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eGenesis and Eledon Pharmaceuticals Announce Collaboration for Use of Tegoprubart in Preclinical Xenotransplantation Studies

Agreement leverages Eledon’s investigational anti-CD40L antibody, tegoprubart, as part of eGenesis’ immunosuppression regimen that prevents xenotransplant rejection in nonhuman primate recipients.
Establishes framework for use of tegoprubart for preclinical xenotransplantation studies in support of eGenesis’ kidney, heart and islet cell programs.

CAMBRIDGE, Mass, January 09, 2023

eGenesis, Inc. (“eGenesis”) and Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), today announced that they have entered into a collaborative research agreement under which eGenesis will gain access to Eledon’s anti-CD40L antibody candidate, tegoprubart, for eGenesis’ ongoing preclinical research and development studies of human-compatible organs and cells for the treatment of organ failure. The collaboration has the potential to span multiple eGenesis programs including kidney, heart and islet cell transplant.

“Despite significant recent progress and momentum in the field of xenotransplantation, improving organ compatibility to prevent rejection remains an ongoing challenge,” said Michael Curtis, Ph.D., Chief Executive Officer of eGenesis. “This collaboration agreement provides eGenesis with access to tegoprubart, an anti-CD40L immune modulating therapy that we believe may be a critical part of an effective immunosuppression regimen for our ongoing and future preclinical studies and could help position us to achieve successful clinical translation into humans.”

“We are excited to partner with eGenesis in support of our combined commitment to offer effective solutions for patients requiring organ or cellular transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We believe this strategic agreement offers a promising step towards helping xenotransplantation become a clinical reality.”

Tegoprubart (formerly known as AT-1501) is an investigational, humanized IgG1 anti-CD40L antibody with high affinity for the CD40 ligand (CD40L, also called CD154). CD40L is an attractive drug development target for transplant immunomodulation since the engagement of the CD40L plays a pivotal role in immune system activation by mediating both antibody and cellular immune responses. Eledon is conducting an international Phase 1b study evaluating tegoprubart for the prevention of rejection in transplant patients receiving a kidney allograft, and recently announced FDA clearance of an IND application to evaluate tegoprubart, in a larger phase 2 study, for the prevention of rejection in patients receiving a kidney allograft transplant.

About Transplantation and Xenotransplantation
Organ failure is a life-threatening condition for which transplantation is considered to be the gold standard treatment. However, the growing demand for organs far outstrips supply – of the more than 100,000 individuals on the organ transplantation waitlist in the U.S., less than 40% will receive a potentially life-saving organ. In addition, the existing organ failure treatment paradigm is suboptimal for patients and the healthcare system due to organ incompatibility and variable donor organ quality.
Xenotransplantation – the transplantation of cells, tissues, and organs from one species to another – is widely viewed by the transplant community to be a viable solution to address the organ shortage crisis. The advent of cutting-edge gene editing technologies, such as CRISPR, has enabled scientists to address the virologic and immunologic hurdles that have historically prevented the advancement of xenotransplantation.

About eGenesis
eGenesis is leveraging a genome engineering-based approach in the development of safe, effective and transplantable organs. The company’s EGEN™ platform is the only technology of its kind to address both viral risk and cross-species molecular incompatibilities. eGenesis has demonstrated durable preclinical success to date and is advancing development programs for kidney transplant, pediatric and adult heart transplant, ex-vivo liver perfusion and islet cell transplant. Learn more at www.egenesisbio.com.

About Eledon Pharmaceuticals
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 an organ or cell-based transplant, living with autoimmune disease, or living with ALS. The company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, Calif. For more information, please visit the company’s website at www.eledon.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about Eledon’s future expectations, plans and prospects, including statements about planned product trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from 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 sites, 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 Eledon’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in Eledon’s 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 Eledon expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

eGenesis PR Contact
Greg Kelley
gkelley@vergescientific.com

eGenesis IR Contact
Sharon Hopkins
sharon@thrustsc.com

Eledon IR Contact
Stephen Jasper, Gilmartin Group
stephen@gilmartinir.com