The FDA granted orphan drug designation to IMCgp100 for the treatment of uveal melanoma.
IMCgp100 (Immunocore) is part of a class of bispecific biologic reagents known as ImmTACs, or immune-mobilizing monoclonal T-cell receptors against cancer.
The agents combine a T-cell receptor-based targeting system with an anti-CD3 effector function designed to activate a specific and potent T-cell response to recognize and destroy cancer cells, according to Immunocore.
IMCgp100 is under evaluation in phase 2a clinical trials for the treatment of late-stage cutaneous and uveal melanoma. More than 85 patients have been treated so far.
The drug also was accepted last year to participate in the European Medicines Agency’s Adaptive Pathways Pilot Program.
Uveal melanoma the most common primary intraocular malignancy in adults. About 4,000 people are diagnosed worldwide each year, accounting for about 3% of melanoma cases.
“Immunocore now has the opportunity to fast-track this important program, which we believe has the scope to offer a treatment option to people who currently have none,” Eliot Forster, CEO of Immunocore, said in a press release. “We look forward to accelerating the ongoing clinical program with IMCgp100.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.