An international partnership between eGenesis in the United States and PorMedTec in Japan has led to the successful production of genetically engineered porcine donors for use in transplantation.

eGenesis, based in Cambridge, MA, is a biotechnology company developing human-compatible organs and cells for the treatment of organ failure. The eGenesis Genome Engineering and Production (EGEN) Platform addresses cross-species molecular incompatibilities and viral risk through genetic engineering. eGenesis is advancing development programs for acute liver failure, kidney transplant, and pediatric as well as adult heart transplant.

The company’s landmark preclinical study using kidneys with these genetics was published in Nature in October 2023, in the article titled, “Design and testing of a humanized porcine donor for xenotransplantation.

Specializing in porcine embryology, PorMedTec provides transplantable organs, tissues, and cells for the treatment of patients with organ failure or intractable diseases. The company was established in 2017 in Kawasaki, Japan, based on research from the Meiji University International Institute for Bio-Resource Research (MUIIBR).

The company aims to address unmet medical needs through its research on cloned pig production, creation of genetically modified pigs as models for human genetic diseases, organ regeneration using the blastocyst complementation method, and cryopreservation of porcine embryos and tissues. PorMedTec manufactures and markets human transplantable organs and tissues as next-generation regenerative medicine products.

As part of a collaboration between the two companies, genetically engineered porcine cells developed by eGenesis were provided to PorMedTec for production using somatic cell nuclear transfer. Cells provided by eGenesis carry the same edits used for its lead organ candidate in development in the United States. These edits include (1) knock out of three genes involved in the synthesis of glycan antigens implicated in hyperacute rejection, (2) insertion of seven human transgenes involved in the regulation of several pathways that modulate rejection: inflammation, innate immunity, coagulation, and complement, and (3) inactivation of the endogenous retroviruses in the porcine genome.

eGenesis and PorMedTec plan to jointly advance the development of genetically engineered organs in Japan to address the massive unmet need in the country, with an initial focus on kidney transplants. The organ shortage in Japan is even more dire than in the United States, with only 3% of waitlist candidates receiving a transplant due to a greater shortage of allogeneic organ donors. The median wait time for a kidney transplant in Japan is fifteen years, compared to four years in the United States.

“In Japan, interest in xenotransplantation is high due to the acute need for organs, but progress in this field has been limited due to the lack of genetically engineered donors with the potential to support human recipients. Birth of a genetically engineered pig with a proven track record in the United States is expected to accelerate progress toward the clinic in Japan,” said Genjiro Miwa, founder & CEO of PorMedTec. “Our mission is to provide transplantable organs, tissues, and cells for the treatment of all patients with organ failure.”

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