GenNBio said it would officially enter the market of transplanting organs from pigs to humans.
“GenNBio’s vision is to provide living tissues, cells, and organs from gnotobiotic miniature pigs for patients,” GenNBio CEO Kim Sung-joo said in a news conference at the Plaza Hotel in Seoul, Wednesday.
|GenNBio CEO Kim Sung-joo speaks during a news conference in Seoul, Wednesday.|
To specialize in xenotransplantation, the company appointed Kim, former head of the Organ Transplantation Center of Samsung Medical Center, as CEO in April. It also appointed Park Chung-gyu, who headed the state-funded Xenotransplantation Research Center, as an outside director in July.
Kim is a transplant surgery expert who has performed more than 2,500 kidney transplants for 35 years. After witnessing patients and families desperately waiting for transplants, he decided to develop organs for heterologous transplants to solve the problem of the organ shortage.
“When I thought that I could no longer delay the development of organs for xenotransplantation, my long-time co-researcher and Genexine Chairman Sung Young-chul proposed the GenNBio’s CEO position,” Kim said. “Not only me but more than 40 colleagues who have been testing and transplanting organs for primates for over a decade moved to GenNBio along with me, to realize the dream of xenotransplantation.”
Xenotransplantation Research Center, which Park used to lead, also joined hands with GenNBio. Since 2004, the research center has been developing gnotobiotic pigs and clinical platforms to implant a pig’s pancreatic islet and cornea into humans. The center was supposed to end the project in May, but a delay in obtaining approval for a trial extended the project period by one year.
Although the center has one more year to finish the project, it could no longer receive the government’s fund for research. In such a situation, the research center decided to continue the project jointly with GenNBio.
“We shared our effort to make xenotransplantation into business with GenNBio. We will focus on commercializing the technology we’re studying together,” Park said.
The clinical trial of transplanting a pig’s pancreatic islet into a diabetic patient went through a review of the Ethics Committee of the International Xenotransplantation Association and obtained the nod from the Institutional Review Board. The trial is in the final stage to win approval from the Ministry of Food and Drug Safety, according to Park.
“We will be able to test implanting a pancreatic islet from a genetically modified miniature pig into a human late this year or early next year,” Park said.
In severe diabetic patients, pancreatic islet transplantation is almost the only treatment. Due to the extreme shortage of pancreatic islets, however, patients have to wait for eight years on average. During the wait, more patients die of complications.
Due to such difficulties, a pig’s pancreatic islet transplantation is rising as an alternative. Porcine pancreatic islets are similar to those of humans, and their immunological advantages have fewer side effects than allogeneic transplants. The supply is easy because they breed easily.
GenNBio is working to remove the side effects of pig transplants. The company addressed the issue of immunological barriers by using genetically engineered (transformed) pigs and immunosuppressants. Gnotobiotic pigs eliminated concerns of zoonotic diseases. The company plans to address potential concerns, such as the endogenous swine virus, through gene-editing techniques, it said.
GenNBio plans to complete the GenN Core Center (GCC), a xenotransplantation research facility on a land of 13,000 pyeong (42,975 square meters), and GenN Transformation Center, a facility for mass production of transgenic pigs and GMP-level heterogeneous organs manufacturing, by 2020.