For Treatment of Uveal Melanoma, FDA Grants Orphan Drug Status to Immunocore’s IMCgp100

For Treatment of Uveal Melanoma, FDA Grants Orphan Drug Status to Immunocore’s IMCgp100

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to IMCgp100 for the treatment of uveal melanoma.

The FDA Office of Orphan Drug Products Development awards this designation to novel drugs and biologics indicated for the safe and effective treatment, diagnosis, or prevention of rare disease or disorders affecting fewer than 200,000 people in the United States.

The decision followed that of the European Medicine’s Agency (EMA), which allowed Immunocore’s drug to participate in its Adaptive Pathways (formerly Adaptive Licensing) pilot program in September 2015.

IMCgp100 belongs to a group of bispecific biologic reagents: the immune-mobilizing monoclonal T-cell receptors against cancer, or ImmTACs, which are based on the company’s proprietary T-cell receptor (TCR) technology.

According to Immunocore Ltd., the agents merge a T-cell receptor-based targeting system and an anti-CD3 effector function intended to activate a specific and potent T-cell response to recognize and eliminate cancer cells. IMCgp100 is now under assessment in a Phase 2a clinical trial for the treatment of late-stage cutaneous and uveal melanoma, with more than 85 patients enrolled at the time of the announcement.

Uveal melanoma is the most common primary intraocular malignancy in adults, with an estimated 4,000 new cases diagnosed each year around the globe. This particular form of cancer accounts for 3 percent of all melanoma cases and involves the eye’s iris, ciliary body, or choroid – the uvea – with tumors arising from the pigment cells, or melanocytes, present in the uvea.

“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,” Immunocore CEO Eliot Foster said in a press release. “We look forward to accelerating the ongoing clinical program with IMCgp100.”

Immunocore is one of the world’s leading biotech companies, with a state-of-the-art immuno-oncology platform, ImmTACs, and a pipeline of wholly-owned and partnered ImmTAC programs with comprehensive clinical data, validated by collaborations with world-leading pharmaceutical companies.

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