Business
Aura Biosciences Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Clinical Development and Operational Highlights
On Track to Initiate Pivotal Trial in Choroidal Melanoma and Phase 1 Trial in Non-Muscle Invasive Bladder Cancer with AU-011 in 2H 2022 Orphan Drug
About this update from Aura Biosciences, Inc.
[{"type":"text","content":"\nOn Track to Initiate Pivotal Trial in Choroidal Melanoma and Phase 1 Trial in Non-Muscle Invasive Bladder Cancer with AU-011 in 2H 2022\n\nOrphan Drug Designation Granted to AU-011 by European Commission for the Treatment of Uveal Melanoma (Includes Choroidal Melanoma)\n\nJohn Maraganore, Ph.D., Joins as a Strategic Advisor\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 fourth quarter and year ended December 31, 2021, and provided clinical development and operational highlights.\n\n“We have begun 2022 with strong momentum, being on track to advance AU-011 in the clinic in multiple indications with significant unmet medical need. We look forward to initiating the pivotal trial in patients with early stage choroidal melanoma, which is the first indication in our ocular oncology franchise, in the second half of this year,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “We are excited to have received Orphan Drug Designation from the European Commission, further validating the important role that AU-011 could play in the treatment of patients with this life-threatening disease globally.”\n\nDr. de los Pinos continued: “We are also excited to expand our pipeline into additional solid tumors by initiating our Phase 1 trial in non-muscle invasive bladder cancer (NMIBC) in the second half of this year. We are encouraged by the NMIBC preclinical data that we presented at the 2022 American Society of Clinical Oncology Genitourinary Cancer Symposium, which supports this indication, as well as the preclinical data that will be presented at the 2022 American Association for Cancer Research Annual Meeting that further supports the broad oncology potential of our VDC platform. Underscoring our pipeline advancement is a solid balance sheet, with our cash position supporting operations into 2024.”\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. 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...