Aura Biosciences, Inc. (NASDAQ: AURA) has reported positive phase 2 end of study results for their first-line treatment of early-stage choroidal melanoma (CM) using Bel-sar (AU-011). The results were presented at the Retina Society Annual Meeting in Lisbon, Portugal, on September 12, 2024.
The phase 2 study (NCT04417530) included 22 patients with early-stage CM and was designed to evaluate the safety, tolerability, and efficacy of up to three cycles of Bel-sar treatment.
The results demonstrated an 80% tumor control rate among phase 3-eligible patients who received the therapeutic regimen, with complete cessation of growth following treatment among responders. This represented a significant improvement, as the post-treatment average growth rate among responders was 0.011 mm/yr, compared to 0.351 mm/yr prior to study entry.
Visual acuity preservation was achieved in 90% of the 10 patients who received the therapeutic regimen, with 80% of these patients being at high risk for vision loss due to the location of their tumors.
The safety profile of Bel-sar was highly favorable, with no treatment-related serious adverse events reported. Ocular treatment-related adverse events were mild (grade 1) and mostly self-limited, with the majority resolving in a median of 6 days.
Dr. Ivana Kim, Director of the Ocular Melanoma Center at Mass Eye and Ear / Harvard Medical School, highlighted the potential of Bel-sar to become the first treatment that achieves the dual goals of treating the tumor while also preserving vision, potentially changing the treatment paradigm for patients with this disease.
Dr. Jill Hopkins, Chief Medical Officer and President of Research and Development at Aura Biosciences, expressed confidence in the phase 2 results, considering Bel-sar as a potential vision-sparing, first-line treatment option for patients with early-stage CM.
Aura Biosciences has received written agreement from the U.S. Food and Drug Administration (FDA) for the design and planned analysis of the global phase 3 Compass trial, which is currently enrolling patients.
Aura Biosciences will be hosting a virtual ocular oncology investor event to discuss the phase 2 end of study data, featuring key opinion leaders in the field.
Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors aiming to preserve organ function, with their lead candidate, Bel-sar (AU-011), in late-stage development for primary choroidal melanoma, and in early-stage development in other ocular oncology indications and bladder cancer. The company is headquartered in Boston, MA. Following these announcements, the company's shares moved 10.1%, and are now trading at a price of $9.99. Check out the company's full 8-K submission here.
