tegoprubart (AT-1501) / Eledon - LARVOL DELTA

Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Operating and Financial Results (GlobeNewswire) - "Research and development (R&D) expenses for the year ended December 31, 2024 were $52.0 million, including $4.3 million of non-cash stock-based compensation expense, compared to $30.3 million, including $1.5 million of non-cash stock-based compensation expense, for the comparable period in 2023. The increase was primarily driven by a rise in clinical development expenses related to the Phase 1b, Phase 2 BESTOW and Phase 2 open-label extension trials for kidney transplantation..."

Commercial • Transplant Rejection

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 (GlobeNewswire) - "Eledon Pharmaceuticals...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...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....'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.'"

Clinical • FDA event • Transplant Rejection

Costimulation blockade: the next generation. (PubMed, Curr Opin Organ Transplant) - "The focus in transplantation is shifting toward safer, long-term therapies with greater accessibility. Investigational agents with subcutaneous delivery methods could overcome logistical challenges, improve adherence, and redefine posttransplant care. These advancements in costimulation blockade may enhance long-term graft survival and transform the management of KT recipients."

Journal • Cardiovascular • Transplantation • CD40LG

AT-1501-K207: Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Eledon Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Transplant Rejection • Transplantation

Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2025 Outlook (GlobeNewswire) - "Completed enrollment of 120 patients in the Phase 2 BESTOW clinical trial approximately four months earlier than originally planned....Completed two financings for combined total gross proceeds of $135.0 million, before deducting any offering related expenses, which is anticipated to support company operations to the end of 2026....Summer 2025: Report updated interim clinical data from the ongoing Phase 1b and long-term efficacy extension studies of tegoprubart in kidney transplantation. 4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.'"

Enrollment closed • Financing • P1 data • P2 data • Transplant Rejection

Transplantation of a genetically modified porcine heart into a live human. (PubMed, Nat Med) - "He was maintained on a costimulation (anti-CD40L, Tegoprubart) blockade-based immunomodulatory regimen...No evidence of porcine cytomegalovirus replication in the xenograft was observed. Strategies to overcome the obstacle of antibody-mediated rejection are needed to advance the field of xenotransplantation."

Journal • Preclinical • Antibody-mediated Rejection • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Cytomegalovirus Infection • Fibrosis • Heart Failure • Immunology • Transplantation • CD40LG

New Developments and Therapeutic Drug Monitoring Options in Costimulatory Blockade in Solid Organ Transplantation: A Systematic Critical Review. (PubMed, Ther Drug Monit) - "The routine use of costimulation blockade in SOT is hindered by problems in efficacy compared with the standard of care. Costimulatory inhibitors could be combined in a calcineurin inhibitor-free regimen. Future PK/pharmacodynamic studies in costimulatory agents and personalized medicine could warrant TDM of these agents."

Journal • Review • Hepatology • Solid Organ Transplantation • Transplantation • CD40LG • CD80 • TNFSF4

Eledon Pharmaceuticals Announces Recent Business Highlights and Third Quarter 2024 Financial Results (GlobeNewswire) - "Anticipated Upcoming Milestones: Mid-2025: Report updated interim clinical data from the ongoing Phase 1b and long-term safety and efficacy extension studies of tegoprubart in kidney transplantation....4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation....Research and development (R&D) expenses for the third quarter of 2024 were $16.5 million, compared to $7.9 million for the comparable period in 2023, an increase of $8.6 million. The increase was primarily driven by a rise in clinical development expenses related to the Phase 1b and Phase 2 BESTOW studies..."

Commercial • P1 data • P2 data • Immunology • Transplant Rejection

Safety and tolerability of tegoprubart in patients with amyotrophic lateral sclerosis: A Phase 2A clinical trial. (PubMed, PLoS Med) - P2a | "Tegoprubart appeared to be safe and well tolerated in adults with ALS demonstrating dose-dependent reduction in pro-inflammatory chemokines and cytokines associated with ALS. These results warrant further clinical studies with sufficient power and duration to assess clinical outcomes as a potential treatment for adults with ALS."

