Transplant Complications Drug Development Pipeline Review, 2018

This report provides an overview of the pipeline landscape for transplant complications. It provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for graft-versus-host disease (GVHD), liver transplant rejection, kidney transplant rejection and lung transplant rejection and features dormant and discontinued products.

GVHD is a complication that can occur after a stem cell or bone marrow transplant and involves the newly transplanted donor cells attacking the transplant recipient’s body. Symptoms include abdominal pain or cramps, nausea, vomiting, diarrhea, dry or irritated eyes, jaundice, shortness of breath, vaginal dryness and weight loss. Treatment consists of immunosuppressants. There are 125 products in development for GVHD.

Organ transplantation replaces an injured or diseased organ with a healthy one. Following a transplant, the immune system may consider the transplanted tissue as foreign and work against it. Patients can develop complications and ultimately reject the new organ. Therefore, immunosuppressive drugs are administered simultaneously. These immunosuppressive drugs prevent the body from either identifying or attacking the foreign organ via various immune responses, blocking organ rejection and facilitating a successful transplant. There are 18 products in development for liver transplant rejection, 49 products in development for kidney transplant rejection and 12 products in development for lung transplant rejection.

Molecular targets acted on by products in development for transplantation complications include tyrosine kinases, caspases and chemokine receptors. Companies operating in this pipeline space include Medeor Therapeutics, Amgen and Novartis.

Scope

– Which companies are the most active within each pipeline?

– Which pharmaceutical approaches are the most prominent at each stage of the pipeline and within each indication?

– To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies?

– What are the most important R&D milestones and data publications to have happened in this disease area?

Reasons to buy

- Understand the overall pipeline, with an at-a-glance overview of all products in therapeutic development for each indication

- Assess the products in development in granular detail, with an up-to-date overview of each individual pipeline program in each indication and a comprehensive picture of recent updates and milestones for each

- Analyze the companies, institutions and universities currently operating in the pipeline and the products being fielded by each of these

- Understand the composition of the pipeline in terms of molecule type, molecular target, mechanism of action and route of administration

