Prospera selected as exclusive donor-derived cell-free DNA (dd-cfDNA) monitoring assay for use in Eledon’s planned Phase 3 trial of tegoprubart in kidney transplantation, expected to initiate in late 2026
AUSTIN, Texas & IRVINE, Calif.--(BUSINESS WIRE)--Natera, Inc. (Nasdaq: NTRA), a global leader in cell-free DNA and precision medicine, and Eledon Pharmaceuticals, Inc. (Nasdaq: ELDN), a clinical stage biotechnology company developing immune-modulating therapies for the management and treatment of life-threatening conditions, today 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. 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.
“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, biopharma at Natera. “We are thrilled to demonstrate how modern, non-invasive solutions like Prospera serve a critical role for monitoring in transplantation that can help direct optimal use of new therapies. This collaboration represents an opportunity to demonstrate the value of using best-in-class technology and incorporating routine molecular surveillance, while generating one of the most comprehensive prospective datasets to date on allograft injury and dd-cfDNA dynamics following kidney transplantation.”
“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. By incorporating longitudinal, non-invasive dd-cfDNA monitoring with Prospera, we believe our study will generate important insights into allograft health and further support our mission to advance tegoprubart as a novel, differentiated therapy in transplantation.”
About Natera
Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver allograft transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
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Forward-Looking Statements (For Natera)
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Forward-Looking Statements (For Eledon)
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including in the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to maintain proper and effective internal control over financial reporting and other risks disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 19, 2026. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ materially from the forward-looking statements contained herein, are discussed in our Annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
Contacts (For Natera)
Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Contacts (For Eledon)
Investor Relations: Stephen Jasper, Gilmartin Group, (858) 525 2047, stephen@gilmartinir.com
Media: Jenna Urban, CG Life, (212) 253 8881, jurban@cglife.com
