[Edaily Reporter KIM SAE-MI ] #No Moon-jong Kolon TissueGene, Inc.(950160), co-CEO of KOLON TissueGene and a key figure in the development of “TG-C” (formerly Invossa)—a cell-gene therapy for osteoarthritis that KOLON CORPORATION has been developing for about 30 years—has stepped down from his position as CEO. This comes about two months after TG-C failed to achieve statistical significance in its first U.S. Phase 3 clinical trial last July.
Kolon TissueGene, Inc. announced on the 18th that CEO Noh had resigned from his position for personal reasons. Consequently, Kolon TissueGene, Inc. has transitioned from its previous co-CEO structure—led by Jeon Seung-ho and Noh Moon-jong—to a sole CEO structure headed by Jeon Seung-ho.
CEO Noh is a key researcher whose career has run parallel to the development history of TG-C. After earning a Ph.D. in Life Sciences from the Korea Advanced Institute of Science and Technology (KAIST), he joined KOLON CORPORATION's Central Technology Institute as a senior researcher in 1995. He subsequently participated in the R&D of TG-C at Kolon TissueGene, Inc. starting in 2001 and oversaw the U.S. Phase 1/2 clinical trials. Kolon TissueGene, Inc. has also introduced CEO Noh in its business reports as a “key researcher” who has been involved in TG-C R&D since its early stages.
CEO Noh continued to lead the company even after the 2019 Inbosa ingredient change scandal. In June 2019, he became the sole CEO following the resignation of then-CEO Lee Woo-seok, and subsequently led the resumption of TG-C’s U.S. clinical trials and Phase 3 development. Last year, a co-CEO system was established when Jeon Seung-ho, former CEO of DAEWOONGPHARMACEUTICAL(069620), joined the company, with CEO Noh overseeing R&D and CEO Jeon handling management and business strategy.
The timing of CEO Noh’s resignation is particularly noteworthy because TG-C’s U.S. Phase 3 clinical trial has reached a critical turning point.
On July 20, Kolon TissueGene, Inc. announced the top-line results of TG-C’s first U.S. Phase 3 clinical trial (TG-G 15302). At the 12-month mark, neither the Visual Analog Scale (VAS)—a co-primary efficacy endpoint—nor the total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) achieved statistical significance compared to the placebo. In the case of the VAS, the degree of improvement in the TG-C treatment group was virtually identical to that in the placebo group.
At the time, CEO Noh personally explained the clinical results. During a press conference, he stated that the degree of improvement in the TG-C group was similar to that seen in previous clinical trials and expressed the view that a stronger-than-expected placebo response contributed to the failure to achieve statistical significance. The company subsequently announced that it would thoroughly analyze the results of the first Phase 3 clinical trial, while entrusting the analysis of the second Phase 3 clinical trial to an external contract research organization (CRO). Topline results from the second U.S. Phase 3 clinical trial are scheduled to be announced next month.
Recent changes have also been observed within the TG-C clinical team. Following the departure of key personnel responsible for U.S. clinical trials and regulatory affairs after the announcement of the first Phase 3 trial results, CEO Noh—who had been involved in TG-C development since its early stages—has now also resigned.
With CEO Noh’s resignation, Kolon TissueGene, Inc. will now determine the future development strategy for TG-C under the sole leadership of CEO Jeon Seung-ho. CEO Jeon served as CEO of DAEWOONGPHARMACEUTICAL from 2018 to 2024 before being appointed CEO of Kolon TissueGene, Inc. in March of last year. Kolon TissueGene, Inc.’s top priority at present is to analyze the causes of the failure in the first Phase 3 clinical trial and, based on the results of the second Phase 3 trial, to rework its future development and approval strategy in collaboration with the U.S. Food and Drug Administration (FDA).
A biotech industry insider commented, “It is significant that CEO Noh, who has been at the forefront of KOLON CORPORATION’s new drug development for about 30 years and has come to symbolize TG-C’s research and development, has stepped down ahead of the announcement of the results from the second U.S. Phase 3 clinical trial.”
