EGenesis Deems Second Transplant of Genetically Modified Porcine Kidney EGEN-2784 Successful
The transplant, which took place at Massachusetts General Hospital MGH, was part of an FDA-authorized Expanded Access pathway.
EGenesis has successfully transplanted EGEN-2784, a porcine kidney that features a number of genetic modifications intended to prevent rejection in human patients, into a second patient, with the intention of treating end-stage kidney disease.1
The transplant, which took place at Massachusetts General Hospital MGH, was part of an FDA-authorized Expanded Access pathway that is expected to treat 2 additional patients with kidney failure. EGenesis reported that the patient, who is named Tim Andrews, is 66 years of age and was previously on dialysis for over 2 years. Because of Andrews has an O-group blood type, receiving a kidney transplant from a human donor would have required a longer than usual waitlist time, potentially in the range of 5 to 10 years. EGenesis stated that Andrews has been discharged from the hospital after receiving EGEN-2784 and is now off dialysis. Furthermore, the company noted that the porcine kidney is functioning as anticipated.
“This procedure is more than a scientific milestone – it represents a new frontier in medicine,” Michael Curtis, PhD, the chief executive officer of eGenesis, said in a statement.1 “We stand at the beginning of a future where organ shortages may no longer dictate patient outcomes. We are immensely grateful to Mr. Andrews, who has placed his trust in our groundbreaking innovation. His willingness to participate in this pioneering effort will help turn the promise of human-compatible organs into a reality. We are thrilled to continue our collaboration with the remarkable team at MGH, whose expertise and dedication have been instrumental in making this vision possible.”
EGEN-2784 includes gene edits intended to knock out 3 genes involved in the synthesis of glycan antigens believed to be related to hyperacute rejection.2 It also includes the addition of 7 human genes related to modulation of rejection.
Notably, an immunosuppression regimen including tegoprubart, an investigational monoclonal antibody directed at the costimulatory CD40L pathway, was administered to Andrews with the intention of improving efficacy and reducing the risk of adverse events. Tegoprubart is being developed by Eledon Pharmaceuticals. The monoclonal antibody is also being evaluated in 3 clinical trials for human kidney transplants.
“Blocking the CD40 Ligand is a critical component of the immunosuppression regimen for effective translation of organ transplant from nonhuman primates into humans,” David-Alexandre C. Gros, MD, Eledon’s chief executive officer, said in a February 7, 2025, statement.3 “Our antiCD40L antibody tegoprubart represents a novel approach to immunosuppression therapy with the potential to improve safety and efficacy and enable patients to live longer with their transplanted organs.”
Andrews is the second person to have received EGEN-2784 under the Expanded Access pathway.2 A previous patient successfully received the porcine kidney in March 2024 at MGH. This patient also received an immunosuppression regimen including tegoprubart. In September 2024, eGenesis received $191 million for the development of EGEN-2784 in a round of Series D financing.
EGenesis is not the only gene-edited porcine kidney product currently in-development for kidney disease.4 United Therapeutics’ UKidney, an investigational gene-edited porcine kidney product intended to treat end-stage renal disease, received clearance of an investigational new drug (IND) application from the FDA earlier in February 2025. In light of the IND clearance, which constitutes the first for a xenokidney product, the company plans to go forward with a phase 1/2/3 clinical trial with the intention of supporting a biologics license application for the product.
“Clearance of our IND for this first-ever clinical trial of a xenokidney represents a significant step forward in our relentless mission to expand the availability of transplantable organs,” Leigh Peterson, PhD, the executive vice president of product development and xenotransplantation at United Therapeutics, said in a February 2025 statement.4 “Our goal is to increase the availability of transplantable organs to offer a therapeutic alternative to a lifetime on dialysis for a large population of patients who are unlikely to receive an allogeneic kidney transplant.”
