Aura Biosciences declares positive results from phase 2 end of study of bel-sar for early-stage choroidal melanoma

Aura Biosciences, Inc., a biotechnology company focused on precision therapies for solid tumors, announced positive results from its Phase 2 trial evaluating bel-sar (AU-011) as a first-line treatment for early-stage choroidal melanoma (CM), a dangerous ocular cancer.

The open-label Phase 2 study (NCT04417530) involved dose escalation in patients with small CM or indeterminate lesions, assessing safety, efficacy, and tolerability over 12 months. Among 22 enrolled patients, bel-sar demonstrated an 80% tumor control rate and preserved vision in 90% of Phase 3-eligible patients, with significantly reduced tumor growth rates. Impressively, 80% of treated patients were at high risk of vision loss, underscoring bel-sar's potential as a vision-sparing therapy. This is notable as the current radiotherapy standard often results in blindness in the treated eye for up to 87% of patients.

Bel-sar showed a favorable safety profile, with no serious treatment-related adverse events. Mild ocular inflammation was self-limiting and resolved quickly, while no posterior inflammation was observed. Aura plans to move forward with a Phase 3 trial, backed by an FDA Special Protocol Assessment (SPA).