Cenyx Biotech is pioneering the development of nanozymes, biocompatible nanocatalysts with enzyme-like activity, to address inflammation in a range of acute and chronic conditions. These nanozymes target reactive oxygen species (ROS), which drive oxidative stress and perpetuate tissue damage in diseases such as cardiovascular, neurodegenerative, gastrointestinal, respiratory, and autoimmune disorders. The company's lead candidates, CX213 and CX301, are based on its intravenously administered nanozyme-P platform and are in development for acute conditions that currently lack emergency rescue medications.
Innovative Nanozyme Technology
Cenyx Biotech's cerium oxide-based nanozymes feature a multi-functional nanoparticle core with a biocompatible polymer surface, created using the company’s INNOSURFACE technology. This design allows the nanozymes to target all types of ROS simultaneously and continue functioning until naturally eliminated from the body. According to Seung-Hoon Lee, founder and CEO of Cenyx Biotech, these nanozymes have the potential to be the first cerium oxide-based nanoparticles to enter clinical trials, possibly as early as 2025.
"Our nanozymes' ability to target ROS again and again, and to reach all the sites in the body where oxidative damage occurs, including the brain, makes them different from the other antioxidants on the market," said Lee. The company has patent applications submitted or registered in several countries and has capacity in place for scale-up manufacturing.
Clinical Pipeline and Preclinical Results
Cenyx Biotech has three pipelines of nanozymes with different routes of administration. Topical nanozyme-D is in preclinical efficacy studies, with animal models of dermatitis showing improvement after application. In-vivo studies of oral nanozyme-E in ulcerative colitis and Crohn’s disease have shown reduced bodyweight reduction and significantly improved disease severity.
CX213 is being developed for subarachnoid hemorrhage (SAH)-induced inflammation and acute hepatic failure. Preclinical efficacy studies indicate that CX213 penetrates the brain, inhibits inflammation, protects cells, significantly improves survival, and is fully excreted. CX301 is in development for the emergency treatment of reperfusion-failed stroke and shows efficacy in animal models of acute respiratory distress syndrome (ARDS) and trauma-induced organ injuries.
"Preclinical studies for CX213 have been completed, and it is on the verge of entering the clinical stage. For CX301, we plan to complete preclinical studies by the end of 2024 and submit the investigational new drug [application] in 2025," Lee stated.
Future Directions
The nanozyme-C pipeline consists of non-cerium oxide-based nanozymes at the discovery stage, with potential in multiple sclerosis, neuromyelitis optica spectrum disorder (NMOSD), and autoimmune encephalitis. Founded in 2016, Cenyx Biotech has received support from the South Korean government and the Korea Drug Development Fund.
"We have seen significant interest from venture capitalists and global pharma for our nanozymes... We are looking for partners to work with us to help us meet the needs of patients around the world, and we strongly believe that there is a lot of market potential here for us and for our future collaborators," Lee concluded.
