Immunocore announces first patient dosed in the Phase 1 trial of IMC-S118AI – its first tissue-specific autoimmune candidate – for patients with type 1 diabetes

The first-in-human study will evaluate safety and clinical activity in HLA-A*02:01-positive patients with type 1 diabetes.

Rhea-AI Summary

Immunocore (IMCR) has dosed the first patient in a Phase 1 trial of IMC-S118AI, its first autoimmune disease candidate.

The first-in-human, dose-escalation study targets HLA-A*02:01-positive patients with type 1 diabetes. It will assess safety, pharmacokinetics—how the body processes the drug—and clinical activity. Immunocore designed the treatment to suppress immune cells attacking insulin-producing beta cells while targeting the affected tissue.

Preclinical findings published in Science Advances on April 1, 2026 showed selective binding to HLA-A*02:01-positive beta cells and suppression of autoreactive T cell activity in live human pancreas tissue slices. The work, conducted with the University of Florida, included tissue from a donor with recent-onset type 1 diabetes and showed protection of beta cells and preservation of insulin secretion.

3 points · 0 major

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Positive

• Moderate pointFirst patient dosed advances Immunocore’s first autoimmune candidate into human testing.
• Minor point. Forward-looking: it has not happened yet and may not happen.Phase 1 dose-escalation trial will assess safety, how the body processes IMC-S118AI, and clinical activity.
• Minor pointPreclinical human pancreas tissue findings showed beta-cell protection and preservation of insulin secretion.

Negative

• Minor pointTrial eligibility is limited to HLA-A*02:01-positive patients with type 1 diabetes.

Key Figures

First patient dosed: 1 patient

First patient dosed

1 patient

IMC-S118AI Phase 1 trial in type 1 diabetes

Key Terms

pharmacokinetics, pd-1 agonist, hla-a*02:01, bispecific molecule

4 terms

pharmacokinetics medical

"evaluate the safety, pharmacokinetics and clinical activity"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

pd-1 agonist medical

"the other end is a PD-1 agonist effector arm"

A PD-1 agonist is a drug or biologic that binds to the programmed death‑1 (PD‑1) receptor on immune cells and activates that receptor’s normal signaling, which reduces T‑cell activity and dampens immune responses. Agonists of PD‑1 are used to suppress unwanted immune reactions—for example in autoimmune disease or to prevent transplant rejection—and are mechanistically the opposite of PD‑1 antagonists (checkpoint inhibitors) used in cancer therapy.

hla-a*02:01 medical

"in HLA-A*02:01-positive patients with type 1 diabetes"

HLA-A*02:01 is a specific genetic variant of the human leukocyte antigen A protein, a display molecule on cells that helps the immune system recognize foreign bits of protein. For investors this matters because many vaccines, cancer immunotherapies, and diagnostic tests work only or best in people with particular HLA types; knowing how common this variant is and whether a therapy targets it affects clinical trial design, patient market size, and commercial prospects.

bispecific molecule medical

"is a novel bispecific molecule designed to down-modulate the immune system"

A bispecific molecule is an engineered therapeutic that can bind two different biological targets at once, often two proteins on the same or different cells. Think of it as a two-ended connector that brings components together—such as a diseased cell and an immune cell—to trigger a specific biological response. For investors, bispecifics can offer the potential for stronger or more precise effects than single-target drugs, but they also add development complexity and regulatory risk.

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Immunocore announces first patient dosed in the Phase 1 trial of

IMC-S118AI – its first tissue-specific autoimmune candidate – for patients with type 1 diabetes

The Phase 1 trial will assess the safety and clinical activity of IMC-S118AI in HLA-A*02:01-positive patients with type 1 diabetes

Preclinical data supporting unique mechanism of action recently published
in Science Advances

(OXFORDSHIRE, England & RADNOR, PA & GAITHERSBURG, MD, US, 15 October 2026) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announced that the first patient with type 1 diabetes (T1D) has been dosed in the Phase 1 trial (NCT07493122) of IMC-S118AI¹.

IMC-S118AI, the Company’s first candidate for autoimmune diseases, is a novel bispecific molecule designed to down-modulate the immune system in a tissue-specific manner to protect beta cells under T cell attack in T1D. One end of the investigational bispecific therapy binds to a preproinsulin peptide presented by HLA-A*02:01 on beta cells to provide tissue-specificity, and the other end is a PD-1 agonist effector arm designed to turn off autoreactive T cells in order to help 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.”

“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. Our goal is to leverage a tissue-targeted approach to protect beta cells and preserve insulin secretion in patients,” said Dr. Mohammed Dar, Executive Vice President, Clinical Development and Chief Medical Officer of Immunocore.

