Eledon Pharmaceuticals Announces Use of Tegoprubart as Key Component of Immunosuppression Regimen in its Second Transplant of a Genetically Modified Pig Kidney into a Human
Eledon Pharmaceuticals (NASDAQ: ELDN) announced that its investigational anti-CD40L antibody, tegoprubart, was used in a successful xenotransplantation of a genetically modified pig kidney into a human at Massachusetts General Hospital (MGH) on January 25, 2025. The patient has been discharged and is now off dialysis for the first time in over two years.
This marks the second kidney xenotransplant at MGH using tegoprubart as a key component of the immunosuppression regimen. The FDA approved MGH to perform two additional xenotransplants this year. Tegoprubart was also used in the second-ever pig-to-human heart transplant at the University of Maryland Medical Center in September 2023.
The drug is currently being evaluated in three global clinical studies for organ rejection prevention in kidney transplants and in a separate trial for islet transplant rejection in type 1 diabetes patients. Eledon plans to report interim clinical trial results in summer 2025 and topline results from its Phase 2 BESTOW kidney transplant trial in Q4 2025.
Eledon Pharmaceuticals (NASDAQ: ELDN) ha annunciato che il suo anticorpo sperimentale anti-CD40L, tegoprubart, è stato utilizzato con successo in una xenotrapianto di un rene di maiale geneticamente modificato in un paziente umano presso il Massachusetts General Hospital (MGH) il 25 gennaio 2025. Il paziente è stato dimesso ed è ora senza dialisi per la prima volta in oltre due anni.
Questo segna il secondo xenotrapianto di rene presso il MGH utilizzando tegoprubart come componente chiave del regime di immunosoppressione. La FDA ha approvato il MGH per eseguire due ulteriori xenotrapianti quest'anno. Tegoprubart è stato anche utilizzato nel secondo trapianto di cuore da maiale a umano presso l'Università del Maryland Medical Center nel settembre 2023.
Il farmaco è attualmente valutato in tre studi clinici globali per la prevenzione del rigetto d'organo nei trapianti di rene e in un trial separato per il rigetto del trapianto di isole nei pazienti con diabete di tipo 1. Eledon prevede di riferire i risultati provvisori degli studi clinici nell'estate del 2025 e i risultati principali del suo trial di Fase 2 BESTOW per il trapianto di rene nel quarto trimestre del 2025.
Eledon Pharmaceuticals (NASDAQ: ELDN) anunció que su anticuerpo experimental anti-CD40L, tegoprubart, fue utilizado con éxito en un xenotrasplante de un riñón de cerdo genéticamente modificado en un humano en el Massachusetts General Hospital (MGH) el 25 de enero de 2025. El paciente ha sido dado de alta y ahora está libre de diálisis por primera vez en más de dos años.
Esto marca el segundo xenotrasplante de riñón en MGH utilizando tegoprubart como un componente clave del régimen de inmunosupresión. La FDA aprobó a MGH para realizar dos xenotrasplantes adicionales este año. Tegoprubart también se utilizó en el segundo trasplante de corazón de cerdo a humano en el Centro Médico de la Universidad de Maryland en septiembre de 2023.
El medicamento se está evaluando actualmente en tres estudios clínicos globales para la prevención del rechazo de órganos en trasplantes de riñón y en un ensayo separado para el rechazo del trasplante de islotes en pacientes con diabetes tipo 1. Eledon planea informar los resultados provisionales de los ensayos clínicos en el verano de 2025 y los resultados finales de su ensayo de Fase 2 BESTOW de trasplante de riñón en el cuarto trimestre de 2025.
Eledon Pharmaceuticals (NASDAQ: ELDN)는 그들의 실험적 항체 anti-CD40L인 tegoprubart가 2025년 1월 25일 매사추세츠 종합 병원(MGH)에서 유전자 변형된 돼지 신장을 인간에게 성공적으로 이식하는 데 사용되었다고 발표했습니다. 해당 환자는 퇴원하였으며, 2년 넘게 처음으로 투석 없이 생활하고 있습니다.
