Slide 1: EQUALISE Interim Data Type B: Lupus Nephritis Patients
EQUALISE Interim Data Type B: Lupus Nephritis Patients 27 September 2022 Exhibit 99.1
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements about Equillium, Inc. (the “Company”). Statements contained in this presentation regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform
Slide 3: Additional Information: Metacrine Transaction
Additional Information Where You Can Find Additional Information Related to the Metacrine Transaction This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval with respect to the proposed merger or otherwi
Slide 4: Lupus Nephritis: The disease and treatment goals
Lupus Nephritis: The disease and treatment goals
Slide 5: Lupus Nephritis in Numbers
50% Of systemic lupus erythematosus patients will develop lupus nephritis, the most common severe manifestation of the disease 100,000 Lupus nephritis patients in the U.S. 10-30% Of patients will progress to end-stage renal disease requiring kidney replacement therapy < 50% Of patients achieve a par
Slide 6: Proteinuria/Albuminuria: Surrogate Markers for Renal Survival
Proteinuria/Albuminuria cause renal damage and fibrosis and are markers of disease activity Early, rapid and deep reductions in proteinuria minimize kidney damage and are predictive of better renal outcomes Goal of treatment is to minimize kidney damage and progression to renal failure, preventing t
Slide 7: Treatment Goals for Lupus Nephritis
Treatment Goals for Lupus Nephritis The goal of therapeutic intervention is to rapidly and deeply reduce urine protein creatinine ratio (UPCR) and reduce steroid administration, noting that patients in the nephrotic range (> 3-3.5 g/d) may take an additional 6-12 months to achieve desired outcomes,
Slide 8: Response to Standard of Care Induction Therapy
Response to Standard of Care Induction Therapy Longitudinal Patterns of Response to Standard of Care Therapy for Lupus Nephritis: Data from the Accelerating Medicines Partnership® (AMP) Lupus Network Week 12 ORR 29% 23% 20% 57% ORR 43% 28% 23% 49% ORR 51% Week 26 Week 52 Abbreviations: SoC Standard
Slide 9: Approved Therapies: Need Remains for Rapid & Deep Responses
Approved Therapies: Need Remains for Rapid & Deep Responses Despite recent approvals, high unmet medical need remains for therapies that induce rapid and deep responses in more patients safely, without broad immuno-suppression Baseline UPCR Mean (SD) 32% 38% 30% 20% 30% 50% 41% 29% 30% 23% 29% 48% P
Slide 10: Itolizumab: Targeting the CD6-ALCAM Pathway In Lupus Nephritis
Itolizumab: Targeting the CD6-ALCAM Pathway In Lupus Nephritis
Slide 11: CD6-ALCAM Pathway is Central to Immuno-inflammation
CD6-ALCAM Pathway is Central to Immuno-inflammation The CD6-ALCAM pathway modulates T cell activity and trafficking and we believe is central to the pathogenesis of multiple immuno-inflammatory diseases CD6 is a co-stimulatory receptor overexpressed on Teff and down-regulated on Treg CD6High cells e
Slide 12: Bench to Bedside: The CD6-ALCAM Pathway In Lupus Nephritis
Bench to Bedside: The CD6-ALCAM Pathway In Lupus Nephritis Exploratory analysis of SLE patients in Type A portion of the EQUALISE study, with elevated UPCR & UACR, showed an improvement with treatment4 Blockade of CD6 shown to be efficacious in multiple pre-clinical models of SLE/LN1 Antigen specifi
Slide 13: A Differentiated Approach to Treating Lupus Nephritis
A Differentiated Approach to Treating Lupus Nephritis A unique, upstream, disease modifying mechanism selectively targeting auto-reactive Teff cell activity and trafficking to promote immune homeostasis and induce durable disease remission Restoration of immune regulation without broad immunosuppres
Slide 14: Summary of Type A – SLE Patients
Summary of Type A – SLE Patients
Slide 15: EQUALISE Study Design: Type A - Systemic Lupus Erythematosus
Primary Objective Assess the safety and tolerability of itolizumab in subjects with systemic lupus erythematosus (SLE) with and without active proliferative lupus nephritis Secondary Objective Characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of itolizumab Type A Patients with active
Slide 16: Safety Overview: Type A
Safety Overview Safety monitored by independent Data Review Committee 49% of subjects experienced at least one adverse event Mostly in the highest dose cohort where multiple injections were required per dose (89% of subjects in 3.2 mg/kg group) Most common terms headache and injection site reaction
Slide 17: Dose-Dependent Pharmacokinetics & Rapid Pharmacodynamics
Dose-Dependent Pharmacokinetics & Rapid Pharmacodynamics *Baseline ADA only: 4/19 (21%); low titer (<200) ADA observed in 3/19 (16%), at 2 (n=1) and 6 (n=2) weeks after the last dose of study drug **Some missing data points due to inadequate sample collection Abbreviations: ADA anti-drug antibodies,
