Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline Review, H2 2016’, provides an overview of the Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer), 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 Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) 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 Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer)

The report reviews pipeline therapeutics for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) 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 Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) therapeutics and enlists all their major and minor projects

The report assesses Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) 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 Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer)

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 Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer)

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 Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) 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

Altor BioScience Corporation

APIM Therapeutics AS

Astellas Pharma Inc.

Bavarian Nordic A/S

BioCancell Ltd

Celgene Corporation

Cold Genesys, Inc.

F. Hoffmann-La Roche Ltd.

Heat Biologics, Inc.

Merck & Co., Inc.

Spectrum Pharmaceuticals, Inc.

Taris Biomedical LLC

UroGen Pharmaceuticals, Ltd.

Vakzine Projekt Management GmbH

Vaxiion Therapeutics, Inc.

Viralytics Ltd.

Viventia Bio Inc.

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 7

List of Figures 8

Introduction 9

Global Markets Direct Report Coverage 9

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) Overview 10

Therapeutics Development 11

Pipeline Products for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Overview 11

Pipeline Products for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Comparative Analysis 12

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Therapeutics under Development by Companies 13

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Therapeutics under Investigation by Universities/Institutes 15

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Pipeline Products Glance 16

Late Stage Products 16

Clinical Stage Products 17

Early Stage Products 18

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Products under Development by Companies 19

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Products under Investigation by Universities/Institutes 21

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Companies Involved in Therapeutics Development 22

Altor BioScience Corporation 22

APIM Therapeutics AS 23

Astellas Pharma Inc. 24

Bavarian Nordic A/S 25

BioCancell Ltd 26

Celgene Corporation 27

Cold Genesys, Inc. 28

F. Hoffmann-La Roche Ltd. 29

Heat Biologics, Inc. 30

Merck & Co., Inc. 31

Spectrum Pharmaceuticals, Inc. 32

Taris Biomedical LLC 33

UroGen Pharmaceuticals, Ltd. 34

Vakzine Projekt Management GmbH 35

Vaxiion Therapeutics, Inc. 36

Viralytics Ltd. 37

Viventia Bio Inc. 38

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Therapeutics Assessment 39

Assessment by Monotherapy Products 39

Assessment by Target 40

Assessment by Mechanism of Action 43

Assessment by Route of Administration 46

Assessment by Molecule Type 48

Drug Profiles 50

ALT-801 - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

ALT-803 - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

apaziquone - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

atezolizumab - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

ATX-101 - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

BC-819 - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

Biologic for Superficial Bladder Cancer - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

cavatak - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

CG-0070 - Drug Profile 87

Product Description 87

Mechanism Of Action 87

R&D Progress 87

CV-301 - Drug Profile 89

Product Description 89

Mechanism Of Action 89

R&D Progress 89

DAB-389EGF - Drug Profile 91

Product Description 91

Mechanism Of Action 91

R&D Progress 91

docetaxel - Drug Profile 92

Product Description 92

Mechanism Of Action 92

R&D Progress 92

Drug for NMIBC - Drug Profile 93

Product Description 93

Mechanism Of Action 93

R&D Progress 93

erlotinib hydrochloride - Drug Profile 94

Product Description 94

Mechanism Of Action 94

R&D Progress 94

gemcitabine hydrochloride - Drug Profile 98

Product Description 98

Mechanism Of Action 98

R&D Progress 98

imiquimod - Drug Profile 99

Product Description 99

Mechanism Of Action 99

R&D Progress 99

lenalidomide - Drug Profile 101

Product Description 101

Mechanism Of Action 101

R&D Progress 101

mitomycin SR - Drug Profile 116

Product Description 116

Mechanism Of Action 116

R&D Progress 116

Monoclonal Antibody to Antagonize EGFR for Superficial Bladder Cancer - Drug Profile 117

Product Description 117

Mechanism Of Action 117

R&D Progress 117

nitroxoline - Drug Profile 118

Product Description 118

Mechanism Of Action 118

R&D Progress 118

P-MAPA - Drug Profile 119

Product Description 119

Mechanism Of Action 119

R&D Progress 119

paclitaxel - Drug Profile 121

Product Description 121

Mechanism Of Action 121

R&D Progress 121

pembrolizumab - Drug Profile 122

Product Description 122

Mechanism Of Action 122

R&D Progress 122

rAd-IFN - Drug Profile 155

Product Description 155

Mechanism Of Action 155

R&D Progress 155

sirolimus albumin-bound - Drug Profile 157

Product Description 157

Mechanism Of Action 157

R&D Progress 157

Vaccine for Oncology - Drug Profile 159

Product Description 159

Mechanism Of Action 159

R&D Progress 159

VAX-014 - Drug Profile 160

Product Description 160

Mechanism Of Action 160

R&D Progress 160

VB-4845 - Drug Profile 161

Product Description 161

Mechanism Of Action 161

R&D Progress 161

vesigenurtucel-L - Drug Profile 163

Product Description 163

Mechanism Of Action 163

R&D Progress 163

VPM-1002 - Drug Profile 168

Product Description 168

Mechanism Of Action 168

R&D Progress 168

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Dormant Projects 170

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Discontinued Products 171

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Product Development Milestones 172

