eGenesis announced that it has completed its second successful human transplant with a genetically engineered pig kidney, with the patient walking out of the hospital and skipping dialysis for the first time in years.
The procedure was performed Jan. 25 by surgeons at the Mass General Transplant Center in Boston as part of the company’s clinical study in patients with end-stage renal disease and kidney failure. Massachusetts General Hospital previously completed the company’s first xenotransplant surgery in March 2024.
“This procedure is more than a scientific milestone—it represents a new frontier in medicine,” eGenesis CEO Michael Curtis, Ph.D., said in a statement. “We stand at the beginning of a future where organ shortages may no longer dictate patient outcomes.”
Out of more than 800,000 people in the U.S. suffering from ESRD, more than 100,000 are currently on the waitlist for a kidney transplant—while only about 25,000 operations are performed each year due to a lack of available organs.
The former Fierce Medtech Fierce 15 winner aims to open up that bottleneck by employing CRISPR gene editing to make organs harvested from pigs a safer option, where the tissue would otherwise be immediately rejected by the human immune system.
That includes the elimination of three antigens that trigger acute responses and the addition of seven human transgenes to help reduce inflammation. Along with the removal of endogenous retroviruses within the porcine genome, eGenesis makes as many as 69 separate edits.
The new recipient, 66-year-old Tim Andrews, has been on dialysis for more than two years and has suffered cardiovascular complications that can come with the condition, including a heart attack.
His wait for a transplant was also complicated by his type O blood, which often extends the average wait time for matching with a compatible donor from the typical three to five years out to five to 10.
As part of the procedure, Andrews also underwent an investigational immunosuppression regimen with tegoprubart, a monoclonal, CD40L antibody being developed by Eledon Pharmaceuticals to disrupt immune cell communication. He was discharged Feb. 1.
“This second kidney xenotransplant conducted at MGH represents another important milestone in the effort to consider new strategies in transplantation and immunosuppression to address the global organ shortage crisis,” said Eledon CEO David-Alexandre Gros, M.D.
“Blocking the CD40 Ligand is a critical component of the immunosuppression regimen for effective translation of organ transplant from nonhuman primates into humans,” Gros said. “Our anti-CD40L 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.”
Tegoprubart is also being evaluated in three global organ rejection studies in patients receiving kidney transplants as well as in a separate investigator-sponsored trial for the prevention of islet transplant rejection in patients with Type 1 diabetes.
eGenesis, Eledon and the MGH received a green light from the FDA last December to proceed with the latest procedure plus two more xenotransplants this year.
This month also saw United Therapeutics, another developer of engineered transplant organs, announce that it received the agency’s go-ahead to launch a clinical trial of its modified pig kidney.
The company said the first xenotransplantation procedure of its UKidney is slated for the middle of this year, out of a total of six patients with ESRD in the initial stage of the clinical trial—with at least 12 weeks between the first and second surgeries.
Designed as a combination phase 1/2/3 study, participants will be monitored closely for 24 weeks post-transplant to collect safety and efficacy data toward a future FDA submission and will then be followed by researchers for the rest of their lives.