Immunocore reports promising HIV trial results

OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & GAITHERSBURG, Md., US - Immunocore Holdings plc (NASDAQ:IMCR), a leader in T cell receptor (TCR) bispecific immunotherapies, presented initial data from their ongoing Phase 1/2 STRIVE trial of IMC-M113V, a potential functional cure for HIV, at the Conference on Retroviruses and Opportunistic Infections (CROI) 2025. The study indicates that IMC-M113V was well tolerated and demonstrated a dose-dependent reduction in the HIV active reservoir and viral control in some patients after pausing antiretroviral treatment (ART).

The trial involved 16 individuals with HIV who were stable on ART. The multiple ascending dose (MAD) portion assessed the safety and efficacy of weekly intravenous infusions of IMC-M113V over a 12-week period, followed by a 12-week analytical treatment interruption (ATI). During this time, no serious adverse events or dose-limiting toxicities were reported. Some mild cases of cytokine release syndrome were noted, which resolved quickly. The company’s robust financial position, with a remarkable gross profit margin of 96.61%, supports its ongoing research and development efforts.

Notably, the trial observed delayed viral rebound or maintained viral control in a subset of participants during the ATI. This included 0 of 5 participants at the lowest dose of 60 mcg, 1 of 5 at 120 mcg, and 2 of 5 at the highest evaluated dose of 300 mcg. These findings are significant when compared to historical data, where the majority of individuals experience viral rebound within 4 weeks of ART interruption.

Dr. Beatriz Mothe, Associate Investigator at the HIV Unit of IrsiCaixa, expressed optimism about the safety profile and initial signs of antiviral activity, especially considering the challenges of interrupting ART for extended periods. She anticipates further data as higher doses are examined.

IMC-M113V is designed to target and destroy HIV-infected immune cells by binding to a specific HLA-A02:01-Gag complex. The STRIVE trial aims to establish safe dosing regimens to potentially allow HIV patients to maintain health without lifelong ART.

While the data presented is preliminary, it suggests a promising step towards a functional cure for HIV. Immunocore continues to evaluate higher doses in the trial, with the goal of achieving sustained control of the virus. Currently trading near its 52-week low, InvestingPro analysis indicates the stock may be undervalued. For deeper insights into Immunocore’s financial health and growth potential, including additional ProTips and comprehensive analysis, investors can access the detailed Pro Research Report available on InvestingPro.

This article is based on a press release statement from Immunocore Holdings plc.

In other recent news, Immunocore Holdings PLC reported its fourth-quarter 2024 earnings, which showed a notable miss on earnings per share (EPS) compared to analysts’ expectations. The company posted an EPS of -0.47, falling short of the anticipated -0.24, while revenue also came in slightly below expectations at $84.05 million against the forecasted $84.53 million. Despite this shortfall, Immunocore demonstrated robust growth in 2024, with total revenues reaching $310 million, marking a 30% increase year-over-year. The company’s flagship product, KymTrak, contributed significantly to this growth with a 34% rise in U.S. revenues and a 65% market penetration.

Looking ahead, Immunocore expects incremental growth for KymTrak in 2025 and is planning to expand its presence in U.S. community settings. The company is also anticipating significant developments in its HIV program and potential new initiatives in autoimmune diseases. Additionally, Immunocore is expanding its clinical pipeline with ongoing trials in melanoma and other areas. The company continues to focus on innovation and diversification, as highlighted by the CEO, Bahija Jallal, who emphasized their commitment to expanding market reach and product availability.

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