- Catholic University–SML Biopharm prove efficacy of Korea’s first personalized mRNA cancer vaccine for colorectal cancer  

- Research results published in *Advanced Science (IF=14.3)*  

Figure Description: Colorectal cancer was implanted into mice, and genes of the engrafted cancer-bearing mice were compared with those of normal mice to derive cancer-specific neoantigens (Neoantigen Selection). After analyzing the characteristics of the derived neoantigens (Epitope Evaluation), the team engineered them to be expressed through a proprietary mRNA platform (mRNA Cancer Vaccine Manufacturing), and confirmed anticancer efficacy in mice (Cancer Vaccine Assessment).  

Neoantigen: A unique protein fragment that appears only in cancer cells and serves as an immune “signpost” enabling immune cells to recognize and attack the cancer.  

A research team led by Professor Jae-Hwan Nam of the Department of Biomedical Sciences at the Catholic University of Korea, in collaboration with biotech company SML Biopharm, has successfully developed Korea’s first personalized mRNA cancer vaccine (PCV) and demonstrated strong anticancer efficacy in animal models. The results were published online in July 2025 in the internationally renowned journal *Advanced Science*.  

Globally, there is increasing interest in personalized cancer vaccines for cancer prevention and treatment. Since the COVID-19 pandemic, the safety and rapid manufacturing capabilities of mRNA vaccine technology have been validated, accelerating the development of “tailor-made therapeutic vaccines” designed according to each cancer patient’s tumor profile. BioNTech and Moderna are leading examples, conducting clinical trials in melanoma, lung cancer, and others, with some vaccines already showing significant results as adjuvant therapies to prevent post-surgical recurrence.  

Against this backdrop, Professor Nam’s team pioneered the development of a therapeutic vaccine in Korea based on individual cancer genomic information using an mRNA platform. In a colorectal cancer mouse model, next-generation sequencing (NGS) was used to identify neoantigens unique to cancer cells. These neoantigens were encoded into an mRNA vaccine, encapsulated in lipid nanoparticles (LNP), and injected. Results showed activation of tumor-specific immune cells (CD8+ T cells and CD4+ T cells), suppression of tumor growth, prevention of post-surgical recurrence, and the establishment of long-term immune memory.  

A particularly notable finding was that neoantigens processed through the MHC-II pathway elicited a stronger anticancer immune response than those through the traditionally studied MHC-I pathway. Moreover, simultaneous administration of neoantigens from both pathways produced a synergistic effect, further enhancing anticancer efficacy. The team also confirmed that combining the vaccine with immune checkpoint inhibitors (such as PD-1 and Tim-3) significantly boosted effectiveness. Additional experiments demonstrated reduced recurrence rates following surgery and validated preventive potential as a prophylactic cancer vaccine in animal models.  

The study was supported by projects from the Ministry of Food and Drug Safety: “Development of Toxicity Evaluation Technology for mRNA Vaccines” and “Establishment of Safety Evaluation Platforms for mRNA-based Neoantigen Cancer Vaccines and International Collaboration.” Doctoral student Sung-Je Cho (Catholic University) served as first author, with Professors Hyun-Ho Yoon and Woo-Ri Kwak (Catholic University), Kwon-Il Kim (Kyung Hee University), Ki-Tae Kim (Seoul National University), Jun Jang (Ewha Womans University), and researchers at SML Biopharm as co-investigators.  

Professor Nam stated: “This research marks Korea’s first case of directly producing and verifying the anticancer efficacy of an mRNA-based personalized cancer vaccine. The fact that the vaccine can induce immune cells to directly attack cancer cells while preserving long-term memory provides an important clue for preventing cancer recurrence and managing chronic cancers.”