Companies mentioned

AbbVie Inc

AbGenomics International Inc

Alexion Pharmaceuticals Inc

AnaptysBio Inc

Angion Biomedica Corp

apceth Biopharma GmbH

Aptevo Therapeutics Inc

Astellas Pharma Inc

Athersys Inc

Balmes Transplantation SAS

Bellicum Pharmaceuticals Inc

Biogen Inc

Bioverativ Inc

Bristol-Myers Squibb Co

Capricor Therapeutics Inc

Catalyst Biosciences Inc

Cell2B Advanced Therapeutics SA

Cellect Biotechnology Ltd

Cellective BioTherapy Inc

Cynata Therapeutics Ltd

Cytodyn Inc

Dompe Farmaceutici SpA

Elsalys Biotech SA

enGene Inc

Enlivex Therapeutics Ltd

F. Hoffmann-La Roche Ltd

Fate Therapeutics Inc

Generon (Shanghai) Corp Ltd

Gilead Sciences Inc

GlaxoSmithKline Plc

Hansa Medical AB

Idogen AB

Incyte Corp

Inspyr Therapeutics Inc

ITB-Med AB

Jazz Pharmaceuticals Plc

Kadmon Corp LLC

Kamada Ltd

Kiadis Pharma NV

Kidney Transplant Rejection

Kymab Ltd

Kyowa Hakko Kirin Co Ltd

LG Chem Ltd

Liver Transplant Rejection

MaaT Pharma

Magenta Therapeutics Inc

MallInckrodt Plc

Medicenna Therapeutics Corp

Mesoblast Ltd

Millennium Pharmaceuticals Inc

Noorik Biopharmaceuticals AG

OncoImmune Inc

Opsona Therapeutics Ltd

Pfizer Inc

Pharming Group NV

Pluristem Therapeutics Inc

Prolong Pharmaceuticals LLC

Quark Pharmaceuticals Inc

RedHill Biopharma Ltd

REGiMMUNE Corp

Sanofi

Seattle Genetics Inc

Seres Therapeutics Inc

Shire Plc

Sublimity Therapeutics Ltd

Syndax Pharmaceuticals Inc

Takeda Pharmaceutical Co Ltd

Targazyme Inc

TC BioPharm Ltd

TolerogenixX GmbH

United BioPharma Inc

Vault Pharma Inc

VBI Vaccines Inc

Veloxis Pharmaceuticals A/S

Visterra Inc

Xenikos BV

XL-protein GmbH

Zai Lab Ltd

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 5

1.2 List of Figures 7

2 Introduction 9

2.1 Transplant Complications Report Coverage 9

2.2 Graft Versus Host Disease (GVHD) - Overview 9

2.3 Liver Transplant Rejection - Overview 9

2.4 Kidney Transplant Rejection - Overview 9

2.5 Lung Transplant Rejection - Overview 9

3 Therapeutics Development 10

3.1 Graft Versus Host Disease (GVHD) 10

3.2 Liver Transplant Rejection 23

3.3 Kidney Transplant Rejection 27

3.4 Lung Transplant Rejection 34

4 Therapeutics Assessment 37

4.1 Graft Versus Host Disease (GVHD) 37

4.2 Liver Transplant Rejection 47

4.3 Kidney Transplant Rejection 53

4.4 Lung Transplant Rejection 60

5 Companies Involved in Therapeutics Development 66

5.1 Graft Versus Host Disease (GVHD) 66

5.2 Liver Transplant Rejection 98

5.3 Kidney Transplant Rejection 100

5.4 Lung Transplant Rejection 112

6 Dormant Projects 116

6.1 Graft Versus Host Disease (GVHD) 116

6.2 Liver Transplant Rejection 122

6.3 Kidney Transplant Rejection 123

6.4 Lung Transplant Rejection 126

7 Discontinued Products 127

7.1 Graft Versus Host Disease (GVHD) 127

7.2 Liver Transplant Rejection 128

7.3 Kidney Transplant Rejection 128

8 Product Development Milestones 129

8.1 Graft Versus Host Disease (GVHD) 129

8.2 Liver Transplant Rejection 145

8.3 Kidney Transplant Rejection 148

8.4 Lung Transplant Rejection 162

9 Appendix 172

9.1 Methodology 172

9.2 Coverage 172

9.3 Secondary Research 172

9.4 Primary Research 172

9.5 Expert Panel Validation 172

9.6 Contact Us 172

9.7 Disclaimer 173

List of Tables

1.1 List of Tables

Table 1: Number of Products under Development for Graft Versus Host Disease (GVHD) 10

Table 2: Number of Products under Development by Companies, Graft Versus Host Disease (GVHD) 12

Table 3: Number of Products under Development by Universities/Institutes, Graft Versus Host Disease (GVHD) 15

Table 4: Products under Development by Companies, Graft Versus Host Disease (GVHD) 16

Table 5: Products under Development by Universities/Institutes, Graft Versus Host Disease (GVHD) 22

Table 6: Number of Products under Development for Liver Transplant Rejection 23

Table 7: Number of Products under Development by Companies, Liver Transplant Rejection 24

Table 8: Number of Products under Development by Universities/Institutes, Liver Transplant Rejection 25

Table 9: Products under Development by Companies, Liver Transplant Rejection 26

Table 10: Products under Development by Universities/Institutes, Liver Transplant Rejection 27

Table 11: Number of Products under Development for Kidney Transplant Rejection 28

Table 12: Number of Products under Development by Companies, Kidney Transplant Rejection 29

Table 13: Number of Products under Development by Universities/Institutes, Kidney Transplant Rejection 30

Table 14: Products under Development by Companies, Kidney Transplant Rejection 31

Table 15: Products under Development by Universities/Institutes, Kidney Transplant Rejection 33

Table 16: Number of Products under Development for Lung Transplant Rejection 34

Table 17: Number of Products under Development by Companies, Lung Transplant Rejection 35

Table 18: Products under Development by Companies, Lung Transplant Rejection 36

Table 19: Number of Products by Stage and Target, Graft Versus Host Disease (GVHD) 38

Table 20: Number of Products by Stage and Mechanism of Action, Graft Versus Host Disease (GVHD) 41

