tegoprubart (AT-1501) / Eledon - LARVOL DELTA

Tolerance Through Mixed Chimerism (Sip-Tego) (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Tatsuo Kawai, MD, PhD | Recruiting ➔ Active, not recruiting

Enrollment closed • Renal Disease • Transplantation

Phase 2 BESTOW trial and the BESTOW EXTENSION: Evaluating the long-term safety and efficacy of tegoprubart in preventing kidney transplant rejection (TTS 2026) - P2 | "Patients received i.v. tegoprubart 20 mg/kg on days 1, 3, 7, 14, 21, 28, then every 21 days, or oral tacrolimus twice daily. BESTOW supports continued development of tegoprubart as a potential alternative to tacrolimus for preserving kidney transplant function and preventing rejection."

Clinical • P2 data • Diabetes • Immunology • Infectious Disease • Metabolic Disorders • Movement Disorders • Transplant Rejection • Transplantation • CD40LG

LEGACY: Phase 3 Randomized Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation (clinicaltrials.gov) - P3 | N=620 | Not yet recruiting | Sponsor: Eledon Pharmaceuticals

New P3 trial • Immunology • Transplant Rejection • Transplantation

Eledon Presents Updated Long-Term Phase 2 BESTOW Extension Study Results at the International Congress of The Transplantation Society (GlobeNewswire) - "The Company also announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to tegoprubart for the prevention of rejection in kidney transplantation....As of the data cutoff in the BESTOW long-term extension study, 90 patients had been followed through 18 months, and 81 patients had been followed through 24 months. Tegoprubart-treated patients maintained statistically significantly higher mean estimated glomerular filtration rate (eGFR), a measure of kidney graft function, at months 18, 21, and 24, with an approximately 13 mL/min/1.73 m² advantage over tacrolimus at month 24 (71 vs. 58 mL/min/1.73 m² [95% CI: 2.6, 23.3])...Following its successful End-of-Phase 2 meeting with the FDA, Eledon remains on track to initiate its global Phase 3 trial of tegoprubart in kidney transplantation (LEGACY) in the fourth quarter of 2026."

Fast track • New P3 trial • P2 data • Immunology • Transplant Rejection • Transplantation

Ongoing UChicago Medicine investigator-initiated study in participants with T1D undergoing islet cell transplantation expanded by three patients. (GlobeNewswire) - "UChicago Medicine is adding three additional patients in its ongoing investigator-initiated islet cell transplantation study evaluating tegoprubart as the core immunosuppressant, expanding the study beyond the 12 patients treated to date. This enrollment expansion builds on previously reported results in which all 12 patients with T1D achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their disease, and a hemoglobin A1c (HbA1c) level below 7.0% following islet cell transplantation and treatment with tegoprubart."

Enrollment status • Immunology • Transplantation • Type 1 Diabetes Mellitus

IND submitted for Eledon-sponsored islet cell transplantation study in type 1 diabetes (GlobeNewswire) - "Eledon has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a planned Company-sponsored, registrational clinical trial evaluating tegoprubart for the prevention of allograft rejection in type 1 diabetes (T1D) patients undergoing pancreatic islet cell transplantation. The planned study would be Eledon’s first Company-sponsored clinical trial in islet cell transplantation and represents an important step in the Company’s registrational pathway for tegoprubart in this patient population."

IND • Immunology • Type 1 Diabetes Mellitus

First patients enrolled in a new investigator-initiated study involving islet cell transplant recipients with T1D and chronic kidney disease. (GlobeNewswire) - "The first patients have been enrolled in an investigator-initiated clinical trial evaluating tegoprubart for the prevention of allograft rejection in patients with T1D and renal dysfunction from chronic kidney disease receiving an islet cell transplant. The study, underway at the University of Chicago Medicine Transplant Institute, evaluates a calcineurin inhibitor–free, tegoprubart-based immunosuppression regimen in patients who are especially susceptible to tacrolimus toxicity, including kidney damage, which has long constrained the use of islet cell transplantation."

Trial status • Chronic Kidney Disease • Immunology • Transplant Rejection • Type 1 Diabetes Mellitus

First islet cell transplant recipient dosed with tegoprubart following conversion from tacrolimus. (GlobeNewswire) - "The first islet cell transplant recipient has been dosed with tegoprubart under a compassionate-use protocol allowing them to switch from their previous tacrolimus-based immunosuppression therapy due to calcineurin inhibitor–related renal dysfunction. This compassionate use of tegoprubart may address an important unmet need among transplant recipients who require lifelong immunosuppression therapy to preserve graft function but experience renal complications often associated with calcineurin inhibitors such as tacrolimus, today’s standard of care."

