IMC-M113V / Immunocore, Bill & Melinda Gates Foundation - LARVOL DELTA

Viral control after antiretroviral therapy interruption is associated with interferon-driven immune programs induced by IMC-M113V, a GagxCD3 T cell engager (AIDS 2026) - P1/2 | "In addition to previously demonstrated direct killing of HIV-infected cells, IMC-M113V redirection of T cells results in induction of a robust interferon-associated immune program that may contribute to post-rebound viral control."

IO biomarker • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD40LG • CD69 • CD8 • HLA-A • TNFRSF9

HIV-1 virome profiling using HIV-PULSE to guide therapeutic and curative interventions. (PubMed, EBioMedicine) - "Our findings demonstrate that HIV-PULSE provides a comprehensive platform for individualised reservoir profiling, advancing future treatment perspectives and efforts towards an HIV-1 cure."

IO biomarker • Journal • Human Immunodeficiency Virus • Infectious Disease

Safety and biologic activity of a bispecific T cell receptor targeting HIV Gag in males living with HIV: a first-in-human trial. (PubMed, Nat Commun) - P1/2 | "PD activity is dose-dependent and strongest in participants with highly IMC-M113V-sensitive Gag77-85 variant sequences. Thus, we provide a promising foundation to evaluate multiple and higher doses of IMC-M113V as a strategy for achieving ART-free virological control."

First-in-human • Journal • P1 data • Human Immunodeficiency Virus • Infectious Disease • HLA-A

HIV GAG x CD3 Soluble TCR Bispecific Reduces the Active HIV Reservoir in a Phase I/II Trial (CROI 2025) - P1/2 | "IMC-M113V (GAGxCD3) is the first HIV ImmTAV in the clinic; a single dose study demonstrated safety and biological activity in antiretroviral therapy (ART)-suppressed PLWH...This study provides the first evidence of antiviral efficacy for this novel mechanism of action. Doses >300 μg and longer ATI duration will be evaluated."

P1/2 data • Human Immunodeficiency Virus • Infectious Disease • CD4 • CXCL10 • HLA-A • IFNG • IL6

Immunocore presents initial multiple ascending dose data for HIV functional cure candidate in an oral presentation at CROI 2025 (GlobeNewswire) - P1/2 | N=53 | STRIVE (2021-002008-11) | Sponsor: Immunocore Limited | "Immunocore Holdings...has today shared initial data from the multiple ascending dose (MAD) portion of its Phase 1/2 STRIVE trial of IMC-M113V, its functional cure candidate for human immunodeficiency virus (HIV)...All doses were well tolerated and no serious adverse events (AEs) or dose limiting toxicities were observed. Mild (Grade 1) cytokine release syndrome, consisting of fever alone that resolved within 4 hours, was observed in five of the six PLWH in the 300 mcg cohort when receiving their first 300 mcg dose...In the 15 evaluable PLWH, delayed viral rebound and/or viremia control at any point during ATI was observed in 0 of 5 PLWH at 60 mcg, 1 of 5 at 120 mcg, and 2 of 5 at 300 mcg. The 3 PLWH with evidence of viral control had a viral load of approximately 200 c/mL at week 8. The historical rate for this observation is 5%. Furthermore, 2 of these 3 PLWH remained off ART for the entire 12 week..."

P1/2 data • Human Immunodeficiency Virus

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

HIV GAG X CD3 SOLUBLE TCR BISPECIFIC: SAFETY AND ACTIVITY IN A FIRST IN HUMAN TRIAL (CROI 2023) - P1/2 | "A single infusion of IMC-M113V was associated with biological activity consistent with the mechanism of action and was well tolerated at doses ≤15 mcg. This study provides the first human safety and PD impact of this novel agent to inform the design of a multiple ascending dose study."

Clinical • Late-breaking abstract • P1 data • Fatigue • Hematological Disorders • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Oncology • CD4 • CXCL8 • HLA-A • IFNG • IL10 • IL2 • IL6 • TNFA

Phase 1/2 study of IMC-M113V in virologically suppressed chronic HIV infection Estudio en fase I/II de IMC-M113V sobre la infección crónica por el VIH con supresión vírica (clinicaltrialsregister.eu) - P1/2 | N=53 | Ongoing | Sponsor: Immunocore Limited

New P1/2 trial • Human Immunodeficiency Virus • Infectious Disease • CD4 • HLA-A