IMMUNEONCO-B (01541.HK): First patient dosed in Phase II trial of IMM2510 plus IMM27M as first-line treatment for advanced HCC

NewTimeSpace News: On 27 August 2026, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (stock code: 01541) voluntarily announced that the first patient has been dosed in the Phase II clinical trial (IMM2510-HCC-201) of IMM2510 in combination with IMM27M as first-line treatment for patients with advanced hepatocellular carcinoma (HCC), a study designed to evaluate the preliminary efficacy and safety of the combination in this patient population.

According to the announcement, since the initial investigational new drug (IND) application for the combination was submitted in 2023, its clinical development has progressed steadily: the Phase Ib trial of the combination in advanced solid tumors has determined the recommended Phase II dose (RP2D), and expansion studies are ongoing in solid tumors following prior immunotherapy failure, including esophageal squamous cell carcinoma and squamous non-small cell lung cancer. Preliminary data showed the combination was generally well tolerated; among 6 evaluable patients with esophageal squamous cell carcinoma in the dose escalation stage, 3 achieved partial response (PR), 2 had stable disease (SD) and 1 had immune-unconfirmed progressive disease (iUPD), representing an objective response rate (ORR) of 50%.

In terms of mechanisms, IMM2510 is the Group's self-developed bispecific molecule targeting vascular endothelial growth factor (VEGF) and programmed cell death ligand 1 (PD-L1), with a monoclonal antibody-receptor fusion protein (mAb-Trap) structure; IMM27M is a next-generation cytotoxic T lymphocyte-associated protein 4 (CTLA-4) antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) activity. Given HCC's strong immunosuppressive and active angiogenesis characteristics, the combination of IMM2510 and IMM27M achieves synergistic coverage of the three targets PD-L1, VEGF and CTLA-4, aiming to significantly improve antitumor efficacy over existing first-line standard treatments and provide a promising novel treatment option for patients with advanced HCC. The announcement also contains a warning statement under Rule 18A.05 of the Listing Rules, noting that the Company cannot guarantee the successful development or eventual commercialization of the combination.

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