Table 21: Number of Products by Stage and Route of Administration, Graft Versus Host Disease (GVHD) 45

Table 22: Number of Products by Stage and Molecule Type, Graft Versus Host Disease (GVHD) 46

Table 23: Number of Products by Stage and Target, Liver Transplant Rejection 48

Table 24: Number of Products by Stage and Mechanism of Action, Liver Transplant Rejection 49

Table 25: Number of Products by Stage and Route of Administration, Liver Transplant Rejection 51

Table 26: Number of Products by Stage and Molecule Type, Liver Transplant Rejection 52

Table 27: Number of Products by Stage and Target, Kidney Transplant Rejection 54

Table 28: Number of Products by Stage and Mechanism of Action, Kidney Transplant Rejection 56

Table 29: Number of Products by Stage and Route of Administration, Kidney Transplant Rejection 58

Table 30: Number of Products by Stage and Molecule Type, Kidney Transplant Rejection 59

Table 31: Number of Products by Stage and Target, Lung Transplant Rejection 61

Table 32: Number of Products by Stage and Mechanism of Action, Lung Transplant Rejection 62

Table 33: Number of Products by Stage and Route of Administration, Lung Transplant Rejection 64

Table 34: Number of Products by Stage and Molecule Type, Lung Transplant Rejection 65

Table 35: Graft Versus Host Disease (GVHD) – Pipeline by AbbVie Inc 66

Table 36: Graft Versus Host Disease (GVHD) – Pipeline by AbGenomics International Inc 66

Table 37: Graft Versus Host Disease (GVHD) – Pipeline by Amgen Inc 67

Table 38: Graft Versus Host Disease (GVHD) – Pipeline by AnaptysBio Inc 67

Table 39: Graft Versus Host Disease (GVHD) – Pipeline by apceth Biopharma GmbH 68

Table 40: Graft Versus Host Disease (GVHD) – Pipeline by Aptevo Therapeutics Inc 68

Table 41: Graft Versus Host Disease (GVHD) – Pipeline by Athersys Inc 69

Table 42: Graft Versus Host Disease (GVHD) – Pipeline by Bellicum Pharmaceuticals Inc 70

Table 43: Graft Versus Host Disease (GVHD) – Pipeline by Biogen Inc 70

Table 44: Graft Versus Host Disease (GVHD) – Pipeline by Bristol-Myers Squibb Co 71

Table 45: Graft Versus Host Disease (GVHD) – Pipeline by Capricor Therapeutics Inc 72

Table 46: Graft Versus Host Disease (GVHD) – Pipeline by Cell2B Advanced Therapeutics SA 72

Table 47: Graft Versus Host Disease (GVHD) – Pipeline by Cellect Biotechnology Ltd 72

Table 48: Graft Versus Host Disease (GVHD) – Pipeline by Cellective BioTherapy Inc 73

Table 49: Graft Versus Host Disease (GVHD) – Pipeline by CSL Ltd 73

Table 50: Graft Versus Host Disease (GVHD) – Pipeline by Cynata Therapeutics Ltd 74

Table 51: Graft Versus Host Disease (GVHD) – Pipeline by Cytodyn Inc 74

Table 52: Graft Versus Host Disease (GVHD) – Pipeline by Elsalys Biotech SA 75

Table 53: Graft Versus Host Disease (GVHD) – Pipeline by enGene Inc 75

Table 54: Graft Versus Host Disease (GVHD) – Pipeline by Enlivex Therapeutics Ltd 76

Table 55: Graft Versus Host Disease (GVHD) – Pipeline by F. Hoffmann-La Roche Ltd 76

Table 56: Graft Versus Host Disease (GVHD) – Pipeline by Fate Therapeutics Inc 77

Table 57: Graft Versus Host Disease (GVHD) – Pipeline by Generon (Shanghai) Corp Ltd 77

Table 58: Graft Versus Host Disease (GVHD) – Pipeline by GlaxoSmithKline Plc 78

Table 59: Graft Versus Host Disease (GVHD) – Pipeline by Incyte Corp 79

Table 60: Graft Versus Host Disease (GVHD) – Pipeline by Inspyr Therapeutics Inc 79

