The archive · Bio & Materials · Technical decision · 2015–2025
eGenesis bets edited pig kidneys can end organ shortage
FDA cleared eGenesis' trial; Expanded Access patients dialysis-free over 7 months.
eGenesis
What the business is
A clinical-stage biotechnology company doing xenotransplantation: it uses genetically edited pigs to produce organs such as kidneys for human transplantation, first advancing pipeline product EGEN-2784 pig kidney into FDA clinical trials.
Starting capital：Early disclosed funding of $38M (2017, Harvard Gazette); completed a $191M Series D round in 2024-09 (led by Lux Capital).
How it started
Founded in 2015 by Harvard Medical School geneticist George Church and former doctoral student Luhan Yang, spun out from Church's lab and licensed Harvard technology. Starting judgment: the biggest obstacles to xenotransplantation are immune rejection and porcine endogenous retroviruses (PERV), and this is exactly the multigene editing problem that CRISPR is good at—in 2015 the lab showed in Science the elimination of all 62 PERVs in pig cells, and in 2017 it also worked with eGenesis to produce 37 PERV-free pigs.
What happened
In 2024-03, under FDA Expanded Access authorization, Massachusetts General Hospital completed the world's first genetically edited pig kidney transplant in a living patient; in 2024-09, it completed a $191M Series D round (led by Lux Capital) to advance EGEN-2784 into formal clinical research; on 2025-01-25, Tim Andrews received a transplant at MGH and was dialysis-free for more than 7 months after surgery, becoming the longest-surviving recipient of a genetically edited pig-derived organ; on 2025-06-14, Bill Stewart became the 2nd recipient in the study and the 3rd recipient globally; on 2025-09-08, FDA approved the IND for EGEN-2784, supporting a Phase 1/2/3 trial in patients aged ≥50, dialysis-dependent, and on transplant waiting lists with end-stage kidney disease (assessed 24 weeks after transplant).
No ending yet — it is still running.
Background
eGenesis is a xenotransplantation company founded in 2015 in Cambridge, Massachusetts, betting that CRISPR can turn pig organs into transplant sources acceptable to humans. Its pipeline product EGEN-2784 pig kidney carries 3 types of edits—knocking out 3 sugar antigens to avoid hyperacute rejection, inserting 7 human transgenes to regulate immunity and coagulation, and inactivating endogenous retroviruses in the pig genome—and is the only organ pipeline in the industry with all 3 types of edits at the same time.
The company was spun out from Harvard's George Church lab, starting with CRISPR's unique ability for multigene editing: in 2015, the lab published the elimination of all 62 PERVs in pig cells in Science, and in 2017 produced 37 PERV-free pigs, addressing one of the biggest safety concerns in xenotransplantation. Over the following decade, it turned the biological problem step by step into verifiable clinical milestones.
In 2024-03, Massachusetts General Hospital completed the world's first genetically edited pig kidney transplant in a living patient under FDA Expanded Access authorization; in 2024-09, the company completed a $191M Series D round (led by Lux Capital); in 2025, the Expanded Access study continued, with Tim Andrews and Bill Stewart successively receiving EGEN-2784 kidney transplants and being dialysis-free after surgery; on 2025-09-08, FDA approved the IND for EGEN-2784, clearing a formal Phase 1/2/3 trial in patients with end-stage kidney disease.
As of 2026-09-01, the formal trial has just begun and long-term outcomes are not yet known. Regardless of the result, eGenesis has advanced 'using genetically edited pig organs to solve transplant shortages' from a scientific idea to a clinical stage with regulatory records and patient data—this is the closest step to validation in this track.
What has to be true
- Demand gap: 800,000 ESRD patients, 90,000 waitlisted, only 25,000-28,000 transplants yearly.
- High barrier: only organ pipeline with all 3 edit types simultaneously.
- Regulatory path: Expanded Access data led to IND; FDA clearance is hard milestone.
- Risk: immune compatibility, long-term function unproven; adverse event could setback category.
What can be applied
Translate vision into auditable milestones; each step had public record, so investors funded before trials.
Aftermath
As of 2026-09-01: eGenesis remains clinical-stage; the formal Phase 1/2/3 trial of EGEN-2784 has just been cleared by FDA; the Expanded Access study continues at MGH; the company advances kidney, liver (acute liver failure), and heart pipelines based on its 3-type gene editing platform. The decisive question—whether genetically edited pig kidneys can be safely tolerated long term in dozens of patients and replace dialysis—has no answer yet; the company's valuation and reason for being are staked on this one question.
Sources
- eGenesis Announces IND Clearance for EGEN-2784 in Kidney Transplant and Landmark Patient Updates in Ongoing Expanded Access Study
- FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD
- eGenesis Raises $191 Million Series D Financing to Advance Lead Program for Kidney Transplant
- Pig organs for human patients: A challenge fit for CRISPR
spotted an error? The archive wants to know.
Your turn
You just read one. Describe what you are building, and see who is betting on the same thing.
Free account · 3 free questions · no card