ImmuneOncia Announces Interim Results from Phase 1b Clinical Trial of Next-Generation CD47 Antibody 'IMC-002' at ASCO 2025
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CHICAGO, June 2, 2025 ~ ImmuneOncia Therapeutics, Inc. has released promising interim results from their ongoing Phase 1b clinical trial of IMC-002, a next-generation CD47-targeting antibody, in combination with lenvatinib for patients with advanced hepatocellular carcinoma (HCC). The data was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA.

The study, which is part of the dose-expansion phase, aimed to evaluate the safety and early efficacy of the combination therapy. According to CEO Heung-Tae Kim, IMC-002 demonstrated a favorable safety profile with no reported cases of neutropenia or thrombocytopenia. Only mild anemia was observed in 2 out of 13 patients (15%), and 96% of adverse events were Grade 1–2, occurring primarily in the first treatment cycle.

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

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In addition to these positive results, AI-powered digital pathology analysis showed a significant difference in response rates based on CD47 expression on tumor cell membranes. Patients with high CD47 expression had an objective response rate (ORR) of 60%, while those with low expression showed no response - a statistically significant difference (p=0.018). These findings support CD47 expression as a predictive biomarker for response.

Professor Jeong-Yong Hong from Samsung Medical Center commented on the potential of this combination therapy as a second-line treatment option for HCC patients with limited alternatives. He noted that the observed 30% response rate is particularly promising, especially when compared to the approximately 10% typically seen with current second-line therapies for HCC.

CEO Heung-Tae Kim also expressed confidence in the potential of IMC-002, stating that two of the three partial responders were resistant to first-line immunotherapy. This suggests that IMC-002 may offer a new path forward via macrophage-based innate immunity. Kim also mentioned plans to enhance their patient selection strategy through AI-driven biomarker analysis.

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

Currently, ImmuneOncia is conducting a Phase 1b trial of IMC-002 in patients with solid tumors. In 2021, the company out-licensed the asset to China's 3D Medicines in a deal worth up to $470 million. Their pipeline also includes other promising treatments such as the PD-L1 antibody IMC-001 and bispecific antibodies IMC-201 and IMC-202. With their recent listing on KOSDAQ in May 2025, ImmuneOncia aims to strengthen its global presence in immuno-oncology.
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