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Aura Biosciences Reports First Quarter 2022 Financial Results and Provides Clinical Development and Operational Highlights
On Track to Meet Multiple Clinical Milestones for AU-011 in 2H 2022: Initiate Pivotal Trial in Choroidal Melanoma, Initiate Phase 1 Trial in Non-Muscle
About this update from Aura Biosciences, Inc.
[{"type":"text","content":"\nOn Track to Meet Multiple Clinical Milestones for AU-011 in 2H 2022: Initiate Pivotal Trial in Choroidal Melanoma, Initiate Phase 1 Trial in Non-Muscle Invasive Bladder Cancer, and Submit IND for Choroidal Metastases\n\n CAMBRIDGE, Mass.--(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 first quarter ended March 31, 2022, and provided clinical development and operational highlights.\n\n“We continue to advance the AU-011 overall development program and look forward to several upcoming clinical milestones, in the second half of this year,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “We remain on track with our Phase 2 suprachoroidal study in early stage choroidal melanoma and plan to finalize a decision on the route of administration and initiate our pivotal program before the end of the year. Beyond primary choroidal melanoma, we continue to build our ocular oncology franchise and we are on track to file an Investigational New Drug application for choroidal metastases, with pre-clinical data presented at ARVO last week. Lastly, we will be initiating our Phase 1 trial in non-muscle invasive bladder cancer, with multiple clinical sites in the US. While we remain focused on preparing for our pivotal trial in choroidal melanoma, we are also excited by the prospect of leveraging our VDC therapies across multiple oncology indications and providing new treatment options for patients with life threatening cancers.”\n\nRecent Pipeline Developments\n\n\nAU-011 is being developed for the treatment of early-stage choroidal melanoma (CM), a life-threatening rare disease with no approved drugs. Orphan Drug Designation was recently granted to AU-011 by the European Commission for the treatment of uveal melanoma (includes CM). AU-011 was previously granted Orphan Drug and Fast Track Designations for this indication by the U.S. Food and Drug Administration (FDA). Aura plans to select the route of administration and treatment regimen to initiate the pivotal program in CM in the second half of 2022.\n\n\n\n\nBeyond primary CM, we continue to build our ocular oncology franchise with choroidal metastases being the second potential ocu...