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IMC-S118AI

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment154
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07493122Study of IMC-S118AI in Type 1 DiabetesPHASE1 NOT YET_RECRUITING 154 — — Apr 1, 2026Nov 1, 2030Mar 25, 2026 - —
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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 — 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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Competitive Landscape -Type 1 Diabetes 76 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY6PHASE3Tirzepatide, Baricitinib, LY4057996, Degludec, Lispro
Novo Nordisk A/S Sponsored ADR Class BNVO5PHASE3Insulin icodec, Insulin glargine, Insulin aspart, NNC0194-0499, Semaglutide
Sanofi SA Sponsored ADRSNY12PHASE3Teplizumab, Brivekimig, Frexalimab, Insulin, TZIELD
DexCom, Inc.DXCM4PHASE3Sotagliflozin
Vertex Pharmaceuticals IncorporatedVRTX3PHASE3VX-880, Biological/Vaccine, VX-264
vTv Therapeutics, Inc. Class AVTVT1PHASE3Cadisegliatin
Beta Bionics, Inc.BBNX2PHASE3Undisclosed
SAB Biotherapeutics, Inc.SABS1PHASE2High Dose SAB-142
MannKind CorporationMNKD2PHASE2Technosphere Insulin, Basal insulin
Insulet CorporationPODD5NAUndisclosed
ICON PlcICLR1PHASE1Sernova Cell Pouch
Creative Medical Technology Holdings, Inc.CELZ1PHASE1CELZ-201 Administration
Tandem Diabetes Care, Inc.TNDM3 — Undisclosed
Immunocore Holdings Plc Shs Sponsored American Depositary Shares Repr 1 ShIMCR1PHASE1IMC-S118AI
MiniMed Group, Inc.MMED2NAUndisclosed
Sana Biotechnology, Inc.SANA1EARLY_PHASE1UP421
Healthcare Services Group, Inc.HCSG1 — Undisclosed
Harvard Bioscience, Inc.HBIO1NAUndisclosed
Unity Health TorontoUBX1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07493122primaryCompletionDate: changed
LOWMay 24, 2026NCT07493122studyFirstPostDate: changed