Natera and Eledon partner on kidney transplant Phase 3 trial

Natera, Inc. (Nasdaq: NTRA) and Eledon Pharmaceuticals, Inc. (Nasdaq: ELDN) have announced a partnership to use Natera's Prospera kidney transplant assessment test in Eledon's planned Phase 3 clinical trial of tegoprubart, an investigational drug intended to prevent organ rejection in kidney transplantation.

Under the agreement, the Prospera test will serve as the exclusive donor-derived cell-free DNA (dd-cfDNA) monitoring assay in the trial. The study is expected to enroll approximately 600 kidney transplant recipients across more than 100 transplant centers globally, with trial initiation planned for late 2026.

Tegoprubart is an anti-CD40L antibody being developed as an alternative to current immunosuppressive therapies such as tacrolimus, which can be associated with toxicities that affect long-term outcomes.

Patients in the trial will undergo longitudinal monitoring with the Prospera test, which uses a two-threshold algorithm measuring both the relative fraction and the calculated amount of total dd-cfDNA to detect early signs of transplant rejection.

According to the companies, this marks the first time the Prospera test will be used as a longitudinal surveillance tool in a large-scale therapeutic clinical trial in transplantation.

"The transplant community has had minimal innovation in therapeutics over the last two decades, and this Phase 3 tegoprubart study represents a pivotal opportunity to make meaningful improvements in patient management," said Eric Matthews, general manager of biopharma at Natera.

"The integration of Prospera into our Phase 3 trial reflects the rigor and innovation we are bringing to the development of tegoprubart," said Steve Perrin, president and chief scientific officer at Eledon. "Kidney transplant patients and physicians need new approaches that can protect the transplanted organ while addressing the limitations of current immunosuppressive regimens."

Eledon said it has established the regulatory framework for the Phase 3 kidney transplantation program. The information above is based on a press release issued by the two companies.

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