Aura Biosciences has announced the FDA has given the company permission to begin clinical studies in patients with ocular melanoma using viral nanoparticle conjugates that bind selectively to cancer cells in the eye.
Elisabet de los Pinos, PhD, founder and CEO of Aura said, “With the advancement of AU-011, we are opening the door for innovation in a completely new therapeutic area where there are no FDA drugs approved today. Our hope is that AU-011 could be used to treat small primary melanomas early, with the potential to eliminate the tumor and preserve vision for patients.”
The Phase 1b open-label, single ascending dose clinical trial is currently enrolling patients with ocular melanoma to evaluate the safety, immunogenicity and preliminary efficacy of two dose levels of AU-011.
About Ocular Melanoma
Ocular or uveal melanoma is a cancer of the eye involving the iris, ciliary and choroid. It begins in the middle of three layers of the wall of the eye. The cause of ocular melanoma is unclear, but UV light is a risk factor. Uveal nevi are common (10% of caucasians), but rarely progress to melanoma. Current treatment includes radiation therapy and sometimes removal of the affected eye. There are currently no other effective treatments on the market.
