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IMC002 (also referred to as claudin 18.2 CAR-T) is an autologous, second-generation chimeric antigen receptor T-cell (CAR-T) therapy developed by Suzhou Immunofoco Biotechnology. It is designed to target Claudin 18.2 (CLDN18.2), a tight junction protein that is selectively overexpressed in various gastrointestinal and solid tumors. IMC002 is uniquely constructed using a VHH (nanobody/single-domain antibody)-based anti-CLDN18.2 binding domain, which confers high specificity for tumor cells. The therapy is currently being evaluated in Phase 1/IIa clinical trials for advanced solid tumors, including gastric cancer, gastroesophageal junction (GEJ) adenocarcinoma, pancreatic cancer, and ovarian carcinoma. IMC002 has demonstrated a promising safety profile and encouraging anti-tumor activity, including pathological complete responses (pCR) and sustained CAR-T expansion within tumor tissues. It has received several U.S. FDA designations, including Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations.
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