Immunocore announced it has recruited the first patient for its Phase I monotherapy clinical trial of IMCgp100, its lead product candidate to treat uveal melanoma.
Uveal melanoma is a cancer (melanoma) of the eye involving the iris, ciliary body, or choroid — which are collectively referred to as the uvea. Tumors arise from the pigment cells (melanocytes) that reside within the uvea, giving color to the eye. These melanocytes are distinct from retinal pigment epithelium cells underlying the retina that do not form melanomas. Uveal melanoma, comprises approximately 3 percent of all melanomas, and currently has no effective treatments.
Immunocore’s immuno-oncology platform technology is called ImmTAC (Immune mobilizing mTCR Against Cancer). ImmTACs are a novel class of biologic drugs based on the company’s proprietary T-cell receptor (TCR) technology, which the company believes have the potential to treat diseases with high unmet medical needs, including cancer, viral infections, and autoimmune diseases.
The Phase I clinical trial will include three escalation cohorts to assess the ideal dose for a subsequent multicenter Phase 2 trial, expected to also begin this year.
IMCgp100, an ImmTAC reagent targeting the melanoma-associated antigen gp100, was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of uveal melanoma in January 2016, and has been included in the European Medicines Agency’s (EMA) Adaptive Pathways pilot program. Orphan Drug status provides incentives to help speed clinical development of the drug for patients with advanced uveal melanoma.
Positive data derived from a Phase 1/2a trial of IMCgp100 in people with advanced uveal and cutaneous melanoma showed durable clinical responses, with five objective responses to dat,e including two partial responses in patients with uveal melanoma. A total of 85 people have been treated with IMCgp100, the company said.
“Advanced uveal melanoma is a rare and devastating disease for which there are currently no effective treatment options. IMCgp100 has shown some promising signs of early clinical activity in this disease setting and could be an effective treatment for this group of patients,” Christina Coughlin, chief medical officer of Immunocore, said in a press release. “We are excited to be able to explore the activity of IMCgp100 in this clinical study in advanced uveal melanoma.”
