Aura Biosciences announced positive results from its Phase 2 trial evaluating belzupacap sarotalocan (bel-sar, also known as AU-011) as a first-line treatment for early-stage choroidal melanoma (CM). The data, presented at the Retina Society annual meeting in Lisbon, Portugal, demonstrated an 80% tumor control rate and 90% visual acuity preservation among patients eligible for Phase 3 trials. The trial, which enrolled 22 patients, also highlighted a significant reduction in tumor growth, with responders showing a post-treatment growth rate of 0.011 mm/year compared to 0.351 mm/year prior to treatment (P<0.0001).

Bel-sar is a papillomavirus-like particle drug conjugate that selectively binds to modified heparin sulfate proteoglycans that are upregulated in tumor cells and works via direct cytotoxic effects on tumor cells and induction of long-term antitumor immunity. In the trial, bel-sar was administered by suprachoroidal injection, followed by activation with infrared light using photodynamic therapy.

According to the study data, bel-sar’s safety profile was highly favorable, with no dose-limiting toxicities and only mild ocular side effects, such as anterior chamber inflammation, which resolved without complications. Aura reports that it is currently enrolling patients in a global Phase 3 trial.