Equillium, Inc. · NASDAQ:EQ
Equillium — Investor Presentation (February 2019)
37 slides from Equillium's investor presentation, Feb 26, 2019
Slide 1: Harnessing Novel Immunobiology
Harnessing Novel Immunobiology February 2019 Exhibit 99.1
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements about Equillium, Inc. (the “Company”). In some cases, you can identify forward-looking statements by the words “will,” “expect,” “intend,” “plan,” “objective,” “believe,” “estimate,” “potential,” “continue” and “ongoing,” or
Slide 3: Executive Summary
Executive Summary Validated therapeutic: itolizumab has shown clinical efficacy in multiple indications – studied by Biocon in >330 patients – and is approved for the treatment of psoriasis in India Pipeline-in-a-product: EQ001 has broad potential disease modifying therapeutic utility; launching mul
Slide 4: Recent Accomplishments and Planned Milestones
Recent Accomplishments and Planned Milestones On track to begin Phase 1b study in Asthma in Q2 2019 On track to begin Phase 1b/2 study in aGVHD in March 2019 Acute Graft Versus Host Disease (aGVHD): awarded Fast Track designation and Orphan Drug designations for both prevention and treatment Nominat
Slide 5: Accomplished Management Team
Accomplished Management Team Dan Bradbury Chairman & Chief Executive Officer Bruce Steel, CFA President & Chief Business Officer Christine Zedelmayer Vice-President of Operations Steve Connelly, PhD Chief Scientific Officer Jason Keyes Chief Financial Officer David Essayan, MD Head of Regulatory Aff
Slide 6: EQ001 Development Strategy
EQ001 Development Strategy We are leveraging our deep understanding of the CD6 pathway to develop EQ001 for multiple severe immuno-inflammatory disorders aGVHD severe asthma Indication Phase 1 Phase 1b / 2 Phase 3 Expected Milestones IND open FDA Fast Track and ODD lupus nephritis Severe asthma proo
Slide 7: CD6 Plays a Central Role in Immuno-inflammation
CD6 Plays a Central Role in Immuno-inflammation
Slide 8: CD6 Role in Immuno-inflammatory Disease
CD6 Role in Immuno-inflammatory Disease Transplant Science Neuro- Inflammation Systemic Autoimmunity Gastrointestinal Ophthalmic Pulmonary Acute Graft-Versus- Host Disease Chronic Graft-Versus-Host Disease Severe Asthma Interstitial Lung Diseases Lupus/Lupus Nephritis Scleroderma Behcet’s Disease Rh
Slide 9: The Basis of Immuno-inflammation
The Basis of Immuno-inflammation Immuno-inflammatory diseases can be fundamentally characterized by an imbalance between effector cell and immuno-regulatory activity Treg Teff Autoimmunity Tolerance Teff Teff Treg Teff
Slide 10: CD6 is Central to Immuno-inflammation
CD6 is Central to Immuno-inflammation Highest levels of CD6 are found on activated T effector cells (Teff) and associated with amplification of the auto-reactive cascade Immune Regulatory “Tolerance” Autoreactive “Autoimmunity”
Slide 11: CD6 Drives Pathogenic T Cell Activity & Trafficking
CD6 Drives Pathogenic T Cell Activity & Trafficking Co-stimulation = Activation Proliferation Differentiation / Survival Trafficking INCREASED PROINFLAMMATORY CYTOKINE SECRETION SUPPRESSION OF REGULATORY PATHWAYS INCREASED TRAFFICKING OF PATHOGENIC T CELLS
Slide 12: EQ001 Inhibits Pathogenic T Cell Activity & Trafficking
EQ001 Inhibits Pathogenic T Cell Activity & Trafficking Inhibition = Activation Proliferation Differentiation / Survival Trafficking RESTORATION OF REGULATORY PATHWAYS DECREASED PROINFLAMMATORY CYTOKINE SECRETION DECREASED TRAFFICKING OF PATHOGENIC T CELLS
Slide 13: Upstream, Disease Modifying Immuno-inflammatory Mechanism
Upstream, Disease Modifying Immuno-inflammatory Mechanism Restoration of immune regulation… without immunosuppression Inhibition of trafficking… into key target organs Inhibition of T effector cells… upstream of current approaches EQ001 is designed to selectively target autoreactive effector T cell
