Aura Biosciences said today that the FDA approved its Investigational New Drug Application for the company’s light-activated viral nanoparticle conjugates for the treatment of ocular melanoma.
The federal watchdog’s approval allows Cambridge, Mass.-based Aura to move forward with initial clinical tests of AU-011. The Phase Ib open-label clinical trial, which is currently enrolling, is designed to evaluate the safety, immunogenicity and preliminary efficacy of 2 dose levels of AU-011 for the treatment of small-to-medium primary ocular melanoma, according to Aura.
“Early detection of ocular melanoma, combined with the administration of AU-011 as a potential vision-sparing therapy, could transform the treatment of patients with this devastating disease,” principal investigator Dr. Brian Marr said in prepared remarks.
Administered through the eye, the company’s AU-011 therapy is composed of viral nanoparticle conjugates that selectively bind to cancer cells in the eye. The treatment is activated using an ophthalmic laser, at which point it specifically destroys tumor cells’ membranes while avoiding healthy eye structures, Aura reported. The FDA has previously granted AU-011 orphan drug designation.
“Receiving IND clearance to enter the clinic for AU-011 is an important step in the development pathway for this novel class of drugs, and I’m thankful to our team of dedicated employees, as well as to our distinguished scientific and clinical advisors, for their contributions that have propelled us to this point,” founder & CEO Elisabet de los Pinos added. “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.”
