Aura Biosciences is advancing bel-sar, a precision therapy, through clinical trials for choroidal melanoma and non-muscle invasive bladder cancer (NMIBC). Recent data from Phase 2 and Phase 1 trials indicate promising results, potentially offering new treatment options for these cancers.
Bel-sar Demonstrates Efficacy in Choroidal Melanoma
Bel-sar has shown an 80% tumor control rate and 90% visual acuity preservation at 12 months in Phase 2 studies for early-stage choroidal melanoma. These results support the ongoing Phase 3 CoMpass trial, a global, randomized study evaluating bel-sar against a sham control. Carol L. Shields, MD, from Wills Eye Hospital, noted the potential of bel-sar to treat choroidal melanoma at an earlier stage, addressing a significant unmet need where current options are limited to observation or radiation, which can lead to vision loss.
The Phase 3 CoMpass trial has received authorization from the European Medicines Agency (EMA) to begin enrolling patients in Europe. The trial includes an enrichment strategy to enroll 100 patients with documented growth, under a Special Protocol Assessment (SPA) agreement with the FDA. Since June 2024, investigators have registered over 100 patients in pre-screening globally, indicating strong interest and enrollment potential.
Early Success in Bladder Cancer with Bel-sar
In an ongoing Phase 1 trial of bel-sar in patients with NMIBC, early data show a clinical complete response in 4 out of 5 patients with low-grade disease after a single low dose of bel-sar with light activation. Visual tumor shrinkage was observed in 2 out of 3 patients with high-grade disease. Elisabet de los Pinos, PhD, CEO of Aura Biosciences, highlighted the potential of bel-sar as an immune-ablative treatment in bladder cancer, delivered via a focal approach in the office.
Notably, immune activation was observed in all patients with available immune staining, showing rapid infiltration of effector CD8+ and CD4+ T-cells. This suggests a bladder urothelial field effect, potentially indicating a broader immune response beyond the target tumor.
The safety profile of bel-sar in the NMIBC trial has been favorable, with less than 10% Grade 1 adverse events and no Grade 2 or higher drug-related adverse events reported.
Aura Biosciences plans to continue developing bel-sar in bladder cancer, focusing on low-grade, intermediate-risk NMIBC patients. The company is planning regulatory discussions to expedite clinical development in this patient population.
Financial Position and Corporate Updates
As of September 30, 2024, Aura Biosciences reported cash and cash equivalents and marketable securities totaling $174.4 million, expected to fund operations into the second half of 2026. Research and development expenses increased to $17.0 million for the third quarter of 2024, driven by manufacturing and development costs for bel-sar.
Sabine Doris Brookman-May, MD, FEBU, has been appointed as Senior Vice President, Therapeutic Area Head Urologic Oncology.
With ongoing clinical trials and a solid financial foundation, Aura Biosciences is poised to advance bel-sar as a potential treatment for choroidal melanoma and bladder cancer, addressing significant unmet medical needs.