Slide 14: Clinical Strategy
Clinical Strategy
Slide 15: Itolizumab is Clinically Validated in Autoimmune Disease
Itolizumab is Clinically Validated in Autoimmune Disease Phase 3 pivotal trial results: demonstrated efficacy & safety in psoriasis patients (n=223) Baseline 12 Weeks 28 Weeks Efficacious Treatment Arm Dosing Week 0-4 Dosing Week 5-12 PASI 75 Week 12 Dosing Week 12+ 0.4mg/kg QW 1.6mg/kg Q2W 27% (p =
Slide 16: Opportunity in Multiple Severe Autoimmune Indications
Opportunity in Multiple Severe Autoimmune Indications Therapeutic Area Therapeutic Indication Scientific Rationale Translational Research Commercial Opportunity Clinical Plan Transplant Science aGVHD cGVHD Pulmonary severe asthma Systemic Autoimmunity systemic lupus, lupus nephritis, scleroderma Gas
Slide 17: GVHD Remains an Area of High Unmet Medical Need
GVHD Remains an Area of High Unmet Medical Need Advanced aGVHD skin Advanced aGVHD Gut Bronchiolitis Obliterans of the Lung in cGVHD aGVHD ~50% of HSCT cGVHD ~30-70% of HSCT Mortality from aGVHD as high as 95% in steroid refractory patients Steroids remain SoC for first-line treatment of aGVHD and c
Slide 18: GVHD is a Significant & Growing Market Opportunity
GVHD is a Significant & Growing Market Opportunity Projected US aGVHD incidence and GVHD prevalence by the year 2025 Annual incidence of aGVHD up to 6,000 Total prevalence of GVHD up to 35,000 Currently, limited available FDA approved therapies Significant need for safe and effective therapies No pr
Slide 19: CD6 Plays a Central Role in GVHD
CD6 Plays a Central Role in GVHD Autoreactive Teff cells drive tissue damage in GVHD Teff cells overexpress CD6 CD6 co-stimulation results in increased Teff cell activation, proliferation and increased secretion of pro-inflammatory cytokines including IFN-γ, TNF-α, IL-6 and IL-17 CD6 co-stimulation
Slide 20: EQUATE Study in aGVHD
EQUATE Study in aGVHD 2:1 Active:Placebo, N ~60 Treatment Frontline therapy within 72 hours of presentation concomitant with steroids Five doses administered Q2W Long term follow-up to 1 year Study Population Patients at first presentation of aGVHD Phase 1b will evaluate high risk patients (adults)
Slide 21: Severe Asthma: Significant Need in Severe Refractory Patients
Severe Asthma: Significant Need in Severe Refractory Patients Severe Asthma patients are characterized by: Requires treatment with high dose inhaled corticosteroids, systemic corticosteroids or biologics (anti-IgE, anti-IL-5) Also includes patients that remain “uncontrolled” despite this therapy Poo
Slide 22: CD6 is Upregulated in Severe Asthma Patients
CD6 is Upregulated in Severe Asthma Patients Analysis of gene expression datasets support the presence of increased CD6, CD4 T cells, and ALCAM in the lung of severe asthma patients In a separate set of patients, analysis of gene expression in lung tissue suggests higher expression of the CD6 ligand
Slide 23: Th17 Cells Expressing CD6 Drive Severe Refractory Asthma
Th17 Cells Expressing CD6 Drive Severe Refractory Asthma Current therapies target downstream signaling of Th2-associated inflammation Current downstream therapies ineffective in patients with low levels of eosinophils No approved therapies EQ001 anti-TSLP anti-IgE anti-IL-5 DP2 Agonist Mepolizumab S
Slide 24: EQUIP Study in Moderate-to-Severe Uncontrolled Asthma
EQUIP Study in Moderate-to-Severe Uncontrolled Asthma Design: Randomized, Double-Blind, placebo controlled, multiple dose, dose escalation study Treatment and Follow-up (12 weeks) EQ001 administered Q2W (SC), weeks 1-8 Final safety, PK/PD, and efficacy assessments at end of week 12 Study Population
Slide 25: Significant Unmet Need in Lupus Nephritis
