[Edaily Reporter Yoo Jin-hee] #Celltrion’s next-generation bispecific antibody anticancer drug, currently under development, has demonstrated overwhelming therapeutic efficacy and tolerability in preclinical trials, signaling a new paradigm in solid tumor treatment.

Celltrion announced on the 12th that it presented interim study results for its immuno-oncology candidate “CT-P72/ABP-102” at the “World Bispecific & T-Cell Engager Summit South Korea” held in Seoul on the 11th.

In this presentation, titled “CT-P72/ABP-102: A HER2 TCE with an Excellent Therapeutic Index (TI),” Celltrion highlighted the new drug candidate’s high selective anticancer efficacy and safety.

According to the presentation, CT-P72/ABP-102 demonstrated potent cytotoxic activity against tumor cells overexpressing human epidermal growth factor receptor 2 (HER2) in in vitro cytotoxicity assays. Conversely, its reactivity was significantly lower against cells at normal levels of HER2 expression, indicating high safety through selective targeting of cancer cells.

Significant results were also achieved in pharmacokinetic (PK) and toxicity studies conducted on primates. Excellent tolerability was confirmed even at a high dose of 80 mg/kg, significantly expanding the “therapeutic index (TI),” which indicates the safe dosage range of the drug.

Notably, this study attracted attention by confirming potent anticancer effects that surpassed existing drugs in a gastric cancer animal model that had developed resistance to standard treatments. Furthermore, by demonstrating excellent efficacy not only in gastric cancer but also in various solid tumors expressing HER2—such as bladder, bile duct, and breast cancers—the study opened the door to the potential for broad expansion of indications.

State-of-the-art microphysiological systems (MPS) were introduced for the breast cancer research. The study successfully demonstrated the process by which T cells—immune cells—penetrate and destroy cancer cells within an artificial organoid environment that closely mimics the patient’s biological environment. As a result, Celltrion has further enhanced the reliability of predicting the drug’s efficacy in actual patients, building on the results of previous animal studies.

Based on these preclinical results, Celltrion plans to accelerate its ongoing Phase 1 clinical trial. The company aims to develop CT-P72/ABP-102 into a “Best-in-Class” new drug that addresses unmet medical needs in the market by overcoming the long-standing limitations of “ENHERTU” (generic name: trastuzumab deruxtecan), the HER2-targeted therapy currently leading the global market, specifically issues related to resistance and tolerability.

CT-P72/ABP-102 is a T-cell engager (TCE) therapy that Celltrion is jointly developing with the U.S. biotech firm ABP Holdings. After receiving approval for its Phase 1 clinical trial plan from the U.S. Food and Drug Administration (FDA) last December, the company is currently in the patient screening phase and plans to apply for Fast Track designation with the FDA within this year.

A Celltrion official stated, “The multi-antibody anticancer drug CT-P72/ABP-102 has demonstrated high anticancer efficacy and excellent tolerability against HER2-overexpressing targets through preclinical studies.” The official added, “As we have also confirmed its therapeutic potential in various solid tumors, we will do our utmost to successfully advance the clinical trials and develop it into a best-in-class new drug that outperforms existing medications.”

Meanwhile, Celltrion is accelerating the diversification of its anti-cancer drug pipeline. The company has further strengthened its new drug development portfolio by commencing patient dosing for three antibody-drug conjugate (ADC)-based candidates (CT-P70, CT-P71, and CT-P73) that have entered Phase 1 clinical trials. These pipeline candidates also received high praise from domestic and international investors and analysts at “Celltrion Science & Innovation Day 2026,” held last month.