Eledon Pharmaceuticals, Inc. · NASDAQ:ELDN
Eledon Pharmaceuticals — Investor Presentation (January 2023)
25 slides from Eledon Pharmaceuticals's investor presentation, Jan 9, 2023
Slide 1: Targeted Immunology CD40/CD40L Therapeutics
Targeted Immunology CD40/CD40L Therapeutics Transplantation | Autoimmunity | ALS January 2023 Exhibit 99.2
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward‐looking statements that involves substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about its strategy, future operations, development of its product cand
Slide 3: Single Company Focus: Leveraging Validated Biology to Develop Immune-Modulating Therapeutics
Single Company Focus: Leveraging Validated Biology to Develop Best-in-Class Immune-Modulating Therapeutics CD40/CD40L pathway validated by extensive historical proof-of-concept data Tegoprubart was engineered to increase potency, half-life and manufacturability vs. other anti-CD40 approaches Targeti
Slide 4: Tegoprubart: Pipeline in a Product Opportunity With Transplantation as the Primary Focus
Tegoprubart: Tegoprubart: Pipeline in a Product Opportunity With Transplantation as the Primary Focus Note: Development plans and timelines may change, including based on US and global regulatory interactions. Product Candidate Indication Development Stage Notes Pre-clinical Phase 1 Phase 2 Phase 3
Slide 5: Mechanism Overview of CD40L Inflammatory Signaling
Mechanism Overview of CD40L Inflammatory Signaling Interaction of CD40 with CD40L on immune cells mediates activation of the co-stimulatory immune pathway, controlling "cross talk” between the adaptive and innate immune systems Maximal activation of inflammatory system is a 3-step process requiring
Slide 6: Tegoprubart: Potential Best-in-Class Anti-CD40/CD40L Antibody
Tegoprubart: Potential Best-in-Class Anti-CD40/CD40L Antibody Targeting CD40 Ligand vs. CD40 Receptor IgG1 vs. fusion protein or pegylated FAB CD40L and CD40 CD40L only Blocking anti-CD40L also inhibits CD11 costimulatory receptors on antigen presenting cells, thus blocking the pro-inflammatory pola
Slide 7: Tegoprubart Experience
Tegoprubart Experience
Slide 8: Tegoprubart Phase 1a/1b Single Ascending Dose Trial Completed in Healthy Subjects and ALS Patients
Tegoprubart Phase 1a/1b Single Ascending Dose Trial Completed in Healthy Subjects and ALS Patients Healthy Volunteers or ALS Patients Receiving Either tegoprubart (mg/kg, IV) or Placebo Subjects Healthy Healthy ALS Healthy Healthy Healthy Tego-prubart Placebo Dose (mg/kg) 0.5 1 1 2 4 8 NA NA n= 6 3
Slide 9: Phase 2a ALS: Trial Design, Safety & Tolerability
Phase 2a ALS: Trial Design, Safety & Tolerability Safety & Tolerability: 35.2% of participants had 1 or more drug-related adverse events (AEs) No drug-related serious or severe AEs Occurrence of drug-related adverse events was balanced across dose cohorts No thrombosis or signs of platelet activatio
Slide 10: Phase 2a ALS: Dose Dependent T and B Cell Target Engagement
Tegoprubart exposure decreased inflammatory biomarker levels in a dose dependent manner 20 biomarkers detected were statistically significantly reduced at one or both of the higher dose levels, including: IgA, IgE, IgM, C3, CXCL9 & CXCL10 Target engagement at 12 weeks increased with dose 1 mg/kg 2 m
Slide 11: Phase 2a ALS: Dose Dependent Reduction in Pro-Inflammatory Biomarkers
1 mg/kg 2 mg/kg 4 mg/kg 8 mg/kg CXCL10 CXCL9 IgA IgE IgM IL-2R IL-16 IL-18 TNFα TNFα-R2 CXCL10 CXCL9 IgA IgE IgM IL-2R IL-16 IL-18 TNFα TNFα-R2 -40 -20 0 20 -40 -20 0 20 -40 -20 0 20 -40 -20 0 20 CXCL10 CXCL9 IgA IgE IgM IL-2R IL-16 IL-18 TNFα TNFα-R2 CXCL10 CXCL9 IgA IgE IgM IL-2R IL-16 IL-18 TNFα
Slide 12: Kidney Transplantation Opportunity & Clinical Development Plan
Kidney Transplantation Opportunity & Clinical Development Plan
Slide 13: Kidney Transplantation Overview
Kidney Transplantation Overview Unmet Need In the 1990s, Calcineurin inhibitors (CNIs) revolutionized the field of transplantation, allowing transplant medicine to grow across transplant types, and providing meaningful treatment to thousands of people CNIs provide excellent 1 year patient and graft
