- Transplant performed at Massachusetts General Hospital as part of a three-patient FDA-authorized Expanded Access study
- Patient discharged from hospital, off dialysis for the first time in over two years
CAMBRIDGE, Mass.--(BUSINESS WIRE)--#engineering--eGenesis, a biotechnology company developing human-compatible engineered organs to address the global organ shortage, today announced the successful transplantation of a genetically engineered porcine kidney into a second patient living with end-stage kidney disease.
The procedure was performed on Saturday, January 25, by surgeons at the Mass General Transplant Center under the U.S. Food & Drug Administration (FDA)-authorized Expanded Access pathway as part of a multi-patient study. This is the first of a total of three patients with diagnosed kidney failure and listed for a transplant to be enrolled in the study. The MGH clinical team also performed the historic first transplant of a genetically engineered porcine kidney, supplied by eGenesis, into a living human in March 2024.
The recipient, 66-year-old Tim Andrews, has been on dialysis for more than two years due to end-stage kidney disease (ESKD). The treatment took a significant toll on his daily life, leaving him feeling constantly fatigued and unable to keep up with his usual activities. In addition to the daily struggles of dialysis, Andrews faced severe complications, including a heart attack in July 2023. His path to a kidney transplant was further complicated by his O-group blood type, which significantly extended his wait time. While most patients wait 3 to 5 years for a kidney, those with O-positive or O-negative blood types often wait 5 to 10 years, making their chances of receiving a donor organ even more difficult.
Due to his age and other factors, he faced a 9% chance of receiving a human kidney transplant within the next five years, while his probability of being removed from the transplant waitlist due to illness or death within that timeframe was 49%. Following successful transplant with an eGenesis porcine kidney (EGEN-2784), Andrews was successfully discharged from MGH on Saturday, February 1 and is now recovering, off dialysis for the first time in over two years, with his new kidney functioning as expected.
“As soon as I woke up after the surgery, the cloud of dialysis disappeared. I felt re-energized and revitalized. It was a miracle. The magnitude of what these doctors and nurses accomplished is unbelievable and I want to thank them for giving me a new lease on life. But this transplant isn’t about me. It’s about all the people who I met at the dialysis clinic, and I saw what they were going through. There are more than 500,000 people on dialysis, and I want to inspire them to never give up hope because that’s what this transplant provides. It’s a glimmer of hope,” Andrews said.
The donor kidney, EGEN-2784, is eGenesis’ lead candidate for kidney transplantation that 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. Without genetic modification, a porcine kidney would be immediately rejected by the human immune system.
“This procedure is more than a scientific milestone – it represents a new frontier in medicine,” said Michael Curtis, Ph.D., Chief Executive Officer, eGenesis. “We stand at the beginning of a future where organ shortages may no longer dictate patient outcomes. We are immensely grateful to Mr. Andrews, who has placed his trust in our groundbreaking innovation. His willingness to participate in this pioneering effort will help turn the promise of human-compatible organs into a reality. We are thrilled to continue our collaboration with the remarkable team at MGH, whose expertise and dedication have been instrumental in making this vision possible.”
“The transplant team at MGH is honored to collaborate with eGenesis in pushing the boundaries of innovation to address the global organ shortage,” said Leonardo V. Riella, MD, PhD, Medical Director for Kidney Transplantation at Massachusetts General Hospital. “Our three-patient study this year will provide critical insights into the long-term viability of xenotransplants as a transformative solution for thousands of patients in need of a life-saving kidney. We are deeply grateful to our patient for entrusting us with his care and for his selfless commitment to advancing the field of xenotransplantation for future recipients worldwide.”
The transplant patient was treated with a unique immunosuppression regimen that included tegoprubart, an investigational monoclonal antibody designed to target the co-stimulatory CD40L pathway. Significant prior research indicates that targeting the CD40L pathway has the potential for better efficacy and improved safety, including reduced risk of side effects, compared to current immunosuppressive drugs. Supplied by Eledon Pharmaceuticals, tegoprubart is currently being evaluated in three clinical trials for kidney allotransplantation. This immunosuppression regimen including tegoprubart is the same protocol used in eGenesis’ previous kidney xenotransplant conducted at MGH in March of last year.
More than 800,000 Americans and millions worldwide suffer from end-stage renal disease or kidney failure. While organ transplantation remains the gold standard treatment for improving survival and quality of life, the severe organ shortage limits the number of kidney transplants to only ~25,000 recipients per year. For those unable to receive a transplant, dialysis remains the only option, but the five-year mortality rate associated with dialysis is 50%, significantly higher than that of the most common cancers. Genetically engineered pig kidneys offer a promising solution to this crisis, potentially expanding access to life-saving transplants to address the critical organ shortage.
About eGenesis
eGenesis is pioneering a genome engineering-based approach to develop safe, effective transplantable organs to end the global organ shortage. Its platform uniquely addresses cross-species molecular incompatibilities and viral risk via its proprietary genetic engineering platform to improve outcomes for patients in need of a transplant. With demonstrated preclinical success, eGenesis is advancing programs in kidney transplantation, acute liver failure, and heart transplantation. Learn more at www.egenesisbio.com. Follow us @egenesisbio.
Contacts
Media Contact
Kimberly Ha
eGenesis
kimberly.ha@egenesisbio.com
