Celltrion has announced promising preclinical data for its investigational immuno-oncology candidate, CT-P72/ABP-102, demonstrating potent antitumor efficacy alongside a highly favorable safety profile. The interim findings also suggest significant potential to expand the drug's therapeutic footprint beyond gastric cancer to an array of other solid tumors, including breast, bladder, and biliary tract cancers.
The South Korean biopharmaceutical company presented these findings on the 11th at the World Bispecific Antibody & T-Cell Engager Summit South Korea in Seoul, following up with a global update on the 12th.
A Highly Selective T-Cell Engager Mechanism
CT-P72/ABP-102 is a novel immunotherapy being co-developed by Celltrion and the U.S.-based biotechnology firm Abpro Holdings. The drug operates as a T-cell engager (TCE), engineered to build a molecular bridge that links cancer cells expressing human epidermal growth factor receptor 2 (HER2)—a protein heavily involved in abnormal cell growth—directly with cytotoxic T cells. This strategic link prompts the patient's own immune cells to directly recognize, infiltrate, and destroy the targeted tumor.
In an in vitro (laboratory) cytotoxicity assay, CT-P72/ABP-102 exhibited an exceptional therapeutic index by aggressively attacking tumor cells with high HER2 expression while showing minimal activity against normal cells with low HER2 expression. This strict selectivity points to a significantly reduced risk of "on-target, off-tumor" toxicity, which has historically hindered solid tumor immunotherapies. Furthermore, in nonhuman primate pharmacokinetics (how a drug moves through the body) and toxicity studies, the candidate proved highly tolerable, showing no major adverse side effects even when administered at a high dose of 80 mg/kg.
Overcoming Existing Therapy Resistance
In animal models implanted with human gastric cancer that had already developed resistance to current standard treatments, the candidate delivered tumor-suppressing effects that outperformed existing benchmark drugs. It replicated this robust performance across animal models for bladder, biliary tract, and breast cancers where HER2 is highly expressed.
To increase the clinical predictability of these findings before entering advanced human trials, Celltrion evaluated the drug's impact on breast cancer utilizing a microphysiological system (MPS). This advanced platform uses patient-derived organoids—miniature, three-dimensional organ-like models—to closely replicate the cellular architecture and microenvironment of an actual patient's tissue. The MPS evaluation successfully confirmed highly effective T-cell infiltration and subsequent tumor clearance within a realistic tissue environment.
Based on this strong preclinical momentum, Celltrion is accelerating its clinical timeline. The company aims to position the candidate as a best-in-class therapy capable of overcoming the resistance and systemic toxicity limitations historically associated with blockbuster HER2-targeting treatments like Enhertu (active ingredient: trastuzumab deruxtecan).
CT-P72/ABP-102 cleared its Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in December of last year and is currently in the patient screening phase ahead of its global Phase 1 clinical trial. Celltrion plans to formally apply for FDA Fast Track designation before the end of the year.
"Through rigorous preclinical trials, CT-P72/ABP-102 has bidirectionally confirmed unmatched tumor-killing efficacy against HER2 high-expression targets and an outstanding safety profile," a Celltrion official stated. "Having demonstrated clear therapeutic potential across a diverse range of solid tumors, we are focused on successfully advancing our upcoming clinical phases to address critical unmet needs in global oncology."
