Noh Moon-jong, CEO of Kolon TissueGene, is the key person to clarify why Invossa-K contained abnormal GP2-293 cells because he has been heading the early-stage research on the gene therapy for osteoarthritis. However, he has kept silent about the issue for over three weeks since the suspension of the drug sales.
Kolon Life Science has not given out a full explanation of why Invossa’s second ingredient of transduced cells contained 293 cells to date.
Kolon Life Science CEO Lee Woo-sok and Managing Director Kim Soo-jung said at a news conference on Thursday last week that “it was unlikely that 293 cells were not filtered out.”
Some of the filters might have been torn, or other things may have contaminated the drug cell. However, these are all speculations, and the company is investigating the researchers who worked at the time, Lee said.
Lee said it was difficult to identify the cause of the problem because all the researchers who worked on Invossa at Kolon TissueGene left the company, except for one person.
Kolon TissueGene mainly developed the early-stage substances for Invossa, and the team came from Kolon’s central research lab. The research team successfully developed cells to make them secrete TGF-β. Then, the team set up Kolon TissueGene in the U.S. to build the master cell bank to commercialize the cell gene therapy.
In Korea, Kolon Life Science sought approval for clinical trials and marketing license based on the cell lines developed by Kolon TissueGene.
Kolon Life Science’s R&D head Yoo Soo-hyun, Managing Director Kim, and Managing Director Choi Heon-sik joined Kolon Life Science after 2010. In other words, researchers at Kolon TissueGene may have the answer to solve the Invossa problem.
Among them, TissueGene’s CTO Noh is the only researcher who still works at the company. Leading Kolon TissueGene’s R&D and clinical trials, Noh has been recently appointed as CEO after former CEO Lee Bum-sup abruptly resigned.
Kolon Life Science CEO Lee told reporters that “no person was remaining at TissueGene who was involved in building the cell line in 2003. However, Noh, who led the early development of Invossa, is still working at TissueGene
Noh graduated from Seoul National University’s Microbiology Department, received Ph.D. in Life Science at KAIST, and entered Kolon Life Science.
He researched Invossa as the head of the life science research team at Kolon’s central research institute, jointly with a research team at Inha University led by professor Lee Kwan-hee in the mid-1990s.
As the joint research team successfully developed the drug candidate for Invossa, Noh’s name was registered as the inventor of the patent.
Even though Noh is the only person within Kolon TissueGen who knows the best why the cell ingredients were mislabeled, he has not mentioned any word on the issue. Noh is reportedly focusing on response measures to the U.S. Food and Drug Administration.
While he was busy dealing with the FDA in the U.S., rumors circulated in Korea that Kolon might have fabricated data to get Invossa approval or that the cells might not have been 293 cells but a third kind.
The Ministry of Food and Drug Safety is worried that its investigation into Kolon TissueGene might be difficult. Only Kolon TissueGene, based in Rockville in the U.S., has the research data for Invossa’s early development and the master cell bank.
The ministry has requested Kolon Life Science to visit TissueGene’s headquarters. If TissueGene refuses to cooperate, there is no way the ministry could push through further.
“On the surface, Kolon is acting as if it is cooperating with the ministry’s investigation, but there is no concrete outcome,” an official at the food and drug safety said, questioning if the company would submit additional data as requested by the ministry.
As Kolon Life Science takes care of all the local matters, Kolon TissueGene is a step away from the Invossa issue.
“Speculations over the second cell ingredient are snowballing. Why can’t TissueGene clarify all the questions,” asked an official in the biotech industry? “It will be important for the company to resume trials in the U.S. In Korea, however, it is a matter of Invossa’s survival in the market.”