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Aura Biosciences Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical Development and Operational Highlights
U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Belzupacap Sarotalocan (bel-sar) for the Treatment of Choroidal Metastasis,
About this update from Aura Biosciences, Inc.
[{"type":"text","content":"\nU.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Belzupacap Sarotalocan (bel-sar) for the Treatment of Choroidal Metastasis, Bel-sar’s Second Ocular Oncology Indication to Receive this Designation\n\nGlobal Phase 3 Trial in Primary Choroidal Melanoma on Track to Begin Dosing in 1H 2023\n\n BOSTON--(BUSINESS WIRE)--\nAura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today reported financial results for the fourth quarter and year ended December 31, 2022, and provided clinical development and operational highlights.\n\n“2023 is off to a strong start with positive interim Phase 2 safety and efficacy data with suprachoroidal administration in early-stage choroidal melanoma. In February, at the Macula Society’s 46th Annual Meeting, we presented average nine-month interim data which strongly supports the assumptions for the success of the global Phase 3 trial, which is on track to dose the first patient in the first half of this year,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “We are also excited to initiate clinical development in our second ocular oncology indication, choroidal metastasis, and to report early Phase 1 data in our non-muscle invasive bladder cancer program in the second half of this year. Our recently strengthened balance sheet positions us well to execute and advance our pipeline to meaningful clinical milestones across ocular and urologic oncology.”\n\n“We are excited that bel-sar was granted Fast Track Designation for choroidal metastasis. There is an important opportunity to develop a new standard of care as we see a large number of patients with this type of metastasis,” said Dr. Cadmus Rich, Chief Medical Officer of Aura Biosciences. “This is the second Fast Track Designation bel-sar has obtained for an ocular oncology indication, which highlights the need for vision preserving treatment options.”\n\nRecent Pipeline Developments\n\n\nBel-sar is being developed for the first-line treatment of early-stage choroidal melanoma (CM), a life-threatening rare disease with no approved therapies.\n\n\n\n\nPositive interim Phase 2 data evaluating suprachoroidal (SC) administration of bel-sar for the first-line treatment of adult patients w...