ImmuneOncia speeds commercialization with product-fit plan

ImmuneOncia will accelerate commercialization with product-specific strategies

Heung-Tae Kim, CEO of ImmuneOncia

Immune landscape shifts in gastric, esophageal, and liver cancers… evidence presented at ESMO

Will pursue ODD for IMC-001 and export IMC-002 technology

ImmuneOncia is concretizing its ‘commercialization strategy that starts with rare cancers’ as entry points for its immuno-oncology portfolio.

 

ImmuneOncia, a subsidiary of Yuhan Corp that specializes in immuno-oncology, presented new clinical results on its PD-L1 antibody IMC-001 (danvastotug) and CD47 antibody IMC-002 at the European Society for Medical Oncology (ESMO) 2025 Congress, outlining a novel strategy for immuno-oncology drug development.

 

Dailypharm met with Heung-Tae Kim, CEO of ImmuneOncia, in Berlin, Germany, to discuss the significance of these achievements and the company’s future roadmap.

 

“IMC-001 demonstrates immune microenvironment shift in gastric, esophageal, and liver cancer”

Heung-Tae Kim, CEO of ImmuneOncia

CEO Kim emphasized the potential of the neoadjuvant (pre-surgery) immunotherapy market at ESMO 2025.

 

He projected that while neoadjuvant immunotherapy is an early field, it will expand as data accumulates.

 

The ‘NeoChance Study (IMC-001)’ presented by the company at ESMO 2025 detailed the results of administering two doses of a PD-L1 antibody preoperatively to patients with resectable gastric, esophageal, and liver cancers.

 

CEO Kim stated, “With just two doses, the tumor's immune environment completely transformed.

 

We directly observed the histological change where tumors, which were essentially immune deserts with almost no immune cells, converted to an inflamed phenotype.” He further stated, “Immune responses were also observed in PD-L1-negative, Microsatellite Stable (MSS) patients.

 

This could provide evidence on its broader applicability in immuno-oncology.” In the study, the 3-year progression-free survival (PFS) and overall survival (OS) rates were 93.8% and 93.8% for gastric cancer, 80.0% and 87.5% for esophageal cancer, and 86.5% and 100% for liver cancer, respectively.

 

Notably, the company is considering expanding its strategy from two doses to three or four doses in combination therapy, as multiple researchers at ESMO advised extending its use in combination with chemotherapy.

 

CD47 signal reinterpreted...“Innate immunity is key” Kim also highlighted the activation of innate immunity as a key differentiator of the CD47 antibody ‘IMC-002’.

 

He explained, “IMC-002 does more than block signals; it induces innate immunity to function strongly in patient groups with tumors with weakened immune-escape mechanisms.” This drug binds near the O-glycosylation site of the CD47 protein, minimizing interaction with red blood cells.

 

CEO Kim stated, “Its minimal hematologic toxicity is the key difference from existing drugs, as it maintains safety even during long-term administration (up to 22 months).

 

IMC-002 simultaneously resolves the toxicity and efficacy issues that caused previous CD47 antibodies to fail.” In actual proteomics analysis, IMC-002 showed more pronounced tumor responses in patient groups exhibiting elevated innate immune-related proteins.

 

Based on this, ImmuneOncia plans to develop predictive biomarkers for future response assessment.

 

From left) Professor Jin-seok Ahn of the Department of Hematology and Oncology at Samsung Medical Center and Professor Sook-ryun Park of the Department of Medical Oncology at Asan Medical Center are photographed with CEO Heung-tae Kim at the ESMO2025 poster presentation site

“Immuno-oncology drugs must ultimately prove themselves through commercialization” CEO Kim clearly distinguished the development paths for its two candidates.

 

He stated, “IMC-001 targets the pre-surgery treatment market, while IMC-002 follows an out-licensing global strategy.

 

Both are progressing under structures that concurrently pursue commercialization and export for each candidate.” CEO Kim further revealed, “We plan to seek conditional approval with NK/T-cell lymphoma, a rare cancer, as the first indication, then expand into high tumor mutational burden (TMB-high) cancers and neoadjuvant therapy.” The global PD-1/PD-L1 antibody market is projected to continue growing, and ImmuneOncia aims to enhance the presence of domestically developed immuno-oncology drugs within it.

 

The company is currently preparing to apply for Orphan Drug Designation (ODD) for IMC-001 and is simultaneously discussing technology transfer for IMC-002 with global pharmaceutical companies.

 

Concluding the interview, CEO Kim reflected on the limitations of biotech companies that often remain confined to licensing deals and returns, and stressed that developing new drugs actually used by patients is the company's reason for being.

 

While expressing ambition for ImmuneOncia to pioneer the commercialization model for domestic immuno-oncology drugs, CEO Kim added, “We will become a company evaluated not by its technology alone, but by its therapies.”