Positive Phase I data for IMCgp100 in metastatic melanoma
Posted: 6 June 2016 | | No comments yet
Immunocore has announced positive data from the first in human, Phase I clinical trial of its lead ImmTAC, IMCgp100…
Immunocore has announced positive data from the first in human, Phase I clinical trial of its lead ImmTAC (Immune mobilising monoclonal TCRs Against Cancer), IMCgp100.
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.
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 at the 2016 American Society for Clinical Oncology (ASCO) annual meeting.
In the study, the drug 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.
Data supports the expansion of the IMCgp100 programme
Commenting on the research, Mark Middleton, Principal Investigator, said: “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 the ImmTAC 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.