FDA Grants Fast-Track Designation Status for Evopoint New-Generation ADC Drug XNW27011
On
June 14, 2024, Suzhou Evopoint Biosesciences Co., Ltd. (hereinafter
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 XNW's global development
and signifies the FDA's recognition of the product's excellent efficacy in
preclinical trials.
Fast
Track Designation (FTD) is one of the FDA's accelerated drug review processes designed to facilitate
the development and expedite the review process of drugs for serious diseases to
better 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 submit
rolling submissions to the FDA when submitting New Drug Application/Biologics
License Application (NDA/BLA). These prioritized policies provide a strong
guarantee 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, and
may offer a new therapeutic modality for patients with Claudin 18.2-expressing
solid tumors. In several solid tumor indications (including gastric cancer and
pancreatic cancer, etc.), the study demonstrated good anti-tumor activity in
both 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 endothelial
tight 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 isoforms, Claudin18.1 and Claudin18.2. Claudin 18.1 is
expressed only in normal lungs, while Claudin18.2 is specifically expressed in
differentiated gastric mucosal epithelial cells. However, Claudin18.2 is
abnormally expressed in many cancer abnormalities, including gastric cancer,
pancreatic ductal adenocarcinoma, esophageal cancer, ovarian cancer, lung
cancer, colon cancer, and biliary tract cancer, with its expression rate
reaches 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 on
its three major technology platforms of independent innovation in targeted
therapy, anti-infection and PROTAC, Evopoint has formed a pipeline of
innovative 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 in
the 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 amount
of billions of dollars. Since its inception, Evopoint has always taken the
responsibility of benefiting human health and is committed to providing
high-quality solutions to major unmet clinical needs worldwide.
