CAMBRIDGE, Mass. — eGenesis has reported new clinical results from its ongoing Expanded Access study of EGEN-2784, a genetically engineered porcine kidney being developed for patients with kidney failure.
Since March 2024, five patients have received EGEN-2784 kidney transplants under Expanded Access in collaboration with the Mass General Brigham health system.
Three patients have maintained kidney function for more than eight months without dialysis, while one has surpassed nine months of dialysis independence, which the company said represents a global record for a genetically engineered porcine kidney transplant.
Two of the five patients have subsequently received human donor kidney transplants. eGenesis said the cases are the first reported transitions from xenotransplantation to allotransplantation and provide evidence that a genetically engineered pig kidney can support patients while preserving the option of a later human kidney transplant.
One of the patients, Tim Andrews, remained dialysis-free for about nine months with an EGEN-2784 kidney before receiving a human donor kidney 82 days after removal of the xenograft. His case was published in The Lancet.
“These patient outcomes provide important evidence that genetically engineered organs may provide sustained kidney function and dialysis independence while preserving the opportunity for a subsequent human transplant,” said Mike Curtis, Ph.D., President and Chief Executive Officer of eGenesis.
“Our goal is to make transplantation available to patients when they need it, without being constrained by the limited supply of human donor organs,” Curtis said.
The U.S. Food and Drug Administration has cleared eGenesis to conduct the Phase 1/2/3 RESTORE trial evaluating EGEN-2784 in 33 patients with kidney failure between the ages of 50 and 70 who are waitlisted for a human donor kidney transplant.
The company expects to begin the RESTORE study in the first quarter of 2027.
EGEN-2784 incorporates three categories of genetic modifications intended to improve compatibility and long-term function in humans. These include eliminating three glycan antigens associated with hyperacute immune rejection, adding seven human transgenes intended to regulate immune and inflammatory responses and improve coagulation compatibility, and inactivating endogenous retroviruses.
Leonardo V. Riella, M.D., Ph.D., Medical Director for Kidney Transplantation at Massachusetts General Hospital, served as principal investigator. Tatsuo Kawai, M.D., Ph.D., Director of the Legorreta Center for Clinical Transplant Tolerance, served as lead transplant surgeon, with support from Nahel Elias, M.D., Surgical Director for Kidney Transplantation.
“The sustained periods of dialysis independence are highly encouraging, and the successful transplantation of human donor kidneys following xenotransplantation demonstrates that this approach can preserve future treatment options,” Riella said.
More than 800,000 Americans and millions of people worldwide are living with end-stage kidney disease, according to eGenesis. The company said about 28,000 kidney transplants were performed in the United States in 2024, underscoring the shortage of available donor organs.
