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Credit: Marcela Ruth Romero \/ iStock \/ Getty Images Plus<\/p>\n Credit: Marcela Ruth Romero \/ iStock \/ Getty Images Plus<\/p>\n
In January 2025, Tim Andrews was non-ambulatory, in a wheelchair, and on dialysis with little hope of not only getting a kidney transplant but also of living much longer. He\u2019d lost all hope and felt like his life was going to end on dialysis and that he had already done his favorite things\u2014fishing, spending time with grandsons, and seeing the Boston Red Sox in person. In June, Andrews threw the first pitch in Fenway Park for a Boston Red Sox home game. That was made possible by receiving a kidney transplant from a genetically modified pig. Today, Andrews is the longest surviving person with a pig organ.<\/p>\n
Andrews isn\u2019t the only person seeing transformational results. A second individual, Bill Stewart, who was on dialysis, received a kidney xenotransplant a little under three months ago and, just a few weeks ago, completed a two-hour bike ride. Although the outcomes of these two procedures are impressive, there are more than 800,000 Americans and millions worldwide who suffer from end-stage kidney disease (ESKD), only 28,000 of whom received human kidney transplants, the gold standard, in 2024 as a result of the severe organ shortage. For those unable to receive a transplant, dialysis remains the only option, which has a five-year mortality rate exceeding 50%, higher than that of the most common cancers. Now, some of them will have the opportunity to receive a pig kidney in hopes of improving their health and lengthening their lives.<\/p>\n
Today, eGenesis announced that the FDA has approved an IND for EGEN-2784, the company\u2019s genetically modified pig kidney, that supports a Phase I\/II\/III study designed to assess safety, tolerability, and efficacy at 24 weeks post-transplant in patients with ESKD who are age 50 or older, dialysis-dependent, and on the kidney transplant waitlist. EGEN-2784 is eGenesis\u2019 lead candidate for kidney transplantation.<\/p>\n
President and chief executive officer at eGenesis, Mike Curtis, PhD, told Inside Precision Medicine, \u201cEven in one patient, you see this massive change, and it helps you realize the potential here\u2014it embodies the whole vision. These little acts really add together to show just what the transformative potential is of this technology, and here we go right now. It\u2019s one of those things where it happens slowly and quickly. It\u2019s rolling. We\u2019re off and running into the registration, which is amazing.\u201d<\/p>\n
Leonardo V. Riella, MD, PhD, medical director for kidney transplantation; lead surgeon Tatsuo Kawai, MD, PhD, director of the Legorreta Center for Clinical Transplant Tolerance; and Nahel Elias, MD, surgical director for kidney transplantation, led the team at Massachusetts General Hospital (MGH).<\/p>\n
A half-century in the making<\/p>\n
The dream of xenotransplantation stretches back more than half a century. In the 1960s, surgeons attempted chimpanzee and baboon kidney transplants in desperate patients, with limited survival times. The most famous early case was that of Baby Fae in 1984, who received a baboon heart at Loma Linda University. She survived for 21 days, a record at the time, but her death underscored the immense immunological barriers.<\/p>\n
In the 1990s and early 2000s, research focused on the genetic engineering of pigs, seen as more practical organ donors than primates. Knockout pigs lacking certain antigens were developed, and incremental progress was made in non-human primate models. Still, until the past few years, no one had achieved long-term survival in a living human.<\/p>\n
The recent wave of successful pig kidney and heart transplants represents the culmination of decades of trial, error, and incremental innovation. CRISPR gene editing, advanced immunosuppression protocols, and improved surgical techniques have converged to turn xenotransplantation from science fiction into tangible clinical practice.<\/p>\n
EGEN-2784 carries three classes of genetic modifications designed to improve compatibility and support long-term function in human recipients: elimination of three glycan antigens to prevent hyperacute immune rejection; insertion of seven human transgenes to regulate immune response, reduce inflammation, improve coagulation compatibility, and regulate complement activation; and inactivation of endogenous retroviruses within the porcine genome to enhance safety. eGenesis is the only company developing organs with all three classes of edits to optimally address safety and efficacy. Without genetic modification, a porcine kidney would be immediately rejected by the human immune system.<\/p>\n
eGenesis is not alone in the race to make xenotransplantation a clinical reality. Revivicor, a subsidiary of United Therapeutics, supplied the genetically modified pig hearts used in landmark procedures at the University of Maryland, where surgeons transplanted hearts into two living patients in 2022 and 2023. While those patients survived for weeks to months, the cases highlighted both the promise and the challenges of pig-to-human transplantation.<\/p>\n
NYU Langone Health and the University of Alabama at Birmingham (UAB) have also advanced the field, performing pig kidney transplants in brain-dead human recipients to study immune responses and organ function. These academic efforts provided critical proof-of-concept data that helped de-risk subsequent living patient transplants.<\/p>\n
Yet eGenesis has differentiated itself through the breadth of its gene-editing strategy. By combining multiple modifications\u2014removing antigens, adding human genes, and inactivating porcine retroviruses\u2014the company aims to address the key safety and efficacy concerns that have historically limited xenotransplant progress. This comprehensive approach may give EGEN-2784 an edge in achieving durable, complication-free outcomes.<\/p>\n
From expanded access to IND Clearance<\/p>\n
Back in 2024, eGenesis did the first-ever porcine kidney transplant on a living patient with Richard Slayman. That summer, eGenesis met with the FDA about extending the expanded access approach to a three-patient trial. That was approved in December of 2024, and Andrews was treated as the first patient of that study shortly thereafter in January 2025.<\/p>\n
\u201cWhat was really compelling about Mr. Andrews relative to Mr. Slayman is that Mr. Andrews had relatively less comorbidity, but he was still declining pretty quickly on dialysis, which was the impetus to get him into the trial,\u201d Curtis said. \u201cHe\u2019s 222 days post-transplant today. Then we treated Mr. Bill Stewart in June. He was the second patient of that three-patient study, and he\u2019s 82 days post-transplant today. The experiences of those three patients have demonstrated to us and the FDA that, first, the early post-transplant period is quite consistent.\u201d<\/p>\n