CT-P72 shows selective tumor-killing activity and low toxicity in preclinical data unveiled at World Bispecific & T-Cell Engager Summit; Celltrion plans to file for FDA fast-track designation this year as it races to develop a best-in-class therapy that overcomes resistance to existing HER2 treatments

Celltrion headquarters. [Celltrion]
Celltrion headquarters. [Celltrion]

Celltrion is accelerating its push to develop a best-in-class next-generation multispecific antibody cancer drug after releasing preclinical data showing strong therapeutic efficacy and low toxicity.

The company said Friday it presented preclinical findings and an indication-expansion strategy for CT-P72/ABP-102, its next-generation multispecific antibody candidate, at the World Bispecific & T-Cell Engager Summit South Korea, held in Seoul.

According to the data presented, CT-P72/ABP-102 demonstrated a highly selective anticancer effect in in vitro cytotoxicity tests — showing potent tumor-killing activity against cells with high expression of human epidermal growth factor receptor 2 (HER2) while causing significantly less damage to cells with low HER2 expression. In pharmacokinetic and toxicity studies conducted in primates, the drug maintained strong tolerability with no serious adverse effects at doses up to 80 milligrams per kilogram, confirming a high therapeutic index.

The data also pointed to broad indication potential. In a gastric cancer animal model that had developed resistance to standard treatments, CT-P72/ABP-102 suppressed tumor growth beyond what existing drugs could achieve. The drug also demonstrated strong anticancer efficacy across mouse models of bladder cancer, biliary tract cancer and breast cancer — all solid tumors that share the same HER2 overexpression profile — suggesting wide applicability across cancer types.

Notably, the research employed a microphysiological system (MPS) using organoids — miniature organ-like structures that replicate human biology — to validate the drug's efficacy against breast cancer. MPS is an advanced tool that precisely evaluates drug responses on artificial chips designed to mimic a real patient's biological environment. Celltrion said the platform allowed it to go beyond the limitations of conventional two-dimensional animal testing, improving the reliability of efficacy predictions — including the drug's ability to drive T-cell infiltration into tumor cells — before actual patient dosing begins.

CT-P72/ABP-102 is a T-cell engager (TCE) immunotherapy that Celltrion is co-developing with US-based biotech ABpro Holdings. The drug works by simultaneously binding to HER2 protein on the surface of cancer cells and immune T cells, triggering the destruction of the tumor.

The US Food and Drug Administration cleared the drug's Phase 1 trial application in December last year, and patient screening is now underway. Celltrion plans to file for FDA fast-track designation before the end of this year to shorten the overall development timeline.

Celltrion aims to use the pipeline to address resistance and efficacy limitations that can arise after treatment with Enhertu, a global blockbuster HER2-targeted therapy. The company is also diversifying its oncology portfolio by initiating patient dosing for three antibody-drug conjugate (ADC) anticancer drug candidates — CT-P70, CT-P71 and CT-P73 — all of which have entered Phase 1 trials.

"CT-P72/ABP-102 has demonstrated, through preclinical studies, both unrivaled anticancer efficacy against high HER2-expressing targets and a strong safety profile," a Celltrion official said. "Having confirmed its potential as a treatment across a range of solid tumors, we will work to complete the remaining clinical stages successfully and establish this drug as a globally innovative therapy that addresses unmet medical needs."


silverpaper@heraldcorp.com