Aura Biosciences Inc. (AURA), a clinical-stage biotechnology company, on Monday announced completion of enrollment in the Phase 3 CoMpass trial for Bel-sar in treating early choroidal melanoma.
Choroidal melanoma is the most common intralocular cancer in adults, with over 11,000 patients diagnosed a year in the U.S. and Europe. Melanomas of the eye may arise in the choroid, ciliary body, and iris, but a high number of patients with indeterminate lesions are not treated immediately given the lack of vision preserving therapies. There are currently no FDA-approved therapies for choroidal melanoma.
Belzupacap sarotalocan (bel-sar) is a virus-like drug conjugate (VDC) with a novel light-sensitive cytotoxin developed for the first-line treatment of choroidal melanoma and other ocular oncological indications. The therapy received Orphan drug designation from the U.S Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in addition to a Fast Track designation from the FDA.
The Phase 3 CoMpass trial is a global, randomized, registration-enabling study that is evaluating bel-sar in a sham-control setting under a special protocol assessment (SPA) agreement with the FDA. The enrollment of 108 patients with choroidal melanoma facilitates the ongoing trial, as the company plans to report on the primary endpoint after 15 months.
Topline data are expected in the second half of 2027.
AURA is currently trading at $6.98, down 2.92%.
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