CAMBRIDGE, Mass– eGenesis, a Cambridge-based biotechnology firm developing genetically engineered organs, said Monday that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to launch a clinical trial of EGEN-2784, a porcine-derived kidney designed for patients with end stage kidney disease (ESKD).
The Phase 1/2/3 trial will test the safety, tolerability, and effectiveness of the experimental kidney over 24 weeks in patients 50 years or older who rely on dialysis and remain on the transplant waiting list.
“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 CEO of eGenesis.
Kevin Longino, CEO of the National Kidney Foundation and a transplant recipient himself, said the milestone reflects growing momentum. “Advances in xenotransplantation are giving our community hope that new options may soon be available to those who need them most,” he said.
The company also highlighted major updates from its ongoing Multi-Patient Expanded Access study. Tim Andrews, 67, who received an EGEN-2784 kidney at Massachusetts General Hospital on Jan. 25, 2025, has now lived more than seven months without dialysis, the longest survival on record for a recipient of a genetically engineered pig organ.
On June 14, 2025, Bill Stewart, 54, became the second patient in the study to undergo the procedure. He had spent more than two years on dialysis and faced long wait times because of his O blood type. Stewart was discharged a week later and no longer requires dialysis.
“I’m so appreciative of the MGH transplant team for giving me this opportunity and a new lease on life,” Stewart said.
Dr. Leonardo V. Riella, medical director for kidney transplantation at MGH and the study’s principal investigator, called the progress “a historic moment for xenotransplantation.” He credited collaboration across academia, industry, and government for the results.
More than 800,000 Americans live with ESKD, and millions more suffer worldwide. In 2024, only 28,000 kidney transplants were performed in the U.S., leaving most patients dependent on dialysis, which carries a five-year mortality rate of more than 50 percent.
EGenesis’ lead candidate, EGEN-2784, incorporates three sets of genetic edits: removing antigens that trigger immediate immune rejection, adding human genes to improve compatibility and function, and disabling pig retroviruses to enhance safety. The company said it remains the only developer using all three approaches simultaneously.
