ImmuneOncia Therapeutics announced promising interim results from its 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, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, demonstrated a 30% partial response rate among evaluable patients, significantly exceeding the approximately 10% typically observed with current second-line therapies for HCC.
Strong Efficacy Signal in Treatment-Resistant Population
Among 10 patients evaluable for efficacy in the dose-expansion phase, 3 patients (30%) achieved a partial response, while the disease control rate reached 80%. The median progression-free survival was 8.3 months. Notably, two patients have remained on treatment for over one year, indicating the potential for sustained therapeutic benefit.
The trial results are particularly encouraging given that two of the three partial responders were resistant to first-line immunotherapy. This suggests that IMC-002 may offer a new treatment pathway through macrophage-based innate immunity for patients who have exhausted conventional options.
Favorable Safety Profile
IMC-002 demonstrated a favorable safety profile with no reported cases of neutropenia or thrombocytopenia, common toxicities associated with first-generation CD47 antibodies. Mild anemia was observed in only 2 of 13 patients (15%), and 96% of adverse events were Grade 1-2, occurring primarily in the first treatment cycle.
Biomarker-Driven Patient Selection
AI-powered digital pathology analysis revealed a statistically significant correlation between CD47 expression levels and treatment response. Patients with high CD47 expression on tumor cell membranes showed a 60% objective response rate, whereas no response was observed in those with low expression (p=0.018). These findings support CD47 expression as a predictive biomarker for response to IMC-002 therapy.
Clinical Significance and Expert Commentary
Professor Jeong-Yong Hong of Samsung Medical Center commented on the clinical significance: "The IMC-002 and lenvatinib combination shows strong potential as a second-line treatment option for HCC patients with limited alternatives. A 30% response rate is particularly promising, especially when compared to the approximately 10% typically observed with current second-line therapies for HCC."
CEO Heung-Tae Kim emphasized the therapeutic potential: "Two of the three partial responders were resistant to first-line immunotherapy, suggesting IMC-002 may offer a new path forward via macrophage-based innate immunity. We are confident that this combination could redefine second-line treatment for HCC and will enhance our patient selection strategy through AI-driven biomarker analysis."
Next-Generation CD47 Targeting
IMC-002 is an IgG4 monoclonal antibody targeting the CD47-SIRPα axis to restore macrophage-mediated phagocytosis of cancer cells. As a second-generation anti-CD47 antibody, it is engineered to minimize binding to normal cells and avoid common toxicities such as hemagglutination and cytopenia that have limited first-generation CD47 therapies.
The antibody works by blocking the CD47/SIRPα interaction, effectively removing the "don't eat me" signal that cancer cells use to evade immune surveillance. This mechanism enhances macrophage-mediated phagocytosis while delivering high efficacy with reduced hematologic toxicity.
Company Pipeline and Commercial Strategy
ImmuneOncia is currently conducting Phase 1b trials 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. The company's pipeline also includes the PD-L1 antibody IMC-001 and bispecific antibodies IMC-201 and IMC-202.
Following its KOSDAQ listing in May 2025, ImmuneOncia aims to strengthen its global presence in immuno-oncology. Founded in 2016, the South Korean clinical-stage biotech company specializes in immuno-oncology with expertise in antibody development and translational science.
