ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (IMMUNEONCO-B, 01541) has dosed the first patient in its Phase II study evaluating the combination of IMM2510 (palverafusp alfa) and IMM27M (tazlestobart) as a first-line treatment for advanced hepatocellular carcinoma (HCC).

The open-label trial, designated IMM2510-HCC-201, is designed to assess safety, tolerability and preliminary antitumour activity of the dual-agent regimen. IMM2510 is a bispecific mAbTrap targeting both PD-L1 and VEGF, while IMM27M is a next-generation CTLA-4 antibody engineered for enhanced antibody-dependent cellular cytotoxicity. The combination aims to address HCC’s immune-suppressive and pro-angiogenic microenvironment by simultaneously modulating PD-L1, VEGF and CTLA-4 pathways.

Clinical development of the duo has advanced steadily since the initial IND submission in 2023. In a preceding Phase Ib dose-escalation study across advanced solid tumours, the recommended Phase II dose was established and cohort expansion is under way in oesophageal squamous cell carcinoma (ESCC) and squamous non-small cell lung cancer following prior immunotherapy failure. Among six efficacy-evaluable ESCC patients, three achieved partial responses, two maintained stable disease and one showed immune-unconfirmed progressive disease, yielding an objective response rate of 50%. Safety data to date indicate the regimen is generally well tolerated.

ImmuneOnco notes that, while PD-L1 inhibitors paired with anti-angiogenic agents or CTLA-4 inhibitors are current global standards for first-line advanced HCC therapy, significant unmet needs persist regarding depth of response and resistance. By integrating anti-VEGF, PD-L1, and CTLA-4 blockade in one regimen, the company seeks to provide a more comprehensive immune activation and improved survival outcomes for patients with advanced HCC.

In accordance with Hong Kong listing rules, ImmuneOnco cautions that successful development and commercialisation of the IMM2510 + IMM27M combination are not guaranteed.