Eledon Pharmaceuticals Announces Use of Tegoprubart in First-ever Transplant of Genetically Modified Kidney from a Pig to a Human
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The recent use of tegoprubart in a groundbreaking kidney xenotransplantation at Massachusetts General Hospital represents a significant advancement in the field of transplant medicine. Tegoprubart's role in suppressing the immune response to foreign organs is pivotal, as traditional immunosuppressive therapies have limitations. The successful application in this high-profile case suggests potential for wider adoption in xenotransplantation, which could eventually alleviate the organ shortage crisis.
From a research perspective, the safety and efficacy data from preclinical and ongoing clinical studies are encouraging. The ability of tegoprubart to function without calcineurin inhibitors, which are commonly used in immunosuppressive regimens but have nephrotoxic side effects, could represent a paradigm shift in post-transplant care. The focus on CD40L, a key mediator in the immune response, is particularly noteworthy as it offers a targeted approach to immunosuppression, potentially reducing the risk of rejection and improving long-term graft survival.
The announcement of tegoprubart's successful use in a xenotransplantation procedure is likely to have positive implications for Eledon Pharmaceuticals' market position. As the company progresses through clinical trials, the data suggesting tegoprubart's safety and effectiveness in preventing organ rejection could lead to increased investor confidence. This is especially relevant given the current organ shortage and the demand for innovative solutions in transplantation.
Investors should monitor the progress of the Phase 2 BESTOW study, which compares tegoprubart to tacrolimus, a current standard in immunosuppression. Positive outcomes from this head-to-head study could significantly impact Eledon's stock valuation, as it may position tegoprubart as a superior alternative in the transplant medication market. The timeline for completion of enrollment by the end of 2024 provides a clear checkpoint for evaluating the company's trajectory and potential market impact.
The broader implications of tegoprubart's successful use in xenotransplantation extend beyond the medical field into healthcare economics. If tegoprubart proves to be a viable immunosuppressant in the long term, it could lead to a shift in transplantation economics. The ability to use organs from genetically modified animals could significantly reduce the cost associated with human organ transplants, which includes not only the surgery but also the prolonged wait times and associated healthcare costs.
Furthermore, the reduction in reliance on human donors could alleviate the economic burden on healthcare systems by shortening waitlists and potentially improving patient outcomes. However, it's essential to consider the cost of developing and producing new drugs like tegoprubart, as these innovative treatments may initially be expensive. Over time, as the technology matures and becomes more widely adopted, economies of scale could lead to reduced costs and increased accessibility for patients in need of transplants.
Historic kidney xenotransplantation procedure conducted at Massachusetts General Hospital
Tegoprubart administration has now been used investigationally to prevent rejection in both kidney and heart pig-to-human xenotransplantations, as well as in human-to-human kidney transplantation
Eledon recently presented results from its ongoing Phase 1b kidney transplantation study which demonstrated that tegoprubart was generally safe and well tolerated and successfully prevented rejection with post-transplant kidney function above historical averages
IRVINE, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human. The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man living with end-stage kidney disease.
“This first-ever kidney xenotransplant marks a pivotal moment for the transplant community and provides hope that this option may one day help solve the current shortage of available organs,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Eledon has now participated in both heart and kidney xenotransplant procedures, further demonstrating tegoprubart’s broad potential in transplant. We are thankful to the patient, the entire medical team at Massachusetts General Hospital, and our partner eGenesis for the privilege to participate in this landmark procedure as we work to achieve our goal of developing tegoprubart as a new and better immunosuppressive option for transplant patients.”
Tegoprubart is being administered to the patient investigationally as part of a regimen designed to suppress the immune system and prevent the body from rejecting the transplanted pig organ. Tegoprubart has been observed to be safe and well-tolerated in multiple studies and in multiple indications, including for the prevention of rejection following kidney transplantation.
“It is exciting to see the clinical application of xenotransplantation to a patient with end stage renal disease,” said Andrew Adams, MD, PhD, Chief, Division of Transplant Surgery, University of Minnesota. “Based on all of the studies performed in preclinical models to date, it is clear that therapies targeting CD40L, like tegoprubart, are critical to controlling the immune response to the xenograft, potentially leading to superior long-term outcomes compared to other immunosuppressive therapies. CD40L sits at the interface of the adaptive and innate immune responses which may explain why therapies designed to block it have such potent effects in xenotransplantation.”
“This procedure represents a significant milestone in the transplantation field and a promising step to address a medical crisis: the worldwide shortage of available organs,” said Leonardo V. Riella, MD, PhD, Medical Director for Kidney Transplantation at Massachusetts General Hospital. “Xenotransplantation represents a unique approach with the potential to provide patients with additional options to access life-saving treatments in a timely manner. We commend the courage of our patient and the skill of the entire team involved in the operation, and I look forward to continued advancements in research with the hope that we can make this novel treatment option available to more patients in the future.”
Multiple clinical and preclinical research efforts are currently underway to evaluate the ability of tegoprubart to reduce the risk of rejection in organ transplant. Eledon is advancing preclinical studies in which tegoprubart is being used as a part of the immunosuppression regimen designed to reduce the risk of rejection in nonhuman primate recipients in xenotransplant procedures. In parallel, Eledon is running two global clinical studies evaluating tegoprubart for the prevention of organ rejection in persons receiving a de novo kidney transplant. The company recently presented results from 11 participants enrolled in its ongoing Phase 1b kidney transplantation study, which demonstrated that tegoprubart, as part of a calcineurin inhibitor free immunosuppressive regimen, was generally safe and well tolerated and both successfully prevented rejection as well as permitted above historical average post-transplant kidney function. The company’s Phase 2 BESTOW study, assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation, is currently recruiting participants, and plans to complete enrollment at the end of 2024.
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
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Source: Eledon Pharmaceuticals
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