Core Insights - Immunocore presented initial data from the multiple ascending dose (MAD) portion of its Phase 1/2 STRIVE trial for IMC-M113V, a functional cure candidate for HIV, at CROI 2025, indicating the treatment is well tolerated and shows potential for viral control after antiretroviral treatment interruption [1][2][3] Group 1: Trial Data and Results - The MAD trial included 16 participants living with HIV who were stable on antiretroviral therapy (ART), with doses evaluated at 60 mcg, 120 mcg, and 300 mcg over 12 weeks, followed by a treatment interruption for up to 12 weeks [4][10] - No serious adverse events or dose-limiting toxicities were reported, with mild cytokine release syndrome observed in five participants at the highest dose [5][6] - Among 15 evaluable participants, delayed viral rebound was noted in 0 of 5 at 60 mcg, 1 of 5 at 120 mcg, and 2 of 5 at 300 mcg, with the historical rate for such observations being 5% [7][8] Group 2: Mechanism and Objectives - IMC-M113V employs a T cell receptor that targets HIV-infected immune cells, aiming to eliminate CD4+ cells containing integrated HIV DNA [10] - The STRIVE trial's objectives include establishing safe dosing regimens alongside ART and quantifying antiviral activity, specifically post-treatment viral control [11][13] Group 3: Future Directions - The company is advancing its clinical candidates to achieve a functional cure for HIV and aims for sustained control of the virus after ART cessation without virological relapse [13][14] - Further data from the trial at higher doses is anticipated, contributing to broader efforts to enable individuals with HIV to maintain health without lifelong ART [3][12]
Immunocore presents initial multiple ascending dose data for HIV functional cure candidate in an oral presentation at CROI 2025