The Business of Biofabrication

Massachusetts-based biotech eGenesis has received a key FDA clearance to launch a landmark clinical trial testing EGEN-2784, a multiplex gene-edited pig kidney designed for human transplantation. The investigational new drug (IND) approval enables a combined Phase 1/2/3 study that will evaluate the organ’s safety and performance in patients with end-stage kidney disease (ESKD) over a 24-week period.

The first cohort will enroll dialysis-dependent patients age 50 and older who are already on the national transplant waiting list—a group that faces long delays and limited options for life-saving therapy.

Biofabrication at the Frontier of Xenotransplantation

EGEN-2784 represents a sophisticated convergence of biofabrication and gene-editing technologies:

• Triple immune-evasion edits – Three porcine glycan antigens are deleted to prevent hyperacute rejection.
• Seven human transgenes – Inserted to modulate immune response, reduce inflammation, and improve coagulation and complement compatibility.
• Retrovirus inactivation – Endogenous porcine retroviruses are silenced to mitigate cross-species infection risks.

These multiplex CRISPR edits transform a standard pig kidney into a “human-compatible” organ, potentially solving a critical supply bottleneck in transplantation. Without these modifications, a pig kidney would be rejected within minutes.

Clinical Context: The ESKD Burden

End-stage kidney disease affects millions globally and often stems from diabetes or uncontrolled hypertension. Current treatments—dialysis or human kidney transplantation—carry high costs, strict dietary limits, and severe quality-of-life trade-offs. The eGenesis program aims to expand the donor pool and reduce dependence on long-term dialysis.

Early Human Experience

The IND clearance follows encouraging data from an FDA-authorized Expanded Access study in which three patients received EGEN-2784 kidneys.

• Tim Andrews, 67, received his transplant at Massachusetts General Hospital in January 2025 and has lived more than seven months dialysis-free—the longest documented survival for a genetically engineered pig organ recipient.
• Bill Stewart, 54, was transplanted in June 2025 and left the hospital dialysis-free just one week later.

These milestone cases underscore the clinical promise of engineered xenografts.

What It Means for Biofabrication

This trial positions eGenesis at the cutting edge of biofabricated organ therapeutics, a sector that blends advanced gene editing, regenerative medicine, and scalable tissue engineering. Success could catalyze:

• A new supply chain for transplantable organs manufactured from gene-edited livestock.
• Downstream applications in 3D-bioprinted scaffolds and hybrid human-animal grafts.
• Regulatory precedents for other engineered tissues, from vascular grafts to whole-organ replacements.

As the study moves forward, the biofabrication community will watch closely—both for clinical outcomes and for signals on how FDA will regulate future human-compatible organs.

About eGenesis

eGenesis is a Cambridge, Massachusetts–based biotechnology company pioneering next-generation xenotransplantation. Founded by a team of leading synthetic biologists and CRISPR innovators, the company leverages multiplex gene-editing and advanced organ-engineering methods to create human-compatible organs sourced from genetically modified pigs. Its pipeline includes kidney, liver, heart, and islet cell programs aimed at alleviating the global shortage of transplantable organs. By integrating cutting-edge genome engineering with scalable biofabrication, eGenesis seeks to transform the future of transplantation and provide life-saving solutions for patients with end-stage organ disease.

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