Biomarker • IO biomarker • Journal • P2a data • Amyotrophic Lateral Sclerosis • CNS Disorders • Fatigue • Immunology • Inflammation • Pain • Transplant Rejection • Transplantation • CD40LG • NEFL

Eledon Pharmaceuticals Announces Positive Initial Data from Subjects with Type 1 Diabetes Treated with Tegoprubart as Part of an Immunosuppression Regimen Following Islet Transplantation in Investigator-Initiated Trial at UChicago Medicine (GlobeNewswire) - P1/2 | N=9 | NCT06305286 | "Eledon Pharmaceuticals...today announced positive data for the first three islet transplant recipients treated with an immunosuppression regimen that includes tegoprubart, the Company’s investigational anti-CD40L antibody, for prevention of islet transplant rejection in subjects with type 1 diabetes (T1D)....Treatment was generally well tolerated in all subjects with no unexpected adverse events or hypoglycemic episodes....The first participant was a 42-year-old female with a baseline weight of 88 kg/194 lbs (BMI of 30). At 90 days post-transplant, the participant’s HbA1c level improved to 6.0% (from 8.4% at baseline) and daily insulin dose decreased to 16 units per day (from 80 units per day at baseline)....The second participant was a 30-year-old female with a baseline weight of 50 kg/110 lbs (BMI of 21)....The third participant was a 37-year-old male with a baseline weight of 92 kg/203 lbs (BMI of 30) with a baseline HbA1C of 9.3%."

P1/2 data • Transplant Rejection

Eledon Announces Completion of Enrollment in Phase 2 BESTOW Clinical Trial Assessing Tegoprubart for Prevention of Organ Rejection in Kidney Transplant Patients (GlobeNewswire) - "Eledon Pharmaceuticals...today announced that it has successfully completed enrollment for its Phase 2 BESTOW clinical trial, which is designed to assess the safety and efficacy of its investigational immunosuppression therapy tegoprubart for the prevention of organ rejection in patients undergoing kidney transplantation. The trial reached its target enrollment of 120 participants approximately four months earlier than originally planned...'we now anticipate reporting top-line results for the BESTOW trial in the fourth quarter of 2025.'"

Enrollment closed • P2 data • Immunology • Transplant Rejection

Eledon Pharmaceuticals Reports Preliminary Second Quarter 2024 Operating Results (GlobeNewswire) - "'We have entered the second half of the year with a strong balance sheet following our oversubscribed $50 million private placement and we are highly encouraged by the progress and reception from the transplant community for our Phase 2 BESTOW trial, which remains on track to complete enrollment by the end of this year,'....Anticipated Upcoming Milestones: Mid-2025: Report updated interim clinical data from the ongoing Phase 1b and long-term safety and efficacy extension studies of tegoprubart in kidney transplantation."

Enrollment status • Financing • P1 data • Transplant Rejection

Eledon Provides Enrollment Update for Phase 2 BESTOW Trial Assessing Tegoprubart for the Prevention of Organ Rejection (GlobeNewswire) - "Eledon Pharmaceuticals...today announced that it has enrolled the 80th participant in its ongoing Phase 2 BESTOW trial assessing tegoprubart for the prevention of rejection in kidney transplantation....We remain on track to complete enrollment by the end of the year.”"

Enrollment status • Transplant Rejection

Eledon Presents Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation (GlobeNewswire) - P1/2 | N=24 | NCT05027906 | Sponsor: Eledon Pharmaceuticals | "We look forward to accruing incremental data through the ongoing Phase 1b and open-label extension studies while continuing to enroll in our Phase 2 BESTOW trial, with enrollment completion anticipated by the end of the year'....Data from historical studies using standard of care, calcineurin inhibitor-based immunosuppression therapy typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 50 mL/min/1.73m2 during the first year after kidney transplant. In the ongoing Phase 1b trial, mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant.'"

