eGenesis, a biotechnology company developing human-compatible engineered organs to address the global organ shortage, announced the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

The transplant was performed by a surgical team at the 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.

The eGenesis donor kidney (EGEN-2784) used for this procedure is the company’s lead candidate for kidney transplant and carries three classes of genome 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. Without genetic modification, a porcine kidney would be immediately rejected by a human recipient.

“This successful procedure heralds a new era in medicine in which we have the potential to eliminate organ supply as a barrier to transplantation and realize our vision that no patient dies waiting for an organ,” said Michael Curtis, PhD, CEO of eGenesis. “We are humbled by the courage and generosity of this patient, who is a true pioneer, enabling this major break-through in science and transplant medicine. The large body of preclinical evidence of long-term recipient survival with EGEN-2784 that we have generated gives us the confidence to evaluate our product in the clinical setting. We are thrilled to collaborate with the team at MGH on this historic procedure given their preeminence in clinical care and research as well as their long-term experience with our technology.”

The immunosuppression regimen used includes approved agents as well as a novel, investigational monoclonal antibody, tegoprubart, targeting the co-stimulatory CD40L pathway. Tegoprubart is supplied by Eledon Pharmaceuticals and is currently being evaluated in two clinical trials for kidney allotransplantation.

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.

Decades of progress in cross-species transplantation, accelerated by the advancement of modern genome editing tools and next-generation sequencing, have enabled eGenesis to progress genetically engineered organs to the clinical setting.

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