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.