eGenesis Completes Second Successful Xenotransplantation as Field Advances

eGenesis has announced the successful completion of its second human transplant using a genetically engineered pig kidney, marking a significant milestone in the field of xenotransplantation. The procedure, performed on January 25, 2025, at the Mass General Transplant Center in Boston, is part of the company's ongoing clinical study for patients with end-stage renal disease (ESRD) and kidney failure.

Breakthrough in Organ Transplantation

The recipient, 66-year-old Tim Andrews, had been on dialysis for over two years and faced complications including a heart attack. With type O blood, Andrews was facing an extended wait time of 5-10 years for a compatible donor. Following the xenotransplant procedure, Andrews was discharged on February 1, having skipped dialysis for the first time in years.

eGenesis CEO Michael Curtis, Ph.D., hailed the procedure as "more than a scientific milestone," stating, "We stand at the beginning of a future where organ shortages may no longer dictate patient outcomes."

The company's approach involves using CRISPR gene editing to make pig organs more compatible with the human immune system. This includes eliminating three antigens that trigger acute responses, adding seven human transgenes to reduce inflammation, and removing endogenous retroviruses from the porcine genome. In total, eGenesis makes up to 69 separate edits to the pig organs.

Innovative Immunosuppression and Clinical Trial Progress

As part of the procedure, Andrews underwent an investigational immunosuppression regimen using tegoprubart, a monoclonal CD40L antibody developed by Eledon Pharmaceuticals. This antibody aims to disrupt immune cell communication, potentially improving transplant outcomes.

Eledon CEO David-Alexandre Gros, M.D., emphasized the importance of blocking CD40 Ligand in translating organ transplants from nonhuman primates to humans. Tegoprubart is currently being evaluated in three global organ rejection studies for kidney transplant patients and a separate trial for islet transplant rejection in Type 1 diabetes patients.

The FDA granted approval to eGenesis, Eledon, and MGH in December 2024 to proceed with this procedure and two additional xenotransplants in 2025. This progress comes as other companies in the field, such as United Therapeutics, also advance their xenotransplantation programs. United Therapeutics recently received FDA clearance to launch a clinical trial of its modified pig kidney, with the first procedure planned for mid-2025.

Addressing the Organ Shortage Crisis

The success of these xenotransplantation procedures offers hope for the more than 800,000 people in the U.S. suffering from ESRD. Currently, over 100,000 patients are on the waitlist for a kidney transplant, with only about 25,000 operations performed annually due to organ shortages.

As the field of xenotransplantation continues to advance, it has the potential to revolutionize organ transplantation and provide a solution to the global organ shortage crisis. The ongoing clinical trials and successful procedures mark significant steps toward making this innovative approach a viable option for patients in need.