CAMBRIDGE, MASS, September 08, 2025
CAMBRIDGE, Mass.–(BUSINESS WIRE)– eGenesis, a biotechnology company developing human-compatible engineered organs to address the global organ shortage, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a clinical trial evaluating EGEN-2784, a genetically engineered porcine-derived kidney, in patients with end stage kidney disease (ESKD).
The IND supports a Phase 1/2/3 study designed to assess the safety, tolerability, and efficacy of EGEN-2784 at 24 weeks post-transplant in patients with ESKD who are age 50 or older, dialysis-dependent, and on the kidney transplant waitlist.
“Clearance of the EGEN-2784 IND and initiation of this clinical study are important steps forward in our mission to end the global organ shortage,” said Mike Curtis, Ph.D., President and Chief Executive Officer of eGenesis. “This trial will allow us to evaluate the transformative potential of EGEN-2784 to address the staggering burden of kidney failure worldwide.”
“Advances in xenotransplantation are giving our community hope that new options may soon be available to those who need them most,” said Kevin Longino, CEO of the National Kidney Foundation and a kidney transplant recipient. “The National Kidney Foundation congratulates eGenesis on this milestone. Patients expressed strong support for the advancement of clinical trials in our recent Xenotransplantation Voice of the Patient report. It is gratifying to know they’re being heard.”
EGEN-2784 is eGenesis’ lead candidate for kidney transplantation. The product carries three classes of genetic modifications designed to improve compatibility and support long-term function in human recipients: 1) Elimination of three glycan antigens to prevent hyperacute immune rejection 2) Insertion of seven human transgenes to regulate immune response, reduce inflammation, improve coagulation compatibility and regulate complement activation 3) 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.
Major Milestones Achieved in Ongoing Multi-Patient Expanded Access Study of EGEN-2784
First Patient Surpasses Seven Months with EGEN-2784 Kidney
Tim Andrews, 67, who received an EGEN-2784 kidney on January 25, 2025, at Massachusetts General Hospital, a founding member of the Mass General Brigham healthcare system, has surpassed seven months post-transplant, making him the world’s longest-living recipient of a genetically engineered porcine-derived organ. Mr. Andrews, who required dialysis for more than two years prior to his transplant, continues to live dialysis-free.
Second Successful Transplant Completed in June
On June 14, 2025, Bill Stewart, 54, became the second patient in the study, and the third patient overall, to receive an EGEN-2784 kidney. Before his transplant, Mr. Stewart underwent dialysis three times per week for more than two years and faced a longer than average wait time for an allotransplant due to his O-group blood type. He was discharged from MGH on June 21st and no longer requires dialysis for the first time in over two years.
“I’m so appreciative of the MGH transplant team for giving me this opportunity and a new lease on life. The care, compassion, kindness, support, and intelligence that the team has invested in my care and studying xenotransplantation will forever be appreciated by my family and me. The commitment to my care has been evident from day one, and it has allowed me to trust in the process and research. I couldn’t be in better hands,” Mr. Stewart said.
Leonardo V. Riella, MD, PhD, medical director for kidney transplantation at MGH, served as the Principal Investigator and led the clinical study, overseeing the multidisciplinary transplant team. Tatsuo Kawai, MD, PhD, Director of the Legorreta Center for Clinical Transplant Tolerance, was the lead transplant surgeon for both procedures, supported by Nahel Elias, MD, Surgical Director for Kidney Transplantation.
“This is a historic moment for xenotransplantation. To see a patient thriving off dialysis for over seven months with a genetically engineered pig kidney is nothing short of groundbreaking,” said Dr. Riella. “This achievement was made possible by extraordinary collaboration across academia, industry, and government. I want to recognize eGenesis for its cutting-edge gene-editing technology and essential partnership; our MGH transplant team for their clinical excellence; and the FDA for their rigorous and supportive guidance. Additional critical industry partners include Eledon, Apellis, and Karius. Together, we are not only making history—we are reshaping the future of transplantation.”
More than 800,000 Americans and millions worldwide suffer from end stage kidney disease or ESKD. While organ transplantation remains the gold standard for improving survival and quality of life among those living with ESKD, due to the shortage of organs only 28,000 kidney transplants were performed in 2024. For those unable to receive a transplant, dialysis remains the only option. The five-year mortality rate associated with dialysis is more than 50%, higher than the most common cancers. Genetically engineered porcine-derived kidneys offer a promising solution to this crisis.
About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. For more information, visit www.egenesisbio.com.
Media Contact
Kimberly Ha eGenesis
Brandon Chase
Mass General Brigham