Kidney and Liver Failure

Kidney Failure

More than 800,000 people in the United States are living with kidney failure, yet only approximately 25,000 kidney transplants are performed each year. As a result, the vast majority of patients rely on dialysis, which is associated with significant morbidity, mortality, and reduced quality of life. The limited supply of donor kidneys means that many patients wait years for a suitable organ for transplant, and many die or become too sick to receive one.

At eGenesis, we are developing genetically engineered porcine organs designed to address these critical unmet needs. Our kidney program is focused on developing transgenic porcine kidneys for transplantation in patients with end-stage kidney disease, with the goal of allowing patients to live independent of dialysis and expanding the availability of transplantable organs beyond the limitations of human donation.

Liver Failure

Liver failure presents a similarly profound unmet medical need. Each year, tens of thousands of patients in the United States are hospitalized with acute-on-chronic liver failure (ACLF), a rapidly progressive syndrome associated with high short-term mortality. Many patients deteriorate too quickly to receive a liver transplant, while others are not eligible for transplantation or face prolonged waits for a suitable donor organ. Today, there are few effective therapies capable of providing temporary liver support while the native liver recovers or a transplant becomes available.

With our liver program we are evaluating a genetically engineered porcine liver perfusion system intended to provide temporary extracorporeal liver support for patients with acute-on-chronic liver failure, with the potential to bridge patients to recovery or to liver transplantation. Together, these investigational programs are intended to expand access to life-saving therapies for patients with organ failure and help address the persistent shortage of donor organs.

Clinical Studies

At eGenesis, we are advancing our investigational kidney and liver programs through a carefully designed clinical development strategy that builds evidence, step-by-step, to evaluate the safety and potential effectiveness of our technologies.

First Ever Clinical Kidney Xenotransplant

In March 2024, Mr. Rick Slayman received an eGenesis EGEN-2784 porcine kidney, becoming the first person in history to receive a transplant of a genetically engineered porcine kidney. The procedure was performed under an Expanded Access authorization granted by the U.S. Food and Drug Administration (FDA). Clinical results from Mr. Slayman’s transplant were subsequently published in the New England Journal of Medicine, establishing an important milestone for the field of xenotransplantation and providing the foundation for additional clinical procedures performed under the FDA’s Expanded Access pathway.

Each subsequent transplant has expanded our understanding of the clinical application of kidney xenotransplantation, including surgical management, recipient recovery, graft function, kidney physiology, immunosuppression, and the recipient immune response. These early clinical experiences are helping to optimize our approach and informing the design of future clinical studies. As evidence continues to accumulate, we expect these key learnings to support the expansion of clinical trials to larger patient populations with the goal of generating the data needed to support future regulatory review and, ultimately, making this investigational therapy available to more patients living with kidney failure.

Patient Experiences

At eGenesis, we recognize and honor the patients who have participated in these pioneering clinical procedures. Their willingness to contribute to early clinical research has generated invaluable knowledge that is advancing the science of xenotransplantation and informing the development of therapies for patients with organ failure.

Disclaimer

Patients who choose to share their personal experiences publicly — including through patient stories, interviews, or social media — do so as private individuals and are not spokespeople for eGenesis. Their statements reflect their own personal experiences and opinions.

FAQs

Xenotransplantation is the transplantation of living cells, tissues, or organs from one species into another. Among potential donor species, pigs are considered the most promising source of transplantable organs because their organ size and physiology are similar to those of humans. Advances in genetic engineering have made it possible to modify the porcine genome to improve compatibility with the human immune system, and decades of scientific research have provided a strong understanding of the biological challenges that must be addressed for successful xenotransplantation. In addition, pigs can be bred using well-established agricultural and biomedical practices, offering the potential to provide a reliable and scalable source of organs for patients in need.
Genetically engineered donor animals are produced by cloning a single genetically modified porcine cell that has been edited to improve compatibility with human biology and the human immune system, while also reducing the risk of transmitting infectious agents from the donor animal to the recipient. These donor animals are raised in specialized, biosecure facilities under carefully controlled conditions designed to promote their health and welfare and further minimize the risk of disease transmission. Once the donor animals reach the appropriate age, their organs are recovered and prepared for use in investigational clinical xenotransplant procedures.
Genetic edits are required to make the cells and organs of a pig more compatible with human cells and the human immune system and reduce the risk of disease transmission from the donor animal to the human recipient. Increasing the compatibility between a pig and human helps to reduce the response of the human immune system when a pig organ is transplanted into a patient.
eGenesis makes three types of edits to the genome (or DNA) of the pig to optimize the safety and efficacy of xenogeneic organs for patients:
1. Inactivation of porcine virus: the first type of edit we make is to prevent a virus common to all pigs (but not humans) from infecting human cells.
2. Prevention of hyperacute rejection: the second type of edit we make is to eliminate (or “knock out”) genes in the pig genome (or DNA) to prevent the pig from making specific molecules to which all humans have antibodies. If exposed to these molecules, the human immune response is so strong that the pig organ will be rapidly and severely damaged as a result, in a process known as “hyper-acute rejection.”
3. Promotion of long-term compatibility and organ function: the third type of edit we make is to add in (or “knock in”) copies of human genes so that the donor animal will produce proteins that help regulate the response of the human immune system, to make the pig kidney more compatible with humans. This helps to protect the pig organ from being rejected once it is transplanted in a patient.
Yes. Because the human immune system recognizes organs from another species as more foreign than organs from a human donor, immunosuppressive medications are currently required following a xenotransplant to help prevent organ rejection.
eGenesis is developing immunosuppressive regimens specifically designed for xenotransplantation with the goal of preventing rejection while preserving the body’s ability to respond to infections and other normal immune challenges. At the same time, we are continuing to advance the genetic engineering of our donor organs to improve their compatibility with the human immune system. As our understanding of the interactions between transplanted porcine organs and the human immune system continues to grow, we hope to further optimize both donor genetics and immunosuppressive strategies, with the long-term goal of reducing the amount of immunosuppression needed while maintaining durable healthy organ function.
Xenotransplantation is being studied as a potential option to expand the number of organs available to patients with organ failure, particularly those who may not have access to a human donor organ. As with any organ transplant, xenotransplantation carries risks, including organ rejection, infection, and other surgical and post-transplant complications. Because a xenotransplant involves an organ from another species, it may also carry risks that are not yet fully understood, including the potential for cross-species infection. Xenotransplantation has not been approved by the FDA; to date, the FDA has cleared several clinical trials evaluating xenotransplantation, as well as on a case-by-case basis for individual patients under the Expanded Access pathway described above.

Real Patients. Real Progress.

Pioneering patients have enabled eGenesis to advance our products into the clinic. Their courage and selflessness will continue to propel cross-species transplantation forward.

Mr. Richard Slayman · 52 days with transplant

The First Living Recipient of a Genetically Edited Porcine Kidney.

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Massachusetts General Hospital
Mr. Tim Andrews · 271 days with transplant

New Record Set with Nine Months Dialysis Independence.

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Massachusetts General Hospital: Kate Flock
Mr. Bill Stewart · 250 days with transplant

Advancing Potential for Future Patients.

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Boston Globe

Advancing New Options for Patients

Kidney and Liver Failure

Clinical Studies

FAQs

Real Patients. Real Progress.

Mr. Richard Slayman · 52 days with transplant

Mr. Tim Andrews · 271 days with transplant

Mr. Bill Stewart · 250 days with transplant

Our team

Meet the people behind eGenesis.