Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Corporate Update (August 2021)
27 slides from Avalo Therapeutics's corporate update, August 2021
Slide 1: AVTX-002 Crohn's Disease – Phase 1b Initial Data (Cohort 1)
Innovation Driven by Compassion AVTX-002 Crohn’s Disease – Phase 1b Initial Data (Cohort 1) August 2021 1 © Copyright 2021. Avalo Therapeutics, Inc. All rights reserved.
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and unc
Slide 3: Today's Agenda
Today’s Agenda Mike Cola Executive Summary and Brief Introduction Chief Executive Officer IBD, Crohn’s Disease, and Ulcerative Colitis Overview • Overview of IBD (Crohn’s Disease and Ulcerative Colitis) Garry Neil, MD • Significant Burden of Illness and Unmet Need; Disease Pathology Chief Scientific
Slide 4: Executive Summary: AVTX-002 Demonstrates Potential Proof-of-Concept in Initial Low-Dose Cohort
Executive Summary: AVTX-002 Demonstrates Potential Proof-of-Concept in Initial Low-Dose Cohort 2nd Positive Proof-of-Concept With AVTX-002 Further Validates the LIGHT MOA in Inflammatory Diseases • Open-label proof-of-concept study in patients with moderate to severe Crohn’s disease who previously f
Slide 5: Inflammatory Bowel Disease, Crohn's Disease, and Ulcerative Colitis Overview
Inflammatory Bowel Disease, Crohn’s Disease, and Ulcerative Colitis Overview 5 © Copyright 2021. Avalo Therapeutics, Inc. All rights reserved.
Slide 6: Inflammatory Bowel Disease Overview
Inflammatory Bowel Disease Overview Significant Unmet Need Exists in Crohn’s Disease and Ulcerative Colitis • Inflammatory bowel disease (IBD) is a broad term indicating chronic inflammation of the gastrointestinal (GI) tract and includes both Crohn’s disease (CD) and ulcerative colitis (UC)1 – Rela
Slide 7: Substantial Opportunity Remains in the Treatment of IBD
Substantial Opportunity Remains in the Treatment of IBD • Majority of cases are designated moderate/severe Severe and treated with pharmacologic intervention disease • Almost all patients with moderate to severe IBD will Surgery receive biologics over the course of treatment1 Biologic agents – Appro
Slide 8: AVTX-002: Clinical Rationale for Use in Treatment of IBD
AVTX-002: Clinical Rationale for Use in Treatment of IBD Role of LIGHT in IBD, Crohn’s Disease, and Ulcerative Colitis 8 © Copyright 2021. Avalo Therapeutics, Inc. All rights reserved.
Slide 9: LIGHT Is a Key Driver of Inflammation
LIGHT Is a Key Driver of Inflammation Member of the TNF Superfamily (TNFSF14) of Proteins, Involved in T-Cell Activation and Inflammation • LIGHT (TNFSF14) is a pro-inflammatory HVEM-Mediated LTβR-Mediated Signaling Pathways Signaling Pathways cytokine and a co-stimulator of T cells and Th1 cytokine
Slide 10: Multiple Lines of Evidence Support Importance of LIGHT in IBD
Multiple Lines of Evidence Support Importance of LIGHT in IBD • Patient data – Elevated levels of LIGHT in patients with CD1 and UC2 – High LIGHT mRNA levels detected in human inflamed intestinal tissue compared with normal tissue1,3 – LIGHT gene upregulation is observed in CD and UC4 • Animal model
Slide 11: Elevated LIGHT Levels Detected in Pediatric Crohn's Disease
Elevated LIGHT Levels Detected in Pediatric Crohn’s Disease Plasma LIGHT levels Were Significantly Elevated in Patients With CD vs Healthy Individuals P<0.0001* 1000 • Approximately 83% of pediatric patients with CD had significantly elevated LIGHT levels LIGHT Level (pg/mL) – Cross-sectional study
Slide 12: AVTX-002: Previous Clinical Study
AVTX-002: Previous Clinical Study Safety and Efficacy in COVID-19 Acute Respiratory Distress Syndrome (ARDS) 12 © Copyright 2021. Avalo Therapeutics, Inc. All rights reserved.
