Biotech firm eGenesis has raised $191 mn to advance its genetically modified pig kidney transplant program, utilizing its gene-editing technology that makes pig organs more compatible with human immune systems. The raised funds will be used to support clinical trials for the company's lead candidate - EGEN-2784 - a pig kidney engineered to be human-compatible after successful, though short-lived, human transplant earlier in 2024.

The procedure represents a breakthrough in xenotransplantation - the process of transplanting organs and tissues between different species - to reduce organ rejection and target long transplant waitlists.

The following article originally appeared in Medical Device Network.

Investors are rallying around the promise of cross-species transplantation, enabling eGenesis to close a $191m Series D financing round to advance its genetically engineered porcine kidney organ.

The US biotech said the funds will advance its candidate – called EGEN-2784 – to a first-in-human study, push its pipeline, and scale production, according to a 4 September press release.

The funding was led by Lux Capital with participation from the investment arms of Eisai and Bayer, amongst others.

eGenesis has developed its organ to combat kidney transplant waitlists for patients with end-stage renal disease or kidney failure. Transplantation is the gold-standard treatment in these patient groups, but demand far exceeds supply. The company states that there are more than 90,000 individuals on a waitlist while approximately 25,000 kidney transplants are performed each year. Most people wait three to five years for a kidney, according to the American Kidney Fund.

eGenesis says its product offers a viable alternative to end waitlist mortality and alleviate transplantable organ shortages.

Lux Capital managing partner Peter Hebert said: “What was once science fiction is now science fact. We are thrilled to support eGenesis in advancing this pivotal modality to address one of the most intractable challenges facing medicine today – the global organ shortage crisis.”

The company is banking on the potential of xenotransplantation – whereby cells, tissues, or organs are transplanted from one species to another. The FDA regulates xenotransplantation without a device element as biologic products, as per guidance updated in 2016.

The company’s modified kidney carries three types of edits, including the insertion of several human transgenes and the removal of porcine ones, which help avoid rejection by the human recipient. According to the company, its technology addresses cross-species molecular incompatibilities and viral risk.

eGenesis became the first company to successfully transplant a porcine kidney into a living patient, named Rick Slayman, in March 2024 under the FDA’s expanded access programme. The end-stage kidney disease patient died two months later, though Massachusetts General Hospital (MGH) – where the procedure was carried out – said there was no indication the death was a result of the transplant. At the time, eGenesis called Slayman a “true pioneer” whose “courage has helped to forge a path forward for current and future patients suffering from kidney failure”.

While xenotransplantation promises organ shortage alleviation in the future, there are still some ethical questions raised by animal rights organisations such as PETA. This includes the ideal quality of living experienced by pigs living on farms, along with the justified use of genetic alteration.

In a July 2024 statement, PETA senior vice president Kathy Guillermo: “Xenotransplantation is a dead end. It’s a waste of humans’ and other animals’ lives, a waste of money, and a waste of an opportunity to create a kinder, simpler solution.

“Every human patient who has received a transplant of an organ removed from a pig has now died, and none has survived more than two months following the procedure. Experimenters must stop tinkering and clean up the organ procurement system. That will save lives.”

For more, please find the original story source here.