Celltrion announced on Friday that its next-generation multi-antibody drug, CT-P72/ABP-102, has demonstrated exceptional efficacy and tolerability, confirming its potential for treating various solid tumors.
The company presented these findings at the World Dual-Specific Antibody & T Cell Engager Summit in Seoul, highlighting the impressive therapeutic index of the HER2 TCE CT-P72/ABP-102.
The data revealed that CT-P72/ABP-102 exhibited potent anti-cancer effects against tumors with high human epidermal growth factor receptor 2 (HER2) expression in laboratory tests. Importantly, its toxicity against low HER2-expressing cells was significantly reduced, indicating a highly selective response to cancer cells. Primate studies also showed excellent tolerability at doses up to 80 mg/kg.
The drug outperformed existing treatments in animal models of drug-resistant gastric cancer. Moreover, it showed promising results in other HER2-overexpressing cancers, including bladder, bile duct, and breast cancers, suggesting broader therapeutic applications.
For breast cancer, researchers used organoids in a microphysiological system (MPS) to confirm strong anti-cancer effects, including enhanced T cell infiltration. Organoids, which are 3D-cultured mini-organs from patient tissues or stem cells, allow for more precise drug efficacy and safety assessments.
The MPS provides a patient-like environment for studying drug responses, enhancing Celltrion’s ability to predict treatment outcomes before human trials, complementing traditional animal studies.
These encouraging results have prompted Celltrion to accelerate clinical development of CT-P72/ABP-102. The company aims to address the limitations of existing HER2-targeted therapies like Enhertu, particularly in terms of drug resistance and tolerability, positioning CT-P72/ABP-102 as a potential best-in-class treatment for unmet medical needs.
CT-P72/ABP-102, co-developed by Celltrion and U.S.-based Abpro Holdings, is an innovative immuno-oncology drug. It functions as a T cell engager (TCE), linking HER2-expressing cancer cells with T cells to enhance immune response against tumors.
Following the U.S. Food and Drug Administration (FDA) approval for Phase 1 trials last December, the drug is now in the patient screening phase. Celltrion plans to seek Fast Track designation from the FDA later this year, potentially expediting its development and review process.