Slide 13: AVTX-002: A Novel First-in-Class Anti-LIGHT (TNFSF14) mAb
AVTX-002: A Novel First-in-Class Anti-LIGHT (TNFSF14) mAb In-licensed From Kyowa Kirin Co., Worldwide Exclusive Rights* for All Indications (2021) • Novel, first-in-class fully human subcutaneous (SQ) monoclonal antibody (mAb) • Only fully human anti-LIGHT mAb • Only anti-LIGHT mAb in clinical devel
Slide 14: A Single Dose of AVTX-002 Reduced LIGHT Levels Dramatically and Rapidly
A Single Dose of AVTX-002 Reduced LIGHT Levels Dramatically and Rapidly • Mean LIGHT levels were comparable at LIGHT Levels (pg/mL) Over Treatment Period baseline across cohorts 400 • Mean LIGHT levels were ~100 pg/mL higher in patients aged ≥60 years • LIGHT levels declined rapidly in the active LI
Slide 15: AVTX-002 Significantly Reduced Respiratory Failure and Mortality in COVID-19 ARDS
AVTX-002 Significantly Reduced Respiratory Failure and Mortality in a Phase 2 Clinical Trial in Patients Hospitalized With COVID-19 ARDS Primary Endpoint: Percentage of Patients Alive and Free of Respiratory Failure at Day 28 100 P=0.274 Free of Respiratory Failure at Day 28 Percentage of Patients A
Slide 16: AVTX-002: Phase 1b Study in Crohn's Disease
AVTX-002: Phase 1b Study in Crohn’s Disease Preliminary Initial Safety and Efficacy Results (Cohort 1) 16 © Copyright 2021. Avalo Therapeutics, Inc. All rights reserved.
Slide 17: AVTX-002 Crohn's Disease Proof-of-Concept Trial Design
AVTX-002 Crohn’s Disease Proof-of-Concept Proof-of-Concept Trial Design Open-Label Proof-of-Concept Clinical Trial of AVTX-002 in adults with moderate to severe, active • Moderate to Crohn’s disease who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment severe disease • An
Slide 18: Clinical Study Patient Population
AVTX-002 Crohn’s Disease Proof-of-Concept: Phase 1b Initial Data (Cohort 1) Clinical Study Patient Population Inclusion Criteria Exclusion Criteria • Male or female, ≥18 to ≤75 years of age • Diagnosis of UC or indeterminate colitis • Documented diagnosis of CD via endoscopy/ • Signs or symptoms of
Slide 19: Patient-Level Data
AVTX-002 Crohn’s Disease Proof-of-Concept: Phase 1b Initial Data (Cohort 1) Patient-Level Data Age Prior Therapy / SES-CD LIGHT (pg/mL) Subject # Response (yrs) # of Prior Lines Baseline 8 Weeks Baseline 8 Weeks Significant mucosal healing: Remicade, Entyvio, Subject 1 42 11 4 455 24 • 64% reduction
Slide 20: Preliminary Efficacy Results (Patient-Level Data)
AVTX-002 Crohn’s Disease Proof-of-Concept: Phase 1b Initial Data (Cohort 1) Preliminary Efficacy Results (Patient-Level Data) Plasma LIGHT Levels SES-CD Scores 500 25 Plasma LIGHT Levels (pg/mL) Subj. 1 Subj. 1 Subj. 2 Subj. 2 400 Subj. 3 20 Subj. 3 SES-CD Score Subj. 4 Subj. 4 300 15 200 10 100 5 0
Slide 21: Independent Preliminary Safety Data Results
AVTX-002 Crohn’s Disease Proof-of-Concept: Phase 1b Initial Data (Cohort 1) Independent Preliminary Safety Data Results – AVTX-002, SQ Injection (1mg/kg) • No serious adverse events attributable to study drug – Consistent with 83-patient COVID-19 ARDS clinical trial1 • Adverse events were mild to mo
Slide 22: Initial Low-Dose Cohort Data Demonstrates Potential Proof-of-Concept
Initial Low-Dose Cohort Data Demonstrates Potential Proof-of-Concept • Open-label proof-of-concept study in patients with moderate to severe Crohn’s disease who previously failed 3 lines of biologic therapies, including anti-TNFα* • Clinically meaningful mucosal healing, determined by colonoscopy, i
Slide 23: AVTX-002 Clinical Program Next Steps
AVTX-002 Clinical Program Next Steps • Crohn’s Disease – Further evaluation of cohort data, including tissue LIGHT levels – Cohort 2 (3 mg/kg dose) fully enrolled; complete data anticipated in 2H21 • Ulcerative Colitis – Expand clinical study to patient with moderate to severe UC refractory to anti-
Slide 24: Summary Comments
Summary Comments 24 © Copyright 2021. Avalo Therapeutics, Inc. All rights reserved.
Slide 25: Summary
Summary • Second positive proof-of-concept with AVTX-002, which we believe further validates the LIGHT mechanism of action in inflammatory diseases (both acute and chronic) • Biomarker-driven approach elucidates novel indications and de-risks clinical programs • Precision medicine approach is being
Slide 26: Clinical-Stage Pipeline
Clinical-Stage Pipeline Clinical Development Stage Mechanism Lead Anticipated Program of Action Indication Designation Early-Stage Mid-Stage Late-Stage Milestone Immunology/Immuno-oncology Received Fast Track COVID-19 ARDS Fast Track Designation* AVTX-002 Anti-LIGHT mAb Inflammatory Top-line Data –
Slide 27: NASDAQ:AVTX
NASDAQ:AVTX www.avalotherapeutics.com 27 © Copyright 2021. Avalo Therapeutics, Inc. All rights reserved.