Kolon Life Science wins Japan patent for mass production of cancer gene therapy KLS-3021

Kolon Life Science has secured a new manufacturing-technology patent in Japan for its anticancer gene-therapy candidate KLS-3021, a move the company says strengthens its position in global development and future commercialization.

Kolon Life Science headquarters in Seoul (Courtesy of Kolon Life Science)

The company said Tuesday that the patent, which covers a method for large-scale production of vaccinia virus using suspension cells, was approved for registration by Japanese authorities. The newly granted patent is separate from earlier intellectual property obtained during the development of KLS-3021, and Kolon Life Science expects similar approvals to follow in other major markets.

KLS-3021 is a next-generation oncolytic virus therapy being developed to treat solid tumors. The drug candidate uses a vaccinia virus that has been engineered to selectively target cancer cells. Kolon Life Science has designed the platform to carry three therapeutic genes -- PH-20, sPD1-Fc, and IL-12 -- each playing a different role in fighting tumors.

PH-20 helps break down hyaluronic acid, a key structural component of tumors, allowing the virus and immune cells to penetrate the tumor more easily. sPD1-Fc blocks immune checkpoint pathways used by cancer cells to escape immune attack. IL-12 boosts the activity of immune cells such as T cells and natural killer cells. Together, the genes are designed to improve direct tumor killing while also activating the body’s immune response against cancer.

The newly approved patent focuses on how the virus is produced. Instead of using cells that grow attached to surfaces, the process relies on suspension cells, which float freely in culture. HeLa S3 cells are grown to a certain density and then infected with the virus at a low infection rate before the virus is collected. According to the company, this method offers higher efficiency, better scalability, and easier automation compared with traditional approaches.

Kolon Life Science said the technology is critical for producing vaccinia-virus therapies at a commercial scale. Patent applications for the same technology have been filed in Korea, the United States, Europe, and China.

Kim Sun-jin, CEO of Kolon Life Science, said the approval is an important milestone. “This decision officially recognizes our production technology for KLS-3021,” he said. “We expect more patent approvals in other countries and will speed up technology transfer talks to stay competitive in global cancer gene-therapy development.”

KLS-3021 has recently drawn attention at international scientific meetings after showing strong preclinical results in several cancer models, including prostate cancer and skin squamous cell carcinoma.