On June 14, 2024, Evopoint Biosciences Co., Ltd. (here in after referred to as Evopoint or "the company") reported that XNW27, a new-generationAntibody-Coupled Drug (ADC) developed by the company, has been granted FastTrack Designation (FTD) status by the FDA for the treatment of gastric cancer (Press release, Evopoint Biosciences, JUN 14, 2024, View Source [SID1234656285]). This designation will provide fast-track approvals for XNW’s global developmentand signifies the FDA’s recognition of the product’s excellent efficacy inpreclinical trials.
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Fast Track Designation (FTD) is one of the FDA’s accelerated drug review processes designed to facilitatethe development and expedite the review process of drugs for serious diseases tobetter fulfill medical needs. By obtaining FTD for a drug, a company developinga new drug will have more opportunities to communicate with the FDA during thesubsequent development and review process. In addition, the company can submitrolling submissions to the FDA when submitting New Drug Application/BiologicsLicense Application (NDA/BLA). These prioritized policies provide a strongguarantee to accelerate the development of new drugs.
About XNW27
XNW27 is a new-generation Antibody-Coupled Drug (ADC) targeting Claudin 18.2. It hasshown promising anti-tumor efficacies in preclinical and clinical trials, andmay offer a new therapeutic modality for patients with Claudin 18.2-expressingsolid tumors. In several solid tumor indications (including gastric cancer andpancreatic cancer, etc.), the study demonstrated good anti-tumor activity inboth low and high Claudin18.2-expressing pharmacological models and patients,with a favorable and manageable safety profile overall.
About Claudin18.2
Claudin18.2is a family of integrin membrane proteins found in epithelial and endothelialtight junctions, discovered by Shorichiro Tsukita et al. in 1998. There are 27members of this family with four transmembrane structural domains that areinvolved in the regulation of paracellular permeability and conductance. The expression profiles of different Claudin proteins in normal tissues vary. Claudin18 gene has two protein iso forms, Claudin18.1 and Claudin18.2. Claudin 18.1 isexpressed only in normal lungs, while Claudin18.2 is specifically expressed indifferentiated gastric mucosal epithelial cells. However, Claudin18.2 isabnormally expressed in many cancer abnormalities, including gastric cancer,pancreatic ductal adenocarcinoma, esophageal cancer, ovarian cancer, lungcancer, colon cancer, and biliary tract cancer, with its expression ratereaches over 50% in gastric cancer and pancreatic cancer. This feature makesClaudin18.2 an ideal target for the immunotherapy of solid tumors.