LigaChem Biosciences Doses First Patient in Global Phase 1/2 Trial of CLDN18.2 ADC LCB02A

First patient dosed in North America following U.S. FDA IND clearance

■    First patient dosed at a leading North American cancer center, marking the clinical start of LigaChem’s in-house CLDN18.2 ADC

■    Multinational trial to enroll up to 191 patients at leading cancer centers in North America and Korea

■    Nonclinical data and trial design to be presented at ESMO Congress 2026 later this month

Daejeon, Korea, October 16, 2026 – LigaChem Biosciences Inc. (KOSDAQ: 141080, “LigaChem”) today announced that the first patient has been dosed in its global Phase 1/2 clinical trial of LCB02A, an in-house antibody-drug conjugate (ADC) candidate targeting Claudin 18.2 (CLDN18.2).

The first patient was dosed on October 15 (local time) at a leading clinical site in North America. Following submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in April and clearance in May, the first patient dosing marks the start of full-scale clinical development of LCB02A.

The multinational, multicenter trial (NCT07460375) will enroll up to 191 patients with CLDN18.2-positive advanced solid tumors who have failed standard therapy, and consists of a Phase 1 dose-escalation part and a Phase 2 dose-expansion part. Phase 1 will evaluate the safety and tolerability of LCB02A and determine the recommended Phase 2 dose (RP2D). Phase 2 will assess anti-tumor activity in cohorts of CLDN18.2-expressing solid tumors, including gastric and gastroesophageal junction cancer and pancreatic cancer.

Leading cancer centers in North America and Korea are participating in the trial. The full list of participating sites is available at ClinicalTrials.gov (NCT07460375).

LigaChem will present two posters at the European Society for Medical Oncology (ESMO) Congress 2026, to be held in Madrid, Spain, from October 23 to 27, covering nonclinical data on LCB02A and the design of the Phase 1/2 trial (Trial in Progress).

LCB02A is built on LigaChem’s proprietary ADC platform, ConjuAll™, and consists of an anti-CLDN18.2 antibody site-specifically conjugated to exatecan, a topoisomerase I inhibitor (Topo1i) payload. LigaChem’s proprietary linker technology, which offers high plasma stability, enables a homogeneous drug-to-antibody ratio (DAR) of 4. LCB02A is the Company’s first program to apply a Topo1 inhibitor payload, expanding its payload portfolio beyond microtubule inhibitors (MMAE, MMAF) and PBDs.

CLDN18.2 is overexpressed on the surface of solid tumor cells, including gastric and pancreatic cancers, while its expression in normal tissues is limited, making it a next-generation oncology target with high unmet medical need. While Astellas’ monoclonal antibody VYLOY® (zolbetuximab) has been approved as a CLDN18.2-targeted therapy, no CLDN18.2-targeted ADC has been approved anywhere in the world to date.

“The first patient dosing of LCB02A is a meaningful milestone, as it marks the entry into full-scale clinical development of our payload diversification strategy, which combines the ConjuAll™ platform with a Topo1 inhibitor payload,” said Sejin Park, Chief Executive Officer of LigaChem Biosciences. “Together with world-renowned cancer centers, we will advance the trial swiftly and demonstrate the differentiated competitiveness of LCB02A in the CLDN18.2 ADC market with data.”