura Biosciences announced interim safety data from an open-label phase 1b/2 study of its lead program, light-activated AU-011, for the treatment of primary ocular melanoma. The findings were presented by Carol Shields, MD, Director of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology of Thomas Jefferson University in Philadelphia, during a late-breaking session at the American Academy of Ophthalmology (AAO) 2017 annual meeting in New Orleans.
The first and second patients in this study were dosed earlier this year by Dr. Shields at Wills Eye Hospital in Philadelphia. The subsequent patients were dosed at centers in Boston, Detroit, Houston and Denver.
AU-011, an investigational, first-in-class targeted therapy, is in development for the treatment of primary ocular melanoma, a rare and life-threatening disease. The phase 1b/2 open-label, ascending single and repeat dose trial of AU-011, will evaluate the safety (primary objective) and preliminary efficacy (secondary objective) in up to 24 adult patients who have a clinical diagnosis of ocular melanoma.
Interim data presented at AAO show that the drug candidate was generally well-tolerated, with no serious adverse events reported, in the first six patients at 3 to 6 months post-treatment of AU-011. The most commonly reported adverse events consisted of anterior and posterior intraocular inflammation, which was managed with administration of topical and/or oral steroid treatment. All patients maintained visual acuity. The preliminary efficacy measurement of tumor thickness on B-scan ultrasound at three months post-treatment shows that all patients had stable disease at 3 months, and only one patient experienced tumor progression at 5 months.
“These preliminary findings are an encouraging step forward in our effort to evaluate the potential of AU-011 for the treatment of ocular melanoma,” said Dr. Shields. “Today there are no treatment options available for patients that can effectively target tumor cells while still preserving vision. We are excited to build on these initial results as this important research progresses.”
“Aura’s goal is to give physicians first-in-class tools that can transform the treatment of ocular melanoma and other cancers when the disease is diagnosed early,” Cadmus Rich, MD, Chief Medical Officer of Aura, said in a company news release. “These are promising early data, and our team is pleased to continue our phase 1b/2 study with Dr. Shields and our other collaborators at leading ophthalmology centers of excellence across the country.”