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.
The bet
Bets CRISPR-edited pig organs avoid rejection: knock out 3 sugar antigens, add 7 human genes, inactivate retroviruses, then FDA Expanded Access and trials.
Early disclosed funding of $38M (2017, Harvard Gazette); completed a $191M Series D round in 2024-09 (led by Lux Capital).
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.
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).
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.
Translate vision into auditable milestones; each step had public record, so investors funded before trials.
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.
FOLLOW THE EVIDENCE
The sources
- eGenesis Announces IND Clearance for EGEN-2784 in Kidney Transplant and Landmark Patient Updates in Ongoing Expanded Access Study eGenesis · egenesisbio.com ·
- FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD HCPLive · hcplive.com ·
- eGenesis Raises $191 Million Series D Financing to Advance Lead Program for Kidney Transplant eGenesis · egenesisbio.com ·
- Pig organs for human patients: A challenge fit for CRISPR Harvard Gazette · news.harvard.edu ·