Ligachem Biosciences (141080.KQ) has completed the first patient dosing of LCB02A, an antibody-drug conjugate (ADC) candidate it is developing in-house, and is moving into full-scale global clinical development. The company plans to assess the drug's safety and anti-tumor activity in patients with solid tumors including gastric and pancreatic cancer.
Ligachem said on the 16th that the first patient in the global Phase 1/2 trial of LCB02A was dosed on the 15th at a clinical site in North America. The dosing follows clearance of the company's investigational new drug application by the U.S. Food and Drug Administration in May.
LCB02A is an ADC targeting claudin 18.2 (CLDN18.2), a protein highly expressed on the surface of some cancer cells in gastric and pancreatic tumors. Using Ligachem's proprietary ConjuAll platform, the company linked exatecan, a drug that interferes with DNA replication in cancer cells, to an antibody that seeks out the protein. Ligachem said the linker technology connecting the antibody and the drug is designed to keep the payload stable in the bloodstream.
The trial will enroll up to 191 patients with CLDN18.2-positive advanced solid tumors who have failed standard treatment. Major cancer centers in North America and South Korea are taking part. The Phase 1 portion will escalate doses in stages to evaluate safety and tolerability and to determine the appropriate dose for Phase 2. The Phase 2 portion will then assess anti-tumor activity in patient cohorts by tumor type, including gastric and gastroesophageal junction cancer and pancreatic cancer.
Ligachem plans to present two posters covering preclinical results for LCB02A and the design of the trial at the European Society for Medical Oncology annual congress (ESMO 2026), held in Madrid from the 23rd to the 27th of this month.
"This first patient dosing is significant because our strategy of broadening the range of payloads linked to antibodies has now entered full clinical development," said Park Se-jin, chief executive of Ligachem Biosciences. "We will move quickly with world-leading cancer centers to prove LCB02A's differentiated competitiveness with data."