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.

Tegoprubart is a novel anti-CD40L antibody that has demonstrated promising efficacy and safety in prior transplant clinical studies. Long-term immunosuppression remains one of the greatest challenges in transplantation, as current standard-of-care therapies, including tacrolimus, can be associated with significant toxicities that can also negatively impact their long-term effectiveness. Tegoprubart is being developed with the goal of improving graft protection while reducing the risk and burden of toxicities commonly seen with current standard-of-care treatments.

As part of the study, patients will undergo longitudinal surveillance monitoring with Prospera, leveraging its unique two threshold algorithm that measures both the relative fraction of dd-cfDNA (dd-cfDNA%) and the calculated amount of total dd-cfDNA (DQS). The Prospera test can detect early signs of rejection allograft injury that may prompt further clinical evaluation, including biopsy.

This collaboration marks the first time the Prospera test will be incorporated as a longitudinal surveillance tool in a large-scale therapeutic clinical trial in transplantation, providing a unique opportunity to evaluate allograft health through serial molecular monitoring while assessing the impact of an investigational immunosuppression regimen.