THE COMPANY
Eledon Pharmaceuticals, Inc. (Eledon or the Company) is a clinical stage biopharmaceutical company using its immunology expertise in
targeting the CD40 Ligand (CD40L, also called CD154) pathway to develop therapies to protect transplanted organs and prevent rejection, and to treat amyotrophic lateral sclerosis (ALS). Our lead compound in development is tegoprubart, an
IgG1, anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target that we believe has broad therapeutic potential.
Tegoprubart is engineered to potentially both improve safety and provide pharmacokinetic, pharmacodynamic, and dosing advantages compared to other anti-CD40
approaches. The CD40L/CD40 pathway is recognized for its prominent role in immune regulation. CD40L is primarily expressed on activated CD4+ T cells, platelets and endothelial cells while the CD40 receptor is constitutively expressed on antigen
presenting cells such as macrophages and dendritic cells, as well as B cells. By blocking CD40L and not the CD40 receptor, tegoprubart inhibits both the CD40 and CD11 costimulatory signaling pathways, providing the potential for improved efficacy
compared to anti-CD40 receptor approaches. Blocking CD40L also increases polarization of CD4+ lymphocytes to Tregs, a specialized subpopulation of T cells that act to suppress an immune response, thus creating a more tolerogenic environment, which
may play a therapeutic role in autoimmune diseases and in the prevention of allograft rejection after solid organ transplantation.
Tegoprubart is
designed to negate the risk of thrombolytic events seen in the first generation of anti-CD40L antibodies by introducing structural modifications that have been shown in preclinical models to eliminate binding to the
Fcg receptors associated with platelet activation without altering the binding of tegoprubart to CD40L. In non-human primate studies, dosing of tegoprubart up to
200 mg/kg per week for 26 weeks, demonstrated no adverse events regarding coagulation, platelet activation or thromboembolism.
Our business strategy is
to optimize the clinical and commercial value of tegoprubart and become a global biopharmaceutical company with a focused immunology franchise. Our strategy is to develop tegoprubart for the prevention of allograft and xenograft rejection, and for
the treatment of autoimmune diseases such as ALS. We selected our indications based on preclinical and clinical data that was generated with either tegoprubart or historical anti-CD40L molecules. In January 2023, we announced our decision to
prioritize resources on our kidney transplantation programs, and discontinue funding of the islet cell transplantation program and the IgAN program. We remain committed to further progressing ALS clinical development and are working with key
stakeholders on potential next steps to do so.
While inhibition of CD40L has shown it may play an important role in immunosuppression in allograft kidney
transplantation, this mechanism of action has also demonstrated that it may be a promising option in xenotransplantation (i.e., transplanting an organ from an animal to a human). In January 2023, we entered into a
non-exclusive collaborative research agreement with eGenesis, Inc. (eGenesis), under which eGenesis gained access to tegoprubart for preclinical and clinical xenotransplantation studies in support
of eGenesis kidney, heart and islet xenotransplantation programs.
Corporate Information
Otic Pharma, Ltd. (Otic) was founded in the State of Israel in 2008. In 2015, Otic established U.S. operations and moved its corporate headquarters
to Irvine, California. In 2017, Otic consummated a reverse merger with Tokai Pharmaceuticals, Inc. (Tokai), a Delaware corporation that was incorporated on March 26, 2004, pursuant to which, among other things, Tokai purchased from
Otic and its stockholders all of the outstanding common and preferred shares of Otic in exchange for the issuance of a certain number of shares of common stock of Tokai (the Reverse Merger). Following the Reverse Merger, Tokai changed
its name to Novus Therapeutics, Inc. On September 14, 2020, we acquired Anelixis Therapeutics, Inc. (Anelixis), a Delaware corporation, after which Anelixis became a wholly owned subsidiary of the Company. On January 4, 2021,
we changed our name from Novus Therapeutics, Inc. to Eledon Pharmaceuticals, Inc.
3