In a recent Science Advances² publication, Immunocore, in collaboration with the University of Florida, demonstrated in live human pancreas tissue slices, including from a recent-onset type 1 diabetes donor, that IMC-S118AI selectively binds to HLA-A*02:01-positive beta cells, and suppresses autoreactive T cell activity around islets, helping protect beta cells and preserve insulin secretion.

The Phase 1 dose escalation trial will evaluate the safety, pharmacokinetics and clinical activity of IMC-S118AI in HLA-A*02:01-positive type 1 diabetes patients.

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About ImmTAAI^® molecules and autoimmune diseases

ImmTAAI (Immune mobilizing monoclonal TCRs Against AutoImmune disease) molecules are novel bispecifics that are designed for tissue-specific down modulation of the immune system. When tethered to the tissue of interest, ImmTAAI candidates suppress autoreactive T cells via PD1 receptor agonism. The Company is enrolling people with type 1 diabetes in a Phase 1 trial and advancing a second candidate for inflammatory dermatological diseases.

About the IMC-S118AI Phase 1 trial

The trial is a first-in-human, Phase 1 dose escalation trial designed to evaluate the safety, pharmacokinetics and clinical activity of IMC-S118AI in HLA-A*02:01-positive patients with type 1 diabetes.

About Immunocore

Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune diseases and infectious diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including nine active clinical and pre-clinical programs​ in oncology, infectious diseases, and autoimmune diseases. The Company’s most advanced oncology TCR therapeutic, KIMMTRAK, has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may”, “will”, “believe”, “expect”, “plan”, “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, statements regarding the design, progress, timing, enrollment, scope, and results of the Phase 1 trial of IMC-S118AI; and the expected clinical benefits of IMC-S118AI. Any forward-looking statements are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual events or results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company’s control. These risks and uncertainties include, but are not limited to, the impact of worsening macroeconomic conditions on the Company’s business, financial position, strategy and anticipated milestones, including Immunocore’s ability to conduct ongoing and planned clinical trials; Immunocore’s ability to obtain a clinical supply of current or future product candidates or commercial supply of KIMMTRAK or any future approved products; Immunocore’s ability to obtain and maintain regulatory approval of its product candidates, including KIMMTRAK; Immunocore’s ability and plans in continuing to establish and expand a commercial infrastructure and to successfully launch, market and sell KIMMTRAK and any future approved products; Immunocore’s ability to successfully expand the approved indications for KIMMTRAK or obtain marketing approval for KIMMTRAK in additional geographies in the future; the delay of any current or planned clinical trials, whether due to patient enrollment delays or otherwise; Immunocore’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; competition with respect to market opportunities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or future regulatory approval; Immunocore’s need for and ability to obtain additional funding, on favorable terms or at all, including as a result of worsening macroeconomic conditions, including changes in inflation and interest rates and unfavorable general market conditions, and the impacts thereon of the war in Ukraine, the conflict in the Middle East, and global geopolitical tension; Immunocore’s ability to obtain, maintain and enforce intellectual property protection for KIMMTRAK or any of its product candidates it or its collaborators are developing; and the success of Immunocore’s current and future collaborations, partnerships or licensing arrangements. These and other risks and uncertainties are described in greater detail in the section titled "Risk Factors" in Immunocore’s filings with the Securities and Exchange Commission, including Immunocore’s most recent Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission on February 25, 2026, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information, except as required by law.

Contact Information

Immunocore
Sébastien Desprez, Head of Communications
T: +44 (0) 7458030732
E: sebastien.desprez@immunocore.com
Follow on LinkedIn: @Immunocore

Investor Relations
Ryan Baker, Vice President, Investor Relations
T: +1 (215) 384-4781
E: ir@immunocore.com

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¹ IMC-S118AI is an investigational agent and not approved by any regulatory authorities.
² Becker M et al. Beta cell–targeted PD-1 agonist inhibits cell-mediated autoimmunity in pancreas tissue slices. Science Advances. 1 Apr 2026. Vol 12, Issue 14. DOI: 10.1126/sciadv.aec9029

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What milestone has Immunocore reached with IMC-S118AI for type 1 diabetes?

The first patient has been dosed in the first-in-human Phase 1 dose-escalation trial of IMC-S118AI. The study evaluates safety, how the body processes the drug, and clinical activity in HLA-A*02:01-positive patients with type 1 diabetes.

How is Immunocore’s IMC-S118AI designed to work?

IMC-S118AI is designed to bind to insulin-producing beta cells and suppress immune cells attacking them. One end binds a preproinsulin peptide presented by HLA-A*02:01 on beta cells; the other activates the PD-1 receptor to turn off autoreactive T cells. Immunocore’s goal is to preserve insulin production and beta-cell mass.