The company has received written confirmation from the U.S. Food and Drug Administration (FDA) regarding agreement on the design of its Phase 3 registration trials designed to evaluate light-activated AU-011 for the treatment of patients with choroidal melanoma. This written confirmation is the result of successful outcome of an “End of Phase 2” meeting with the FDA.
The data presented at the meeting show that multiple administrations of light-activated AU-011 are well-tolerated with no related serious adverse events, severe adverse events or dose-limiting toxicities observed.
Phase 1b/2 clinical data for AU-011, the Company’s lead product candidate for the primary treatment of choroidal melanoma, will be presented 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.
Julie Feder has joined Aura as Chief Financial Officer, and Kylie Reynolds has joined as Vice President of Finance.
Interim data show that AU-011 has been generally well-tolerated in the multiple ascending dose cohort of the ongoing clinical trial.
Interim data presented today show that AU-011 has been generally well-tolerated, and early efficacy results are very promising.
Aura announced that it has closed $30 million in Series C financing, which will support ongoing clinical development, enabling buildout of company infrastructure and GMP manufacturing
Aura announced that researchers at Massachusetts Eye and Ear (MEE), Emory University and the National Cancer Institute (NCI) have generated preclinical data that demonstrate the ability of light-activated AU-011 to target and selectively destroy ocular melanoma tumors.
Molecular Cancer Therapeutics
Kines R, Varsavsky I, Choudhary S, Bhattacharya D, Spring S, McLaughlin R, Kang S, Grossniklaus H, Vavvas D, Monks S, MacDougall J, de los Pinos E, Schiller J
Aura announced that Cadmus Rich, M.D., has joined the company’s leadership team as Chief Medical Officer.
Interim Phase 1b/2 data on AU-011 presented by Carol Shields, M.D., at AAO 2017 show safety and preliminary efficacy at three months post-treatment.
Carol Shields, M.D., of the Wills Eye Hospital in Philadelphia, will present data from Aura's Phase 1b clinical safety study of AU-011 at AAO 2017.
National Institutes of Health