#USA #Chicago #HCC #ImmuneOncia #IMC-002

ImmuneOncia's Promising Update on IMC-002 Clinical Trial

On June 2, 2025, ImmuneOncia Therapeutics, led by CEO Heung-Tae Kim, disclosed interim findings from the Phase 1b clinical trial for its cutting-edge CD47-targeting antibody, IMC-002. This update was revealed during the prestigious American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA. The study focuses on patients suffering from advanced hepatocellular carcinoma (HCC) and evaluates the combination of IMC-002 with lenvatinib.

Trial Overview

The clinical trial, considered a dose-expansion phase, primarily assesses the safety and initial efficacy of this combination therapy. Remarkably, IMC-002 has shown a favorable safety profile, with no instances of neutropenia or thrombocytopenia reported. Out of 13 patients involved, mild anemia occurred in only 2 (15%), and the vast majority of adverse events (96%) were classified as Grade 1 or 2, mainly occurring during the first cycle of treatment.

Among 10 patients who were evaluable for efficacy, 3 individuals demonstrated a partial response (PR), resulting in a response rate of 30%. Furthermore, the disease control rate (DCR) achieved an impressive 80%, and the median progression-free survival (PFS) stood at 8.3 months. Significantly, two patients remained under treatment for over one year, illustrating the potential for long-lasting therapeutic benefits.

AI-Powered Insights

AI-driven digital pathology analyses revealed a striking 60% objective response rate (ORR) in patients exhibiting high levels of CD47 expression on the tumor cell membranes. Conversely, no responses were noted in patients with low expression levels, a statistics that emphasizes the role of CD47 as a predictive biomarker (p=0.018).

Professor Jeong-Yong Hong from Samsung Medical Center remarked on the promising nature of IMC-002's combination with lenvatinib as a second-line treatment alternative for HCC patients who have limited options available. Notably, the reported 30% response rate stands in stark contrast to the approximately 10% typically observed with current second-line therapies for HCC.

CEO Heung-Tae Kim emphasized the important implications of these findings, indicating that two of the three individuals who showed partial responses were resistant to first-line immunotherapy. This highlights IMC-002's potential to provide a new therapeutic direction, leveraging the body's macrophage-based innate immunity. Kim confidently expressed that this combination could redefine second-line treatment strategies for HCC and enhance patient selection through biomarker analysis powered by AI technologies.

About IMC-002

IMC-002 is an IgG4 monoclonal antibody targeting the CD47-SIRPα axis designed to restore macrophage-mediated phagocytosis of cancer cells. Notably, it is a second-generation anti-CD47 antibody, engineered to minimize binding to healthy cells and mitigate common toxicities like hemagglutination and cytopenia.

Currently, ImmuneOncia is progressing with the Phase 1b trial of IMC-002 for patients with solid tumors. The company made headlines in 2021 by out-licensing the asset to China's 3D Medicines in a deal potentially worth $470 million. Alongside IMC-002, ImmuneOncia is also developing additional products like the PD-L1 antibody, IMC-001, and bispecific antibodies IMC-201 and IMC-202. Following its recent KOSDAQ listing in May 2025, the firm aims to fortify its global footprint in the field of immuno-oncology.

Conclusion

In summary, the data presented at ASCO 2025 showcase IMC-002 as a promising candidate in the treatment landscape for hepatocellular carcinoma, particularly beneficial for patients with limited treatment options. With its impressive safety profile and significant early efficacy indicators, ImmuneOncia Therapeutics is poised to make a remarkable impact in cancer therapy.