Slide 14: CNI Nephrotoxicity Over Time is a Leading Cause of Long-Term Kidney Transplant Graft Failure
CNI Nephrotoxicity Over Time is a Leading Cause of Long-Term Kidney Transplant Graft Failure Source: Nankivell 2003; ATC 2018; Vincenti 2007. At 6 months post transplant: ~24% of CNI treated patients demonstrate kidney impairment Up to 1/3 of CNI treated patients experience New Onset Diabetes After
Slide 15: Incidence of CNI Related Nephrotoxicity Increases with Time Post Transplant
Incidence of CNI Related Nephrotoxicity Increases with Time Post Transplant Across Organ Types Source: Kemper, 2014. Organ Transplant Duration of CNI Exposure (Years) CNI Nephrotoxicity (defined as decreased kidney function / histology) Kidney-Pancreas 1 5 10 30% 55% 100% Liver 4 5 16% 18% Bone Marr
Slide 16: Anti-CD40L in the Prevention of Transplant Rejection
Anti-CD40L in the Prevention of Transplant Rejection Naïve B Cell B7 BCR CD40 Surgical stress results in cellular damage to the graft and phagocytosed by antigen presenting cells (APCs) MHC Presentation and Costimulatory Signaling in secondary and tertiary lymphoid tissues Clonal expansion Secretion
Slide 17: Inhibition of CD40L Improved Survival vs. CD40 Inhibition in NHP Kidney Transplantation
Inhibition of CD40L Improved Survival vs. CD40 Inhibition in Non-Human Primate (NHP) Kidney Transplantation Monotherapy Studies In aggregated data from published studies, NHPs receiving anti-CD40L (e.g., 5c8, AI794, IDEC-131) immunomodulation monotherapy post kidney transplantation had longer averag
Slide 18: Recent NHP Experience: Advantage of Blocking CD40L vs. CD40R in Xenotransplantation
Recent NHP Experience has Demonstrated Advantage of Blocking CD40L vs. CD40R in Xenotransplantation Source: Adams @ ACT 2021
Slide 19: Tegoprubart Prolonged Graft Survival vs. CNI Regimen in NHP Islet Cell Transplant
Tegoprubart Prolonged Graft Survival vs. CNI Containing Regimen (CIS) in a Non-Human Primate Islet Cell Transplant Model… Source: Kenyon, 2021. Mean Survival (Days) Rejection Free Survival Overall Islet Graft Survival CIS (n=2) CIS (n=2) Tegoprubart (n=6) Tegoprubart (n=6)
Slide 20: Tegoprubart Associated With Better Metabolic Control and Healthier Animals
… And Tegoprubart was Associated With Better Metabolic Control as Well as Healthier Animals Overall as Demonstrated by Body Weight Tegoprubart (AT-1501) vs. CNI Regimens (CIS) in NHP Islet Cell Transplantation Model Source: Kenyon @ IPITA 2021.
Slide 21: Phase 1b Kidney Transplantation Study Design
Phase 1b Kidney Transplantation Study Design 52-week, open label, single dose level study Up to 12 participants undergoing kidney transplantation at multiple sites in Canada, the United Kingdom and Australia Kidney transplant using standard induction therapy plus maintenance therapy with tegoprubart
Slide 22: Phase 2 BESTOW Kidney Transplantation Study Design
Phase 2 BESTOW Kidney Transplantation Study Design 52-week, head-to-head, superiority trial, open label, 2-arm, active comparator safety, PK, and efficacy study Approximately 120 participants (60/arm) undergoing kidney transplantation at multiple sites in the United States and other countries Partic
Slide 23: Kidney Allograft Function is an Early Predictor of Future Graft Failure
Kidney Allograft Function is an Early Predictor of Future Graft Failure eGFR at 12 months is associated with subsequent death-censored graft failure Source: Am J Kidney Dis. 2011 Mar; 57(3):466-75. Graft function measured using eGFR at 12 months post transplant is associated independently with subse
Slide 24: Single Company Focus: Leveraging Validated Biology to Develop Immune-Modulating Therapeutics
Single Company Focus: Leveraging Validated Biology to Develop Best-in-Class Immune-Modulating Therapeutics CD40/CD40L pathway validated by extensive historical proof-of-concept data Tegoprubart was engineered to increase potency, half-life and manufacturability vs. other anti-CD40 approaches Targeti
Slide 25: Eledon Pharmaceuticals
Eledon Pharmaceuticals 19900 MacArthur Blvd., Suite 550 Irvine, California 92612, USA info@eledon.com +1 949-238-8090
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