LigaChem Doses First Patient in Global Trial of Cancer-Targeting ADC

LigaChem Biosciences headquarters LigaChem Biosciences has begun global clinical development of its proprietary Claudin 18.2 (CLDN18.2)-targeting antibody-drug conjugate (ADC) candidate, LCB02A. The company announced on Oct. 16 that the first patient had been dosed in its global Phase 1/2 clinical trial at a clinical site in North America on Oct. 15, local time. The milestone comes approximately five months after the U.S. Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application in May. The trial is a multinational, multicenter study involving up to 191 patients with CLDN18.2-positive advanced solid tumors whose disease has progressed despite standard treatment. Phase 1 will assess the drug’s safety and tolerability and determine the recommended Phase 2 dose (RP2D). The subsequent Phase 2 portion will focus on evaluating antitumor activity in patients with CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal junction cancer and pancreatic cancer. Major cancer centers in North America and South Korea are participating in the study. LCB02A is a key pipeline candidate developed using LigaChem Biosciences’ proprietary ADC platform, ConjuAll. It consists of a CLDN18.2-targeting antibody site-specifically conjugated to exatecan, a cytotoxic payload. Exatecan belongs to the topoisomerase 1 (Topo1) inhibitor class, which interferes with DNA replication in cancer cells. The candidate also represents an expansion of the company’s payload portfolio beyond the microtubule inhibitors and pyrrolobenzodiazepine (PBD)-based agents it previously used. According to the company, LCB02A incorporates its proprietary linker technology designed for high stability in the bloodstream. This enables a uniform drug-to-antibody ratio of four (DAR 4), with four drug molecules attached to each antibody. ADCs are considered a next-generation cancer treatment approach that uses antibodies to target specific cells and deliver cytotoxic drugs directly into them, aiming to maximize antitumor activity while reducing damage to healthy tissue. In the CLDN18.2-targeted treatment market, Astellas’ monoclonal antibody Vyloy has already received regulatory approval, but no CLDN18.2-targeting ADC has yet been approved worldwide. CLDN18.2 has attracted attention as a next-generation oncology target because it is overexpressed on the surface of certain solid tumor cells, including gastric and pancreatic cancer cells, while its expression in normal tissue is relatively limited. LigaChem Biosciences plans to present two posters at the European Society for Medical Oncology (ESMO 2026) annual congress, scheduled for Oct. 23–27 in Madrid, Spain. The presentations will cover LCB02A’s preclinical research findings and clinical trial design, highlighting the candidate’s technological differentiation to medical professionals and industry representatives worldwide. LigaChem Biosciences CEO Park Se-jin said the first patient dosing marked an important milestone as the company’s diversification strategy combining its ConjuAll platform with a Topo1 inhibitor payload entered clinical development. He added that the company would seek to demonstrate LCB02A’s competitiveness through clinical data by advancing the trial swiftly. Shares of LigaChem Biosciences rose sharply on the KOSDAQ following the announcement. As of 9:33 a.m. on Oct. 16, the stock was trading at 68,700 won, or approximately $51.06, up 9.39% from the previous trading day, reflecting heightened market expectations surrounding the clinical program.