Initial Findings from IMC-M113V Trial for HIV Functional Cure Strategy Shows Potential
Beatriz Mothe, MD, PhD discusses the Phase 1/2 STRIVE trial of IMC-M113V, a T cell receptor bispecific therapy targeting HIV-infected cells
Beatriz Mothe, MD, PhD, an infectious disease specialist at the IrsiCaixa AIDS Research Institute and attending physician at HUGTIP, Badalona, presented Immunocore's early findings from the phase 1/2 STRIVE trial on IMC-M113V (Eudract number: 2021-002008-11), a novel HIV functional cure candidate, at CROI 2025, held March 9-12, in San Francisco, California. The trial explores the potential of IMC-M113V, a T-cell receptor bispecific therapy designed to target and eliminate HIV-infected cells, offering hope for a functional cure for people living with HIV (PLWH).
Mothe explained the novel mechanism behind IMC-M113V, highlighting its unique approach to HIV treatment. "IMC-M113V is a completely new molecule. It's a T-cell receptor bispecific that works by bridging an HIV-infected cell and an effector T-cell, which can then destroy the infected cell. This is a very novel approach that has never been tested before as part of an HIV cure strategy," she said. The therapy targets the HIV reservoir and aims to reduce the virus in the body, potentially offering a cure.
The trial is still ongoing, but early results show positive signs of antiviral activity. Mothe emphasized that the trial is a dose-escalation study, where cohorts of five to six participants receive increasing doses of IMC-M113V. "So far, the doses we've tested have been well tolerated, and we're seeing a dose-dependent effect on the HIV reservoir. This means that the higher the dose, the greater the reduction in the HIV reservoir and the stronger the antiviral effect," she said.
Mothe also noted that the study observed a reduction in cell-associated HIV RNA, a key marker of the active HIV reservoir, as a significant outcome. "The reduction in cell-associated RNA is really important because it reflects the active HIV reservoir. The higher doses of IMC-M113V have shown a stronger effect on reducing this RNA, which is very promising for the potential of this therapy," she explained.
The findings from the trial suggest that IMC-M113V could help induce post-treatment viral control. "Some participants have shown control of the virus after stopping antiretroviral treatment for a period of time. This is a significant outcome because it shows that the therapy may help achieve control over HIV, even after treatment interruption," said Mothe.
Mothe highlighted the next steps: "We need to keep increasing the doses and confirm the antiviral effects we're seeing. We're also expanding the cohort to see if these findings hold true for a larger number of participants," she said. She also acknowledged that the safety of the higher doses will play a key role in determining the future of the trial.
Mothe also noted, "What makes this approach so exciting is that it bypasses the exhaustion or loss of function of HIV-specific T cells. Instead of relying on these T cells, IMC-M113V works by bridging the HIV-infected cells with effector T cells. This is a different strategy, and it's something we’ve never seen before in the HIV field."
Looking ahead, Mothe is hopeful about the potential of IMC-M113V, "This therapy represents a new strategy, one that could ultimately help us achieve a functional cure for HIV. We're still in the early stages, but the early data is very promising," she concluded.
