eGenesis, a biotechnology company developing human-compatible organs and cells for the treatment of organ failure, and PorMedTec, a global leader in porcine embryology, have successfully produced genetically engineered porcine donors in Japan for use in trans­plan­tation.

As part of a collaboration between the two companies, genetically engineered porcine cells developed by eGenesis were provided to PorMedTec for production using the somatic cell nuclear transfer, or cloning, process. Cells provided by eGenesis carry the same edits used for its lead organ candidate in development in the US. 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. The company’s landmark preclinical study using kidneys with these genetics was recently published in Nature.

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 transplant. 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.

“Production of our first donors outside the United States is a critical milestone for eGenesis. This demonstrates the potential of broadening our reach and the promise of our platform to additional geographies and patient populations in need,” said Mike Curtis, PhD, Chief Executive Officer of eGenesis. “We are thrilled to partner with PorMedTec, a global leader in porcine cloning and production, to advance our organ products to end waitlist mortality, extend lives, and ultimately transform the treatment of organ failure.”

“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, PorMedTec. “Our mission is to provide transplantable organs, tissues, and cells for the treatment of all patients with organ failure.”

“Very few patients on the waiting list with end-stage organ failure can undergo transplantation in Japan due to the lack of organ donors. Dialysis burdens patients and their families and generally results in a decreased quality of life. The medical costs are enormous – in Japan, 2 trillion yen (about US$13 billion) is spent annually on renal dialysis, constituting 4% of the total medical expenditure of the country,” said Hiroshi Nagashima, Founder & Chief Scientist / CEO, PorMedTec and Professor, Meiji University. “Cloning technology will enable the use of an alternative organ supply using genetically engineered porcine donors. Our goal is to provide a sustainable supply of organs to all patients in need of transplant.”