이는 MGH에서 tegoprubart를 면역억제 요법의 주요 구성요소로 사용하는 두 번째 신장 이식입니다. FDA는 MGH에서 올해 추가로 두 개의 이식을 수행할 수 있도록 승인했습니다. Tegoprubart는 또한 2023년 9월 메릴랜드 대학교 의료 센터에서 두 번째 돼지-인간 심장 이식에 사용되었습니다.
현재 이 약물은 신장 이식에서 장기 거부 방지를 위한 세 가지 글로벌 임상 연구와 제 1형 당뇨병 환자의 췌장 섬 이식 거부를 위한 별도의 시험에서 평가되고 있습니다. Eledon은 2025년 여름에 임상 시험의 중간 결과를 보고할 계획이며, 2025년 4분기에는 Phase 2 BESTOW 신장 이식 시험의 주요 결과를 발표할 예정입니다.
Eledon Pharmaceuticals (NASDAQ: ELDN) a annoncé que son anticorps expérimental anti-CD40L, tegoprubart, a été utilisé avec succès dans une xenotransplantation d'un rein de porc génétiquement modifié chez un humain au Massachusetts General Hospital (MGH) le 25 janvier 2025. Le patient a été sorti et ne nécessite plus de dialyse pour la première fois depuis plus de deux ans.
Ceci marque la deuxième xenotransplantation rénale au MGH utilisant tegoprubart comme un composant clé du régime d'immunosuppression. La FDA a approuvé le MGH pour réaliser deux autres xenotransplantations cette année. Tegoprubart a également été utilisé lors de la seconde transplantation cardiaque de porc à humain au Centre Médical de l'Université du Maryland en septembre 2023.
Le médicament est actuellement évalué dans trois études cliniques mondiales pour la prévention du rejet d'organes dans les transplantations rénales et dans un essai séparé pour le rejet des transplantations d'îlots chez les patients atteints de diabète de type 1. Eledon prévoit de rapporter les résultats intermédiaires des essais cliniques à l'été 2025 et les résultats globaux de son essai de phase 2 BESTOW sur la transplantation rénale au quatrième trimestre 2025.
Eledon Pharmaceuticals (NASDAQ: ELDN) gab bekannt, dass sein experimenteller anti-CD40L-Antikörper, tegoprubart, am 25. Januar 2025 erfolgreich bei einer Xenotransplantation einer genetisch modifizierten Schweinsniere in einen Menschen im Massachusetts General Hospital (MGH) verwendet wurde. Der Patient wurde entlassen und ist nun zum ersten Mal seit über zwei Jahren von der Dialyse befreit.
Dies markiert die zweite Xenotransplantation einer Niere am MGH unter Verwendung von tegoprubart als Schlüsselbestandteil des ImmunSuppressionsregimes. Die FDA genehmigte das MGH, in diesem Jahr zwei zusätzliche Xenotransplantationen durchzuführen. Tegoprubart wurde auch beim zweiten Herztransplantat von Schwein zu Mensch im Universitätsklinikum Maryland im September 2023 verwendet.
Das Medikament wird derzeit in drei globalen klinischen Studien zur Verhinderung von Organabstoßung bei Nierentransplantationen sowie in einer separaten Studie zur Abstoßung von Inselzelltransplantaten bei Typ-1-Diabetes-Patienten bewertet. Eledon plant, im Sommer 2025 vorläufige Ergebnisse der klinischen Studien zu berichten und die Gesamtergebnisse seiner Phase-2-BESTOW-Nierentransplantationsstudie im vierten Quartal 2025 zu präsentieren.
- Second successful xenotransplant procedure using tegoprubart as key immunosuppression component
- FDA approval for two additional xenotransplants at MGH
- Patient successfully discharged and taken off dialysis
- Multiple ongoing clinical trials for tegoprubart in various transplant applications
- Initial data showed first cases of insulin independence without tacrolimus in islet transplant trial
- None.
Insights
The successful use of tegoprubart in a second xenotransplantation represents a significant milestone in addressing the critical organ shortage crisis. This achievement is particularly noteworthy as it demonstrates reproducible success in xenotransplantation, a field that could revolutionize organ transplantation.
