Research & Development
Aura to Present Interim Phase 1b/2 Clinical Data for AU-011 at the International Society of Ocular Oncology 2019 Annual Meeting
21 March 2019 - - US-based Aura Biosciences, a specialist in the development of novel targeted therapies in ocular oncology, will present interim clinical data from its Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the company's lead product candidate for the primary treatment of primary choroidal melanoma, in an oral presentation at the International Society of Ocular Oncology 2019 annual meeting being held next week, the company said.

This open-label, multicenter trial is designed to investigate single and multiple ascending doses of light-activated AU-011 in approximately 52 adult subjects with clinically diagnosed primary choroidal melanoma.

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% 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.

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma.

The therapy consists of proprietary viral-like particle bioconjugates 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, 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 US Food and Drug Administration and is currently in clinical development.

Aura Biosciences is developing a new class of therapies to selectively target and destroy cancer cells. Its lead program, AU-011 in primary choroidal melanoma, is being developed under a CRADA with the National Cancer Institute, part of the National Institutes of Health
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