Date: 2016-06-06
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Immunocore (UK)
Product: IMCgp100
Action
mechanism:
- cell therapy/gene therapy/immunotherapy product/bispecific protein. IMCgp100 is a bispecific biologic known as a T cell redirector. It is incorporating an engineered T cell receptor (TCR) specific for a peptide antigen derived from the protein gp100 presented in the context of HLA A2 on the surface of melanoma cells. The TCR is fused to an anti-CD3 scFv fragment that recruits and activates non-melanoma specific T cells (killer T cells) in physical contact with the cancer T cell. IMCgp100 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.
Disease: melanoma
Therapeutic
area: Cancer - Oncology
Country: UK, USA
Trial
details:
- This Phase I study is designed to assess the safety profile and establish a tolerable dose of IMCgp100 in HLA A2 positive malignant melanoma patients. In the second part of the trial, patients will receive an extended course of treatment with a view to assessing the effect of the drug on disease. Patients in the dose escalation phase may also be offered repeat treatment with a dose that has been demonstrated to be tolerable. (NCT01211262).
Latest
news:
- • On June 6, 2016, Immunocore 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. In a presentation entitled: “Safety, Pharmacokinetics and Efficacy of IMCgp100, a First-inClass 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.
• On October 31, 2013, Immunocore has announced that its most advanced ImmTAC drug, IMCgp100 for the treatment of late stage melanoma, has reached Maximum Tolerated Dose (MTD) and the dose escalation part of this Phase I clinical study has been completed. The company has now initiated a Phase IIa clinical trial in the UK and USA. Immunocore’s Phase I dose escalation study in 31 patients with late stage malignant melanoma was designed to evaluate the safety of IMCgp100 and to establish a tolerable dose. Dose dependent toxicity has been demonstrated and the MTD established as 600 ng/kg. Data from the Phase I trial indicate promising early signs of efficacy. Immunocore has now initiated a Phase IIa study to optimize the dosing regimen and maximise the efficacy of IMCgp100.
Is
general: Yes
