Claudin 18.2 for solid tumors

At present, four main types of Claudin 18.2 targeted therapies have been approved for clinical trials – monoclonal antibodies, CAR-T cell therapy, bispecific antibodies and ADCs. Among these, anti-CLDN18.2 monoclonal antibody therapy represents the most widely adopted therapeutic approach using Claudin 18.2. One of the challenges in the development of a targeted monoclonal antibody is to design an antibody that differentiates between the isoforms by specifically recognizing Claudin 18.2 but not Claudin 18.1. This is difficult to do because the only difference between these two splice variants is a change of 7-8 amino acids in the first extracellular loop [12]. Having a high-quality Claudin 18.2 antigen can help pharmaceutical companies achieve breakthrough using this target.

IMAB362 (also known as Zolbetuximab and Claudiximab) developed by Ganymed Pharmaceuticals AG, is a Claudin 18.2 antibody drug that has entered Phase III of clinical trial. It is a novel chimeric IgG1 antibody highly specific to Claudin 18.2. It binds to Claudin 18.2 on the tumor cell surface and stimulates cellular and soluble immune effectors that activate antibody-dependent cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) [11].

CAR-T cells can also recognize Claudin 18.2 expressed on tumor cells, and directly attack these tumor cells. In May of 2020, the world’s first CAR-T therapy targeting Claudin 18.2 CT-041 got FDA’s IND clearance. Results from phase I clinical trial published in 2019 show a total objective response rate of 33% [13].

In June of 2020, the world’s first Claudin18.2/PD-L1 bispecific antibody preclinical data was published on AACR. In July of 2020, Amgen received the first approval of CD3/Claudin 18.2 bispecific antibody AMG 910 to enter clinical stage.


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