
eGenesis: Revolutionizing transplantation with a gene editing platform for human-compatible organs.
eGenesis controls the full xenotransplant supply chain after acquiring the facilities, equipment, land, and staff of ICBiotec in May 2020. That vertical integration covers research, cloning, donor production, and release testing inside high-biosecurity facilities. The company states it is the only developer carrying all three edit classes on its donor organs for safety and efficacy.
The platform combines retroviral inactivation, triple glycan knockout, and human transgene insertion across kidney, liver, and heart programs. Clinical execution adds a further edge, with the first living-patient porcine kidney transplant in March 2024, five Expanded Access kidney patients by 2026, and cleared Investigational New Drug applications for kidney and liver.
Source: egenesisbio.com
Demand for transplantable organs far exceeds supply, with more than 800,000 people in the United States living with end-stage renal disease and over 90,000 on the kidney waitlist against roughly 25,000 annual kidney transplants. Human-compatible donor organs from eGenesis offer a potential alternative to waitlist mortality as clinical evidence accumulates. The September 2024 Series D financing of 191 million dollars led by Lux Capital funds the RESTORE Phase 1/2/3 kidney trial and scaled production.
The liver program extends the same opportunity into acute-on-chronic liver failure in intensive care through the OrganOx extracorporeal system. Continued Expanded Access results, the planned RESTORE study, and the preclinical heart program position eGenesis to address kidney, liver, and heart failure markets as xenotransplantation moves toward formal clinical adoption.
Source: egenesisbio.com
The EGEN genome engineering and production platform underpins three organ programs at eGenesis. Lead candidate EGEN-2784 is a gene-edited porcine kidney with triple glycan knockouts, seven human transgenes, and silenced retroviruses for patients with end-stage kidney disease. The program holds a cleared Phase 1/2/3 Investigational New Drug application and an ongoing Expanded Access study at Massachusetts General Hospital.
EGEN-5784 ELC pairs a gene-edited porcine liver with the OrganOx extracorporeal cross-circulation system for acute-on-chronic liver failure, also under a cleared Investigational New Drug application. EGEN-4467 is a preclinical gene-edited porcine heart candidate that extends the same editing approach to heart transplant.
Source: egenesisbio.com