Kolon Life Science said Monday that it delivered an oral presentation at the annual meeting of the American Society of Gene & Cell Therapy (ASGCT) on preclinical findings for KLS-3021, an investigational anticancer gene therapy candidate targeting triple-negative breast cancer (TNBC).
ASGCT is regarded as one of the leading international conferences in cell and gene therapy, and oral presentation opportunities are typically reserved for studies recognized for their scientific significance and differentiation. This year’s meeting was held in Boston from last Monday to Friday (local time).
Kolon Life Science headquarters in Seoul (Courtesy of Kolon Life Science)
The presentation, titled “KLS-3021: A Next-Generation Oncolytic Vaccinia Virus Inducing Cancer-Specific Long-Term Immune Memory Through Tumor Microenvironment Remodeling in Triple-Negative Breast Cancer,” highlighted the candidate’s ability not only to lyse tumor cells in TNBC models, but also to reprogram the immunosuppressive tumor microenvironment (TME) into a setting favorable for antitumor immunity while inducing durable immune memory.
TNBC is considered one of the most difficult-to-treat forms of breast cancer due to limited targeted treatment options and high risks of recurrence and metastasis. Low immunogenicity and an immunosuppressive TME have also been cited as major reasons for the limited efficacy of existing immunotherapies in these patients.
KLS-3021 is a next-generation anticancer gene therapy based on a recombinant vaccinia virus platform. Engineered to express PH20, IL-12 and sPD1-Fc, the therapy is designed to simultaneously induce direct tumor cell killing, remodel the TME by degrading extracellular matrix (ECM) barriers, and activate antitumor immune responses. The company emphasized that the candidate is differentiated by its ability to overcome both physical tumor barriers and immune suppression in addition to tumor lysis.
Researchers evaluated the anticancer efficacy and immunological changes induced by KLS-3021 in an orthotopic TNBC model designed to better replicate the in vivo tumor environment.
Following a single intratumoral administration after tumors reached a certain size, KLS-3021 demonstrated dose-dependent tumor growth inhibition, with complete remission (CR) observed in the high-dose group. Analysis of tumor tissue within five days of treatment showed reduced levels of hyaluronic acid, a major ECM component, suggesting effective disruption of the tumor’s physical barrier.
Immune cell analysis within the TME further showed increased macrophage infiltration and activation of antitumor immune response markers, while immunosuppressive macrophages decreased. Based on these findings, the researchers concluded that KLS-3021 successfully remodeled the immunosuppressive TME into a more conducive environment for antitumor immunity.
Particularly notable was the formation of long-term antitumor immune memory. When the same cancer cells were reintroduced into mice that had achieved CR, tumor formation was significantly suppressed compared with treatment-naïve controls. Splenocyte analysis also revealed robust systemic antitumor immune responses, along with meaningful increases in central memory and effector memory CD8⁺ T-cell populations.
The research team said the findings suggest that KLS-3021 could offer a new therapeutic strategy to overcome the high recurrence and metastasis risks associated with TNBC by remodeling the immunosuppressive TME and inducing durable immune memory.
Kolon Life Science is also continuing research on KLS-3021 across multiple solid tumors, including prostate cancer, cutaneous squamous cell carcinoma (cSCC), and head and neck squamous cell carcinoma (HNSCC). Following the ASGCT presentation, the company plans to further strengthen global R&D partnerships and commercialization discussions.
“This presentation is particularly meaningful because it demonstrated that KLS-3021 has the potential not only to suppress tumors in triple-negative breast cancer, but also to remodel the tumor microenvironment and induce long-term immune memory,” Kolon Life Science CEO Lee Han-guk said. “Based on the validated preclinical data, we will continue to refine our development strategy for KLS-3021 as a next-generation immuno-oncology platform targeting solid tumors and focus our capabilities on translating this into global business achievements.”
Kim Ji-hye
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