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Aura Biosciences Announces Orphan Drug Designation Granted to AU-011 by European Commission for the Treatment of Uveal Melanoma (Includes Choroidal Melanoma)
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug
About this update from Aura Biosciences, Inc.
[{"type":"text","content":" CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced that the European Commission has granted Orphan Drug Designation to AU-011, its first VDC product candidate, for the treatment of uveal melanoma. The designation of uveal melanoma includes choroidal melanoma as well as melanomas of the iris and the ciliary body. Choroidal melanoma represents approximately 90% of uveal melanomas.\n\n“There are currently no approved drug therapies for the treatment of early-stage choroidal melanoma, and receiving Orphan Drug Designation from EMA underscores the unmet need that AU-011 could fill for patients with this life-threatening disease,” said Mark De Rosch, Ph.D., Chief Operating Officer and Head of Regulatory Affairs. “We have alignment with U.S. and European agencies on our pivotal program and are on track to initiate this program before the end of 2022.”\n\nThe European Commission grants Orphan Drug Designation for medicinal products intended to treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union (EU) and when no satisfactory method of diagnosis, prevention, or treatment of the condition can be authorized. The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market.\n\nAU-011 was previously granted Orphan Drug Designation for the treatment of uveal melanoma by the U.S. Food and Drug Administration.\n\nAbout AU-011\n\nAU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in clinical development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparin sulphate proteoglycans (HSPGs), which are modified and overexpressed on the tumor cell surface of malignant cells in the choroid and AU-011 delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant cells with a pro-immunogenic cell death that can activate the immune system generating long term anti-t...