Kolon Life Science stated on the 23rd that it plans to add indications for its new drug candidates KLS-3021 and KLS-2031 and strengthen the foundation for global commercialization.

The company plans to share preclinical study results obtained from the newly expanded indications through journal publications and conference presentations, and actively use them in discussions on joint development and technology transfer with global pharmaceutical companies.

KLS-3021 is a next-generation anticancer gene therapy candidate that loads therapeutic genes (PH-20, IL-12, sPD1-Fc) onto a recombinant vaccinia virus with enhanced cancer cell selectivity. In addition to the virus’s direct oncolytic mechanism, it is characterized by being designed to degrade the tumor stroma to facilitate immune cell penetration into cancer tissue and to induce an anticancer immune response.

Kolon Life Science is recently expanding the indications of KLS-3021 to head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer (TNBC). These two cancer types are high-risk cancers with poor prognosis at advanced or recurrent stages and limited treatment options, and they also show low response rates to existing immuno-oncology therapies, making them areas where new therapeutic approaches are required. The company is conducting related preclinical studies and is aiming to publish a paper on HNSCC in the first half of the year. It also plans to submit the TNBC study results within the year.

Previously, the company disclosed the preclinical study results of KLS-3021 in prostate cancer and cutaneous squamous cell carcinoma (cSCC) through journal publications and conference poster presentations. In these studies, KLS-3021 significantly reduced tumor volume with a single administration and reportedly demonstrated therapeutic effects not only on primary tumors but also on metastatic lesions in adjacent lymph nodes in metastatic tumor models.

Another pipeline, KLS-2031, is a recombinant adeno-associated virus (rAAV)-based gene therapy candidate designed to express the GAD65, GDNF, and IL-10 genes, which are involved in suppressing neuroinflammation and modulating hyperexcited pain signaling pathways. The company is continuing to publish preclinical study results related to painful diabetic peripheral neuropathy (PDPN) in academic journals while also pursuing additional indication expansions.

Kolon Life Science plans to refine its development strategy based on objective validation through indication expansion studies and journal publications, and to broaden discussions with global partners. Kim Sun-jin, CEO of Kolon Life Science, said, “We are continuously confirming the potential for indication expansion of our candidates and publishing the findings to enhance data reliability,” adding, “Based on the accumulated evidence, we will expand discussions on global joint development and technology exports.”

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