Kolon Life Science Registers Canadian Patent for KLS-3021 Production Technology

Mass Production Technology Enhancing Manufacturing Efficiency

Kolon Life Science announced on June 10 that its production technology patent for the anti-cancer gene therapy candidate KLS-3021 has been granted in Canada. This follows the initial registration in Japan at the end of last year, marking an additional secured right.

Kolon Life Science Headquarters. Kolon Life Science

This patent relates to the "method for large-scale production of vaccinia virus using suspension cells." The process involves culturing HeLa S3 cells in suspension at a specific density, infecting them with the virus at a low multiplicity of infection (MOI 0.01–0.1) to allow for viral amplification, and then harvesting the virus from the cells.

This process is regarded as a core technology for commercial-scale production of vaccinia virus for anti-cancer purposes. Suspension cells do not require a culture surface, making it easier to scale up the culture volume and simplifying the process overall. As a result, they are considered better suited for mass production and the introduction of automated processes than adherent cells. According to the company, a low MOI allows the virus to spread and amplify stepwise, meaning high yields can be achieved with a small initial inoculum.

Kolon Life Science explained that the patent decision in Canada confirms the uniqueness and completeness of the KLS-3021 production platform. The company also noted that this is significant for expanding its commercialization base in North America. Kolon Life Science has already applied for patents in major countries such as Korea, the United States, Europe, and China, and expects to further strengthen its global production rights network.

KLS-3021 is a next-generation oncolytic virus therapy candidate under development, targeting the treatment of solid tumors. Kolon Life Science has constructed a platform by loading three therapeutic genes—PH-20, sPD1-Fc, and IL-12—into a vaccinia virus engineered for enhanced cancer cell selectivity. The platform is designed to simultaneously improve intratumoral penetration, direct cancer cell killing, and anti-tumor immune activation.

PH-20 breaks down hyaluronan, a main extracellular matrix (ECM) component of tumors, thereby facilitating the penetration of both the virus and immune cells into the tumor. sPD1-Fc blocks the PD-L1/2 pathway to inhibit immune evasion by cancer cells, while IL-12 activates anti-cancer immune cells such as T cells and NK cells, enhancing tumor control capability.

KLS-3021 has recently attracted attention by demonstrating significant preclinical results in various cancer types. In a prostate cancer orthotopic transplant model, a single administration led to a significant reduction in tumor size. In human cutaneous squamous cell carcinoma (cSCC) cell lines, the candidate showed selective cytotoxicity toward tumor cells and tumor-killing ability via viral replication, compared to normal human epidermal keratinocytes.

In a recent preclinical study on head and neck squamous cell carcinoma (HNSCC) presented at AACR 2026, anti-tumor effects were observed regardless of PD-L1 expression levels. The company believes this supports the potential for KLS-3021 to be applied to a broader range of cancer types.

Kolon Life Science CEO Lee Hanguk stated, "The granting of this Canadian patent demonstrates that the scope of rights for KLS-3021 is being reliably expanded from therapeutic technology to production processes. We will continue to strengthen our competitiveness by securing rights in key countries going forward."

This content was produced with the assistance of AI translation services.