Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) – Pipeline Review, H2 2016’, provides in depth analysis on Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) targeted pipeline therapeutics.

The report provides comprehensive information on the Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2), targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) targeted therapeutics development and features dormant and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data.

Scope

The report provides a snapshot of the global therapeutic landscape for Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2)

The report reviews Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) targeted therapeutics under development by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) targeted therapeutics and enlists all their major and minor projects

The report assesses Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) targeted therapeutics based on mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news and deals related to Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) targeted therapeutics

Reasons to buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand the targeted therapy areas and indications for Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2)

Identify the use of drugs for target identification and drug repurposing

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) development landscape

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Companies mentioned

Aduro BioTech, Inc.

Amgen Inc.

BriaCell Therapeutics Corp.

GlaxoSmithKline Plc

Humabs BioMed SA

KaloBios Pharmaceuticals, Inc.

Morphotek, Inc.

Sillajen Biotherapeutics

Takeda Pharmaceutical Company Limited

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) Overview 8

Therapeutics Development 9

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Products under Development by Stage of Development 9

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Products under Development by Therapy Area 10

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Products under Development by Indication 11

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Pipeline Products Glance 13

Late Stage Products 13

Early Stage Products 14

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Products under Development by Companies 15

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Products under Development by Universities/Institutes 18

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Therapeutics Assessment 20

Assessment by Monotherapy/Combination Products 20

Assessment by Mechanism of Action 21

Assessment by Route of Administration 23

Assessment by Molecule Type 25

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Companies Involved in Therapeutics Development 27

Aduro BioTech, Inc. 27

Amgen Inc. 28

BriaCell Therapeutics Corp. 29

GlaxoSmithKline Plc 30

Humabs BioMed SA 31

KaloBios Pharmaceuticals, Inc. 32

Morphotek, Inc. 33

Sillajen Biotherapeutics 34

Takeda Pharmaceutical Company Limited 35

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Drug Profiles 36

GSK-3196165 - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

lenzilumab - Drug Profile 39

Product Description 39

Mechanism Of Action 39

R&D Progress 39

Monoclonal Antibody to Inhibit GM-CSF for Immunological Disorders - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

MORAb-022 - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

namilumab - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

OrienX-010 - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

pexastimogene devacirepvec - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

STINGVAX - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

SVBR-1GM - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

talimogene laherparepvec - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

Vaccine to Target CD40L and GM-CSF for Oncology - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Dormant Projects 68

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Discontinued Products 71

Granulocyte Macrophage Colony Stimulating Factor (GMCSF or Colony Stimulating Factor or CSF or Molgramostin or Sargramostim or CSF2) - Featured News & Press Releases 72

May 31, 2016: Transgene Announces Poster Presentation at ASCO Annual Meeting on the Phase 3 PHOCUS Clinical Trial with Pexa-Vec Oncolytic Immunotherapy 72

May 18, 2016: Amgen To Present Data on IMLYGIC (talimogene laherparepvec) At ASCO 2016 72

May 18, 2016: BriaCell Appoints Contract Research Organization, Cancer Insight, to Manage Its Upcoming Phase I/IIa Clinical Trials in Advanced Breast Cancer 73

May 16, 2016: SillaJen Announces Commercial Manufacturing Agreement with ABL Europe For Lead Oncolytic Virus, Pexa-Vec 74

Apr 18, 2016: GSK announces start of a phase II study to evaluate an anti GM-CSF antibody for inflammatory hand osteoarthritis 74

Apr 12, 2016: BriaCell Files a Patent Application to Protect Additional Cancer Vaccines With Genetic Features Thought to Promote Strong Anti-Tumor Activity 75

Apr 05, 2016: BriaCell Targeting Launch of Its Phase I/II Clinical Trial During Current Quarter 76

Mar 29, 2016: SillaJen Enrolls First U.S. Patient in Multinational Phase 3 Trial for Pexa-Vec in Advanced Liver Cancer 76

Mar 29, 2016: BriaCell Discovers Gene Signature of BriaVax Cancer Vaccine Consistent With Exceptional Efficacy in Clinical Trial 77

Mar 16, 2016: NICE consults on ‘no’ recommendation for skin cancer drug talimogene laherparepvec 78

Jan 05, 2016: SillaJen Announces First Patient Randomized in Multinational Phase 3 Trial for Pexa-Vec in Advanced Liver Cancer 78

Dec 20, 2015: Moffitt Cancer Center And UC Davis Suspends Clinical Trial Of KaloBios’ Leukemia Drug 79

Dec 17, 2015: European Commission Approves Amgen's IMLYGIC (talimogene laherparepvec) As First Oncolytic Immunotherapy In Europe 79

Dec 07, 2015: Morphotek Announces Phase 1 Results From MORAb-022-001 Trial in Healthy Subjects and Patients with Mild-to-Moderate Rheumatoid Arthritis 81

Nov 16, 2015: Amgen to Present IMLYGIC (Talimogene Laherparepvec) Data at the 2015 International Congress of the Society for Melanoma Research 81

Appendix 83

Methodology 83

Coverage 83

Secondary Research 83

Primary Research 83

Expert Panel Validation 83

Contact Us 83

Disclaimer 84

List of Tables

List of Tables

Number of Products under Development for, H2 2016 9

Number of Products under Development by Therapy Area, H2 2016 10

Number of Products under Development by Indication, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Early Stage Products, H2 2016 14

Number of Products under Development by Companies, H2 2016 15

Products under Development by Companies, H2 2016 16

Products under Development by Companies, H2 2016 (Contd..1) 17

Number of Products under Investigation by Universities/Institutes, H2 2016 18

Products under Investigation by Universities/Institutes, H2 2016 19

Assessment by Monotherapy/Combination Products, H2 2016 20

Number of Products by Stage and Mechanism of Action, H2 2016 22

Number of Products by Stage and Route of Administration, H2 2016 24

Number of Products by Stage and Molecule Type, H2 2016 26

Pipeline by Aduro BioTech, Inc., H2 2016 27

Pipeline by Amgen Inc., H2 2016 28

Pipeline by BriaCell Therapeutics Corp., H2 2016 29

Pipeline by GlaxoSmithKline Plc, H2 2016 30

Pipeline by Humabs BioMed SA, H2 2016 31

Pipeline by KaloBios Pharmaceuticals, Inc., H2 2016 32

Pipeline by Morphotek, Inc., H2 2016 33

Pipeline by Sillajen Biotherapeutics, H2 2016 34

Pipeline by Takeda Pharmaceutical Company Limited, H2 2016 35

Dormant Projects, H2 2016 68

Dormant Projects (Contd..1), H2 2016 69

Dormant Projects (Contd..2), H2 2016 70

Discontinued Products, H2 2016 71

List of Figures

List of Figures

Number of Products under Development for, H2 2016 9

Number of Products under Development by Therapy Area, H2 2016 10

Number of Products under Development by Top 10 Indication, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Early Stage Products, H2 2016 14

Assessment by Monotherapy/Combination Products, H2 2016 20

Number of Products by Mechanism of Actions, H2 2016 21

Number of Products by Stage and Mechanism of Actions, H2 2016 21

Number of Products by Routes of Administration, H2 2016 23

Number of Products by Stage and Routes of Administration, H2 2016 23

Number of Products by Molecule Types, H2 2016 25

Number of Products by Stage and Molecule Type, H2 2016 25

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