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IMC-S118AI

Phase 1

Type 1 Diabetes | Monoclonal antibody | Metabolic |Immunocore Holdings plc|Last Updated: Mar 25, 2026

Target and mechanism

Molecular targetPD1
Target classReceptor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment154

FDA Designations

No designations recorded

Clinical trial landscape

IMC-S118AI · 1 trial · 3 indications

Phase 1 1
NCT07493122Study of IMC-S118AI in Type 1 DiabetesType 1 Diabetes
NOT YET_RECRUITING154 Analytics
PHASE1NOT YET_RECRUITING
Study of IMC-S118AI in Type 1 Diabetes
Type 1 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with ≥1 treatment-emergent serious adverse event (SAE)
Up to 60 weeks
Number of participants with ≥1 treatment-emergent adverse event (AE)
Up to 45 weeks
Number of participants with clinically significant changes in safety laboratory parameters
Up to 45 weeks
Number of participants with clinically significant changes in vital signs
Up to 45 weeks
Number of participants with clinically significant changes in electrocardiogram (ECG)
Up to 45 weeks
Number of participants with dose interruptions, reductions, or discontinuations
Up to 21 weeks

Secondary Endpoints

Plasma concentration of IMC-S118AI
Up to 21 weeks
Number of participants with anti-IMC-S118AI antibody formation
Up to 31 weeks
AUC of serum C-peptide after a 2 h MMTT at Week 25
Week 25
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Ascending DoseEXPERIMENTALParticipants receive single ascending doses of IMC-S118AI.
Multiple Ascending DoseEXPERIMENTALParticipants receive multiple ascending doses of IMC-S118AI.

Interventions

NameTypeDescription
IMC-S118AIBIOLOGICALIMC-S118AI solution for infusion/injection
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Body mass index (BMI): 18 to 25 kg/m2 * History of a diagnosis of T1D * HLA type: HLA-A\*02:01 * Shows signs of remaining beta-cell function Exclusion Criteria: * Non-T1D (type 2 diabetes, monogenic diabetes, and secondary diabetes) * History of recurrent hypoglycaemia due t...

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Frequently asked questions about IMC-S118AI

What is IMC-S118AI used for?

IMC-S118AI is an investigational monoclonal antibody being developed for Type 1 Diabetes. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in a controlled clinical trial to evaluate its safety and efficacy in adults with Type 1 Diabetes.

What does IMC-S118AI target?

IMC-S118AI targets PD1, a receptor involved in immune regulation. By binding to PD1, the drug is designed to modulate immune responses, which may be relevant in the context of Type 1 Diabetes. The exact mechanism of action is being investigated in clinical trials.

Who is developing IMC-S118AI?

IMC-S118AI is being developed by Immunocore Holdings plc, a biopharmaceutical company listed on the stock exchange under the ticker IMCR. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and efficacy in patients with Type 1 Diabetes.

What phase is IMC-S118AI in?

IMC-S118AI is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is designed to assess the drug's safety, tolerability, and preliminary efficacy in adults with Type 1 Diabetes.

What clinical trials is IMC-S118AI in?

IMC-S118AI is being studied in a Phase 1 clinical trial with the identifier NCT07493122. This trial, titled 'Study of IMC-S118AI in Type 1 Diabetes', is a randomized, controlled study that plans to enroll 154 participants aged 18 years and older. The trial is not yet recruiting participants.

Is IMC-S118AI the same as other PD1-targeting drugs?

IMC-S118AI is a distinct investigational monoclonal antibody that targets PD1. While other PD1-targeting therapies exist, IMC-S118AI is a unique asset being developed by Immunocore for Type 1 Diabetes. No alternative names for IMC-S118AI have been disclosed in the available information.