The regulator raised suspicion that Kolon Life Science might have tampered with data when it sought approval for Invossa-K, now-suspended treatment for arthritis.
The Ministry of Food and Drug Safety said it has requested Kolon to submit additional data to support the company’s claim that the cells used for Invossa were GP2-294 cells derived from the kidney.
On Monday, the ministry disclosed the interim result of the cell analysis on Invossa, saying that the transformed cells, the second ingredient of the drug, among the working cell bank were GP2-293 cells from the kidney, not cartilage-derived cells.
The ministry is investigating the master cell bank.
However, Kolon’s claim is not consistent with the data the company had submitted to seek approval for Invossa, the ministry said.
The previously submitted data showed that the second ingredient of the drug was cartilage-derived cells and the data did not have any ground that they were kidney-derived cells, it added.
The ministry noted: The second cell ingredients demonstrated similar expressions of proteins and genes with those of cartilage cells; the DNA fingerprints of the second cell ingredient were identical to the DNA of cartilage cells; the second cell ingredients included surface proteins of cartilage cells; lab animals injected with the second ingredient had their cartilage regenerated; and the gag-pol expression only existing in 293 cells was not detected in the second cell ingredients.
If Kolon’s allegation that the cells were 293 cells from the first place is correct, the cells could not show similarity in protein and gene expressions to that of cartilage-derived cells, the ministry said.
“It is impossible that 293 cells expressed the characteristics of cartilage cells in various tests. Comprehending this with scientific logic is difficult. I think Kolon might have changed the story,” a ministry official said.
An employee at a cell gene therapy developer also said, “I can’t understand that why the data submitted by Kolon, which was supposed to prove that the second ingredient was cartilage-derived cells, was 293 cells.”
If the suspicion turns into reality, there could have been two scenarios.
The cells were cartilage-derived at the time of approval but were later replaced by 293 cells, or the cells were 293 cells before approval, but the company fabricated data to make the cells look cartilage-derived ones.
Kolon on Monday said the master cell bank was 293 cells, meaning that Invossa cells have been 293 cells from the early stage of the development.
If the cells have been replaced with 293 cells after winning approval, Kolon’s allegation has been false, which hurts the credibility of the clinical data.
The ministry is placing more weight on the possibility that Kolon could have faked data.
“We asked Kolon to submit the same data that it had submitted to prove that the company’s allegation is true. If the results come out differently, we can say that the company manipulated data,” another ministry official said.
Kolon Life Science squarely denied the ministry’s accusation.
“The data we had submitted to the food and drug safety ministry was the same with the one we submitted to the U.S. Food and Drug Administration for clinical trial application. The FDA verified the same data and granted approval for trials,” a Kolon Life Science official said. “It is nonsense to claim that we fabricated data. If we do the test now, the result will be the same.”