eGenesis provided a clinical update from an ongoing Expanded Access study of EGEN-2784, its genetically engineered porcine kidney for treatment of kidney failure.
The company reports that five patients have received EGEN-2784 transplants since March 2024 in collaboration with the Mass General Brigham health system.
According to the company, three patients have achieved sustained kidney function for more than eight months without the need for dialysis, and one patient has surpassed nine months of dialysis independence, which the company claims is a new global record for a genetically engineered porcine kidney transplant and remains on study.
eGenesis states that two patients subsequently transitioned to human donor kidney transplants, described as the first reported transitions from xenotransplantation to allotransplantation.
The company also noted that the U.S. Food and Drug Administration has cleared a Phase 1/2/3 RESTORE trial of EGEN-2784 in 33 patients aged 50 to 70 who are waitlisted for a human donor kidney, with initiation expected in the first quarter of 2027.
EGEN-2784 carries three classes of genetic modifications intended to address rejection, immune and coagulation responses, and endogenous retrovirus safety, and the program was conducted with investigators and surgeons at Mass General Brigham.
