ImmuneOncia, the immuno-oncology specialty subsidiary of Yuhan Corporation, said on Oct. 19 that it unveiled at the European Society for Medical Oncology (ESMO 2025) in Berlin, Germany, the phase 1 clinical results demonstrating the safety and anticancer efficacy of its antibody new drug in development.
ImmuneOncia is developing an antibody new drug that blocks signals so cancer cells cannot evade attacks by immune cells. They are IMC-002, which blocks the CD47 protein commonly found on cancer cells, and "Danvastotug (IMC-001)," an antibody targeting the PD-L1 protein that helps cancer cells evade immune attack.
According to the company, excellent safety was confirmed in the phase 1 trial of IMC-002. It acts strongly on cancer cells while having little effect on normal cells such as red blood cells, minimizing blood-related side effects including anemia. Conventional CD47 antibodies often bind not only to cancer cells but also to normal red blood cells, leading to a higher likelihood of side effects.
Kim Heung-tae, CEO of ImmuneOncia, said, "IMC-002 is an innovative therapy that overcomes the limitations of conventional CD47 antibodies," adding, "It has been confirmed as a CD47 antibody with virtually no hematologic toxicity."
The company also said it identified clues in some patients that could predict drug response in advance, and it expects this could be used for future research on personalized treatments.
ImmuneOncia said Danvastotug was safely applied when administered before surgery to patients with gastric cancer, esophageal cancer, and hepatocellular carcinoma, and it also showed an improvement in long-term survival rates.
A total of 48 patients received two doses before surgery. For gastric cancer, progression-free survival (PFS), the rate of no disease progression for three years, and overall survival (OS), the rate of survival for three years after treatment, were each 93.8%. For esophageal cancer, PFS and OS were 80.0% and 87.5%, respectively, and for liver cancer they were 86.5% and 100%.
In addition, analysis of changes in patients' immune environments before and after administration observed reactivation of immune cells to attack cancer cells. This suggested the potential to develop personalized immunotherapy strategies for patients in the future.
Park Sook-ryeon, a professor of medical oncology at Asan Medical Center in Seoul who led the clinical trial, said, "Preoperative immunotherapy using Danvastotug is a new approach that is safe and effectively enhances antitumor immunity," adding, "It is especially meaningful that we confirmed the potential for immunotherapy even in PD-L1–negative and microsatellite-stable (MSS) gastrointestinal cancer patients." MSS gastrointestinal cancer is a refractory cancer that does not respond to monotherapy with conventional immuno-oncology drugs.
Kim said, "With this announcement, we simultaneously confirmed the safety of IMC-002 and the applicability of Danvastotug to preoperative immunotherapy," adding, "As a next-generation immuno-oncology platform corporations, we will work to strengthen our global competitiveness."