South Korea-based ImmuneOncia Therapeutics Inc on Monday reported interim results from the ongoing Phase 1b clinical trial of its next-generation CD47-targeting antibody, IMC-002, in combination with lenvatinib for patients with advanced hepatocellular carcinoma (HCC).

The data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA.

The study, part of the dose-expansion phase, evaluated the safety and early efficacy of the combination therapy. IMC-002 demonstrated a favourable safety profile with no reported cases of neutropenia or thrombocytopenia. Mild anaemia was observed in 2 of 13 patients (15%), and 96% of adverse events were Grade 1-2, occurring primarily in the first treatment cycle.

Among 10 patients evaluable for efficacy, 3 (30%) showed a partial response (PR), while the disease control rate (DCR) reached 80%. The median progression-free survival (PFS) was 8.3 months. Notably, two patients have remained on treatment for over one year, indicating the potential for sustained therapeutic benefit.

AI-powered digital pathology analysis showed a 60% objective response rate (ORR) in patients with high CD47 expression on tumour cell membranes, whereas no response was observed in those with low expression -- a statistically significant difference (p=0.018). These findings support CD47 expression as a predictive biomarker for response.

IMC-002 is an IgG4 monoclonal antibody targeting the CD47-SIRP alpha axis to restore macrophage-mediated phagocytosis of cancer cells. It is a second-generation anti-CD47 antibody designed to minimise binding to normal cells and avoid common toxicities such as hemagglutination and cytopenia.

ImmuneOncia is currently conducting Phase 1b trial of IMC-002 in patients with solid tumours. In 2021, the company out-licensed the asset to China's 3D Medicines in a deal worth up to USD470m. Its pipeline also includes the PD-L1 antibody IMC-001 and bispecific antibodies IMC-201 and IMC-202.