Tegoprubart
- Generic Name
- Tegoprubart
- Drug Type
- Biotech
- Unique Ingredient Identifier
- EK87C62XNH
Tegoprubart Successfully Used in Second Pig-to-Human Kidney Xenotransplant at MGH
• Massachusetts General Hospital successfully performed its second pig-to-human kidney transplant using Eledon's tegoprubart as a key immunosuppressant, with the patient now off dialysis after two years.
• Tegoprubart, an anti-CD40L antibody, demonstrates potential in preventing organ rejection by blocking multiple costimulatory receptors, marking a significant advancement in xenotransplantation.
• The procedure, performed on January 25, 2025, represents a crucial milestone in addressing the global organ shortage crisis, with MGH planning two additional xenotransplants this year.
TNX-1500 Shows Promising Safety Profile in Phase I Trial for Transplant Recipients
• Tonix Pharmaceuticals' TNX-1500, an anti-CD40L monoclonal antibody, demonstrated favorable safety and tolerability in Phase I trial with 26 healthy subjects across three dose cohorts.
• The drug showed effective immune modulation, successfully blocking anti-KLH antibody responses, with a half-life ranging from 19.6 to 37.8 days depending on dosage.
• Following positive results, Tonix plans to advance TNX-1500 to Phase II trials for kidney transplant recipients, with potential applications in preventing transplant rejection and treating autoimmune diseases.
FDA Approves Clinical Trials for Pig Kidney Transplants in Humans, Addressing Organ Shortage
• The FDA has approved clinical trials for two companies, United Therapeutics and eGenesis, to transplant genetically modified pig kidneys into humans with kidney failure.
• United Therapeutics will begin with six patients in mid-2025, potentially expanding to 50, while eGenesis will start with three patients, monitoring them closely.
• These trials aim to address the critical shortage of donor kidneys, with over 550,000 Americans facing kidney failure and approximately 100,000 on the transplant waiting list.
• Both companies have genetically modified pig genes to reduce organ rejection and improve compatibility with human bodies, but ethical and safety concerns persist.
Eledon's Tegoprubart Shows Promise in Functional Cure for Type 1 Diabetes
Eledon Pharmaceuticals reports a breakthrough in type 1 diabetes treatment, with two patients achieving insulin independence after receiving islet cell transplants combined with its experimental drug, tegoprubart. This pilot study, part of a broader effort to find safer immunosuppressant alternatives, marks a significant step towards functional cures for the disease.
Eledon Pharmaceuticals' Tegoprubart Shows Promise in Transplantation Therapies
• Eledon Pharmaceuticals completed Phase 2 BESTOW trial enrollment for tegoprubart in kidney transplantation, with topline results expected in Q4 2025.
• Updated Phase 1b data supports tegoprubart's safety and tolerability in preventing kidney transplant rejection, showing stable eGFR in patients.
• Initial data from a UChicago Medicine trial indicates tegoprubart may enable insulin independence in type 1 diabetes patients post-islet transplantation.
• Eledon secured $135 million in financing, expected to sustain operations through 2026, supporting ongoing clinical development of tegoprubart.
Xenotransplantation Advances: Pig Kidney Transplants Show Promise in Addressing Organ Shortage
• Towana Looney became the longest-living recipient of a pig kidney transplant, exceeding 60 days post-surgery, marking a significant milestone in xenotransplantation.
• Tim Andrews received a genetically-edited pig kidney at Massachusetts General Hospital, becoming the second living person with such a transplant and is now dialysis-free.
• United Therapeutics received FDA approval for a clinical trial of its UKidney, a gene-edited porcine kidney, signaling a move towards formal xenotransplantation studies.
• Researchers are sharing data and refining techniques to improve the safety and efficacy of pig organ transplants, addressing the critical shortage of human donor organs.
Tonix Pharmaceuticals' TNX-102 SL Awaits FDA Decision for Fibromyalgia Treatment
• Tonix Pharmaceuticals' TNX-102 SL, a non-opioid analgesic, has been assigned an FDA PDUFA goal date of August 15, 2025, for fibromyalgia treatment, potentially offering a new option for millions.
• TNX-102 SL demonstrated significant pain reduction and improved sleep quality in Phase 3 trials, addressing key fibromyalgia symptoms with a well-tolerated safety profile.
• The FDA previously granted Fast Track designation to TNX-102 SL, highlighting the urgent need for innovative treatments for fibromyalgia, a condition affecting mostly women.
• If approved, TNX-102 SL could be the first in a new class of drugs for fibromyalgia in over 15 years, providing a novel approach to managing this chronic pain disorder.
Tegoprubart Shows Promise in Preventing Rejection of Transplanted Islet Cells
• A clinical trial at UChicago Medicine suggests tegoprubart may improve outcomes for patients with unstable type 1 diabetes receiving islet transplants.
• Two out of three patients achieved normal blood sugar levels and eliminated insulin injections after islet transplantation with tegoprubart.
• Islet engraftment was estimated to be three to five times higher with tegoprubart compared to standard immunosuppression drugs.
• Researchers hope these findings will lead to wider adoption of islet transplantation as a standard therapy for brittle type 1 diabetes.
Tegoprubart Shows Promise in Achieving Insulin Independence After Islet Transplantation
• Initial data from a University of Chicago study show that tegoprubart, an anti-CD40L antibody, helped two out of three patients achieve insulin independence after islet transplantation.
• Islet engraftment was three to five times higher in patients treated with tegoprubart compared to those receiving standard tacrolimus-based immunosuppression.
• Tegoprubart was generally well-tolerated, with no unexpected adverse events or severe hypoglycemic episodes reported during the study.
