CareDx and Eledon Pharmaceuticals Announce Collaborative Research Agreement
Eledon to use AlloSure to help assess the efficacy of AT-1501 in the prevention of rejection in Eledon’s upcoming renal transplantation trials
SOUTH SAN FRANCISCO, Calif. and IRVINE, Calif., October 19, 2021 -- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, and Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN), a clinical stage biopharmaceutical company developing precision therapies that target the CD40 Ligand pathway for use in organ and cellular transplantation, and for the treatment of amyotrophic lateral sclerosis (ALS) and autoimmune diseases, today announced a collaborative research agreement to use AlloSure to help assess the efficacy of Eledon’s investigational AT-1501 in the prevention of rejection in upcoming renal transplantation trials.
“At CareDx, we focus on innovation and working with leaders in the transplant space. With Eledon, we continue this proven strategy by partnering on their AT-1501 development program,” said Reg Seeto, CEO and President of CareDx. “This agreement allows us to bring our leading innovative offerings like AlloSure earlier in drug development as Eledon develops the next generation of transplant therapeutics.”
In July of this year, Eledon announced that it had received approval from Health Canada to commence human trials of AT-1501 in renal transplantation. The study will be a multicenter, open label trial, in 6 to 12 subjects, to evaluate the safety, efficacy and pharmacokinetics of AT-1501 in de novo kidney transplant recipients. Eledon anticipates initiating the trial in the fourth quarter of this year with interim data read-outs beginning in late 2022.
“This collaboration agreement provides Eledon with access to CareDx’s best-in-class technologies,” stated David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Our partner’s experience with biomarkers and predictive algorithms gives us the opportunity to gather important insights on the potential for longer term allograft survival rates as we advance AT-1501 through clinical development. We are pleased to partner with the market leader in broader transplantation services and look forward to working together towards supporting transplant patients.”
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CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.
About Eledon Pharmaceuticals and AT-1501
Eledon Pharmaceuticals is a clinical stage biotechnology company using its expertise in targeting the CD40 Ligand (CD40L, also called CD154) pathway to develop potential treatments for persons requiring organ or cellular transplantation, living with amyotrophic lateral sclerosis (ALS), or living with an autoimmune disease. The company’s lead compound in development is AT-1501, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target with broad therapeutic potential. For more information, please visit the company’s website at: www.eledon.com.
CareDx Forward Looking Statements
This press release includes forward-looking statements related to CareDx, Inc., including statements regarding its collaborative research agreement with Eledon to use AlloSure to assess the efficacy of Eledon’s investigational AT-1501 (the “Collaboration”), the potential benefits and results that may be achieved through the Collaboration and statements regarding Eledon’s expectations regarding the timing for its AT-1501 renal transplantation trial initiation and readout. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that the CareDx does not realize the expected benefits of the Collaboration; risks that Eledon fails to initiate the AT-1501 human trial in the fourth quarter of 2021 with interim data read-outs beginning in late 2022; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed by CareDx with the SEC on February 24, 2021 and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
Eledon Pharmaceuticals Forward Looking Statements
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 the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned 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: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. 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 significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, 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.
Chief Marketing Officer
Eledon Pharmaceuticals, Inc.
Corey Davis, Ph.D.
LifeSci Advisors, LLC