China’s Center for Drug Evaluation (CDE) has accepted a clinical trial filing for IMC002, an in-house developed CLDN18.2-targeted chimeric antigen receptor (CAR)-T therapy by Suzhou Immunofoco. This marks a significant milestone for the Chinese firm, which aims to develop the drug for treating advanced digestive system tumors with CLDN18.2 expression, including advanced gastric cancer/adenocarcinoma of the esophagogastric junction (AEG) and advanced pancreatic cancer.
IMC002: Mechanism and Development
IMC002 is an autologous CAR-T cell therapy targeting CLDN18.2, based on a highly specific VHH antibody. Preclinical and investigator-initiated trial (IIT) studies have demonstrated good safety and effectiveness for IMC002. The highly specific VHH antibody endows the therapy with better tolerability and potentially a larger clinical dose window and indication range. This positions IMC002 as a promising candidate for addressing significant unmet needs in oncology.
Company Background and Pipeline
Founded in 2020, Immunofoco is also developing IMC001, an EpCAM-targeted autologous CAR-T cell therapy currently in Phase I. The company’s focus on innovative CAR-T therapies underscores its commitment to advancing treatments for advanced cancers with limited therapeutic options.
Future Outlook
With CDE acceptance for clinical trials, Immunofoco is poised to further explore the therapeutic potential of IMC002 in patients with advanced digestive system tumors. This development highlights the company’s progress in bringing next-generation CAR-T therapies closer to clinical application.-Fineline Info & Tech
