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Aura Biosciences Reports Second Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights
Strengthened Clinical and Regulatory Leadership Team with Key Appointments Start-up Activities for the Global Phase 3 Trial Ongoing with Release of Drug
About this update from Aura Biosciences, Inc.
[{"type":"text","content":"\nStrengthened Clinical and Regulatory Leadership Team with Key Appointments\n\n\nStart-up Activities for the Global Phase 3 Trial Ongoing with Release of Drug Product Manufactured with Commercial Process and First Patient Expected to be Dosed in 2H 2023\n\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 second quarter ended June 30, 2023, and provided clinical development and operational highlights.\n\n\n“As we build momentum across our portfolio, we are happy to welcome Drs. Bruce Brown and Anthony Daniels as our Therapeutic Area Heads in Urologic Oncology and Ocular Oncology, respectively, as well as Dr. Richard Mountfield as our new Senior Vice President of Regulatory Affairs and Quality. These key appointments are critical in supporting our corporate growth and expansion of our clinical programs in two important oncology therapeutic areas with high unmet medical needs for patients,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.\n\n\nDr. de los Pinos added, “We are excited to announce that we have released our drug product manufactured using the commercial process to be used in the global Phase 3 trial and remain encouraged by the progress we have made with the start-up activities, with multiple sites ready to enroll patients in the United States. We remain focused on the execution of our clinical studies and plan to share 12- month data from the Phase 2 trial in choroidal melanoma in the second half of 2023.”\n\n\nRecent Pipeline Developments\n\n\n\nGlobal Start up Activities for the Phase 3 trial ongoing.\n\n\nThe Phase 3 trial is designed as a superiority trial comparing belzupacap sarotalocan (bel-sar) versus sham. The trial is a global Phase 3, randomized, multi-center, masked study, and it is intended to enroll approximately 100 patients randomized 2:1:2 to receive high dose regimen of bel-sar, low dose regimen of bel-sar with suprachoroidal (SC) administration, or a sham control.\n\n\n\n\n\nThe primary endpoint is time to tumor progression and the first key secondary endpoint is a composite time to event analysis that will compare the tumor control and visual acuity of the bel-sar high dose regi...