Aura Biosciences said today that it enrolled and dosed the 1st patient in the Phase Ib trial of its light-activated AU-011 viral nanoparticle conjugate therapy for the treatment of ocular melanoma. The company also said that the FDA granted fast track designation to its targeted treatment, which will give priority review for the company’s New Drug Application.
Administered through the eye, the company’s AU-011 therapy is composed of viral nanoparticle conjugates that selectively bind to cancer cells in the eye. The treatment is activated using an ophthalmic laser, at which point it specifically destroys tumor cells’ membranes while avoiding healthy eye structures, Aura reported.
“Patients with ocular melanoma currently have few treatment options available that can effectively destroy tumor cells while still preserving vision. 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,” Dr. Carol Shields said in prepared remarks. Shields is the co-director of the ocular oncology service at Wills Eye Hospital and a member of Aura’s clinical advisory board.
The company plans to evaluate the safety of 2 dose levels of AU-011 in the Phase Ib study, which is slated to enroll up to 12 adult patients with small-to-medium primary ocular melanoma.
“We look forward to evaluating and advancing AU-011 alongside Dr. Shields and other renowned researchers at ocular oncology centers of excellence in the U.S.,” founder & CEO Elisabet de los Pinos added. “Moreover, we will continue to work closely with the FDA under AU-011’s fast track designation to shape our clinical program with their input. Ultimately, our goal is to equip the physicians who diagnose ocular melanoma early with a new targeted therapy that both prevents tumor growth and leaves other key ocular structures unaffected, thereby preserving vision for patients.”