Aura Biosciences, Inc., a clinical-stage biotech company that develops a new class of virus-like drug conjugate therapies for multiple cancer indications, announced that AU-011, the first-ever VDC product candidate, has been granted Orphan Drug Designation by the European Commission for the treatment of uveal melanoma. Uveal melanoma encompasses choroidal cancer as well as malignant melanoma of the iris and ciliary body. Choroidal melanoma accounts for roughly 90% of uveal melanomas.
“There are presently no effective drug options for patients for the treatment of (early-stage) choroidal melanoma, and obtaining orphan drug designation from the EMA highlights the unmet need that AU-011 could fill for patients suffering from this life-threatening disease,” stated Mark De Rosch, Ph.D., COO and Head of Regulatory Affairs. “We have reached an agreement with the United States and European agencies on our crucial program, and we are on schedule to launch it by the end of 2022.”
Orphan Drug Designation is granted by the European Commission to medicinal products designed to treat life-threatening or chronically severe conditions that affect fewer than 6 in 10,000 people in the European Union and for which no adequate method of diagnosis, treatment, or prevention is authorized. In the EU, the classification confers specific advantages and incentives, such as protocol support, fee concessions, and 10 years of marketing authorization after the drug is on the market.
The US Food and Drug Administration previously granted AU-011 Orphan Drug Designation for the treatment of uveal melanoma.