ImmuneOncia Announces Interim Results from Phase 1b Clinical Trial of Next-Generation CD47 Antibody 'IMC-002' at ASCO 2025

ImmuneOncia Therapeutics' IMC-002, a CD47-targeting antibody, demonstrated promising early efficacy and a favorable safety profile in a Phase 1b trial for solid tumors, showing a 30% partial response rate and an 80% disease control rate. Notably, AI-powered digital pathology analysis identified CD47 expression as a predictive biomarker, with a 60% objective response rate in patients with high CD47 expression (p=0.018). CEO Heung-Tae Kim suggests IMC-002 could offer a new treatment path for immunotherapy-resistant hepatocellular carcinoma (HCC) patients, potentially redefining second-line treatment strategies.

Analysis

ImmuneOncia Therapeutics' IMC-002, a second-generation anti-CD47 monoclonal antibody, demonstrated a promising clinical profile in its Phase 1b dose-expansion study for solid tumors. The therapy exhibited a favorable safety profile, with no reported cases of neutropenia or thrombocytopenia and only mild anemia observed in 15% of patients (2 out of 13); 96% of adverse events were low-grade (Grade 1-2) and primarily occurred in the first treatment cycle. Early efficacy signals are encouraging, with 30% of evaluable patients (3 out of 10) achieving a partial response and an 80% disease control rate, coupled with a median progression-free survival of 8.3 months. Notably, two patients continued treatment for over a year, suggesting potential for durable benefit. A key finding from AI-powered digital pathology analysis is the identification of CD47 expression as a statistically significant predictive biomarker (p=0.018), with a 60% objective response rate observed in patients with high CD47 expression on tumor cell membranes, compared to no response in the low-expression cohort. This biomarker-driven approach, as highlighted by CEO Heung-Tae Kim, could significantly enhance patient selection and positions IMC-002 as a potential new therapeutic option for hepatocellular carcinoma (HCC), particularly for patients resistant to first-line immunotherapy, by leveraging macrophage-based innate immunity. The drug's design aims to minimize hematologic toxicities common with first-generation CD47 inhibitors, a critical differentiation point. ImmuneOncia out-licensed IMC-002 in 2021, indicating external validation of its potential.

Key Decisions for Investors

• Investors should assess IMC-002's potential in the competitive CD47 inhibitor landscape, noting its differentiated safety profile and the strategic advantage offered by the AI-driven CD47 expression biomarker for patient stratification.
• Closely monitor upcoming clinical milestones for IMC-002, including progression to later-phase trials and data readouts, particularly in hepatocellular carcinoma, to validate the durability of response and broader applicability.
• Consider the implications of these findings for the immuno-oncology sector, especially regarding therapies targeting innate immunity and strategies to overcome resistance to existing checkpoint inhibitors.
• Evaluate the out-licensing agreement from 2021 for its terms and partners, as this could provide insights into the asset's perceived value and future development pathway.