Data Update From Phase 1b Trial Shows Continued Tegoprubart Benefits

Islet Cell Transplant Patient Treated As Kidney Data Presentation Is Announced

First Transplant Of A Pig Kidney Uses Tegoprubart To Prevent Immune Rejection

3Q23 Reported With Review Of Clinical Progress

Robert LeBoyer

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Eledon Pharmaceuticals

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Summary.&nbsp;&nbsp;The journal Nature has published a preclinical study by Eledon&#8217;s research collaborator detailing changes genetic changes to porcine (pig) cells and the results of their transplantation. In September, the second successful transplant of an engineered pig heart to a human patient used Eledon&#8217;s tegoprubart for immune suppression. These developments have overcome technological barriers and could make trans-species organ transplantation a clinical reality.
Collaborator&#8217;s Study Details Some Of The Changes To Make Xenotransplants Compatible.&nbsp;While transplantation of an organ from one human to another (allograft) requires overcoming the immune system&#8217;s response to reject it, an organ from another species has many more immunological challenges. The Nature article by eGenesis,&nbsp;Eledon&#8217;s research collaborator, describes the design, creation, and results from genetically engineered porcine transplants into a cynomolgus monkey model. The article describes 69 genomic edits to the donor tissue, the addition of 7 human genes, and inactivation of endogenous retroviruses. In vitro functional analyses showed that the edited kidney endothelial cells modulated inflammation at a level that was indistinguishable from that of human endothelial cells. This data shows the genetically edited cells were highly compatible with the human immune system. The transplanted monkeys survived up to 758 days (108 weeks), a significant result.
Successful Xenotransplantation To A Human Is A Breakthrough. In September, a human patient successfully received a genetically engineered porcine heart, for only the second time ever.&nbsp; Tegoprubart was included in the post-transplant immunosuppressive regimen over the standard-of-care drugs. We see the inclusion of tegoprubart as a strong measure of confidence in its ability to prevent rejection with less toxicity. As xenotransplantation becomes a clinical reality, it could increase the number of transplants preformed and demand for tegoprubart.&nbsp;
As described in <a href="https://www.channelchek.com/news-channel/eledon-pharmaceuticals-eldn-initiating-coverage-with-an-outperform-rating-and-10-price-target">our report published September 27</a>, about 25,000 patients receive kidney transplants in the US each year, while another 110,000 are on a waiting list for a donor organ. After transplantation, patients must take immunosuppressive drugs to prevent the organ from being rejected. The current standard of care includes tacrolimus, mycophenolate, and steroids, even though these drugs have toxicities that lead to organ failure in about 10 to 12 years. Eledon is conducting a Phase 1b study testing tegoprubart in kidney transplantation and the Phase 2 BESTOW trial testing tegoprubart against tacrolimus in kidney transplantation.
Phase 1b Data Presentation Has Been Scheduled. Eledon announced the scheduling of a data update from the Phase 1b trial using tegoprubart in kidney transplant patients on November 2nd at the American Society of Nephrology Kidney Week. We expect the presentation to add to the initial data presented in April with additional patients followed for longer timeframes.&nbsp;
Conclusion. The study published in Nature showed proof-of-concept in preclinical models, while the successful heart transplant was a milestone in the transplantation field. While we believe clinical practice with engineered organs is years away, Eledon and eGenesis could emerge as leaders in the field. Near term, we expect the stock to be driven by milestones related to the kidney transplant trials. We are reiterating our Outperform rating and $10 price target

Eledon Pharmaceuticals (ELDN)

Journal Publishes Study On Tissue Engineering For Xenotransplantation Surgery

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Data Update From Phase 1b Trial Shows Continued Tegoprubart Benefits (ELDN)

Islet Cell Transplant Patient Treated As Kidney Data Presentation Is Announced (ELDN)

First Transplant Of A Pig Kidney Uses Tegoprubart To Prevent Immune Rejection (ELDN)

3Q23 Reported With Review Of Clinical Progress (ELDN)

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