Immunocore (Nasdaq: IMCR), a commercial-stage biotechnology company with U.S. operations in Radnor, Pennsylvania, and Gaithersburg, Maryland, announced on October 15, 2026 that the first patient with type 1 diabetes (T1D) has been dosed in its Phase 1 trial (NCT07493122) of IMC-S118AI. IMC-S118AI is the company’s first candidate for autoimmune diseases and is an investigational agent not approved by any regulatory authority.
“With our modular bispecific platform already validated in oncology and with initial proof of concept in infectious disease indications, we are now focused on evaluating this technology in a third therapeutic area,” said Dr. Mohammed Dar, Executive Vice President, Clinical Development and Chief Medical Officer of Immunocore. “Our goal is to leverage a tissue-targeted approach to protect beta cells and preserve insulin secretion in patients.”
A Targeted Approach to Protecting Beta Cells
IMC-S118AI is a novel bispecific molecule designed to down-modulate the immune system in a tissue-specific way, protecting the insulin-producing beta cells that come under T cell attack in T1D. One end of the molecule binds to a preproinsulin peptide presented by HLA-A*02:01 on beta cells, giving it tissue specificity. The other end is a PD-1 agonist designed to turn off autoreactive T cells, helping preserve insulin production and beta cell mass.
“This is a very exciting development for the type 1 diabetes community. We know that T1D is not a systemic autoimmune disease; it is exquisitely targeted to the insulin-making beta cells which comprise just 1% of the pancreas,” said Prof. Colin Dayan, Professor of Diabetes and Metabolism, Department of Immunology and Immunotherapy at the University of Birmingham. “In T1D, we need a high degree of safety for tissue-specific therapies to be chosen over insulin that we have used for over 100 years. This targeted immune therapy specific for beta cells, now in a Phase 1 trial could offer us an effective and well-tolerated treatment option, if supported by clinical data.”
Preclinical Data in Live Human Pancreas Tissue
In a recent Science Advances publication, Immunocore and the University of Florida showed in live human pancreas tissue slices, including tissue from a donor with recent-onset T1D, that IMC-S118AI selectively binds to HLA-A*02:01-positive beta cells and suppresses autoreactive T cell activity around the islets, helping protect beta cells and preserve insulin secretion.
Inside the Phase 1 Trial
The first-in-human, dose-escalation trial will evaluate the safety, pharmacokinetics, and clinical activity of IMC-S118AI in HLA-A*02:01-positive patients with T1D.
IMC-S118AI is part of Immunocore’s ImmTAAI (Immune mobilizing monoclonal TCRs Against AutoImmune disease) class of bispecifics, designed to suppress autoreactive T cells through PD-1 agonism once tethered to a specific tissue. Beyond T1D, the company is advancing a second ImmTAAI candidate for inflammatory dermatological diseases.
About Immunocore
Immunocore is a commercial-stage biotechnology company developing a class of T cell receptor (TCR) bispecific immunotherapies, called ImmTAX, for cancer, autoimmune diseases, and infectious diseases. Its pipeline includes nine active clinical and preclinical programs. Its most advanced therapy, KIMMTRAK, is approved for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.
