IMC-S118AI first-in-human dose-escalation in T1D
Immunocore Phase 1/1b single- and multiple-ascending-dose study of IMC-S118AI, a pre-proinsulin × PD-1 ImmTAAI molecule, in HLA-A*02:01-positive people with Type 1 diabetes who still make some of their own insulin. Safety is primary; mixed-meal C-peptide at week 25 is secondary. No results.
Primary endpoints
- Incidence and severity of adverse events, treatment-emergent events and serious events
- Clinically significant changes in safety labs, vital signs and ECG
- Dose interruptions, reductions or discontinuations
Results so far
No results. ClinicalTrials.gov NCT07493122 remains not-yet-recruiting as of 25 March 2026 (estimated n=154, start April 2026, primary completion November 2030). EU CT 2025-524449-28-00 was authorised in July 2026 with an EU start of 10 August 2026 and estimated recruitment start 1 August 2026 (planned n=134; UK and Australia). Authorisation is not enrolment, and neither registry has posted efficacy tables.
The full picture
This is Immunocore’s first Type 1 test of IMC-S118AI. The molecule is meant to bind a pre-proinsulin peptide on HLA-A*02:01 beta cells and locally agonise PD-1. The trial asks whether single and repeated intravenous doses are tolerable, how the drug behaves in blood, and — only as a secondary question in the multiple-dose part — whether mixed-meal C-peptide at week 25 looks different from placebo.
Use both registries. ClinicalTrials.gov is the NCT record and is still not-yet-recruiting. CTIS is the more recent EU/UK/Australia authorisation. Do not treat an EU start date as a C-peptide result.