Ligachem Bioscience Submits Global Phase 1/2 IND Application for Claudin18.2 ADC 'LCB02A'

Accelerating Payload Diversification

Ligachem Bioscience announced on April 14 that it has submitted a global Phase 1/2 clinical trial Investigational New Drug (IND) application for 'LCB02A', its in-house developed antibody-drug conjugate (ADC) candidate targeting Claudin18.2.

This clinical trial is a multi-national, multi-center study that will be conducted at major clinical sites in the United States, Canada, and Korea. LCB02A received its official clinical trial registration number (NCT07460375) from the world's largest clinical information platform, ClinicalTrials.gov, on March 10, marking the official start of its clinical development. Ligachem Bioscience plans to complete the approval process within the first half of this year and aims to administer the first dose to patients by mid-2026.

LCB02A is a new drug candidate developed using Ligachem Bioscience's proprietary ADC platform technology, ConjuAll™. Notably, this pipeline applies 'Exatecan', a topoisomerase I inhibitor (Topo1i), rather than previously favored microtubule inhibitors such as MMAE and MMAF, or the PBD class. This represents a significant expansion of the company's ADC technology portfolio.

The global ADC market has recently seen increased attention toward Topo1 inhibitor-based ADCs following the success of Daiichi Sankyo's Enhertu. Through LCB02A, Ligachem Bioscience aims to demonstrate its ability to diversify ADC payloads and, by combining a proprietary linker technology with high blood stability, expects to achieve both superior safety and potent efficacy compared to existing therapies.

Claudin18.2 is a protein that is overexpressed on the surface of solid tumor cells such as gastric and pancreatic cancers. It is a target with extremely high unmet medical needs worldwide. Although many global pharmaceutical companies are developing ADCs targeting Claudin18.2, Ligachem Bioscience aims to secure competitiveness as a 'best-in-class' new drug, despite being a latecomer, through its unique linker-payload combination strategy.

Yongju Kim, CEO of Ligachem Bioscience, stated, "LCB02A is a key pipeline developed by combining our proprietary platform technology with the Topo1 inhibitor payload, Exatecan. Through the upcoming global Phase 1/2 clinical trials, we will prove the differentiated value of LCB02A in the CLDN18.2 ADC market and further strengthen our position as a global leader in the ADC field."

This content was produced with the assistance of AI translation services.