Equillium, Inc. · NASDAQ:EQ
Equillium — Investor Presentation (October 2019)
36 slides from Equillium's investor presentation, Oct 1, 2019
Slide 1: Harnessing novel immunobiology
Company Logo harnessing novel immunobiology October 2019 www. Equilliumbio.com
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: Delivering powerful new treatment approaches
Delivering powerful new treatment approaches Focused on immuno-inflammatory diseases with high unmet need Driven by an accomplished team rapidly delivering key milestones Our lead asset, itolizumab, is unique, modulating both the activity and trafficking of Teff cells Initial clinical programs are t
Slide 4: Accomplished Management Team
Accomplished Management Team Dan Bradbury Chairman & Chief Executive Officer Bruce Steel, CFA President & Chief Business Officer Steve Connelly, PhD Chief Scientific Officer Krishna Polu, MD Chief Medical Officer Jason Keyes Chief Financial Officer Christine Zedelmayer Vice-President of Operations a
Slide 5: Itolizumab (EQ001) First-in-class Lead Program
Itolizumab (EQ001) First-in-class Lead Program First-in-class anti-CD6 mAb that inhibits the activity and trafficking of Teff cells by selectively targeting the CD6/ALCAM pathway Broad potential ‘pipeline in a product’ –multiple high-value indications applicable, three clinical studies underway Vali
Slide 6: Itolizumab Development Strategy
Itolizumab Development Strategy Equilliumis well-capitalized and staffed to execute on key programs uncontrolled asthma aGVHD Indication Phase 1 Phase 1b / 2 Phase 3 Expected Milestones FDA Fast Track Orphan Drug Designation Lupus nephritis EQUATE Phase 1b/2 aGVHD trial initiated March 2019 Data to
Slide 7: The CD6/ALCAM pathway
The cd6/alcam pathway
Slide 8: CD6/ALCAM Pathway Central to Immuno-inflammation
CD6/ALCAM Pathway Central to Immuno-inflammation T CELL APC / TISSUE ALCAM CD6 CD6 is a co-stimulatory receptor expressed on T cells, differentially expressed on subsets of innate lymphoid (ILC) and natural killer (NK) cells, but not on T regulatory cells (Treg) Activated leukocyte cell adhesion mol
Slide 9: Itolizumab Modulates CD6/ALCAM Pathway
ALCAM EQ001 CD6 Itolizumab Humanized IgG1 Kappa Binds to domain 1 of human CD6 with 1.3 nM affinity Inhibits ALCAM binding to CD6 Non-depleting, modulatory action Manufacturing and formulation Manufactured in CHO cells at commercial scale IV and SC formulations available Dosing Half-life IV/SC @ 20/
Slide 10: CD6 – Central Role in T Effector Cell Development
CD6 –Central Role in T Effector Cell Development Highest levels of CD6 are found on activated T effector cells (Teff) and associated with amplification of the auto-reactive cascade CD6 Low/- CD6+ CD6Hi Treg Weak Signalling Tnaive Strong Signalling Teff Th1 Th2 Th17 CD6 Immune Regulatory “Tolerance”
Slide 11: CD6/ALCAM Pathway Central to Immuno-inflammation
CD6/ALCAM Pathway Central to Immuno-inflammation ACTIVITY TRAFFICKING Increased proinflammatory cytokine secretion Optimal immune synapse formation, activation and proliferation Increased trafficking of Teff cells into target tissues Suppression of regulatory pathways Company Logo Chart
Slide 12: Itolizumab Inhibits Pathogenic T Cell Activity & Trafficking
Itolizumab Inhibits Pathogenic T Cell Activity & Trafficking ACTIVITY TRAFFICKING Decreased proinflammatory cytokine secretion Inhibits optimal synapse formation co-stimulation, activation and proliferation Decreased trafficking of Teff cells into target tissues Restoration of regulatory pathways Ch
Slide 13: Upstream, Disease Modifying Immuno-inflammatory Mechanism
