Kolon Life Science Receives Patent Grant Decisions for KLS-3021 Mass Production Technology in Korea, the U.S., and Australia

▷ Secures patent grant decisions in key markets for a suspension cell culture-based process for large-scale vaccinia virus production
▷ Establishes a manufacturing technology foundation for commercial-scale virus production

Kolon Life Science announced on October 27 that it has received successive decisions to grant patents in Korea, the United States, and Australia for a core manufacturing technology used in KLS-3021, its investigational cancer gene therapy. Building on these decisions, the company plans to accelerate the global commercialization of KLS-3021 and strengthen its manufacturing capabilities in Korea.

The patent covers a “method for mass production of vaccinia virus using suspension cells.” The process involves infecting HeLa S3 cells grown in suspension with vaccinia virus at a low multiplicity of infection (MOI) of 0.01–0.1, then harvesting the virus amplified within the cells.

The process is considered a key technology for producing oncolytic vaccinia virus at a commercial scale. Suspension cells are well suited to large-scale culture because they are less constrained by available culture surface area. Low-MOI conditions also offer advantages for productivity. A small amount of virus initially infects a subset of cells, after which the virus replicates within those cells and spreads to neighboring cells. Repeated cycles of this process enable efficient viral amplification.

The decisions are particularly significant as they were issued in Korea, the company’s research and manufacturing base; the United States, the world’s largest pharmaceutical market; and Australia, a key market in the Asia-Pacific region. Following patents in Japan, China, and Canada, the latest decisions expand the geographical scope of protection and strengthen the company’s global patent portfolio for large-scale vaccinia virus production technology. Kolon Life Science plans to continue expanding global patent protection for both the therapeutic technologies and manufacturing processes associated with KLS-3021.

KLS-3021 is a next-generation oncolytic virus-based cancer gene therapy candidate being developed by Kolon Life Science for the treatment of solid tumors. It uses a recombinant vaccinia virus engineered for enhanced cancer cell selectivity and carrying therapeutic genes, including PH-20, IL-12, and sPD1-Fc. It is designed to simultaneously promote viral spread within tumors, cancer cell death, and the activation of antitumor immunity.

Han-gook Lee, CEO of Kolon Life Science, stated, “These patent grant decisions are meaningful because they establish a foundation for protecting, in key markets, the manufacturing technology that will support the successful commercialization of KLS-3021.” He added, “We will continue to strengthen our patent portfolio across both therapeutic technologies and manufacturing processes to build a solid foundation for the global commercialization of KLS-3021 and further enhance its competitiveness.”