- [ESMO On-Site Interview] Kim Heung-tae, CEO of ImmuneOncia
- 스피드 바카라-targeting antibody 'IMC-002' shows anticancer efficacy with no hematologic toxicity
- PD-L1-targeting antibody 'IMC-001' demonstrates potential for preoperative immunotherapy

Kim Heung-tae (left), CEO of ImmuneOncia, is interviewed by THE BIO at the European Society for Medical Oncology Congress (ESMO 2025) in Berlin, Germany, on October 19 (local time). (Photo: Reporter Ji Yong Jun)
Kim Heung-tae (left), CEO of ImmuneOncia, is interviewed by THE BIO at the European Society for Medical Oncology Congress (ESMO 2025) in Berlin, Germany, on October 19 (local time). (Photo: Reporter Ji Yong Jun)

[by Ji, Yong Jun] "Next year, as we celebrate our 10th anniversary, we are determined to achieve our company-wide objective of 'technology export.'"

Kim Heung-tae, CEO of ImmuneOncia, shared this perspective during an interview with <THE BIO at the European Society for Medical Oncology (ESMO 2025) Congress held in Berlin, Germany, on October 19 (local time), where he also discussed the company's future strategic direction.

At ESMO 2025, ImmuneOncia unveiled two clinical trial results from its key pipeline through a poster presentation, featuring its antibody drug candidates, ‘IMC-002 (development code; anti-스피드 바카라 monoclonal antibody)’ and ‘Danverstotug (development code IMC-001; anti-PD-L1 monoclonal antibody).’

"We have evaluated the safety profile of IMC-002, a 스피드 바카라-targeting antibody candidate, and validated the clinical potential of IMC-001, which targets PD-L1," Kim explained. "The safety and structural differentiation of IMC-002 have been confirmed through preclinical studies and Phase 1a/b clinical trials."

IMC-002 is a monoclonal antibody that targets 스피드 바카라, promoting the activation of macrophages to recognize and eliminate cancer cells. The antibody demonstrates strong binding affinity to 스피드 바카라-expressing tumor cells, while maintaining minimal binding to red blood cells.

Epitope mapping and in silico modeling analyses demonstrated that IMC-002 binds in proximity to the O-glycosylation site of the 스피드 바카라 protein. Kim explained that this unique binding characteristic is anticipated to minimize hematological toxicity.

"IMC-002 is an innovative therapeutic candidate that overcomes the limitations of conventional 스피드 바카라 antibodies. It is a 스피드 바카라-targeting antibody that exhibits negligible binding to red blood cells enabling effective cancer cell eradication without associated toxicity," Kim emphasized.

ImmuneOncia conducted a proteomic analysis to identify differences in protein expression between patients exhibiting partial response (PR) and those with stable disease (SD). Through this analysis, the company identified potential biomarker candidates capable of predicting treatment response.

IMC-002 is currently being evaluated in a Phase 1b clinical trial in three cohorts: liver cancer, biliary tract cancer, and triple-negative breast cancer (TNBC). "Beyond its role in blocking 스피드 바카라 signaling, we have identified a correlation between elevated innate immune activation indices and tumor response. We intend to integrate these immune activity indices into future clinical trials to enhance therapeutic efficacy," Kim remarked.

Kim Heung-tae (left), CEO of ImmuneOncia, is interviewed by THE BIO at the European Society for Medical Oncology Congress (ESMO 2025) in Berlin, Germany, on October 19 (local time). (Photo: Reporter Ji Yong Jun)
Kim Heung-tae (left), CEO of ImmuneOncia, is interviewed by THE BIO at the European Society for Medical Oncology Congress (ESMO 2025) in Berlin, Germany, on October 19 (local time). (Photo: Reporter Ji Yong Jun)

Another pipeline asset, IMC-001, a PD-L1-targeting monoclonal antibody, yielded positive results in a neoadjuvant immunotherapy clinical trial involving patients with resectable gastric, esophageal, and liver cancers. According to ImmuneOncia, a total of 48 patients (16 for each cancer type) received two preoperative doses of Danverstotugprior to surgical resection.

The trial outcomes demonstrated promising long-term efficacy in all three cancer types. In gastric cancer, both the 3-스피드 바카라 progression-free survival (PFS) and overall survival (OS) rates reached 93.8%. For esophageal cancer, the 3-스피드 바카라 PFS and OS rates were 80.0% and 87.5%, respectively. In liver cancer, patients achieved a 3-스피드 바카라 PFS rate of 86.5% and an OS rate of 100%.

"With only two preoperative administrations of IMC-001, the tumor immune microenvironment showed marked improvement. Notably, we observed a transition to an 'immune-active' phenotype, characterized by increased T-cell infiltration within the tumor," Kim explained.

"Achieving curative treatment without adverse effects represents the first tangible example of the potential application of immunotherapy in the preoperative setting. This outcome could lay the foundation for our company to enter the neoadjuvant market," he further commented.

Kim announced plans to implement a two-track strategy that integrates the commercialization and technology licensing of IMC-001. He revealed that by 2026, the company intends to submit an application for Orphan Drug Designation (ODD) for IMC-001 targeting NKT cell lymphoma, with both commercialization and licensing-out efforts progressing in parallel. The ODD designation, once granted, would enable regulatory approval based on Phase 2 clinical trial results alone.

"IMC-001 is expected to first obtain product approval for NKT-cell lymphoma, followed by expansion into gastrointestinal cancer indications. Its commercial potential is also high, as it may qualify for 'conditional approval' without the need for a Phase 3 clinical trial," Kim stated.

"As an orphan drug, IMC-001 will hold a strategic advantage in global licensing-out (L/O, technology export) negotiations once commercialization is achieved," Kim emphasized. He acknowledged that the PD-L1 inhibitor market remains highly competitive and presents formidable entry barriers, dominated by major players such as Roche's Tecentriq, Pfizer's Bavencio, and AstraZeneca's Imfinzi. Nonetheless, Kim expressed confidence that a successful market entry would generate a significant impact.

Kim also shared his ambition to develop IMC-001 into a ‘second Leclaza.’ He further revealed that the company has set 2026 as the target 스피드 바카라 for the technology export (L/O) of IMC-002. With next 스피드 바카라 marking ImmuneOncia’s 10th anniversary, the company aims to designate it as the first 스피드 바카라 of successful technology export.

"IMC-001 demonstrates excellent safety and strong therapeutic efficacy, and once commercialized, it is poised to become a 'best-in-class' drug," Kim said. "IMC-002 will emerge as a 'game changer,' distinguished by its clear biomarker-based responsiveness in a field where most existing 스피드 바카라-targeting antibodies have failed," he added.

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