Business
Aura Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights
Enrolling Patients in Global Phase 3 CoMpass Trial in Small Choroidal Melanoma and Indeterminate Lesions; Granted SPA Agreement by FDA Data Expected Mid-2024
About this update from Aura Biosciences, Inc.
[{"type":"text","content":"\nEnrolling Patients in Global Phase 3 CoMpass Trial in Small Choroidal Melanoma and Indeterminate Lesions; Granted SPA Agreement by FDA\n\n\nData Expected Mid-2024 from Ongoing Phase 1 Trial in Bladder Cancer\n(Non-Muscle Invasive Bladder Cancer and Muscle Invasive Bladder Cancer)\n\n\nStrong Cash Position into Second Half of 2026\n\n\n BOSTON--(BUSINESS WIRE)--\nAura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors to preserve the function of the afflicted organ with cancer, today reported financial results for the fourth quarter and year ended December 31, 2023, and provided recent business highlights.\n\n\n“We’re excited to expand bel-sar into bladder cancer, as we leverage our therapy’s unique mechanism of action in additional solid cancer indications with major unmet medical need,” said Elisabet de los Pinos, Ph.D., CEO of Aura Biosciences. “Bel-sar is a potential vision-and-organ sparing therapy that we believe will change the standard of care in ocular oncology, in particular choroidal melanoma, where there are no treatment options except radiotherapy which leads to vision loss, or surgical removal of the eye. There is an urgent need to develop vision-sparing therapies, as all eye cancers represent an estimated 60,000 patients annually in the US and EU. This is a multi-billion dollar market, which includes choroidal melanoma, choroidal metastases, and ocular surface cancers. Our financial strength allows us to fund multiple clinical programs through major inflection points while enabling the flexibility to expand bel-sar into additional indications, starting with bladder cancer.”\n\n\nRecent Pipeline Developments\n\n\nGlobal Phase 3 CoMpass trial actively enrolling patients for the treatment of small choroidal melanoma (CM) and indeterminate lesions (ILs).\n\n\n\nThe trial is a superiority trial comparing treatment with bel-sar versus a sham control arm. The trial is a global Phase 3, randomized, multi-center, masked study, and is intended to enroll approximately 100 patients randomized 2:1:2 to receive three cycles of treatment with either high or low doses of bel-sar, or a sham control.\n\n\n\nThe Company received written agreement from the U.S. Food and Drug Administration (FDA) under an SPA for the overall design, statistical analysis ...