The Work Necessary to Bring Porcine Kidney Transplant to the Clinic
David-Alexandre Gros, MD, the chief executive officer of Eledon Pharmaceuticals, also discussed other future plans for the company.
This is the third part of an interview with David-Alexandre Gros, MD. For the first part, click here. For the second part, click here.
David-Alexandre C. Gros, MD
Credit: Eledon
EGenesis is currently developing EGEN-2784, a porcine kidney that features a number of genetic modifications intended to prevent rejection in human patients, which is to be used alongside an immunosuppression regimen that includes Eledon Pharmaceuticals’ tegoprubart, an investigational monoclonal antibody intended to improve the efficacy and safety of kidney transplants. Earlier this year, the companies successfully completed 2 in-human kidney xenotransplants with this regimen.
Following those successes, CGTLive® spoke with David-Alexandre C. Gros, MD, Eledon’s chief executive officer, to learn more about the company's next steps. Gros went over future plans for bringing EGEN-2784 to the clinic, as well as additional programs that Eledon is working on involving tegoprubart.
CGTLive: What is Eledon planning for the future when it comes to kidney xenotransplant?
David-Alexandre C. Gros, MD: We've just done this our second kidney xenotransplant, and while it's exciting, we remain in maybe not the early innings, but we're probably now in the early-middle innings in terms of being able to develop these organs and bring them in a more mainstream manner to the public, into patients that are waiting for organs.
What still needs to be developed is is multiple-fold. We still need to do full clinical trials, but now the FDA has begun to give a path forward into those clinical trials, and those are the trials that will need to be run in order to get approval from the agency. From a technical perspective, and that's associated with those trials, we also need to to continue to optimize the immunotherapy regimen that will be given alongside those organs. Xenotransplantation is very different from allotransplantation. It's much harder to control, as you can imagine, an organ that came from a different species. As such, there continues to be work, which is what we're doing as a function and as a part of the trials in order to figure out what is going to be the best regimen that can be given.
And finally, of course, we're going to need to over time fully build up the manufacturing capacity (in this case, the breeding capacity) to make sufficient organs to help meet the demand, which, as we mentioned, could be thousands and thousands of kidneys or hearts or other organs a year. In terms of us, we're going to continue to be very active here. Today, we have collaborations truly around the world, from here, to Europe, to China, and we are going to continue to do multiple different types of xenotransplantations. We very much look forward to being able to continue to partner with the xenotransplantation players around the globe.
Is there anything else you want to share?
I think the last message I will leave with people is that for us at Eledon, this is going to be a very exciting year. Last year, we presented our first sets of data in allotransplantation (human to human transplantation) both for kidney, as well as islet cell.
Islet cell transplants could help bring functional cures to type 1 diabetes. This year, we expect to have a lot more data. So we expect to continue to have data and use in xenotransplantation of course, we expect to have our phase 2 data from our first head-to-head trial in tacrolimus in the fourth quarter of this year—and there we're looking to show that tegoprubart is superior to tacrolimus. It's a direct head-to-head trial looking at superiority, and that's defined by kidney function or estimated glomerular filtration rate.
Finally, later on this year, we also expect to be able to share some more updated news on our phase 2 trial in islet cell transplantation. At some point this year, we'll likely also give an update and release data on the preclinical work that we've done in kidney transplantation.
So for us, xenotransplant is an important part of what we do, but it remains overall, just a portion of what the company is working on, and a portion of the promise that tegoprubart may bring. We're very excited to look at the future data and be able to share that with the transplant community more broadly.
This transcript has been edited for clarity.
