Date: 2016-12-02
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the Society for Melanoma Research (SMR) 2016 Congress
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: uveal melanoma
Therapeutic
area: Cancer - Oncology
Country: UK, USA
Trial
details:
- IMCgp100-102 is a Phase I study of the weekly intra-patient escalation dose regimen with IMCgp100 as a single agent in patients with metastatic uveal melanoma. According to this regimen, all patients in the trial will receive 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose escalation will commence at the third weekly dose at C1D15. The Phase I testing of the intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter. (NCT02570308)
Latest
news:
- • On November 9, 2016, Immunocore announced the presentation of data from its Phase I trial in uveal melanoma of IMCgp100 at the Society for Melanoma Research (SMR) 2016 Congress. These data demonstrate early evidence of monotherapy activity of IMCgp100 in patients with uveal melanoma and strengthens the data announced at ASCO 2016.
The title of the presentation is: "A Phase I study of IMCgp100, a soluble HLA-A2 restricted gp100-specific T cell receptor-CD3 therapeutic with solid tumour activity in patients with advanced uveal melanoma". In the study, 15 patients with uveal melanoma were treated and are evaluable for efficacy. Preliminary Phase I results suggest activity in uveal melanoma. Durable objective responses were observed and the disease control rate was 53% at 16 weeks and 40% at 24 weeks. The study’s dosing regimen included an intra-patient escalation to mitigate the risk of cytokine release and IMCgp100 demonstrated a favourable safety profile with manageable T cell mediated toxicity.
The Phase I study in uveal melanoma will identify the escalated dose that can be administered in the intra-patient escalation regimen. The pivotal Phase II study in uveal melanoma is on track to start dosing patients during the first quarter of 2017.
- • On March 30, 2016, Immunocore announced that it has recruited the first patient into a Phase I monotherapy trial of its lead programme, IMCgp100, for the treatment of uveal melanoma. The trial will include three Phase I escalation cohorts to determine the optimal dose for the pivotal Phase II study, which is expected to start in 2016, and will take place at a number of leading centres around the world.
Is
general: Yes
