Osteosarcoma – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Osteosarcoma – Pipeline Review, H2 2016’, provides an overview of the Osteosarcoma pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Osteosarcoma, complete with analysis by stage of development, drug target, 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 therapeutic development for Osteosarcoma 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 of Osteosarcoma

The report reviews pipeline therapeutics for Osteosarcoma 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 Osteosarcoma therapeutics and enlists all their major and minor projects

The report assesses Osteosarcoma therapeutics based on drug target, 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 related to pipeline therapeutics for Osteosarcoma

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 important and diverse types of therapeutics under development for Osteosarcoma

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 Osteosarcoma pipeline depth and focus of Indication therapeutics

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

Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Companies mentioned

Advaxis, Inc.

Amgen Inc.

AVEO Pharmaceuticals, Inc.

Bayer AG

Bellicum Pharmaceuticals, Inc.

Celldex Therapeutics, Inc.

CytRx Corporation

Eleison Pharmaceuticals LLC

Exelixis, Inc.

Isofol Medical AB

MediaPharma s.r.l.

Merck & Co., Inc.

Merrimack Pharmaceuticals, Inc.

Netris Pharma S.A.S.

Novartis AG

Oncolys BioPharma Inc

Pfizer Inc.

Shionogi & Co., Ltd.

Teijin Pharma Limited

United Therapeutics Corporation

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 8

List of Figures 9

Introduction 10

Global Markets Direct Report Coverage 10

Osteosarcoma Overview 11

Therapeutics Development 12

Pipeline Products for Osteosarcoma - Overview 12

Pipeline Products for Osteosarcoma - Comparative Analysis 13

Osteosarcoma - Therapeutics under Development by Companies 14

Osteosarcoma - Therapeutics under Investigation by Universities/Institutes 16

Osteosarcoma - Pipeline Products Glance 17

Clinical Stage Products 17

Early Stage Products 18

Osteosarcoma - Products under Development by Companies 19

Osteosarcoma - Products under Investigation by Universities/Institutes 20

Osteosarcoma - Companies Involved in Therapeutics Development 21

Advaxis, Inc. 21

Amgen Inc. 22

AVEO Pharmaceuticals, Inc. 23

Bayer AG 24

Bellicum Pharmaceuticals, Inc. 25

Celldex Therapeutics, Inc. 26

CytRx Corporation 27

Eleison Pharmaceuticals LLC 28

Exelixis, Inc. 29

Isofol Medical AB 30

MediaPharma s.r.l. 31

Merck & Co., Inc. 32

Merrimack Pharmaceuticals, Inc. 33

Netris Pharma S.A.S. 34

Novartis AG 35

Oncolys BioPharma Inc 36

Pfizer Inc. 37

Shionogi & Co., Ltd. 38

Teijin Pharma Limited 39

United Therapeutics Corporation 40

Osteosarcoma - Therapeutics Assessment 41

Assessment by Monotherapy Products 41

Assessment by Target 42

Assessment by Mechanism of Action 45

Assessment by Route of Administration 48

Assessment by Molecule Type 50

Drug Profiles 52

3D-QM - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

3D-QMS - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

ADXS-HER2 - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

aldoxorubicin hydrochloride - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

AM-7209 - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

AU-101 - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

AV-203 - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

axitinib - Drug Profile 78

Product Description 78

Mechanism Of Action 78

R&D Progress 78

cabozantinib s-malate - Drug Profile 84

Product Description 84

Mechanism Of Action 84

R&D Progress 84

Cellular Immunotherapy for GD2 Expressing Solid Tumors - Drug Profile 102

Product Description 102

Mechanism Of Action 102

R&D Progress 102

Cellular Immunotherapy to Target HER2 for Glioblastoma Multiforme and Osteosarcoma - Drug Profile 104

Product Description 104

Mechanism Of Action 104

R&D Progress 104

Cellular Immunotherapy to Target MAGE-A1, MAGE-A3 and NY-ESO-1 for Oncology - Drug Profile 105

