CT-P72 data unveiled at World Bispecific & T-Cell Engager Summit; selective tumor response and low toxicity confirmed; indications expanded to breast, biliary tract cancers
Celltrion is accelerating its push to develop a best-in-class next-generation multi-specific antibody immunotherapy, releasing preclinical data demonstrating strong therapeutic efficacy and low toxicity for the drug candidate.
The company announced Monday that it presented preclinical findings and an indication-expansion strategy for CT-P72/ABP-102, its next-generation multi-specific antibody drug candidate, at the World Bispecific & T-Cell Engager Summit South Korea, held in Seoul.
According to the presentation, CT-P72/ABP-102 showed potent tumor-killing activity against HER2-overexpressing cells in in vitro cytotoxicity tests, while demonstrating markedly reduced activity against HER2-low-expressing cells — a highly selective anticancer effect. In primate pharmacokinetic and toxicity studies, the drug maintained excellent tolerability with no serious adverse effects at doses up to 80 mg/kg, confirming a high therapeutic index.
The data also pointed to broad disease applicability. In gastric cancer animal models with resistance to standard treatments, CT-P72/ABP-102 outperformed existing therapies in suppressing tumor growth. The drug also demonstrated strong anticancer efficacy across multiple HER2-overexpressing solid tumor mouse models — including bladder, biliary tract and breast cancers — suggesting wide potential for indication expansion.
Notably, the research employed a microphysiological system using organoids — miniature organ-like structures — to validate efficacy against breast cancer. The microphysiological system is an advanced tool that precisely evaluates drug responses on an artificial chip designed to replicate the biological environment of actual patients. Celltrion said it improved the reliability of drug efficacy predictions — including T-cell infiltration into tumor cells — beyond the limitations of conventional two-dimensional animal studies, before human dosing begins.
CT-P72/ABP-102 is a T-cell engager immunotherapy co-developed by Celltrion and US-based biotech ABL Bio Holdings. The drug works by binding HER2 proteins on the surface of cancer cells to immune T cells, triggering cancer cell death.
The US Food and Drug Administration cleared an investigational new drug application for a Phase 1 trial in December, and patient screening is now underway. Celltrion plans to apply for fast-track designation from the FDA this year to shorten the development timeline.
Through this pipeline, Celltrion aims to overcome resistance and efficacy limitations that can arise following treatment with Enhertu, the global blockbuster therapy. The company is also diversifying its oncology portfolio by initiating patient dosing for three antibody-drug conjugate-based 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 HER2-overexpressing targets and a strong safety profile," a Celltrion official said. "Having confirmed its potential as a treatment across various solid tumors, we will work to successfully complete the remaining clinical stages and establish it as a globally innovative new drug that addresses unmet medical needs."
silverpaper@heraldcorp.com
