Potential for Accelerated Regulatory Approval in Europe
(Oxford, UK, 9 September 2015) Immunocore Limited, a world-leading biotechnology company developing novel T cell receptor (TCR) based biological drugs to treat cancer, viral infections and autoimmune disease, today announced that its lead product, IMCgp100, has been accepted to participate in the European Medicines Agency’s (EMA) Adaptive Pathways (formerly Adaptive Licensing) pilot programme. This is part of the EMA’s strategy of providing timely access for patients to new medicines to treat serious conditions with a high unmet medical need.
Immunocore is one of a small number of companies to have been accepted into this programme and plans to seek conditional approval for IMCgp100 for the treatment of patients with metastatic uveal melanoma, a rare and fatal disease with few available treatment options.
Conversion to full approval will be subject to the successful completion of a Phase II clinical trial in uveal melanoma with long-term follow-up data.
Dr. Christina Coughlin, Chief Medical Officer at Immunocore, said: “We are delighted to have been accepted into the EMA Adaptive Pathways pilot programme, an accelerated development project that further underscores the potential benefits that IMCgp100 can bring to patients with uveal melanoma, a fatal disease that has few other treatment options. We are grateful for the collaborative regulatory feedback from the EMA on the design of our development programme as well as feedback from the European HTA agencies and patient advocacy organisations that are participating in our Adaptive Pathways pilot project.” Dr. Coughlin added: “We are very pleased to be working with leading European experts in the clinical management of patients with uveal melanoma.”
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