CAMBRIDGE, MA – March 21, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that 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, will be highlighted in an oral presentation at the International Society of Ocular Oncology (ISOO) 2019 Annual Meeting being held March 22-26, 2019, in Los Angeles.
“These 18-month safety and efficacy data demonstrate that light-activated AU-011 is well-tolerated, including with multiple administrations, and has shown initial evidence of tumor control and preservation of visual acuity even in high risk patients whose tumors are close to the fovea and optic disk,” said Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear, Associate Professor of Ophthalmology, Harvard Medical School, and lead author of the presentation.
“Light-activated AU-011 continues to show a compelling degree of tumor control, tolerability and vision preservation as a potential first line treatment option for patients with small choroidal melanoma and indeterminate lesions, especially given the lack of targeted treatment options for these patients,” commented Cadmus Rich, M.D., Chief Medical Officer of Aura. “It is also remarkable that no drug-related severe adverse events, serious adverse events or dose limiting toxicities have been observed in the study to date. We are excited to share these data with the medical community at ISOO this year.”
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. The details for the ISOO 2019 presentation are as follows:
Title: Eighteen Month Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma
Date and time: Sunday, March 24, 2019; 11:10-11:15am PT
Location: The Ritz-Carlton Marina del Rey
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 primary treatment of 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.
About Aura Biosciences
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 (NCI), part of the National Institutes of Health. For more information, visit www.aurabiosciences.com.
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