NEW YORK – Immunocore on Friday announced several strategic priorities and pipeline updates including plans to grow the use of Kimmtrak (tebentafusp) in HLA-A*02:01-positive metastatic uveal melanoma.
The Oxfordshire, UK-based firm also said that it is developing an autoimmune therapy dubbed IMC-U120AI, or CD1a x PD1. This therapy is the first in Immunocore's pipeline that won't require patients to have a specific human leukocyte antigen (HLA) type to be eligible.
With regard to Kimmtrak, since the T-cell receptor (TCR) therapy first netted approval in the US in 2022 for treating advanced HLA-A*02:01-positive uveal melanoma, Immunocore has launched the drug in 23 countries and has plans to expand its indications.
For example, Kimmtrak is undergoing testing in two registrational Phase III trials. First, Immunocore is evaluating Kimmtrak as a second-line treatment for HLA-A*02:01-positive cutaneous melanoma patients in the ongoing Phase III TEBE-AM clinical trial. Second, the European Organization for Research and Treatment of Cancer (EORTC) is evaluating it as an adjuvant therapy for HLA-A*02:01-positive uveal or ocular melanoma patients.
In a third Phase III trial, Immunocore is investigating the melanoma therapy brenetafusp with Bristol Myers Squibb's Opdivo (nivolumab) and pitting the combination against Opdivo monotherapy or BMS's Opdualag (Opdivo plus relatlimab). The firm expects to report top-line results from these Phase III trials starting in 2026.
The firm said it will expand enrollment in several of its Phase I/II oncology trials during 2025, including those evaluating its PRAME- and PIWIL1-directed treatments. For instance, the firm is evaluating several brenetafusp combinations in certain ovarian and non-small cell lung cancer patients and is evaluating IMC-R117C (its treatment that targets PIWIL1) in HLA-A*02:02-positive advanced solid tumor patients, including colorectal cancer patients. It also recently began enrolling advanced solid tumor patients in a Phase I dose-escalation trial of another investigational treatment, IMC-P115C (PRAME-A02-HLE), which is designed with a longer half-life than brenetafusp.
Beyond oncology, Immunocore said it will file a clinical trial application seeking permission to begin studying two autoimmune disease candidates, IMC-S118AI and the non-HLA restricted IMC-U120AI, in 2025 and 2026, respectively.
At the end of 2024, Immunocore estimated it had $820 million in unaudited cash, cash equivalents, and marketable securities. The company will present its fourth quarter and full-year 2024 financial results in late February.