Enrollment status • P1 data • Transplant Rejection

Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients (clinicaltrials.gov) - P2 | N=132 | Enrolling by invitation | Sponsor: Eledon Pharmaceuticals

Trial completion date • Trial primary completion date • Immunology • Transplant Rejection • Transplantation

Eledon Pharmaceuticals to Present Updated Data from Ongoing Phase 1b Trial of Tegoprubart in Patients Undergoing Kidney Transplantation at the American Transplant Congress (GlobeNewswire) - "Eledon Pharmaceuticals, Inc...today announced that the Company will participate in the American Transplant Congress (ATC) taking place in Philadelphia, PA from June 1-5, 2024. The Company will present a poster that features updated data from Eledon’s ongoing open-label Phase 1b trial and open-label extension study evaluating tegoprubart for the prevention of rejection in patients undergoing kidney transplantation."

P1 data • Immunology • Transplant Rejection

Eledon Announces Clinical Progress with Tegoprubart in the Prevention of Transplant Rejection (GlobeNewswire) - P1b | N=24 | NCT05027906 | Sponsor: Eledon Pharmaceuticals | "Eledon Pharmaceuticals...the company reported updated data from its ongoing Phase 1b trial demonstrating tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated....Results demonstrated that tegoprubart is generally safe and well-tolerated and support tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation. Aggregate mean estimated glomerular filtration rate (eGFR) – a measure of kidney function – measured above 60 mL/min/1.73m2 at all reported time points after day 30....The company plans to present this data at the upcoming American Transplant Congress in Philadelphia, PA, in early June 2024."

P1 data • Transplant Rejection

The Second GE Pig Heart Transplant in a Living Human Offers Great Hope for Xenotransplantation (ATC 2024) - "The patient received modified immunosuppression, including CD40-CD40L blocking the costimulation pathway (Tegoprubart)... The 2nd GE pig heart transplant provides further clues about the mechanism of graft dysfunction directed toward the role of Ab and complement. However, the Ab source could not be determined. Inadequate IS and exogenous Ab infusion through blood and its products likely contributed."

Late-breaking abstract • Antibody-mediated Rejection • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • Nephrology • Transplantation • CD40LG

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=3 | Recruiting | Sponsor: University of Chicago | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Immunomodulating • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus

Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN) (clinicaltrials.gov) - P2 | N=24 | Terminated | Sponsor: Eledon Pharmaceuticals | This voluntary business-related decision was not related to the safety of tegoprubart (AT-1501). Available safety data demonstrated tegoprubart to be safe and well tolerated.

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Trial termination • Glomerulonephritis • IgA Nephropathy • Renal Disease

Eledon Pharmaceuticals Announces 12th Participant Enrolled in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Organ Rejection (GlobeNewswire) - "Eledon Pharmaceuticals...announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation."

Enrollment status • Transplant Rejection

Eledon Pharmaceuticals Announces Use of Tegoprubart in First-ever Transplant of Genetically Modified Kidney from a Pig to a Human (GlobeNewswire) - P2 | N=120 | NCT05983770 | Sponsor: Eledon Pharmaceuticals | "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."

Enrollment status • P1 data • Transplant Rejection • Transplantation

Safety, Tolerability, and Efficacy of Immunomodulation With A in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D) (clinicaltrials.gov) - P1/2 | N=3 | Not yet recruiting | Sponsor: University of Chicago

Combination therapy • Immunomodulating • New P1/2 trial • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus

Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2024 Outlook (GlobeNewswire) - "First half of 2024: Report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation....End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation."

Enrollment status • P1 data • Transplant Rejection • Transplantation

Eledon Pharmaceuticals to Present Data from Ongoing Phase 1b Trial of Tegoprubart in Patients Undergoing Kidney Transplantation at the American Society of Nephrology Kidney Week 2023 Annual Meeting (GlobeNewswire) - "Eledon Pharmaceuticals...today announced that the Company will present a poster at the American Society of Nephrology’s upcoming Kidney Week 2023 Annual Meeting taking place in Philadelphia, PA from November 2-5, 2023. The poster will highlight new data from Eledon’s ongoing open-label Phase 1b trial evaluating tegoprubart for the prevention of rejection in kidney transplantation."

P1 data • Transplant Rejection