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

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Presentation on theme: "IgG-Fc Fusion Proteins and Immunomodulation: What Does the Science Tell Us?"— Presentation transcript:

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

2

3 Introduction/Overview

4 Biology of Immunoglobulin G

5 Fc Fused-FVIII: Immunomodulation and Tolerogenics

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

7 Fc Fusion Proteins and Neonatal Exposure

8 Fc Fusion of FVIII and Half-Life Prolongation

9 PEGylation of FVIII and Half-Life Prolongation

10 PEGylated FVIII: Immunomodulation and Tolerogenics

11 rVIII-SingleChain (CSL627) and Half-Life Prolongation

12 The Impact of Modified Pharmacokinetics of EHL Agents on Clinical Practice

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

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

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

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

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

18 PROTECT VIII Summary Results: Bleeding and Dosing

19 Interim Analysis of Pathfinder™3 Trial

20 rVIII-SingleChain (CSL627): AFFINITY Study Design

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

22 Case Study 1: Previously Untreated Patient

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

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

25 Factors to Consider When Personalizing Prophylaxis

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

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

28 Application of EHL rFVIII Replacement Agents for ITI

29 Summary and Conclusions

30 Abbreviations

31 Abbreviations (cont)


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