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Aura Biosciences Presents Final Phase 1b/2 Data for its first Virus-Like Drug Conjugate, AU-011, in Patients with Choroidal Melanoma at the American Academy of Ophthalmology 2021 Annual Meeting
Presentations Include Final Safety and Efficacy Data from the Phase 1b/2 Trial using Intravitreal Administration and Updated Safety Data from the Phase 2
About this update from Aura Biosciences, Inc.
[{"type":"text","content":"\nPresentations Include Final Safety and Efficacy Data from the Phase 1b/2 Trial using Intravitreal Administration and Updated Safety Data from the Phase 2 Trial using Suprachoroidal Administration\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of data evaluating its first VDC, AU-011, in indeterminate lesions (ILs) and choroidal melanoma (CM), including final safety and efficacy data from the Phase 1b/2 trial using intravitreal (IVT) administration, as well as updated safety results from the Phase 2 trial using suprachoroidal (SC) administration. The results are presented as part of the American Academy of Ophthalmology (AAO) 2021 Annual Meeting.\n\n“The final safety and efficacy data from the Phase 1b/2 trial using intravitreal administration presented today, along with the data from the Phase 2 trial using suprachoroidal administration, provide a high level of confidence for further clinical development in patients with indeterminate lesions or choroidal melanoma,” said Carol Shields, MD, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University. “I believe AU-011 may offer patients a safe, effective first-line therapy for early-stage disease that preserves vision, a critical component in patients’ quality of life often neglected with today’s current treatment options.”\n\nFinal 12-Month Safety and Efficacy Data from Phase 1b/2 Trial with IVT administration\n\nThe Phase 1b/2 trial (NCT03052127) evaluated the safety and efficacy of AU-011 using IVT administration for the treatment of ILs and CM. A total of 56 patients were enrolled in the Ph1b/2 trial including the single and multiple dose escalation cohorts and received up to two cycles of therapy (therapeutic regimen). As part of an enrichment strategy agreed with FDA, patients with small tumors with active growth were enrolled in the Phase 2 part of the study (expansion cohort). This group of patients (n=14) received the therapeutic regimen and were evaluated for the tumor growth rate, tumor control, and visual acuity preservation as the efficacy endpoints. These endpoints have been agreed with FDA and are planned to be used in the...