Product Description 105

Mechanism Of Action 105

R&D Progress 105

celyvir - Drug Profile 106

Product Description 106

Mechanism Of Action 106

R&D Progress 106

CGS-200 - Drug Profile 107

Product Description 107

Mechanism Of Action 107

R&D Progress 107

cisplatin SR - Drug Profile 108

Product Description 108

Mechanism Of Action 108

R&D Progress 108

dihydroartemisinin - Drug Profile 110

Product Description 110

Mechanism Of Action 110

R&D Progress 110

dinutuximab - Drug Profile 111

Product Description 111

Mechanism Of Action 111

R&D Progress 111

everolimus - Drug Profile 113

Product Description 113

Mechanism Of Action 113

R&D Progress 113

glembatumumab vedotin - Drug Profile 125

Product Description 125

Mechanism Of Action 125

R&D Progress 125

irinotecan hydrochloride - Drug Profile 130

Product Description 130

Mechanism Of Action 130

R&D Progress 130

ligerin - Drug Profile 141

Product Description 141

Mechanism Of Action 141

R&D Progress 141

LLL-12 - Drug Profile 142

Product Description 142

Mechanism Of Action 142

R&D Progress 142

Modufolin - Drug Profile 143

Product Description 143

Mechanism Of Action 143

R&D Progress 143

Monoclonal Antibody for Osteosarcoma - Drug Profile 145

Product Description 145

Mechanism Of Action 145

R&D Progress 145

Monoclonal Antibody to Inhibit GD2 for Oncology - Drug Profile 146

Product Description 146

Mechanism Of Action 146

R&D Progress 146

Monoclonal Antibody to Target Ganglioside GD2 for Neuroblastoma and Osteosarcoma - Drug Profile 147

Product Description 147

Mechanism Of Action 147

R&D Progress 147

MPE-8.3 - Drug Profile 149

Product Description 149

Mechanism Of Action 149

R&D Progress 149

NP-137 - Drug Profile 150

Product Description 150

Mechanism Of Action 150

R&D Progress 150

OBP-702 - Drug Profile 151

Product Description 151

Mechanism Of Action 151

R&D Progress 151

Oligonucleotides to Inhibit Thymidylate Synthase and Dihydrofolate Reductase for Osteosarcoma and Colon Cancer - Drug Profile 152

Product Description 152

Mechanism Of Action 152

R&D Progress 152

pazopanib hydrochloride - Drug Profile 153

Product Description 153

Mechanism Of Action 153

R&D Progress 153

pembrolizumab - Drug Profile 160

Product Description 160

Mechanism Of Action 160

R&D Progress 160

Peptide to Target COX-2 and MAS-GPCR for Oncology - Drug Profile 191

Product Description 191

Mechanism Of Action 191

R&D Progress 191

radium Ra 223 dichloride - Drug Profile 193

Product Description 193

Mechanism Of Action 193

R&D Progress 193

RSF-101 - Drug Profile 202

Product Description 202

Mechanism Of Action 202

R&D Progress 202

S-588410 - Drug Profile 203

Product Description 203

Mechanism Of Action 203

R&D Progress 203

SEN-461 - Drug Profile 205

Product Description 205

Mechanism Of Action 205

R&D Progress 205

Small Molecules to Agonize Vitamin D3 Receptor for Osteosarcoma - Drug Profile 206

Product Description 206

Mechanism Of Action 206

R&D Progress 206

Small Molecules to Inhibit CaMKII for Osteosarcoma - Drug Profile 207

Product Description 207

Mechanism Of Action 207

R&D Progress 207

T-2GES - Drug Profile 208

Product Description 208

Mechanism Of Action 208

R&D Progress 208

Vaccine for Osteosarcoma - Drug Profile 209

Product Description 209

Mechanism Of Action 209

R&D Progress 209

Osteosarcoma - Dormant Projects 210

Osteosarcoma - Discontinued Products 212

Osteosarcoma - Product Development Milestones 213

Featured News & Press Releases 213

Apr 28, 2016: FDA Grants Advaxis Fast Track Designation for ADXS-HER2 for Patients with Newly-Diagnosed, Non-Metastatic, Surgically-Resectable Osteosarcoma 213

Apr 20, 2016: Celldex Therapeutics Presents Data Supporting the Clinical Development of Glembatumumab Vedotin at the AACR Annual Meeting 2016 213

Apr 13, 2016: Sarcoma Foundation of America Honors Advaxis for Advancements in Immunotherapy Platform 214

Mar 23, 2016: Advaxis Hosts Research Reception to Review Late-Breaking ADXS-HER2 at AACR Abstract 215

Mar 21, 2016: Survival Results with Advaxis HER2 Targeted Immunotherapy in Canine Osteosarcoma Published in Clinical Cancer Research 215

Mar 16, 2016: Merrimack to Present on ONIVYDE (irinotecan liposome injection) at the 2016 American Association for Cancer Research Annual Meeting 216

Jan 19, 2016: Advaxis Expands Intellectual Property for Lm Technology Platform 216

Dec 01, 2015: Advaxis Receives Orphan Drug Designation in the European Union for ADXS-HER2 for the Treatment of Osteosarcoma 217