Upstream, Disease Modifying Immuno-inflammatory Mechanism Itolizumab acts upstream and selectively targets autoreactive effector T cells, while sparing regulatory T cells to promote immune tolerance and durable disease remission Synergistic inhibition of multiple Teff cells and cytokines* Inhibition
Slide 14: Clinical Strategy
Clinical Strategy
Slide 15: Uncontrolled moderate to severe asthma
Uncontrolled moderate to severe asthma A heterogeneous disease characterized by different Teff cell subtypes and other innate immune cells driving both allergic and autoimmune mechanisms, leading to chronic airway inflammation 2.6mm Severe asthma patients in the U.S. 1.3mm Patients uncontrolled by s
Slide 16: CD6-ALCAM Implicated Broadly in the Pathogenesis of Asthma
CD6-ALCAM Implicated Broadly in the Pathogenesis of Asthma Type 2 Inflammation Non-Type 2 / Th17 Inflammation Allergens Irritants, pollutants, microbes, and viruses TSLP IL-25 IL-33 IL-13 IL-4, IL-5, IL-13 IL-6 TGF-ΒV IL-23 CXCL8 GM-CSF IL-4 IL-5 IL-6, IL-17, IL-8 IFN- Y TNF IL-3, IL-4, IL-5, IL-9 B
Slide 17: Itolizumab May Address the Full Spectrum of Uncontrolled Asthma
Itolizumab May Address the Full Spectrum of Uncontrolled Asthma Th2-High Eosinophils Th2-Low Low Eosinophils Non-Th2 Neutrophils Reciprocally regulated Th2 Th2 Th17 Th17 Response to steroids Current therapies target downstream signaling of Th2-associated inflammation Current downstream therapies ine
Slide 18: Itolizumab Targets both Th2 and Non-Th2 Asthma Pathogenesis
Itolizumab Targets both Th2 and Non-Th2 Asthma Pathogenesis Modulating CD6-ALCAM pathway attenuates activity and trafficking of Th1 (IFN-y), Th2 (IL-4,5,13), Th17 (IL-17) cells and cytokines in multiple models of autoimmune and allergic inflammation Transcriptional and histological analyses support
Slide 19: Upregulation of CD6 & ALCAM in Severe Asthma Patients
Upregulation of CD6 & ALCAM in Severe Asthma Patients Examination of gene expression datasets and lung tissue support the presence of increased CD6, CD4 T cells, and ALCAM in the lungs of severe asthma patients Analysis of two different gene expression datasets support the presence of increased CD6,
Slide 20: EQUIP Study in Uncontrolled Asthma
EQUIP Study in Uncontrolled Asthma EQUIP Study Population: Uncontrolled moderate to severe asthma patients Study Design Primary Objectives Secondary Objectives Phase 1b N=32 Randomized, double-blind, placebo controlled, dose escalation study Assess the safety and tolerability of subcutaneous dosing
Slide 21: Acute graft-versus-host disease (aGVHD)
Acute graft-versus-host disease (aGVHD) A multisystem complication of allogeneic hematopoietic stem cell transplants, or allo-HSCT, caused by T eff cells, recognizing and attacking the recipient’s body 8,500 Allo-HSCT’s performed in 2016 4% procedural growth year-over-year 30-70% Allo-HSCT patients
Slide 22: CD6+ T Cells Drive GVHD
aGVHD CD 6+ T Cells Drive GVHD Bar Chart Irradiation leads to activation of donor T cells T cell Proliferation and secretion of proinflammatory cytokine Activated donor T cells infiltrate tissues (Graphic) GUT SKIN LIVER Company Logo
Slide 23: Itolizumab is a Differentiated aGVHD Treatment Option
aGVHD Itolizumab is a Differentiated aGVHD Treatment Option Acute GVHD Company Logo Itolizumab 0-100 days post-transplant First line positioning Dual mode of action inhibits the activity and trafficking of Teff cells Potential disease-modifying therapy with durable benefit Immunomodulatory vs. immun
Slide 24: Strong Scientific Rationale for Itolizumab in aGVHD
aGVHD Strong Scientific Rationale for Itolizumab in aGVHD Scientific Rationale th 17 cells expressing CD6 play a critical role in the pathogenesis of aGVHD th17 cells are steroid resistant ALCAM expressed on target organs facilitates infiltration of CD6+ Teff cells Studies have shown a high th17:Tre
