eGenesis Announces World’s First Successful Transplant of Genetically Engineered Porcine Kidney in a Living Patient

– Marks historic milestone and opens new frontier in transplantation to address kidney shortage affecting millions of patients globally

– Transplant was conducted at Massachusetts General Hospital and authorized by the U.S. FDA under a single Expanded Access protocol

Excerpt from the Press Release:

CAMBRIDGE, Mass.–(BUSINESS WIRE)–eGenesis, a biotechnology company developing human-compatible engineered organs to address the global organ shortage, today announced the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

The transplant was authorized by the U.S. Food & Drug Administration (FDA) under the Expanded Access pathway and performed by a surgical team at Massachusetts General Hospital (MGH) led by Tatsuo Kawai, MD, PhD and Nahel Elias, MD. The patient suffers from end-stage renal disease and lacked other therapeutic options following the loss of vascular access to support continued use of dialysis. Following the procedure, the patient is in good condition and recovering well at MGH.

More than 800,000 people in the U.S., and millions globally, suffer from end-stage renal disease or kidney failure, a life-threatening condition for which transplantation is considered the gold standard treatment option to improve quality of life and outcomes. Yet the demand for organs far outpaces supply, with more than 90,000 individuals on the kidney waitlist and approximately 25,000 kidney transplants performed each year. Human compatible donor organs developed by eGenesis offer a potentially viable alternative to end waitlist mortality and alleviate the shortage of transplantable organs.

The eGenesis donor kidney (EGEN-2784) used for this procedure is the company’s lead candidate for kidney transplant and carries three classes of edits: (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 pathways that modulate rejection: inflammation, innate immunity, coagulation, and complement, and (3) inactivation of the endogenous retroviruses in the porcine genome. eGenesis is the only company in the industry developing organs that carry all three classes of edits to address organ safety and efficacy. Without genetic modification, a porcine kidney would be immediately rejected by a human recipient.

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