Commercial • Renal Disease

Kidney Transplantation (GlobeNewswire) - "Following its successful End-of-Phase 2 meeting with the FDA, Eledon remains on track to initiate its global Phase 3 trial of tegoprubart in kidney transplantation (LEGACY) in the fourth quarter of 2026. The LEGACY trial is expected to enroll approximately 600 patients, with a primary endpoint of non-inferiority versus tacrolimus at 52 weeks based on a composite of biopsy-proven acute rejection (BPAR), graft loss, and death...First highly sensitized kidney transplant patient dosed under compassionate use....Third patient treated in investigator-initiated kidney transplant tolerance study."

Commercial • New P3 trial • Trial status • Immunology • Transplantation

Gene-edited hypoimmune islets as a cure for type 1 diabetes: a review of the immunological challenges. (PubMed, Expert Opin Biol Ther) - "Durable graft survival will likely require multimodal approaches combining gene-edited islets with adjunct immunomodulation (e.g. teplizumab, low-dose ATG, tegoprubart) and metabolic support. If these long-term challenges can be overcome, gene-edited hypoimmune islets could transform T1DM treatment paradigms."

First-in-human • Journal • Review • Diabetes • Immunology • Infectious Disease • Metabolic Disorders • Transplant Rejection • Transplantation • Type 1 Diabetes Mellitus

The Company anticipates the following milestones in 2026 and over the next 12 months (GlobeNewswire) - "Initiate Phase 3 clinical trial evaluating tegoprubart in kidney transplantation in late 2026; Support the initiation of an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant in 2026; Initiate company-sponsored, registration path study evaluating tegoprubart in islet cell transplantation; Support the initiation of an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant; Receive FDA regulatory guidance on the path to market for tegoprubart in xenotransplantation."

FDA event • New P3 trial • Immunology • Renal Disease • Transplant Rejection

Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D) (clinicaltrials.gov) - P1/2 | N=70 | Active, not recruiting | Sponsor: University of Chicago | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus

Breakthrough - T1DM and Chronic Kidney Disease (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: University of Chicago | Initiation date: Apr 2026 ➔ Apr 2027

Trial initiation date • Chronic Kidney Disease • Nephrology • Renal Disease • Transplantation • Type 1 Diabetes Mellitus

Natera…and Eledon Pharmaceuticals…announced a strategic partnership to incorporate Natera’s Prospera kidney transplant assessment test into Eledon’s planned Phase 3 clinical trial of tegoprubart, an investigational therapy designed to prevent organ rejection in kidney transplantation (Businesswire) - "Eledon has established the regulatory framework for its Phase 3 kidney transplantation program and plans to initiate the trial in late 2026. Under the agreement, Natera’s Prospera test will serve as the exclusive dd-cfDNA monitoring assay in the Eledon study. The trial has an enrollment target of approximately 600 kidney transplant recipients across over 100 transplant centers globally."

Licensing / partnership • New P3 trial • Transplant Rejection • Transplantation

Eledon Pharmaceuticals…announced new long-term data from its Phase 2 BESTOW clinical program evaluating tegoprubart in patients undergoing kidney transplantation, presented in oral and poster presentations at the American Transplant Congress (ATC) (GlobeNewswire) - "The presentations highlight updated results from the Phase 2 BESTOW trial and new long-term follow-up data from the Phase 2 BESTOW extension study....Tegoprubart-treated patients maintained higher mean eGFR over time, including a statistically significant approximately 12 mL/min/1.73 m² advantage at month 18 versus tacrolimus (74 vs. 61 mL/min/1.73 m²; p<0.05). No biopsy-proven acute rejection (BPAR) events were observed in tegoprubart-treated patients after the first six months post-transplant, compared with seven BPAR events (9.4% of tacrolimus-treated patients) reported in the tacrolimus arm. Patient-reported outcomes at 52 weeks favored tegoprubart, with statistically significant improvements versus tacrolimus on two validated measures of symptom burden."

