FDA Grants Fast-Track Designation Status for Evopoint New-Generation ADC Drug XNW27011
On June 14, 2024, Evopoint Biosciences Co., Ltd. (here in after referred to as Evopoint or “the company”) announced that XNW27011, a new-generation Antibody-Coupled Drug (ADC) developed by the company, has been granted Fast Track Designation (FTD) status by the FDA for the treatment of gastric cancer. This designation will provide fast-track approvals for Evopoint's global developmentand signifies the FDA's recognition of the product's excellent efficacy inpreclinical trials.
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 developing a new drug will have more opportunities to communicate with the FDA during the subsequent 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 XNW27011
XNW27011 is a new-generation Antibody-Coupled Drug (ADC) targeting Claudin 18.2. It has shown 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
Claudin18.2 is a family of integrin membrane proteins found in epithelial and endo the lialtight junctions, discovered by Shorichiro Tsukita et al. in 1998. There are 27 members of this family with four transmembrane structural domains that are involved 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 is expressed only in normal lungs, while Claudin18.2 is specifically expressed in different iated gastric mucosal epithelial cells. However, Claudin18.2 is abnormally 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 makes Claudin18.2 an ideal target for the immunotherapy of solid tumors.
About Evopoint
Founded in 2017, Evopoint is a platform-based innovative drug company with both scientific researching strengths and commercialization capabilities. Based onits three major technology platforms of independent innovation in targetedtherapy, anti-infection and TPD, Evopoint has formed a pipeline ofinnovative drugs such as BLI inhibitors, EZH2 inhibitors, hURAT1 inhibitors,and new-generation ADCs, covering disease areas such as oncology, anti-infection and metabolism. Currently, the company has several products inthe clinical development stage. Relying on excellent product data and external licensing capabilities, Evopoint has entered into several external licensing collaborations with renowned companies at home and abroad, with a total amountof billions of dollars. Since its inception, Evopoint has always taken the responsibility of benefiting human health and is committed to providinghigh-quality solutions to major unmet clinical needs worldwide.
