Aura Biosciences to Present Long-Term Clinical Data for AU-011 at the 37th Annual Scientific Meeting of the American Society of Retina Specialists

24th July 2019

CAMBRIDGE, MA – July 24, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that two-year 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 37th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) being held July 26- 30, 2019 in Chicago, Illinois.

“There is an urgent unmet medical need for targeted treatment options for patients suffering from primary choroidal melanoma, a life-threatening form of eye cancer. Emerging results from the Phase 1b/2 trial of light-activated AU-011 demonstrate tumor control and visual acuity preservation, warranting continued development of the program.”

Amy C. Schefler, M.D., Associate Professor of Clinical Ophthalmology, Weill Cornell Medical College/Houston Methodist Hospital and the University of Texas Health Science Center

Title: Two-Year Results of an Ongoing Phase 1b/2 Open Label Clinical Trial of AU-011 for the Primary Treatment of Small to Medium Choroidal Melanoma,

Presenter: Amy C. Schefler, M.D., Associate Professor of Clinical Ophthalmology, Weill Cornell Medical College/Houston Methodist Hospital and the University of Texas Health Science Center

Session: Ocular Oncology Symposium

Date and time: Monday, July 29, 2019; 9:35 -9:41am CDT

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.