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FDA clears IND application for Aura Biosciences’ AU-011 for ocular melanoma

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The FDA has cleared an investigational new drug application for light-activated AU-011 in ocular melanoma, allowing clinical testing to begin, according to a press release from Aura Biosciences.

AU-011 is a targeted therapy administered through an intravitreal injection and consists of viral nanoparticle conjugates that bind to cancer cells in the eye. The drug is then activated with an ophthalmic laser, destroying the membranes of tumor cells.

A phase 1b open-label single ascending dose clinical trial is currently enrolling, the release said. It will evaluate the drug’s safety, immunogenicity and preliminary efficacy in two dose levels.

“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,” Elisabet de los Pinos, PhD, founder and CEO of Aura, said in the release. “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.”