• These findings suggest tegoprubart's potential as a novel immunosuppressant to improve islet transplantation outcomes for individuals with type 1 diabetes.
Tegoprubart Shows Promise in Improving Islet Cell Transplant Outcomes for Type 1 Diabetes
• Tegoprubart, an experimental immunosuppressant, demonstrates encouraging results in islet cell transplants for Type 1 diabetes, potentially reducing or eliminating the need for insulin injections.
• In a study of three patients, two achieved insulin independence and normal A1C levels after tegoprubart treatment, while the third significantly reduced insulin needs.
• Tegoprubart shows improved islet cell engraftment and reduced toxicity compared to the standard immunosuppressant tacrolimus, offering a potentially safer and more effective option.
• Eledon is continuing to study tegoprubart in clinical trials to assess its safety and efficacy in kidney transplants, animal organ transplants, and ALS.
Stem Cell Therapy Cures Type 1 Diabetes in Illinois Woman, Offering Hope for Functional Cure
• Marlaina Goedel, a 30-year-old woman from Illinois, has been cured of type 1 diabetes after 25 years of insulin dependence through a pioneering islet cell transplant.
• The experimental therapy involves transplanting islet cells into the liver, enabling the body to produce insulin independently, with Goedel ceasing insulin injections within four weeks.
• The clinical trial utilized tegoprubart, an experimental drug that prevents immune system rejection of transplanted cells, showing promising results in stabilizing blood sugar levels.
• Researchers are optimistic about the potential for functional cures in type 1 diabetes, with plans for additional trials to expand the treatment's availability.
Eledon's Tegoprubart Shows Promise in Type 1 Diabetes Islet Transplantation
• Eledon Pharmaceuticals' tegoprubart, as part of an immunosuppression regimen, enabled insulin independence in two of three type 1 diabetes subjects after islet transplantation.
• Islet engraftment was three to five times higher in subjects treated with tegoprubart compared to those receiving standard tacrolimus-based immunosuppression.
• The treatment with tegoprubart was generally well-tolerated, with no unexpected adverse events or hypoglycemic episodes reported in the study.
• These findings suggest tegoprubart's potential to improve islet transplant outcomes and reduce reliance on tacrolimus, offering a safer alternative for T1D patients.
Tegoprubart Shows Promise in Improving Islet Cell Transplant Outcomes for Type 1 Diabetes
• Tegoprubart, an experimental immunosuppressant, demonstrates encouraging results in islet cell transplantation for Type 1 diabetes, potentially reducing or eliminating the need for insulin injections.
• In a study of three patients, two achieved insulin independence and normal A1C levels after islet cell transplants with tegoprubart, while the third significantly reduced insulin needs.
• Tegoprubart's mechanism, administration as a 15-minute infusion every three weeks, and reduced toxicity compared to tacrolimus offer a potential advancement in immunosuppression.
• Ongoing clinical trials are assessing tegoprubart's safety and efficacy in kidney transplants, animal organ transplants, and ALS, with hopes for broader application in transplant medicine.
Lantidra Approved for Brittle Type 1 Diabetes, Offering New Hope for Insulin Independence
• Lantidra, derived from deceased donor pancreas, is the first FDA-approved therapy for brittle type 1 diabetes, addressing severe low blood sugar episodes.
• Clinical trials showed that 70% of Lantidra recipients no longer required insulin one year post-transplant, with over 90% experiencing no hypoglycemia.
• A clinical trial testing tegoprubart after islet cell transplant shows early signs of success in the first three patients.
• Lantidra is available exclusively at UI Health in Chicago for eligible adults with type 1 diabetes meeting specific health criteria.
Eledon's Tegoprubart Shows Promise in Type 1 Diabetes Islet Transplantation
• Eledon Pharmaceuticals reports that tegoprubart, as part of an immunosuppression regimen, enabled insulin independence in two of three type 1 diabetes subjects after islet transplantation.
• Islet engraftment was three to five times higher in subjects treated with tegoprubart compared to those receiving standard tacrolimus-based immunosuppression.
• The treatment with tegoprubart was generally well-tolerated, with no unexpected adverse events or hypoglycemic episodes reported in the study.
• These findings support tegoprubart's potential as a novel immunosuppression option for advancing islet transplantation as a transformative therapy for type 1 diabetes.
Eledon's Tegoprubart Shows Promise in Type 1 Diabetes Islet Transplantation
• Eledon Pharmaceuticals reports that tegoprubart, combined with an immunosuppression regimen, enabled insulin independence in two of three T1D subjects post-islet transplant.
• Islet engraftment was three to five times higher in subjects treated with tegoprubart compared to those receiving standard tacrolimus-based immunosuppression.
• The treatment with tegoprubart was generally well tolerated, with no unexpected adverse events or hypoglycemic episodes reported during the study.
• Data from the UChicago Medicine investigator-initiated trial were presented at the 5th IPITA/HSCI/Breakthrough T1D Stem Cells Summit.
Eledon Pharmaceuticals Completes Enrollment in Phase 2 BESTOW Trial of Tegoprubart for Kidney Transplant Rejection
• Eledon Pharmaceuticals completed enrollment for its Phase 2 BESTOW trial of tegoprubart, an immunosuppression therapy, four months ahead of schedule.
• The BESTOW trial assesses tegoprubart's safety and efficacy in preventing organ rejection in kidney transplant recipients, compared to tacrolimus.
• The primary endpoint is graft function at 12 months post-transplant, measured by estimated glomerular filtration rate (eGFR).
• Top-line results from the BESTOW trial are anticipated in the fourth quarter of 2025, marking a potential advancement in immunosuppression therapy.
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