Kolon Life Science Secures Canadian Patent for Scalable Oncolytic Virus Manufacturing Process

Kolon Life Science announced on Wednesday that it has received a notice of allowance for a patent in Canada covering the manufacturing process of KLS-3021, its oncolytic virus candidate designed to treat solid tumors. This development strengthens the company’s intellectual property portfolio and improves its prospects for commercialization in the North American market.

The patent specifically protects a large-scale production method for vaccinia-virus-based therapies utilizing suspension-cultured HeLa S3 cells. This technology aims to enhance manufacturing efficiency and scalability, which are essential for the commercial production of oncolytic virus treatments.

This Canadian patent allowance expands Kolon Life Science’s global patent holdings, which already include granted patents in South Korea, the United States, Europe, and China.

According to Kolon Life Science, the patented manufacturing platform allows for efficient viral amplification starting from a small initial inoculum. It also supports automated, large-scale production processes. The use of suspension-cultured cells, which do not require attachment to surfaces, makes this method more suitable for industrial-scale manufacturing compared to traditional cell-culture techniques.

KLS-3021 is a next-generation oncolytic virus candidate developed on an engineered vaccinia virus platform. The therapy is designed to selectively target cancer cells and deliver three therapeutic genes—PH-20, sPD1-Fc, and IL-12—to improve tumor penetration, enhance immune responses, and increase anticancer activity.

Preclinical studies have shown promising results for KLS-3021 across multiple cancer types. In an orthotopic prostate cancer model, a single dose significantly reduced tumor size. Additionally, laboratory tests demonstrated selective toxicity toward cancer cells over normal cells in a human skin cancer model.

Lee Han-kuk, CEO of Kolon Life Science, emphasized the importance of the patent allowance, stating, "This patent allowance helps secure both the intellectual property and manufacturing capabilities needed for KLS-3021's future commercialization."

He added, "We will continue strengthening our global IP portfolio and expanding our presence in major markets."

This patent approval marks a critical step in Kolon Life Science’s efforts to bring innovative oncolytic virus therapies to market, leveraging advanced manufacturing technologies to meet commercial-scale demands.