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Eledon CEO Announces Phase 3 Kidney Transplant Program Launch
"During the first half of the year, we made meaningful progress establishing the regulatory framework for our planned Phase 3 kidney transplantation program, which we expect to initiate later this year," said David-Alexandre Gros, Chief Executive Officer of Eledon. "The continued strength of our clinical data, including sustained long-term kidney function in BESTOW and the compelling results from the UChicago Medicine islet cell transplantation study, reinforces the potential of tegoprubart to improve outcomes across multiple transplant settings. We look forward to advancing our Phase 3 program and expanding the clinical evidence for tegoprubart across additional transplant indications."
NewcelX Completes FDA Pre-IND Meeting, Advances NCEL-101 Clinical Trial
NewcelX (NCEL) announced the completion of its Type B Pre-IND meeting with the U.S. Food and Drug Administration. The agency provided constructive feedback and alignment on the company's proposed development strategy, providing clarity regarding the regulatory pathway toward launching a clinical trial of NCEL-101 for type 1 diabetes in combination with Eledon Pharmaceuticals' (ELDN) anti-CD40L antibody, tegoprubart, an investigational immunomodulatory agent. The meeting results represent a significant milestone toward the clinical development of an innovative treatment paradigm targeting a potential functional cure for type 1 diabetes. The FDA provided favorable feedback on NewcelX's Chemistry, Manufacturing, and Controls processes and preclinical program allowing the Company to proceed toward its Investigational New Drug enabling activities.
Natera Partners with Eledon for Kidney Transplant Trial
Natera (NTRA) and Eledon Pharmaceuticals (ELDN) announced a strategic partnership to incorporate Natera's Prospera kidney transplant assessment test into Eledon's planned Phase 3 clinical trial of tegoprubart. 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.
Eledon Pharmaceuticals Announces New Kidney Transplant Data
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 taking place June 20-24 in Boston, Massachusetts. 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. Among patients who completed 12 months of treatment in the BESTOW study, 96% of tegoprubart-treated patients and 86% of tacrolimus-treated patients entered the BESTOW long-term extension study. As of the data cutoff, mean follow-up was 21 months, with: 89 patients followed through 18 months, 20 patients followed through 24 months, and the longest-followed ongoing patient followed for approximately 33 months. Kidney graft function, as assessed by estimated glomerular filtration rate, stabilized after the first month of treatment and remained higher in tegoprubart-treated patients than in tacrolimus-treated patients at each reported time point. At month 18, tegoprubart-treated patients demonstrated a statistically significant approximately 12 mL/min/1.73 m higher mean eGFR compared with tacrolimus-treated patients. No biopsy-proven acute rejection events were observed in tegoprubart-treated patients after the first six months of treatment. In the tacrolimus arm, seven of 11 total BPAR events occurred after six months, including two events after 12 months: one new case of active antibody-mediated rejection and one recurrent case of active T-cell-mediated rejection with aAMR. Patient-reported outcome measures demonstrated lower symptom burden among tegoprubart-treated patients compared with tacrolimus-treated patients at 52 weeks, with statistically significant improvements on the Modified Transplant Symptom Occurrence and Symptom Distress Scale and the KDQOL-36 Symptoms and Problems domain. In an exploratory analysis of patients who experienced rejection post-transplant, those who remained on tegoprubart maintained higher mean eGFR than tacrolimus-treated patients who experienced rejection, with the observed difference increasing. Long-term follow-up from the Phase 1b study for patients treated at the 20 mg/kg dose of tegoprubart was consistent with the Phase 2 BESTOW results, with no BPAR episodes observed after six months in tegoprubart-treated patients. In the Phase 1b study, long-term data was available for 16 patients; eight patients have been followed through 24 months, and the longest-followed ongoing patient has been on tegoprubart for approximately 3.5 years. In the BESTOW long-term extension study, key central nervous system and kidney-related adverse events were observed more frequently in the tacrolimus arm than in the tegoprubart arm, including headache, extremity pain, fall or loss of balance, and acute kidney injury, respectively. Diarrhea was observed more frequently in the tacrolimus arm than in the tegoprubart arm during long-term follow-up. This pattern was consistent with the first-year BESTOW results, in which diarrhea was reported in 34% of tacrolimus-treated patients vs. in 22% of tegoprubart-treated patients. No graft loss, no progressive multifocal leukoencephalopathy, no post-transplant lymphoproliferative disorder, no BK or CMV nephropathy/disease, and no new malignancies were reported in the BESTOW long-term extension study. No new proteinuria was reported on the tegoprubart arm. One death occurred in the tegoprubart arm and was not attributed to study drug.
NewcelX Submits NCEL-101 Clinical Trial Application to FDA
NewcelX (NCEL) announced the submission of a pre-investigational new drug briefing package to the FDA to support the proposed first-In-human clinical trial of NCEL-101 in combination with tegoprubart, an investigational immunomodulatory agent being developed by Eledon Pharmaceuticals (ELDN). The submission represents a significant milestone toward the clinical development of an innovative treatment intended for a potential cure for type 1 diabetes.
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