Slide 18: Exploratory Analysis of SLE Subjects with Elevated Proteinuria
Exploratory Analysis of SLE Subjects with Elevated Proteinuria Low grade proteinuria is both present and treatable in patients with SLE and provides positive signal of drug activity for the treatment of lupus nephritis Abbreviations: ACR urine albumin-to-creatinine ratio, UPCR urine protein-to-creat
Slide 19: Type A Summary
Subcutaneous administration of itolizumab (0.4 - 2.4 mg/kg doses) was well tolerated Reduced tolerability was observed at the 3.2 mg/kg dose with over 50% of patients discontinuing treatment after the first dose, 2-3 injections per dose were required Consistent with the mechanism of action of itoliz
Slide 20: Interim Data Type B – LN Patients
Interim Data Type B – LN Patients
Slide 21: EQUALISE Study Design: Type B – Lupus Nephritis
Primary Objective Assess safety and tolerability Secondary Objectives Characterize pharmacokinetics (PK) and pharmacodynamics (PD) Assess clinical activity: ∆ in UPCR Proportion of subjects with CR/PR in apLN ∆ in daily and cumulative prednisone dose ∆ in serologic markers and eGFR ∆ in SLEDAI-2K Ty
Slide 22: Key Demographics
Key Demographics Baseline Characteristics Safety Population (n=13) Age: Mean (SD) / Range 33.7 (11.8) / 20-58 Female: n (%) Female 12 (92%) Race: n (%) Country: n (%) White: 1 (8%) / Asian: 12 (92%) US: 3 (23%) / India: 10 (77%) SLE Duration (years): Mean (SD) / Range 7.3 (7.5) / 1-29 LN Duration (y
Slide 23: EQUALISE Type B Summary: subjects dosed
EQUALISE Type B Summary: 13 subjects dosed Database cut on September 2, 2022, analysis includes: 13 subjects enrolled and dosed (Safety Population) 12 subjects have received > 1 dose and a post-baseline assessment (Efficacy Population) 1 subject discontinued without a post-baseline efficacy assessme
Slide 24: Interim Safety Data Summary - Type B
Interim Safety Data Summary - Type B Safety Overview 77% of subjects reported at least one adverse event- predominantly mild to moderate in severity 2 subjects (15%) with AESI (lymphopenia) reported 2 subjects (15%) with at least 1 SAE (all SAEs unrelated to study treatment) Early termination of 3 s
Slide 25: Assessment of PK/PD and Anti-Drug Antibodies
Assessment of PK/PD and Anti-Drug Antibodies PK profile at 1.6 mg/kg comparable between Type A and B patients Reduction of cell surface CD6 (PD marker) is consistent with the mechanism of action To date, no subjects exhibited high titers of ADA, no changes to PK in ADA positive subjects Based on int
Slide 26: Clinical Responses at 12 & 28 Weeks
Clinical Responses at 12 & 28 Weeks 18% Week 28/EOS (n=6) Best response (n=12) ORR: 83% Week 12 (n=11) 17% 33% 33% 17% 33% 25% 25% 17% 56% 27% Best response shown for all subjects dosed with > 1 dose; UPCR based on spot urine collection Based on interim data from 2 Sep 2022 – subject to change. Abbr
Slide 27: Longitudinal Disposition
First noted Complete Response = > 50% reduction in UPCR and < 0.5 g/g First noted Complete Response = > 50% reduction in UPCR and 0.5-0.7 g/g First noted Partial Response = > 50% reduction in UPCR End of Treatment Ongoing End of Study Longitudinal Disposition (n=13) Sub. 1: 2.6 g/g Sub. 2: 3.9 g/g S
Slide 28: Change in UPCR and Best Clinical Response by Subject
Maximum Reduction in UPCR (%) Sub.1 2.2 g/g Sub.13 1.4 g/g Sub.7 4.5 g/g Sub.8 0.9 g/g Sub.3 4.6 g/g Sub.2 0.6 g/g Sub.11 0.1 g/g Sub.4 0.5 g/g Sub.5 0.6 g/g Sub.6 0.2 g/g 100 90 80 70 60 50 40 30 20 10 0 -10 -20 -30 -40 -50 -60 -70 -80 -90 -100 Sub.12 6.8 g/g Sub.9 0.9 g/g 67% overall response rate
Slide 29: Change in UPCR over time
Change in UPCR over time Week 12 Number of Subjects 10 9 Median -51.3% 6.2 mg Mean (SD) -36.7% (49.3%) 10.5 (10.7) mg Week 28/EOS^ Number of Subjects 6 5 Median -59.1% 5.0 mg# Mean (SD) -57.7% (28.0%) 7.5 (5.7) mg# Baseline Change in UPCR from Baseline Daily Steroid Dose (prednisone equivalents) Num
Slide 30: Itolizumab added to SoC Shows Clinically Meaningful Benefit
Itolizumab added to SoC Shows Clinically Meaningful Benefit EULAR/ERA-EDTA Treatment Duration Treatment Goal1 AMP SoC data2,3 (Mean baseline UPCR ~3.4) Itolizumab Interim Analysis (Mean baseline UPCR ~5.8) 3 months Reduction in proteinuria at least 25% Not reported 7 of 11 (64%) by Week 12 6 months
Slide 31: EQUALISE Type B Interim Data Highlights
EQUALISE Type B Interim Data Highlights 5/6 (83%) achieved complete or partial response (ORR) in UPCR by 28 weeks / EOS 8/12 (67%) achieved > 50% reduction in UPCR achieving at least partial response 4/6 (67%) achieved > 80% reduction in UPCR by 28 weeks / EOS Mean proteinuria reduction of > 60% (>
Slide 32: Next Steps
Next Steps Key learnings from EQUALISE Type B lupus nephritis interim data: Itolizumab continues to demonstrate a favorable safety and tolerability profile at 1.6 mg/kg dose through six months of treatment Emerging product profile suggests differentiation in early, rapid, and deep responses in highl