The drug's unique mechanism targeting CD40L positions it as a potential cornerstone therapy in transplantation. What's particularly compelling is the drug's versatility, being evaluated across multiple transplant scenarios:
- Prevention of rejection in kidney transplants (Phase 1b and Phase 2 BESTOW trial)
- Islet cell transplantation for Type 1 diabetes
- Xenotransplantation procedures (pig-to-human kidney and heart)
The upcoming clinical milestones create significant value-driving catalysts:
- Summer 2025: Phase 1b and long-term safety data in kidney transplant
- Q4 2025: Phase 2 BESTOW trial topline results
- 2025: Additional xenotransplants planned at MGH
The early success in achieving insulin independence without tacrolimus in islet transplantation is particularly promising, as it suggests potential superiority over current standard-of-care treatments. With over 90,000 patients awaiting kidney transplants in the US alone, the market opportunity for an effective immunosuppressant that enables both traditional and xenotransplantation is substantial.
Patient treated in procedure, conducted at Mass General Transplant Center and in collaboration with partner eGenesis, was recently released from hospital
Investigational therapy tegoprubart targets CD40 ligand (CD40L) with potential to improve both safety and efficacy compared to standard of care immunosuppression regimens
IRVINE, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a key component of the immunosuppression therapy regimen in a patient who recently received a transplanted kidney from a genetically modified pig. The procedure was performed on January 25, 2025, by surgeons at Massachusetts General Hospital (MGH) in collaboration with our partner eGenesis. In December 2024, MGH received Food and Drug Administration (FDA) approval to proceed with this transplant and plans to perform two additional xenotransplants this year, further advancing the field of xenotransplantation. Following the successful transplant, the patient was discharged from the hospital and is now off dialysis for the first time in over two years.
“This second kidney xenotransplant conducted at MGH represents another important milestone in the effort to consider new strategies in transplantation and immunosuppression to address the global organ shortage crisis. We are grateful to the patient, the team at MGH, and our partner eGenesis for supporting tegoprubart’s central role in these landmark procedures,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Blocking the CD40 Ligand is a critical component of the immunosuppression regimen for effective translation of organ transplant from nonhuman primates into humans. Our anti-CD40L antibody tegoprubart represents a novel approach to immunosuppression therapy with the potential to improve safety and efficacy and enable patients to live longer with their transplanted organs.”
Similar to the first-ever kidney xenotransplant, also conducted at MGH in March 2024, tegoprubart is being administered to the current patient investigationally as part of a regimen designed to prevent the body from rejecting the transplanted pig organ. Tegoprubart is designed to block CD40L and has been shown to inhibit multiple costimulatory receptors including CD40 and CD11, key components of how immune cells communicate with one another. Based on extensive prior research, tegoprubart has been observed to be generally safe and well-tolerated in multiple potential indications, including for the prevention of rejection following kidney allotransplantation.
“I would like to thank Eledon for their work supporting this historic xenotransplant. Immunosuppression presents one of the greatest challenges for transplantation in both human and non-human organs. The need for advancements in immunosuppressive medications is critical for advancing our field and improving the quality of life for transplant patients everywhere,” said Dr. Leonardo Riella, MD, PhD, Medical Director for Kidney Transplantation at Massachusetts General Hospital.
Tegoprubart was also used as a cornerstone component of the chronic immunosuppression regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human, performed at the University of Maryland Medical Center in September 2023. Currently, tegoprubart is being evaluated in three global clinical studies for the prevention of organ rejection in patients receiving kidney transplants and in a separate investigator sponsored trial for the prevention of islet transplant rejection in patients with type 1 diabetes (T1D). Eledon recently announced initial data from this investigator-initiated islet transplant trial, conducted by the research team at the University of Chicago Medicine Transplant Institute, that demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection.
The Company plans to report updated interim clinical trial from its ongoing Phase 1b and long-term safety and efficacy extension studies in kidney transplant this summer, topline results from its Phase 2 BESTOW kidney transplant trial in the fourth quarter of 2025, and longer-term follow up results from the investigator-led islet transplant clinical trial at UChicago Medicine Transplant Institute later this year.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
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Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
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Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com
Media Contact:
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CG Life
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Source: Eledon Pharmaceuticals
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