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news.US-based biotech firm Aura Biosciences received orphan disease designation from the US Food and Drug Administration (FDA) for its drug AU-011 for the treatment of Uveal Melanoma, also referred to as Ocular Melanoma (OM).
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AU-011 includes Viral-like Nanoparticles that show highly selective targeting of solid tumors while leaving normal epithelium untouched.
Uveal Melanoma is an aggressive form of cancer that develops in the uvea, or uveal tract, of the eye.
The primary tumor is diagnosed when it is still in the eye but currently it has no targeted therapies and is usually treated with an invasive radioactive plaque placed against the exterior of the eye near the tumor.
Multiple surgeries are required for the treatment and can lead to cataracts, retinopathy and loss of vision.
Aura Biosciences founder and CEO Elisabet de los Pinos said: "There are currently no approved drug therapies for the treatment of uveal melanoma which is a rare but life threatening disease.
"We are thrilled to receive this Orphan Drug Designation that, together with the positive preclinical data, is enabling us to move this drug one step closer to the clinic."
Ocular Melanoma Foundation co-founder and chairman Grant Allen said: "Aura’s novel approach has the potential to dramatically improve the outcomes, and hope, for patients with uveal melanoma."
The company said that the first oral presentation of its pre-clinical research, ‘Evaluating the in vivo efficacy of a first-in-class drug for the treatment of primary uveal melanoma’, was recently delivered by McGill University Health Centre researchers at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.