Immunocore’s IMCgp100 Receives Promising Innovative Medicine (PIM) Designation Under UK Early Access to Medicines Scheme (EAMS) for the Treatment of Patients with Uveal Melanoma
(Oxford, UK and Conshohocken, US, 11 December 2017) Immunocore Limited, the world’s leading TCR company focused on delivering first-in-class biological therapies that transform lives, today announces that it has been informed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) that IMCgp100 has been granted Promising Innovative Medicines (PIM) designation for the treatment of patients with metastatic uveal melanoma.
PIM designation is an early indication that IMCgp100 is a promising candidate for the UK’s Early Access to Medicines Scheme (EAMS), intended for the treatment, diagnosis or prevention of metastatic uveal melanoma. This is based on early Phase I clinical trial data published at the Society for Immunotherapy of Cancer (SITC) annual meeting in November. IMCgp100 will be a suitable candidate for entry into Step II of the EAMS process, for which Immunocore is in a pivotal registrational clinical trial in patients with metastatic uveal melanoma. Following this, IMCgp100 will enter the EAMS scientific opinion assessment step.
For more information on clinical trials involving IMCgp100, please visit clintrials.gov.
James Sandy, Chief Development Officer at Immunocore, commented: “We are delighted by the MHRA’s decision to award PIM designation to IMCgp100, which gives us scope to accelerate the approval process for IMCgp100, and bringing us a step closer toward making IMCgp100 available for patients with uveal melanoma, for which there are currently no effective treatment options available.”
IMCgp100 was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) in January 2016 and participated in the EMA’s Adaptive Pathways Pilot Programme.
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