[Edaily Reporter KIM SAE-MI ] #Noh 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—comprising Jeon Seung-ho and Noh Moon-jong—to a structure led solely 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 the KOLON CORPORATION Central Technology Institute as a senior researcher in 1995. Subsequently, he participated in the research and development 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 JINDO.CO.,LTD business reports as a “key researcher” who has been involved in TG-C research and development since its early stages.
CEO Noh continued to lead the company even after the 2019 Inbosa ingredient change incident. 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) nor the total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)—both of which were co-primary efficacy endpoints—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). The announcement of the topline results from the second U.S. Phase 3 clinical trial, originally scheduled for next month, has been postponed to December.
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 the development of TG-C since its early stages—has now also resigned.
With CEO Noh’s resignation, Kolon TissueGene, Inc. will now determine TG-C’s future development strategy 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 of 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 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.”
