On October 15, 2018 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that it will be highlighting its Phase 1b/2 clinical data for AU-011, the Company’s lead product candidate for the primary treatment of choroidal melanoma, in two oral presentations at the American Academy of Ophthalmology (AAO) 2018 Annual Meeting being held October 27-30, 2018, at McCormick Place in Chicago (Press release, Aura Biosciences, OCT 15, 2018, View Source [SID1234529922]).
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"Following the positive interim results reported in July 2018 from this ongoing Phase 1b/2 study evaluating AU-011 in patients with choroidal melanoma, we are pleased to be sharing these updated, one-year results with the medical community at AAO this year," said Elisabet de los Pinos, Ph.D., Founder and Chief Executive Officer of Aura. "There are no FDA approved therapies for the treatment of choroidal melanoma, the most common type of primary eye cancer. Patients are currently treated with radiotherapy and surgery which typically results in severe vision loss, along with a plethora of other severe adverse effects and comorbidities. If approved, AU-011 will be the first targeted therapy for the treatment of choroidal melanoma, with the potential to preserve vision and transform the treatment paradigm for these patients."
In addition to the AAO clinical data presentations, Aura has been selected to present its innovative technology for the treatment of choroidal melanoma as part of the Innovation Showcase during the Ophthalmology Innovation Summit (OIS@AAO) taking place Thursday, October 25, 2018, at the Marriot Marquis Chicago. Dr. de los Pinos will give the presentation which will provide an update on Aura Biosciences.
Details for the oral presentations at AAO 2018:
Title: One-Year Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Primary Choroidal Melanoma
Presenter: Brian P. Marr, M.D., Columbia University Medical Center
Session: Ocular Oncology
Date and Time: Saturday, October 27, 2018, from 3:21 – 3:29 PM CT
Location: Room E350
Title: One-Year Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Primary Choroidal Melanoma
Presenter: Brian P. Marr, M.D., Columbia University Medical Center
Session: Ocular Pathology, Oncology
Date and Time: Monday, October 29, 2018, from 3:57 – 4:04 PM CT
Location: Room E350
About Choroidal Melanoma
Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary ocular tumor 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 to the liver in about 40-50 percent of cases in the long term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).
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.