List of Figures

1.2 List of Figures

Figure 1: Number of Products under Development for Graft Versus Host Disease (GVHD) 10

Figure 2: Number of Products under Development by Companies, Graft Versus Host Disease (GVHD) 11

Figure 3: Number of Products under Development by Universities/Institutes, Graft Versus Host Disease (GVHD) 14

Figure 4: Number of Products under Development for Liver Transplant Rejection 23

Figure 5: Number of Products under Development by Companies, Liver Transplant Rejection 24

Figure 6: Number of Products under Development by Universities/Institutes, Liver Transplant Rejection 25

Figure 7: Number of Products under Development for Kidney Transplant Rejection 27

Figure 8: Number of Products under Development by Companies, Kidney Transplant Rejection 28

Figure 9: Number of Products under Development by Universities/Institutes, Kidney Transplant Rejection 30

Figure 10: Number of Products under Development for Lung Transplant Rejection 34

Figure 11: Number of Products under Development by Companies, Lung Transplant Rejection 35

Figure 12: Number of Products by Top 10 Targets, Graft Versus Host Disease (GVHD) 37

Figure 13: Number of Products by Stage and Top 10 Targets, Graft Versus Host Disease (GVHD) 37

Figure 14: Number of Products by Top 10 Mechanism of Actions, Graft Versus Host Disease (GVHD) 40

Figure 15: Number of Products by Stage and Top 10 Mechanism of Actions, Graft Versus Host Disease (GVHD) 40

Figure 16: Number of Products by Routes of Administration, Graft Versus Host Disease (GVHD) 44

Figure 17: Number of Products by Stage and Routes of Administration, Graft Versus Host Disease (GVHD) 44

Figure 18: Number of Products by Top 10 Molecule Types, Graft Versus Host Disease (GVHD) 45

Figure 19: Number of Products by Stage and Top 10 Molecule Types, Graft Versus Host Disease (GVHD) 46

Figure 20: Number of Products by Top 10 Targets, Liver Transplant Rejection 47

Figure 21: Number of Products by Stage and Top 10 Targets, Liver Transplant Rejection 47

Figure 22: Number of Products by Top 10 Mechanism of Actions, Liver Transplant Rejection 48

Figure 23: Number of Products by Stage and Top 10 Mechanism of Actions, Liver Transplant Rejection 49

Figure 24: Number of Products by Routes of Administration, Liver Transplant Rejection 50

Figure 25: Number of Products by Stage and Routes of Administration, Liver Transplant Rejection 50

Figure 26: Number of Products by Molecule Types, Liver Transplant Rejection 51

Figure 27: Number of Products by Stage and Molecule Types, Liver Transplant Rejection 52

Figure 28: Number of Products by Top 10 Targets, Kidney Transplant Rejection 53

Figure 29: Number of Products by Stage and Top 10 Targets, Kidney Transplant Rejection 53

Figure 30: Number of Products by Top 10 Mechanism of Actions, Kidney Transplant Rejection 55

Figure 31: Number of Products by Stage and Top 10 Mechanism of Actions, Kidney Transplant Rejection 55

Figure 32: Number of Products by Routes of Administration, Kidney Transplant Rejection 57

Figure 33: Number of Products by Stage and Routes of Administration, Kidney Transplant Rejection 57

Figure 34: Number of Products by Top 10 Molecule Types, Kidney Transplant Rejection 58

Figure 35: Number of Products by Stage and Top 10 Molecule Types, Kidney Transplant Rejection 59

Figure 36: Number of Products by Targets, Lung Transplant Rejection 60

Figure 37: Number of Products by Stage and Targets, Lung Transplant Rejection 60

Figure 38: Number of Products by Mechanism of Actions, Lung Transplant Rejection 61

Figure 39: Number of Products by Stage and Mechanism of Actions, Lung Transplant Rejection 62

Figure 40: Number of Products by Routes of Administration, Lung Transplant Rejection 63

Figure 41: Number of Products by Stage and Routes of Administration, Lung Transplant Rejection 63

Figure 42: Number of Products by Molecule Types, Lung Transplant Rejection 64

Figure 43: Number of Products by Stage and Molecule Types, Lung Transplant Rejection 65

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