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Oxford, UK – Immunocore, a world-leading biotechnology company developing novel T cell receptor (TCR) based biological drugs to treat cancer, infectious diseases and autoimmune disease, today announced that positive data from the first in human, Phase I clinical trial of its lead ImmTAC (Immune mobilising monoclonal TCRs Against Cancer), IMCgp100, was presented in a poster discussion session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 5th 2016.
IMCgp100 is a first-in-class bi-specific biologic known as a T cell redirector. This ImmTAC binds, with picomolar affinity, to a melanoma associated target, gp100; once bound IMCgp100 redirects all T cells, including non-cancer specific T cells, to kill the cancer cells.
In a presentation entitled: “Safety, Pharmacokinetics and Efficacy of IMCgp100, a First-in-Class Soluble TCR Anti-CD3 Bispecific T Cell Redirector With Solid Tumour Activity: Results From the FIH Study in Melanoma” Mark Middleton MD, Professor of Experimental Cancer Medicine at the University of Oxford, and Principal Investigator for the Study, presented data from the First-In-Human study of IMCgp100 in metastatic melanoma, treating 84 patients in total.
In the study, IMCgp100 showed a favourable safety profile at the established recommended Phase II dose, with prolonged responses observed in both uveal and cutaneous melanoma. Tumour shrinkages in patients with a particularly poor prognosis and those with checkpoint resistant disease were also reported. Some immune mediated toxicities were observed predominantly in the first few doses and were manageable. Rapid T cell infiltration into tumours coinciding with immune activation occurred within days following the first dose in both cutaneous and uveal melanoma patients.
Mark Middleton, Principal Investigator, commented: “These are promising data, we know how to give the drug safely and we are seeing prolonged responses in both uveal and cutaneous melanoma. It is also really encouraging to see tumours shrink in patients with high LDH and/or liver tumour burden. These exciting data strongly support the further development of IMCgp100, in patients with uveal and cutaneous melanoma.”
Dr. Christina Coughlin, Chief Medical Officer of Immunocore, added: “We are delighted that the data strongly supports the expansion of the IMCgp100 programme into both cutaneous and uveal melanoma Phase II trials and we look forward to progressing our lead programme through further clinical development.”
In January 2016 the US Food and Drug Administration (FDA) also granted Orphan Drug Designation to IMCgp100 for the treatment of uveal melanoma. Furthermore, Immunocore has participated in the European Medicines Agency’s (EMA) Adaptive Pathway pilot programme with IMCgp100. Earlier this year, Immunocore initiated a Phase I clinical study of IMCgp100 in patients with uveal melanoma and a combination Phase Ib/II trial with MedImmune’s checkpoint inhibitors durvalumab and tremelimumab.