IMC-I109V / Immunocore - LARVOL DELTA

Immunocore presents Phase 1 data for hepatitis B candidate at AASLD’s The Liver Meeting (The Manila Times) - "...IMC-I109V is generally well tolerated in all evaluated doses and exhibits pharmacodynamic (PD) effects consistent with its mechanism of action, including reduction in HBsAg levels, clearance of which is indicative of resolved hepatitis B infection...At doses ≥ 7 mcg, consistent PD activity was observed, including a dose-dependent decrease in HBsAg, which typically reached a nadir by day 8."

P1 data • Hepatitis B

IMC-I109V, A SOLUBLE T CELL RECEPTOR (TCR) BISPECIFIC TARGETING HBSAG (ENVXCD3), IS TOLERABLE AND ACTIVE AGAINST HEPATITIS B IN A FIRST-IN-HUMAN (FIH) SINGLE ASCENDING DOSE (SAD) STUDY (AASLD 2025) - "One participant in the 20 µg group developed Grade 2 cytokine release syndrome that responded promptly to dexamethasone, resolving within 4 hours. IMC-I109V was associated with rapidly reversible MoA-related AEs in people with HBeAg-negative CHB. The FIH evidence for dose-dependent reductions in HBsAg via this novel mechanism supports further evaluation of IMC-I109V in multiple dose regimens aimed at achieving sustained HBsAg loss."

First-in-human • IO biomarker • P1 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • HLA-A • IL6

Immunocore reports second quarter financial results and provides a business update (GlobeNewswire) - "KIMMTRAK (tebentafusp-tebn) net revenues of $98.0 million in Q2 2025, growing by 30% year-over-year; Phase 3 TEBE-AM trial on track to complete enrollment in 1H 2026; Dose selection for PRISM-MEL-301 Phase 3 trial expected in 2H 2025; Phase 1 single ascending dose HBV data for IMC-I109V will be presented at the 2025 AASLD Liver Meeting."

Enrollment status • P1 data • Sales • Trial status • Hepatocellular Cancer • Melanoma • Uveal Melanoma

Immunocore reports fourth quarter and full year 2024 financial results and provides a business update (GlobeNewswire) - "The Company continues to enroll people living with HIV (PLWH) in the multiple ascending dose (MAD) part of the Phase 1 clinical trial with IMC-M113V and will present data from the initial three cohorts during the first quarter of 2025...The Company completed the single ascending dose (SAD) portion of the Phase 1 trial with IMC-I109V for people living with hepatitis B virus (HBV) and plans to present this data in the second half of 2025...The Company plans to file a CTA or investigational new drug application (IND) for IMC-S118AI (PPI x PD1) in the second half of 2025...The Company plans to file a CTA/IND for IMC-U120AI in 2026, initially for a Phase 1 dose escalation trial in atopic dermatitis."

IND • P1 data • Atopic Dermatitis • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Type 1 Diabetes Mellitus

Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Immunocore Ltd | N=180 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • HLA-A

Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Immunocore Ltd | N=108 ➔ 180

Enrollment change • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • HLA-A

Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Immunocore Ltd

New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation • HLA-A

IMC-I109V, a novel T cell receptor (TCR) bispecific (ENVxCD3) designed to eliminate HBV-infected hepatocytes in chronic HBV patients: initial data from a first-in-human study (EASL-ILC 2022) - "The concomitant HBsAg declines and ALT elevations indicate that a single, very low dose of IMC-I109V elicited on-target activity consistent with the TCR bispecific (ENVxCD3) mechanism of action, without adverse events. These results are encouraging for the prospect of identifying a tolerable and active treatment regimen with higher and repeat dosing. Enrolment in Part 1 dose escalation continues to evaluate this novel mechanism designed to eliminate HBV-positive hepatocytes."

Clinical • P1 data • Hepatitis B • Hepatology • Inflammation • HLA-A

Immunocore announces dosing of first patient with ImmTAV bispecific molecule for chronic Hepatitis B (GlobeNewswire) - "Immunocore Holdings Plc...announces the dosing of the first patient in the first-in-human clinical trial of IMC-I109V, a new class of bispecific protein immunotherapy that is being developed for the treatment of patients with chronic hepatitis B (HBV) infection (CHB). Wholly owned IMC-I109V is the first candidate in development using Immunocore’s immune-mobilising monoclonal T cell receptors against virus (ImmTAV®) platform to enter clinical trials."

Trial status • Hepatitis B • Infectious Disease

Immunocore Provides Business Update and Reports Full Year 2020 Financial Results (GlobeNewswire) - "IMC-I109V – HBV...the Company announced the publication of novel therapeutic approach with the potential to provide a functional cure for chronic hepatitis B, in leading peer-reviewed journal, Hepatology. These data support on-target efficacy of the lead HBV ImmTAV against HBV-infected hepatocytes. The Company plans to initiate dosing in the single ascending dosing portion of the trial in mid-2021."

Trial status • Hepatitis B • Infectious Disease

[VIRTUAL] NOVEL HLA-E SPECIFIC IMMTAV® MOLECULES FOR THE TREATMENT OF HEPATITIS B (AASLD 2020) - "IMC-I109V, an HBV specific ImmTAV that can eliminate HBV infected cells in vitro, is currently undergoing first in human studies in chronic Hepatitis B. Similar to all current TCR-based therapeutics, IMC-I109V is restricted to targeting an allele from the highly polymorphic HLA class I complex... We have successfully engineered an HBV-specific ImmTAV that targets a virus-derived peptide presented by the universally expressed HLA-E molecule, regardless of polymorphism. This allows universal application of the ImmTAV platform to eliminate HBV-antigen positive cells."

Hepatitis B • Hepatology • Infectious Disease • IFNG

[VIRTUAL] Immtav, a novel immunotherapy approach to eliminate hepatitis B virus (EASL-ILC-I 2020) - "ImmTAV molecules can potently and specifically eliminate HBV-infected cells, even in the presence of SOC nucleos(t)ide analogues. Our lead ImmTAV molecule IMC-I109V has now gone through preclinical development to support first-in-human trials. These data provide evidence of a novel immunotherapeutic strategy that aims to achieve a rapid functional cure for people living with chronic HBV."

Hepatitis B • Hepatology • Infectious Disease