CAMBRIDGE, MA – June 14, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that interim clinical data from its ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the treatment of primary choroidal melanoma, will be highlighted in an oral presentation at the European Society of Ophthalmology 2019 Congress being held June 13-16, 2019, in Nice, France.

“The data with additional follow up time continues to demonstrate a good tolerability and safety profile of light-activated AU-011 at single and multiple administrations. There is also consistent evidence of tumor control and visual acuity preservation, which are key benefits of this novel treatment. Interest in AU-011 as a potential first line treatment for early stage disease is very high as current treatments for primary choroidal melanoma typically result in severe vision loss and ocular morbidity.”

Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear, Associate Professor of Ophthalmology, Harvard Medical School

Oral presentation details are as follows:

Title: Interim Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma

Presenter: Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear and Associate Professor of Ophthalmology, Harvard Medical School

Session: Innovation in Retina

Date and time: Friday, June 14, 2019; 3:00-3:12pm CEST

Location: Gallieni 5, Acropolis Convention Centre

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.