Slide 25: EQUATE Study for First-line Treatment in aGVHD
aGVHD EQUATE Study for First-line Treatment in aGVHD EQUATE Study Population: First-line treatment of newly diagnosed aGVHD patients Study Design Phase 1b N~24 (high-risk Macmillan criteria Open-label,3x3, dose escalation Primary Objectives Assess the safety and tolerability of intravenous (IV) dosi
Slide 26: Lupus nephritis
Lupus nephritis a heterogeneous disease that is the most frequent and serious manifestation of system lupus erythematosus (SLE) 100,000 Lupus nephritis patients in the U.S. 50%-75% Of patients do not respond to frontline treatments 40% Of severe, proliferative patients will progress to end-stage ren
Slide 27: T Cell Directed Therapies Represent a Promising Approach
T Cell Directed Therapies Represent a Promising Approach Activated APC’s/dendritic cells T cells play a central role in the immunopathogenesis of lupus, with aberrant T cell activation and function leading to defective peripheral tolerance Effector cytokines T cells also secrete pro-inflammatory cyt
Slide 28: Itolizumab Targets Lupus Nephritis Pathogenesis
Itolizumab Targets Lupus Nephritis Pathogenesis Scientific Rationale Teffcells play a central role in the pathogenesis of lupus Multiple Teffcells/cytokines, such Th1/IFN-γ, Th2/IL-4 and Th17/IL-17 have been implicated Elevated Th17cells are accompanied by a decrease of Tregcells, promoting loss of
Slide 29: Treating Lupus Nephritis Today
Treating Lupus Nephritis Today – Similar Treatment for All Patients (Graphic) Standard diagnostics unable to inform biological differences between patients All patients treated uniformly with limited choices Patients may be exposed to ineffective therapies Payers pay for treatments that are ineffect
Slide 30: Treating Lupus Nephritis Tomorrow – Individualized Therapy
Treating Lupus Nephritis Tomorrow –Individualized Therapy (Graphic) Biomarker driven diagnostics inform differences between patients and guide treatment Therapy benefit -to-risk improved for patients who may respond Use of ineffective treatments minimized –lower overall cost to health care system Co
Slide 31: ALCAM is a Predictive Biomarker in Active Lupus Nephritis
ALCAM is a Predictive Biomarker in Patients with Active Lupus Nephritis Unbiased screening of >1100 urinary proteins identified urinary ALCAM as a strong predictor of disease activity in lupus nephritis patients Urinary Biomarker Outperforms Standard Disease Biomarkers in Lupus Nephritis* Urinary AL
Slide 32: EQUALISE Study in Lupus Nephritis
EQUALISE Study in Lupus Nephritis (LN) Study Design Primary Objectives Secondary/Exploratory Objectives Type A Cohort (SLE Patients): Phase 1b N=24 Open-label, dose escalation in patients with active or inactive SLE without LN Type B Cohort (active LN patients): Phase 1b N=32 Randomized, double-blin
Slide 33: Corporate
Corporate
Slide 34: Corporate: Biocon partnership
Corporate Biocon Exclusive rights for the U.S. & Canada and rights to negotiate itolizumab licensing in select ex-North America markets Robust IP portfolio and 12-year Biologics Exclusivity Biocon partnership provides risk-mitigated product supply on attractive terms CMC completed and itolizumab cur
Slide 35: Summary
Summary First in class: Itolizumab is the first antibody targeting the novel CD6/ALCAM pathway for the treatment of severe immune-inflammatory disorders Pipeline in a product: Itolizumab has broad potential disease modifying therapeutic utility Focused Development: Strong scientific rationale and tr
Slide 36: Equillium, Inc. contact details
Equillium, Inc.2223 Avenida de la Playa / Suite 105La Jolla, CA 92037www.equilliumbio.comir@equilliumbio.com