Nov 30, 2015: CapGenesis Files Five Orphan Drug Designation Requests with the FDA and EMA for CGS-200 as a Topical Analgesic 217

Jul 21, 2015: Advaxis Expands Intellectual Property for Lm Technology Platform in HER2 218

May 04, 2015: CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 219

May 01, 2015: Eleison Announces Successful Completion of Stage 1 of its Phase II Trial of ILC (Inhaled Lipid-complexed Cisplatin) for Pediatric Bone Cancer 220

Apr 28, 2015: Advaxis Enhances Lm-LLO Cancer Immunotherapy Intellectual Property With USPTO Patent Addressing ADXS-HER2 220

Nov 04, 2014: Advaxis to Present Data of ADXS-cHER2 at the Society for Immunotherapy of Cancer 29th Annual Meeting 221

Appendix 222

Methodology 222

Coverage 222

Secondary Research 222

Primary Research 222

Expert Panel Validation 222

Contact Us 222

Disclaimer 223

List of Tables

List of Tables

Number of Products under Development for Osteosarcoma, H2 2016 12

Number of Products under Development for Osteosarcoma – Comparative Analysis, H2 2016 13

Number of Products under Development by Companies, H2 2016 15

Number of Products under Investigation by Universities/Institutes, H2 2016 16

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Development, H2 2016 18

Products under Development by Companies, H2 2016 19

Products under Investigation by Universities/Institutes, H2 2016 20

Osteosarcoma – Pipeline by Advaxis, Inc., H2 2016 21

Osteosarcoma – Pipeline by Amgen Inc., H2 2016 22

Osteosarcoma – Pipeline by AVEO Pharmaceuticals, Inc., H2 2016 23

Osteosarcoma – Pipeline by Bayer AG, H2 2016 24

Osteosarcoma – Pipeline by Bellicum Pharmaceuticals, Inc., H2 2016 25

Osteosarcoma – Pipeline by Celldex Therapeutics, Inc., H2 2016 26

Osteosarcoma – Pipeline by CytRx Corporation, H2 2016 27

Osteosarcoma – Pipeline by Eleison Pharmaceuticals LLC, H2 2016 28

Osteosarcoma – Pipeline by Exelixis, Inc., H2 2016 29

Osteosarcoma – Pipeline by Isofol Medical AB, H2 2016 30

Osteosarcoma – Pipeline by MediaPharma s.r.l., H2 2016 31

Osteosarcoma – Pipeline by Merck & Co., Inc., H2 2016 32

Osteosarcoma – Pipeline by Merrimack Pharmaceuticals, Inc., H2 2016 33

Osteosarcoma – Pipeline by Netris Pharma S.A.S., H2 2016 34

Osteosarcoma – Pipeline by Novartis AG, H2 2016 35

Osteosarcoma – Pipeline by Oncolys BioPharma Inc, H2 2016 36

Osteosarcoma – Pipeline by Pfizer Inc., H2 2016 37

Osteosarcoma – Pipeline by Shionogi & Co., Ltd., H2 2016 38

Osteosarcoma – Pipeline by Teijin Pharma Limited, H2 2016 39

Osteosarcoma – Pipeline by United Therapeutics Corporation, H2 2016 40

Assessment by Monotherapy Products, H2 2016 41

Number of Products by Stage and Target, H2 2016 43

Number of Products by Stage and Mechanism of Action, H2 2016 46

Number of Products by Stage and Route of Administration, H2 2016 49

Number of Products by Stage and Molecule Type, H2 2016 51

Osteosarcoma – Dormant Projects, H2 2016 210

Osteosarcoma – Dormant Projects (Contd..1), H2 2016 211

Osteosarcoma – Discontinued Products, H2 2016 212

List of Figures

List of Figures

Number of Products under Development for Osteosarcoma, H2 2016 12

Number of Products under Development for Osteosarcoma – Comparative Analysis, H2 2016 13

Number of Products under Development by Companies, H2 2016 14

Number of Products under Investigation by Universities/Institutes, H2 2016 16

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Products, H2 2016 18

Assessment by Monotherapy Products, H2 2016 41

Number of Products by Top 10 Targets, H2 2016 42

Number of Products by Stage and Top 10 Targets, H2 2016 42

Number of Products by Top 10 Mechanism of Actions, H2 2016 45

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 45

Number of Products by Routes of Administration, H2 2016 48

Number of Products by Stage and Routes of Administration, H2 2016 48

Number of Products by Molecule Types, H2 2016 50

Number of Products by Stage and Molecule Types, H2 2016 50

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