Immunofoco, has achieved a significant milestone with the approval of Investigational New Drug (IND) applications by both the U.S. Food and Drug Administration (FDA) and the China Center for Drug Evaluation (CDE) for IMC001, an autologous CAR-T cell therapy targeting EpCAM. This groundbreaking approval marks a pivotal moment in the treatment landscape for advanced solid tumors, particularly gastrointestinal malignancies. In August 2023, the product was granted Orphan Drug Designation (ODD) by the U.S. FDA.
EpCAM, a biomarker abundantly expressed in circulating tumor cells (CTCs) of gastrointestinal tumors, presents a promising therapeutic target due to its low expression in normal tissues. IMC001, the first CAR-T product targeting EpCAM, employs a novel approach akin to treating solid tumors as hematologic malignancies. This strategy holds immense potential for expanding treatment options in gastrointestinal cancers, including advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ).
The clinical efficacy and safety of IMC001 were initially demonstrated in Investigator-Initiated Trials (IIT), showcasing promising results in advanced gastric cancer patients. Notably, a recommended safe and effective dose was identified, with an overall response rate (ORR) of 40%, including partial remissions (PR) observed in two out of five patients. One PR patient underwent successful radical surgery for gastric cancer post-treatment, demonstrating the potential for durable responses with IMC001 therapy.
