Stable Isotope Labeled Zolbetuximab Biosimilar – Anti-CLDN18.2 mAb – Research Grade

Description of Zolbetuximab Biosimilar - Anti-CLDN18.2 mAb - Research Grade

General information about Zolbetuximab

Zolbetiximab is a monoclonal antibody currently under investigation as a potential treatment for pancreatic tumors and gastrointestinal adenocarcinomas. This therapeutic antibody targets isoform 2 of Claudin-18. Claudin-18 protein is encoded by CLDN18 gene and is a member of claudin family of proteins. The members of this family of proteins are key components in the structure of tight junctions also known as zonulae occludentes. Tight junctions form the paracellular space which is the intercellular space between epithelial cells. Claudin family of proteins contain four transmembrane domain whose C-terminus and N-terminus are both located in the cytoplasm. The isoform 2 of CLDN18 protein is restricted to differentiated epithelial cells located at the gastric mucosa tight junctions. However, once malignant transformation occurs, the cell polarity is disturbed and results in isoform 2 CLD18 epitopes being exposed on the surface of cancer cells. Hence, isoform 2 of CLDN18 has been considered as a potential candidate for in targeted therapy for different forms of cancer such as esophagus, pancreatic, ovarian and lung tumors.
Zolbetiximab binds to isoform 2 CLDN18 which results in immune-mediated lysis of this protein. The attachment of Zolbetiximab to isoform 2 CLDN18 causes cancer cell death as a result. Zolbetiximab was in phase II clinical trials as of January 2013. Preliminary results based on phase II ‘FAST’ trial supported zolbetiximab as a potential drug for advanced gastric cancer. Currently zolbetiximab is in phase III of clinical trials. So far zolbetuximab therapy has been well tolerated, Furthermore, the monoclonal antibody showed antitumor activity among patient with isoform 2 CLDN18-positive advanced gastric or gastroesophageal junction cancers. The phase III study consists of administering Zolbetiximab plus mFOLFOX6 vs placebo plus mFOLFOX6. mFOLFOX6 is a combination of three different chemotherapies such as Oxaliplatin, Leucovorin, and Fluorouracil which are also a current treatment option for patients with advanced gastric or gastroesophageal junction adenocarcinoma or cancer. This product is for research use only.