Kolon Life Science Wins KLS-3021 Patent Approvals

Kolon Life Science has secured official patent approvals in key countries for its core manufacturing process technology, aimed at commercializing the oncolytic vaccinia virus-based gene therapy KLS-3021. The company announced on October 27 that it received patent registrations consecutively in Korea, the United States, and Australia.

The central patent involves a method for mass-producing vaccinia virus using suspension cells. This method entails infecting HeLa S3 cells cultured in suspension with the virus at a low multiplicity of infection (MOI) of 0.01 to 0.1. Afterward, the process recovers the proliferated virus. Suspension cells are advantageous for large-scale culture due to their ability to overcome space constraints and maximize productivity through repeated proliferation of cells even with a small amount of virus.

The strategic importance of these registrations is heightened by the inclusion of the United States, the world's largest pharmaceutical market, and Australia, a significant hub in the Asia-Pacific region. Kolon Life Science has already obtained patents in Japan, China, and Canada. KLS-3021 is an oncolytic virus-based therapy under development for treating solid tumors.

It integrates therapeutic genes like PH-20, IL-12, and sPD1-Fc into a recombinant vaccinia virus that enhances cancer cell selectivity. This approach aims to stimulate viral spread within tumors, induce cancer cell death, and activate anticancer immunity. Kolon Life Science's CEO, Lee Han-guk, emphasized that this decision lays the groundwork for securing the production technology necessary for the successful commercialization of KLS-3021 in major markets.