Significant Unmet Need in Lupus Nephritis Despite SoC, up to 40% of patients with severe proliferative disease will progress to end-stage renal disease (ESRD) Systemic lupus erythematosus (SLE) is a heterogeneous, multisystem, auto-immune disease characterized by the presence of multiple autoantibod
Slide 26: T Cells are Central to Immuno-pathogenesis of Lupus Nephritis
Nature Reviews Nephrology T Cells are Central to Immuno-pathogenesis of Lupus Nephritis T cells lie at the center of activation of the adaptive and innate immune system in Lupus Nephritis Innate and adaptive immune response to nuclear histone proteins (e.g. dsDNA) Autoantibodies form and deposit in
Slide 27: Translational Data Supports Targeting CD6 in Lupus Nephritis
Supportive preclinical data from mouse models of lupus and glomerulonephritis (GN) Treatment with anti-CD6 mAb shows improvement in disease activity in Lupus model Treatment with anti-CD6 mAbs shows improvement in renal function in GN model Analysis of LN kidney biopsies show upregulation of CD6 in
Slide 28: Limited Clinical Pipeline in Lupus Nephritis
Limited Clinical Pipeline in Lupus Nephritis T cell approaches have demonstrated promising efficacy, but have been discontinued due to safety concerns B cell focused approaches have failed in Lupus Nephritis Lupus is both a B cell and T cell mediated disease Many development programs have been plagu
Slide 29: Urinary Biomarkers May Guide Development Plan
Urinary Biomarkers May Guide Development Plan Leveraging urinary biomarkers can optimize drug development in Lupus Nephritis Address heterogeneity – determine patient response by urinary levels of CD6-ALCAM Optimize Therapeutic Index – urinary biomarkers to optimize dose selection and maximize thera
Slide 30: Lupus Nephritis Next Steps
Lupus Nephritis Next Steps Expand assessment of CD6-ALCAM pathway urinary biomarkers as part of companion diagnostic strategy We plan to initiate a Phase 1b proof-of-concept study in the second half of 2019 Trial will enroll adults with active proliferative Lupus Nephritis (Class III or IV +/- Class
Slide 31: Corporate
Corporate
Slide 32: Partnership with a Leading Global Biopharma Company
Partnership with a Leading Global Biopharma Company Leading global biologics manufacturer with FDA regulated cGMP facilities World’s fourth largest insulin producer, and leading bio-similar developer: insulin glargine (Lantus®), adalimumab (Humira®), bevacizumab (Avastin®), etanercept (Enbrel®) Tras
Slide 33: Partnership for U.S. & Canada
: Partnership for U.S. & Canada Equillium exclusive licensee to itolizumab for U.S. & Canada Biocon is a significant minority shareholder in Equillium Biocon partnership provides clinical and commercial supply of our drug product: Biocon has completed CMC & manufactures drug product at commercial sc
Slide 34: Intellectual Property & Market Exclusivity
Intellectual Property & Market Exclusivity Patent term Provisional Application (2039) Method of treating severe asthma Pending PCT Application (2037) Method of treating lupus Pending Applications (2030-2034) Formulation patent Method of treating MS (High Th17) Granted US Patents (2028) Molecule’s se
Slide 35: Executive Summary
Executive Summary Validated therapeutic: itolizumab has shown clinical efficacy in multiple indications – studied by Biocon in >330 patients – and is approved for the treatment of psoriasis in India Pipeline-in-a-product: EQ001 has broad potential disease modifying therapeutic utility; launching mul
Slide 36: EQ001 Development Strategy
EQ001 Development Strategy We are leveraging our deep understanding of the CD6 pathway to develop EQ001 for multiple severe immuno-inflammatory disorders aGVHD severe asthma Indication Phase 1 Phase 1b / 2 Phase 3 Expected Milestones IND open FDA Fast Track and ODD lupus nephritis Severe asthma proo
Slide 37: Equillium, Inc.
Equillium, Inc. 2223 Avenida de la Playa / Suite 108 La Jolla, CA 92037 www.equilliumbio.com