Kolon Life Science announced that it will present the preclinical research results of its next-generation anticancer gene therapy candidate, KLS-3021, for prostate cancer in a poster session at the 2025 European Society for Medical Oncology (ESMO) conference, which will be held in Berlin, Germany, from October 17 to 21, 2025 (local time). This marks the first time that research results on KLS-3021 for prostate cancer will be released.
Exterior view of Kolon Life Science headquarters in Magok-dong, Gangseo-gu, Seoul. Kolon Life Science
Recently, due to aging populations and changes in lifestyle, the incidence and prevalence of prostate cancer have been steadily increasing worldwide. For prostate cancer, the mainstream approach is to closely monitor the patient's condition without local treatments such as surgery or radiation, or systemic therapies such as hormone or chemotherapy, depending on the patient's circumstances and the biological activity of the cancer cells (Gleason score).
However, in some patients, the disease progresses to an incurable stage during the observation period, and there are currently no biological markers to predict this progression. Therefore, there is a growing need to develop new therapies to address these unmet medical needs.
KLS-3021 is a next-generation gene therapy that uses a recombinant vaccinia virus with enhanced cancer cell selectivity, loaded with therapeutic genes (PH-20, IL-12, and sPD1-Fc). Its key feature is a significantly enhanced anticancer effect, achieved by combining the virus's direct cytotoxicity with cancer control through immune cell activation.
In this anticancer efficacy evaluation using an orthotopic prostate cancer tumor model, a single administration of KLS-3021 resulted in a significant reduction in tumor size, and it showed superior anticancer effects compared to the control anticancer drug docetaxel. In a metastatic tumor model, the treatment effect extended not only to the primary tumor but also to adjacent lymph nodes, suggesting the potential for future development as a therapy for metastatic cancer.
Additionally, tissue analysis revealed that, after administration of KLS-3021, the virus was widely distributed within the tumor, and the extracellular matrix (ECM)-the dense structure surrounding the cancer tissue-was disrupted. Immune response analysis also confirmed a strong shift in the immune system toward cancer suppression, with increased activity of immune cells that attack cancer and a decrease in immune cells that promote cancer growth.
Kim Sunjin, CEO of Kolon Life Science, stated, "Through these research results, KLS-3021 has demonstrated new possibilities even in the field of prostate cancer, where existing treatment options are limited," adding, "With this ESMO presentation as a starting point, we will continue active discussions with global researchers and accelerate clinical development."
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