IgG-Fc Fusion Proteins and Immunomodulation: What Does the Science Tell Us?

Slides:

Advertisements

Similar presentations

INHIBITOR TO ANTIHEMOPHILIC FACTOR Djajadiman Gatot Division of Hematology Oncology Department of Child Health FMUI - CMGH.

Advertisements

© 2014 Direct One Communications, Inc. All rights reserved. 1 Recent Advances in Preventing Bleeding, Reducing Inhibitors, and Managing Acute Bleeding.

© 2014 Direct One Communications, Inc. All rights reserved. 1 Treatment of Hemophilia: What’s in the Pipeline? Kerry Hege, MD Indiana University School.

WFH Bangkok 2004 Factor VIII-Von Willebrand Factor Inhibitors and Immune Tolerance Inhibitor Elimination Immune Tolerance Induction (ITI)

© 2014 Direct One Communications, Inc. All rights reserved. 1 Expanding Therapeutic Options for Hemophilia A and B: Results of Recent Clinical Trials Holleh.

Hemophilia Management: Joint Bleeds and Prophylaxis.

This program will include a discussion of off-label treatment and investigational agents not approved by the FDA for use in the United States.

Sites of Action in Coagulation System Novel Factor Xa and DT Inhibitors.

Burden of Atrial Fibrillation The Percentage of Strokes Attributable to AF Increases With Age.

Challenges and Opportunities in the Management of ANCA-Associated Vasculitis.

Managing Bleeds in Patients Anticoagulated With Warfarin and Other Agents.

Advances in Managing Inhibitors in Patients With Hemophilia A

Prophylaxis Considerations for Teenagers and Young Adults With Severe Hemophilia.

Advanced NSCLC Without Actionable Mutations

Thrombosis, Cancer, and NOACs

PrEP Effectiveness. Preexposure Prophylaxis Translating the Clinical Trials Into Clinical Practice.

Emergency Management of NOAC Bleeding

Introduction Antiplatelet Agents ADP Receptor Antagonists.

Extended Half-life Factor Products in the Management of Hemophilia

Managing Hereditary Angioedema

Individualizing Prophylaxis in Hemophilia

Optimizing the Treatment of Recurrent/Metastatic SCCHN

Issues in the Management of Hemophilia: A Best Practice Series

Addressing Iron Deficiency in Chronic HF

Oral Anticoagulants in AFa,b A Brief History.

Surveying the Safety of NOACs in the Real World

Tailoring Hemophilia Prophylaxis Therapy

Are We Closer to Personalized Medicine in MS?

Applying Real-World Evidence in Atrial Fibrillation Into Clinical Care:

Addressing Challenges in Factor VIII Inhibitors in Children With Hemophilia.

Efficacy and Safety of Edoxaban in Patients With AF and HF

Antithrombotic Protection in CAD and HF

Individualizing Factor Replacement Therapy for Patients With Hemophilia.

EHL Technologies in Hemophilia Care

Detecting and Treating Asparaginase-Related Toxicities in Acute Lymphoblastic Leukemia.

Issues in the Management of Hemophilia: A Best Practice Series

A Better Solution For Cancer Patients With VTE?

Targeting BTK Signaling in B-Cell Malignancies

Oral Anticoagulation in AF

Program Goals Overview Glatiramer Acetate 3 Times a Week.

The Science of Gene Therapy for Hemophilia

Advancing the Treatment of IBD With Biologics

Using Heart Rate as a Biomarker in Clinical Practice.

Treating CD30-Expressing Cutaneous T-Cell Lymphoma

Program Goals. Technological Advances in Longer-Acting Factor Replacement Therapy for Hemophilia.

Clinicians' Corner in Dyslipidemia

What Does It Take to Be a Long-Acting Replacement Therapy in Hemophilia A?

Prolonging the Effects of Factor IX Replacement Therapy in Hemophilia B.

Cancer-Associated Thrombosis

Extended Half-life Factor Products in the Management of Hemophilia

Updates From the 2015 Meetings in Hemophilia

Current Challenges in Managing Hemophilia

Evaluating BTK Inhibitors in CLL

PEARLS OF WISDOM WITH COMBINATION THERAPY IN PAH

Optimizing Joint Health in Hemophilia

Etiology and Incidence Pathophysiology Hemophilia is due to a defect in thrombin generation on the platelet surface.

Reducing Risk for CV Outcomes

Factor Xa Inhibitors in Coronary Artery Disease

5 Good Minutes on Atrial Fibrillation-related Stroke

Selecting Treatment Approaches in Hemophilia

AMD Therapy: Where Are We Now and Where Are We Going?

Would Patients With Hemophilia B Benefit From Switching to Extended Half-Life Factor Products?

Real-World Evidence.

Presented By Caroline Dartigeas at 2016 ASCO Annual Meeting

Introduction. Welcome to this program, titled De-Escalating Therapy in Epilepsy: A Return to Monotherapy.

Identifying TRK Fusions in Head and Neck Cancer

My PAH Patient.

Examining the Role of Pharmacokinetics in Hemophilia

PCSK9 Inhibitors and Real-World Evidence

Presentation transcript:

IgG-Fc Fusion Proteins and Immunomodulation: What Does the Science Tell Us?

Introduction/Overview

Biology of Immunoglobulin G

Fc Fused-FVIII: Immunomodulation and Tolerogenics

rFVIIIFc: Reduced Immunogenicity and Induction of Tolerance in Hemophilia A Mice

Fc Fusion Proteins and Neonatal Exposure

Fc Fusion of FVIII and Half-Life Prolongation

PEGylation of FVIII and Half-Life Prolongation

PEGylated FVIII: Immunomodulation and Tolerogenics

rVIII-SingleChain (CSL627) and Half-Life Prolongation

The Impact of Modified Pharmacokinetics of EHL Agents on Clinical Practice

Safety/Efficacy Data Supporting the Benefits of EHL Agents in Hem-A

FVIII Fc Fusion Protein (rFVIIIFc): A-LONG Study Design

FVIII Activity vs Time Profile for EHL rFVIIIFc and Standard rFVIII: A-LONG

FVIII Fc Fusion Protein (rFVIIIFc): Kids A-LONG Trial Methods and Results

Safety and Efficacy of BAY 94-9027: Study Design of PROTECT VIII

PROTECT VIII Summary Results: Bleeding and Dosing

Interim Analysis of Pathfinder™3 Trial

rVIII-SingleChain (CSL627): AFFINITY Study Design

AFFINITY Results: Treatment Regimens Prior to Study Entry and at Study End

Case Study 1: Previously Untreated Patient

Case Study 2: Switching a Previously Treated Patient From Standard rFVIII to EHL rFVIIIFc

Case Study 2: FVIII Activity in Prophylactically Treated Patient Switched to rFVIIIFc Fusion Protein

Factors to Consider When Personalizing Prophylaxis

Case Study 3: Patient With Inhibitors, Rescue ITI With rFVIIIFc

Case Study 3: Patient With Inhibitors, Rescue ITI With rFVIIIFc (cont’d)

Application of EHL rFVIII Replacement Agents for ITI

Summary and Conclusions

Abbreviations

Abbreviations (cont)