LigaChem Biosciences Doses First Patient in Trial of ADC "LCB02A" Targeting Gastric, Pancreatic Cancers
Global Phase 1/2 trial launched, enrolling up to 191 patients
Research results to be presented at ESMO this month
LigaChem Biosciences has begun global clinical trials of LCB02A, a candidate antibody-drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2) that it developed in-house.
LigaChem Biosciences said on October 16 that it had dosed the first patient in the global Phase 1/2 trial of LCB02A. The first dose was administered on October 15 local time at a clinical trial site in North America. The U.S. Food and Drug Administration (FDA) had approved the Investigational New Drug (IND) application for the trial in May.
The trial will enroll up to 191 patients in North America and South Korea with advanced CLDN18.2-positive solid tumors whose disease has not responded to standard treatment. Phase 1 will assess safety and tolerability and determine the recommended dose for Phase 2. Phase 2 will evaluate antitumor activity in patients with CLDN18.2-expressing solid tumors, including gastric, gastroesophageal junction, and pancreatic cancers.
LCB02A is a candidate developed using LigaChem Biosciences' ADC platform, ConjuAll. The candidate uses site-specific conjugation to link an anti-CLDN18.2 antibody with exatecan, a cytotoxic drug. Exatecan is a topoisomerase 1 (Topo1) inhibitor payload. In addition to the microtubule inhibitors and PBD-class payloads it has used previously, the company has expanded the range of payload types it applies.
LigaChem Biosciences plans to present two posters featuring preclinical research results for LCB02A and the clinical trial design at the European Society for Medical Oncology (ESMO) annual congress, which will be held in Madrid, Spain, from October 23 to 27.
CLDN18.2 is a protein expressed in cancers including gastric and pancreatic cancer, and the development of targeted therapies is active. The only currently approved CLDN18.2-targeted therapy is Astellas' monoclonal antibody Vyloy (generic name: zolbetuximab); no CLDN18.2-targeted ADC has been approved to date.
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Park Sejin, CEO of LigaChem Biosciences, said, "The first patient dose of LCB02A is significant because it marks the entry into clinical development of our payload diversification strategy, which combines the ConjuAll platform with a Topo1 inhibitor payload. We will advance the trial swiftly and demonstrate LCB02A's competitiveness with data."
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