#South Korea #Kolon TissueGene #TG-C #OARSI #Songdo

Kolon TissueGene Presents Long-Term Safety Data at OARSI World Congress

In April 2025, Kolon TissueGene made waves at the Osteoarthritis Research Society International (OARSI) World Congress, held in Songdo, South Korea, showcasing significant advancements regarding its investigational therapy, TG-C. This congress marked a historic event as it was the first time OARSI convened in Korea, providing a platform for Kolon to present groundbreaking data regarding the long-term safety and potential efficacy of TG-C, the world's pioneering cell and gene therapy aimed at osteoarthritis.

Significant Findings and Presentations

On April 25, the team at Kolon TissueGene delivered a compelling presentation titled, "TG-C, the First Potential DMOAD Intra-Articular Cell-Based Gene Therapy with Long-Term Safety and Insight into Delaying Total Knee Arthroplasty (TKA)." This presentation was underpinned by extensive long-term follow-up data. The analysis incorporated results from 33 subjects who participated in a U.S. Phase 2 trial along with 110 subjects from a Phase 3 trial, all of whom completed two years of follow-up.

The data analysis was performed in a blinded manner, ensuring that both the TG-C treatment and placebo groups were evaluated objectively. This methodological rigor provides a strong foundation for the results shared during the session.

Safety Profile

Over the course of nearly 15 years of observation in the United States, Kolon TissueGene reported no treatment-related tumor cases among subjects enrolled in the TG-C trials. Additionally, the incidence of cancer in TG-C subjects was lower when compared to the general U.S. population, according to data from the National Cancer Institute's SEER program. Such findings bolster the argument for TG-C's safety and may serve as a critical indicator of its viability in clinical applications.

Efficacy Indicators

Moving beyond safety, Kolon TissueGene also highlighted efficacy data that compared the rate and timing of knee replacement surgery among TG-C treated subjects versus the overarching osteoarthritis population. The data, originating from the Osteoarthritis Initiative (OAI)—a large-scale, longitudinal study—revealed that merely 7% of TG-C treated subjects underwent total knee arthroplasty, with the median time to surgery extending to 5.7 years post-osteoarthritis onset. In contrast, 15.5% of eligible patients from the larger cohort underwent surgery at a median duration of 5.1 years following their arthritis diagnosis.

These pivotal findings indicate that TG-C could potentially replace or at the very least, significantly postpone the necessity for surgical intervention. If further validated, these trends would distinguish TG-C as a disease-modifying osteoarthritis drug (DMOAD), a significant advancement in therapeutic options for osteoarthritis management.

Expert Insights and Future Directions

The co-CEO of Kolon TissueGene, Dr. Moon Jong Noh, emphasized the importance of the event, stating, "We are honored to share meaningful TG-C data at the first-ever OARSI congress held in Korea. This underscores our optimism for FDA approval and recognition of TG-C as the world's first DMOAD therapy." Meanwhile, co-CEO Seng Ho Jeon reflected on their strategic approach, noting: "The scientific data presented strongly supports TG-C's safety and efficacy, making it a potential global blockbuster treatment."

As TG-C continues its trajectory toward regulatory approval, Kolon TissueGene's approach reflects a dual strategy encompassing regulatory pathways and commercialization efforts aimed at establishing TG-C as a frontrunner in the treatment of knee osteoarthritis.

Conclusion

The OARSI World Congress served as a pivotal moment for Kolon TissueGene, shining a light on the promising future of TG-C in altering the landscape of osteoarthritis treatment. As global healthcare progresses toward innovative therapeutic options, TG-C stands poised to offer not just a glimpse but potentially transform the management of osteoarthritis on a global scale.

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Disease-Modifying Osteoarthritis Drug (DMOAD).