P2 data • Patient reported outcomes • Transplant Rejection

CD40L Co-Stimulation Blockade with Tegoprubart as a Non-Toxic Calcineurin Inhibitor-Free Immunosuppression for Beta Cell Replacement Therapy: Preliminary Results from a Pilot Clinical Study (ATC 2026) - "Preliminary data from the first six patients indicate that Tegoprubart with mycophenolate is well-tolerated and effective in preventing islet graft loss, with no unexpected adverse events. Further observations are warranted to validate these findings."

Clinical • Cardiovascular • Diabetes • Hypoglycemia • Infectious Disease • Metabolic Disorders • Type 1 Diabetes Mellitus • CD40LG

Phase 2 BESTOW Trial: Evaluating Tegoprubart's Safety and Efficacy in Preventing Kidney Transplant Rejection (ATC 2026) - P2 | "Patients received tegoprubart 20 mg/kg IV on days 1, 3, 7, 14, 21, 28, and every 21 days thereafter, or twice daily oral tacrolimus. The BESTOW study results provide a basis for continuing the development of tegoprubart as a potential alternative to tacrolimus for preserving allograft function and preventing kidney transplant rejection."

Clinical • P2 data • Immunology • Infectious Disease • Movement Disorders • Transplant Rejection • Transplantation

Phase 2 Bestow Extension Trial Evaluating Tegoprubart's Long-Term Safety and Efficacy in Preventing Kidney Transplant Rejection (ATC 2026) - P2 | "Participants will continue the same treatment regimen they were receiving in the parent Phase 2 BESTOW study (tegoprubart 20 mg/kg intravenously every 3 weeks or tacrolimus orally twice daily). The BESTOW extension study may support the continued development of tegoprubart as a promising long-term alternative to tacrolimus for maintaining allograft function and preventing kidney transplant rejection."

Clinical • P2 data • Cardiovascular • Diabetes • Hypertension • Immunology • Movement Disorders • Nephrology • Transplant Rejection • Transplantation

Eledon Announces Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes (T1D) at UChicago Medicine (GlobeNewswire) - "The results were presented...at the American Diabetes Association 86th Scientific Sessions....All patients treated in the study (n=12) showed rapid improvement in glycemic control following islet transplantation and treatment with tegoprubart, with stable islet graft function observed across the cohort over a median and maximum post-transplant follow-up period of 8 and 22 months, respectively. All 12 patients achieved insulin independence, meaning that they no longer needed chronic, exogenous insulin therapy to manage their T1D. Also, all patients demonstrated a most recent hemoglobin A1C ('HbA1c') below the diabetic threshold of 6.5%, with a mean most recent HbA1c of approximately 5.4% across the cohort."

P1 data • Type 1 Diabetes Mellitus

Eledon Announces Presentation of Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes at American Diabetes Association (ADA) 2026 Scientific Sessions (GlobeNewswire)

P1 data • Transplantation • Type 1 Diabetes Mellitus

Eledon Pharmaceuticals to Present New Long-Term Data from Phase 2 BESTOW Trial of Tegoprubart for the Prevention of Rejection in Kidney Transplantation at American Transplant Congress (GlobeNewswire) - "Results will include updated data from the Phase 2 BESTOW clinical trial and new long-term data from the Phase 2 BESTOW extension study."

P2 data • Transplant Rejection

2026 Anticipated Upcoming Milestones (GlobeNewswire) - "(i) Receive FDA guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment; (ii) Report long-term data from Phase 1b and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation; (iii) Receive FDA regulatory guidance on the path to market for tegoprubart in islet cell transplantation and xenotransplantation; (iv) Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant; (v) Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant; (vi) Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction."

Clinical data • FDA event • New trial • Transplant Rejection • Transplantation

Breakthrough - T1DM and Chronic Kidney Disease (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: University of Chicago

New P1/2 trial • Chronic Kidney Disease • Nephrology • Renal Disease • Transplantation • Type 1 Diabetes Mellitus

Anticipated Upcoming Milestones (GlobeNewswire) - "Receive FDA guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment. Report long-term data from Phase 1 and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation. Receive FDA regulatory guidance on path to market for tegoprubart in islet cell transplantation and xenotransplantation. Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant. Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant. Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction."

Clinical protocol • New trial • P1 data • P2 data • Transplantation

Presented 24-month follow-up data from eight patients enrolled in the Phase 1b long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium. (GlobeNewswire) - "The data continue to support the favorable safety and tolerability profile of tegoprubart with no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation reported during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m² at 12 months to 74.2 mL/min/1.73 m² at 24 months."

P1 data • Transplantation