ImmuneOncia Therapeutics, Inc. (CEO Heung-Tae Kim) announced interim results today 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.
https://mma.prnewswire.com/media/2700898/ImmuneOncia_Logo.jpg
The study, part of the dose-expansion phase, evaluated the safety and early efficacy of the combination therapy. IMC-002 demonstrated a favorable safety profile with no reported cases of neutropenia or thrombocytopenia. Mild anemia 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 tumor 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.
Professor Jeong-Yong Hong of Samsung Medical Center commented, “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 stated, “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.”
IMC-002 is an IgG4 monoclonal antibody targeting the CD47-SIRPa axis to restore macrophage-mediated phagocytosis of cancer cells. It is a second-generation anti-CD47 antibody designed to minimize 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 tumors. In 2021, the company out-licensed the asset to China's 3D Medicines in a deal worth up to $470 million. Its 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.
About IMC-002IMC-002 is a novel immune checkpoint inhibitor targeting CD47, a “don't eat me” signal expressed on cancer cells. By blocking the CD47/SIRPa interaction, IMC-002 enhances macrophage-mediated phagocytosis. It is engineered to deliver high efficacy while minimizing binding to red blood cells and avoiding hematologic toxicity.
About ImmuneOncia Therapeutics, Inc.Founded in 2016, ImmuneOncia is a South Korean clinical-stage biotech company specializing in immuno-oncology. With expertise in antibody development and translational science, the company is advancing a pipeline of checkpoint inhibitors and bispecific antibodies to address unmet needs in cancer treatment.
Media ContactJiwon HeoImmuneOncia Therapeutics, Inc.Email: PR@immuneoncia.com Website: www.immuneoncia.com
https://c212.net/c/img/favicon.png?sn=CN00631&sd=2025-06-02
View original content to download multimedia:https://www.prnewswire.com/news-releases/immuneoncia-announces-interim-results-from-phase-1b-clinical-trial-of-next-generation-cd47-antibody-imc-002-at-asco-2025-302470514.html
SOURCE ImmuneOncia Therapeutics, Inc.
https://rt.newswire.ca/rt.gif?NewsItemId=CN00631&Transmission_Id=202506021430PR_NEWS_USPR_____CN00631&DateId=20250602