Kolon Life Invo ... Watershed at the end of May
The controversy over Kolon Life Sciences' osteoarthritis gene therapy product 'Invo sake migration' has not been heard. We are interested in when the results of the inspection will be received without the confirmation of the due diligence schedule of the Korea Food and Drug Administration's office.
The controversy over Kolon Life Science 's "Invasive Squeeze" gene (osteoarthritis gene therapy) has not been heard.
We are interested in when the results of the inspection will be received without the confirmation of the due diligence schedule of the Korea Food and Drug Administration's office.
It is expected that the end of May, which will include the results of the self-test of the domestic pharmacy clinic and the decision of the US Food and Drug Administration (FDA) to resume clinical operation,
◇ 100 billion won poured into invoices, to survive
Invo is an injection consisting of two liquids containing one liquid containing human chondrocytes (HC) and a transfected cell (TC) containing chondrocyte growth factor (TGF-β1).
The two are mixed in 3 to 1 and injected into the knee joints of patients with moderate knee osteoarthritis.
In 2017, it was licensed as the first gene therapy product in Korea from the KFDA.
The problem arose when it was discovered that the data submitted to the place of detention at the time of the authorization were different from the actual pharmaceutical ingredients.
The licensure was described as chondrocytes containing growth factors for two transgenic cells, but it was identified as a kidney cell (293-derived cells) in a genetic system test (STR, Short Tandem Repeat).
The Kolon Group has developed an invoicing company that poured KRW 110 billion for about 19 years, but it was a mistake to know about the transformed cells of Invo.
That period lasted for 15 years from 2004 when the results of the transfection cell characterization were published.
This is the first time that a developer has misunderstood the ingredients of pharmaceuticals, according to Kolon Life Sciences.
Other biotech companies also say "it does not make sense."
◇ "originally 293 cells were derived from" vs "
Currently, it is clear that only the 293-derived cells of Invo Corp. and Invo Corp., both of which have been undergoing clinical trials in the US, are all transfected.
Nobody can give a cool explanation about the changed background or background.
In this regard, Kolon Life Sciences and KFDA are opposed to each other.
Kolon Life Sciences claims that if 293 cells were found in both the US and the domestic invoices, they would have used consistent cells throughout the process, from initial development to commercialization.
The current scientific common sense is that it is unlikely that cell lines that are cryopreserved at cryogenic temperatures will deteriorate.
In the meantime, we emphasized that safety and efficacy have been sufficiently confirmed through clinical trials since we used consistent cells from the beginning.
It is the logic that Kolon Life Sciences claims to change the permission of the item, not the cancellation of the license.
On the other hand, the Food and Drug Administration is investigating how the transfected cells of the circulating Invivo transfected into 293-derived cells.
As a result of reviewing the data submitted by Kolon Life Science in the past, it was reasonable to judge the transfected cells as cartilage cells at that time.
Kolon Life Science must submit relevant materials to KFDA by May 14th.
◇ Patient group "Cancel invoices permission" ... Class action movements
It is also controversial that cells with 'tumorigenicity' characteristics, in which the 293 derived cells proliferate indefinitely, are also controversial.
Originally, Kolon Life Science announced on the first day of the press conference that it was concerned about the tumorigenicity of transgenic cells in the early stages of development and that it had completed radiation irradiation (exposure or exposure to radiation or radiation).
Both the FDA and the US FDA are aware of the tumorigenicity of transgenic cells and have confirmed that they are well known to be killed after administration of radiation as well as radiation.
"The transfected cells are designed to act as a sort of 'pocket' for the growth factors, and they are killed in the human body," said an official from Kolon Life Science. I had to confirm the number of times I had to go. "
Patient groups and civic groups voiced their intention to immediately cancel the permission of the invoices and urged patients to submit voluntary remedies to prevent unnecessary litigation.
Actual class action lawsuits are also detected for patients who have received actual invoices.
Law firm Ohkim has recently opened a separate website and is seeking consumers to file lawsuits against Kolon Life Sciences.
In connection with this, the KFDA decided to conduct a long-term follow-up survey on the health status of 3,500 patients treated with Invivo for 15 years.
◇ Drug Treatment Department "Kolon Tissue Jean"
The pharmacy office is in the process of coordinating the on-site inspection of Kolon Tissue Jean, the developer of the in-house company, and the biologics and wishes of cell banks.
I will confirm whether the cells were 293-derived cells from the first stage of development through due diligence.
However, since Kolon Tissue Jean as well as the cell bank are both American companies, cooperation with Kolon Life Science is essential for proper investigation.
Kolon Life Sciences said that it would not only provide all of the data required by the KFDA, but also actively cooperate with the investigation.
It is estimated that it will take more than a month to receive the materials from Kolon Life Science and complete the due diligence and self-verification.
This is also the story when all the tests are going smoothly, so we can not specify the length of time.
Choi Seung-jin, head of the Biological Drug Quality Control Division at the KFDA, said, "We are in the process of coordinating the due diligence schedule through Kolon Life Science." It is expected that by the end of May, once data is received from the company and self-
In May, meetings with Kolon Tissue Jin and the US FDA are likely to take place.
Kolon Life Science announced this fact to the US FDA at a press conference on March 1, and announced that it will discuss the clinical reopening with a meeting in mid-May.
In this regard, the industry is also wondering if the food industry will follow the US FDA's decision.
The Phase III clinical trials in the United States were stopped in this incident.
"The results of the meetings between the US FDA and Kolon Life Science could be used as a reference but did not set a policy," Choi said. "Administrative disposition will be discussed after the results of the tests are out and the facts are known."