Cambridge, Massachusetts — September 3, 2026
eGenesis announced an important clinical update from its ongoing Expanded Access study of EGEN-2784, a genetically engineered porcine kidney being developed for patients with kidney failure. Since March 2024, five patients have received EGEN-2784 kidney transplants through the Expanded Access program conducted in collaboration with the Mass General Brigham health system. The company reported that three patients achieved sustained kidney function for more than eight months without dialysis, while one patient remained dialysis-independent for more than nine months, establishing a new reported duration for a genetically engineered porcine kidney transplant. Two patients subsequently transitioned to human donor kidney transplantation, providing important clinical evidence for the potential role of xenotransplantation as an approach that could provide temporary kidney function while patients remain eligible for a future human donor transplant.
EGEN-2784 Provides Extended Dialysis Independence
The latest clinical experience highlights the potential of genetically engineered pig kidneys to provide meaningful kidney function in patients affected by kidney failure. Among the five patients treated under Expanded Access, the company reported sustained periods of dialysis independence in multiple recipients. One patient, Tim Andrews, achieved approximately nine months of dialysis independence with an EGEN-2784 kidney before receiving a human donor kidney 82 days after removal of the xenograft. His clinical experience was also reported in The Lancet. Importantly, two patients successfully transitioned from an engineered porcine kidney to a human donor kidney, representing the first reported cases of this type of transition following xenotransplantation. These experiences provide early clinical evidence that an engineered kidney could potentially serve as a bridge to transplantation while preserving the possibility of subsequent treatment with a human donor organ.
Engineered Kidney Uses Multiple Genetic Modifications
EGEN-2784 incorporates multiple genetic modifications intended to address major barriers associated with xenotransplantation. The engineered porcine kidney contains three classes of genetic modifications, including the elimination of three glycan antigens designed to reduce hyperacute immune rejection. Seven human transgenes have also been introduced to help regulate immune responses, reduce inflammation, improve coagulation compatibility and regulate complement activation. In addition, endogenous retroviruses have been inactivated as part of the product’s safety strategy. Together, these modifications are intended to improve compatibility between the porcine organ and human recipients while supporting kidney function following transplantation. The clinical observations from the Expanded Access program are therefore providing eGenesis with additional experience as it prepares to evaluate the approach in a controlled clinical development program.
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eGenesis Prepares Phase 1/2/3 RESTORE Study
Following the Expanded Access experience, eGenesis is preparing to advance EGEN-2784 into the FDA-cleared Phase 1/2/3 RESTORE clinical trial, which is expected to begin in the first quarter of 2027. The study is planned to evaluate EGEN-2784 in 33 patients with kidney failure who are between 50 and 70 years of age and currently waitlisted for a human donor kidney transplant. The upcoming trial represents an important transition from individual Expanded Access experiences toward a structured clinical evaluation of genetically engineered kidney transplantation. The company’s clinical development strategy is focused on addressing the severe shortage of human donor organs that limits access to transplantation for patients with end-stage kidney disease. The sustained dialysis independence reported in the Expanded Access program, together with successful subsequent human transplantation in two patients, provides early clinical evidence supporting continued investigation of EGEN-2784 as eGenesis moves toward its next-stage clinical development program.
Source: eGenesis press relese
