Kolon Life Science has secured a Singapore patent for its osteoarthritis cell and gene therapy "TG-C," expanding its business foundation across Asia. The company's strategy is to strengthen its production base in preparation for the commercialization of TG-C.
Kolon Life Science said Thursday that a patent for a "pharmaceutical composition for the prevention or treatment of osteoarthritis," related to TG-C being developed by affiliate Kolon TissueGene, has been approved for registration in Singapore. Kolon Life Science is responsible for the development and commercialization of TG-C in the Asian region. The patent was previously registered in the United States, Korea, Japan and Australia, and has also been filed in China and Canada.
TG-C is an osteoarthritis cell and gene therapy injected into the knee joint cavity. It is administered by mixing a first solution composed of allogeneic cartilage-derived chondrocytes with a second solution made of irradiated transformed cells carrying the TGF-β1 gene, in a 3-to-1 ratio.
This patent relates to a composition and manufacturing method for stably securing cells of a certain size during the TG-C production process. It includes technology that manages cell size uniformly by utilizing a cell filtration mesh of a specific pore size when removing aggregates that form during the cell culture process or separating cells into a single-cell state.
With the patent registration decision, Kolon Life Science has secured rights in Singapore to the composition and manufacturing method for obtaining the two types of cells used in TG-C within a certain size range and utilizing them as an intra-articular injection. The company expects this to strengthen the quality control foundation of its manufacturing process. The company also expects the patent acquisition to serve as a foundation for future global commercialization, as Singapore is considered a major hub for Asia's bio and healthcare industry.
The company is also preparing for production in anticipation of commercialization. Through its subsidiary Kolon Biotech, Kolon Life Science is building advanced process facilities meeting current good manufacturing practice (cGMP) standards and upgrading automated processes to secure mass-production capabilities for cell and gene therapies.
"This patent registration shows that our core technological competitiveness in stably securing cells within a certain size range and maintaining product uniformity during the TG-C manufacturing process is being recognized overseas as well," Kolon Life Science CEO Lee Han-kook said. "We will strive to enhance the global commercialization and technological competitiveness of TG-C."
Meanwhile, Kolon TissueGene plans to announce the topline results of TG-C's U.S. Phase 3 clinical trial in July. It will then begin preparations to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA), targeting submission in the first quarter of next year.
