The main cell used in Kolon Life Science's osteoarthritis cell gene therapy treatment Invossa has been confirmed to be different from the one approved for marketing in Korea.
Kolon Life Science held an emergency meeting on April 1 and announced that it will stop sales of Invossa. The recruitment of Phase 3 clinical trials patients for entry into the U.S. market has also been temporarily suspended.
Based on the analysis data of the transfected cell (TC), one of the main components of Invossa, carried by US subsidiary Kolon Tissue Gene in 2004, the company thought that TC is derived from cartilage cells. However, Kolon Tissue Gene, currently in Phase 3 of the U.S. clinical trials of Invossa, confirmed that the TC is a 293-derived cell and reported the data to Kolon Life Science and the U.S. Food and Drug Administration (FDA) on March 29 (local time). Kolon Life Science reported this to the Korean Ministry of Food and Drug Safety (MFDS) on March 30. The data was confirmed by the STR test, a genetic sequencing test, conducted by an external agency upon request of Kolon Tissue Gene.
The Korean biopharmaceutical industry is worried that this situation would lead to invalidation of the domestic sales license of Invossa and that the U.S. clinical data would become useless. In response, Kolon Life Science said such possibilities are unlikely because the problem is a mislabeling of the component, not a change in the component itself. It said the same cell has been used throughout the whole process from the first production of the Master Cell Bank (MCB) to the next step of the working cell bank and product production.
Pharmaceutical companies are worried that this would dampen the growth of the bio-pharmaceutical industry, which has just started blooming. An industry observer said, "This situation may damage the entire biopharmaceutical industry as there will be growing calls for securing the safety of biopharmaceuticals."
Meanwhile, Kolon Life Science plans to draw out the results of the STR test and consult with the MFDS. If the STR test proves that there is no problem with the safety of Invossa, the company plans to change the name of the TC cell and apply for the change of the license. It will also hold a meeting with the U.S. FDA in mid-May.