Featured News & Press Releases 172

Aug 10, 2016: TARIS Biomedical Launches Second Phase 1b Clinical Trial of TAR-200 (GemRIS) in Patients with Bladder Cancer 172

May 06, 2016: Spectrum Pharmaceuticals Highlights an Oral Presentation on Apaziquone at the 2016 Annual Meeting of the American Urological Association Education and Research (AUA) in San Diego, California, May 6-10, 2016 172

May 05, 2016: UroGen Pharma Announces Data Presentations Related to its Clinical Stage Uro-Oncology Candidates at the American Urology Association’s 2016 Annual Meeting 173

Apr 07, 2016: Heat Biologics Announces Cost-Saving Measures and Focused Corporate Strategy to Achieve Important Clinical Milestone 174

Feb 25, 2016: Heat Biologics Provides Update on Its HS-410 Phase II Monotherapy Bladder Cancer Trial Arm 174

Feb 19, 2016: Spectrum Pharmaceuticals Announces FDA Acceptance of NDA Filing for EOquin (apaziquone for intravesical instillation) 174

Feb 10, 2016: FDA Lifts Heat Biologics Partial Clinical Hold 175

Feb 03, 2016: Heat Biologics Reports Update on Its HS-410 Phase 2 Bladder Cancer Trial 175

Jan 26, 2016: Heat Biologics CSO to Present Interim Results From the Monotherapy Arm in Its Ongoing HS-410 Phase 2 Bladder Cancer Trial at the Phacilitate Immunotherapy World Conference 175

Jan 13, 2016: UroGen Pharma Expands Uro-Oncology Clinical Pipeline with Addition of TLR-7 Agonist Phase 2 Asset 176

Nov 06, 2015: Heat Biologics Reports HS-410 Phase 1 Bladder Cancer Trial Results at the Society for Immunotherapy of Cancer Annual Meeting 177

Nov 03, 2015: Results of Heat Biologics' HS-410 Phase 1 Safety Trial in Non-Muscle Invasive Bladder Cancer to be Presented at SITC Annual Meeting 178

Oct 26, 2015: Spectrum Pharmaceuticals Initiates Apaziquone Pivotal Trial for the Treatment of Non-Muscle Invasive Bladder Cancer Following SPA Agreement 178

Aug 17, 2015: Spectrum Pharmaceuticals Announces Agreement with FDA on the Special Protocol Assessment (SPA) for the Upcoming Apaziquone Phase 3 Trial in Patients with Non-Muscle Invasive Bladder Cancer 179

Jul 02, 2015: Viventia Begins Recruitment of Clinical Centers as it Prepares to Initiate Phase 3 Clinical Trial of Vicinium(TM) for the Treatment of Non-Muscle-Invasive Bladder Cancer 180

Appendix 181

Methodology 181

Coverage 181

Secondary Research 181

Primary Research 181

Expert Panel Validation 181

Contact Us 181

Disclaimer 182

List of Tables

List of Tables

Number of Products under Development for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer), H2 2016 11

Number of Products under Development for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Comparative Analysis, H2 2016 12

Number of Products under Development by Companies, H2 2016 14

Number of Products under Investigation by Universities/Institutes, H2 2016 15

Comparative Analysis by Late Stage Development, 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 Development by Companies, H2 2016 (Contd..1) 20

Products under Investigation by Universities/Institutes, H2 2016 21

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Altor BioScience Corporation, H2 2016 22

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by APIM Therapeutics AS, H2 2016 23

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Astellas Pharma Inc., H2 2016 24

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Bavarian Nordic A/S, H2 2016 25

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by BioCancell Ltd, H2 2016 26

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Celgene Corporation, H2 2016 27

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Cold Genesys, Inc., H2 2016 28

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by F. Hoffmann-La Roche Ltd., H2 2016 29

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Heat Biologics, Inc., H2 2016 30

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Merck & Co., Inc., H2 2016 31

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Spectrum Pharmaceuticals, Inc., H2 2016 32

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Taris Biomedical LLC, H2 2016 33

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by UroGen Pharmaceuticals, Ltd., H2 2016 34

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Vakzine Projekt Management GmbH, H2 2016 35

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Vaxiion Therapeutics, Inc., H2 2016 36

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Viralytics Ltd., H2 2016 37

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Pipeline by Viventia Bio Inc., H2 2016 38

Assessment by Monotherapy Products, H2 2016 39

Number of Products by Stage and Target, H2 2016 41

Number of Products by Stage and Mechanism of Action, H2 2016 44

Number of Products by Stage and Route of Administration, H2 2016 47

Number of Products by Stage and Molecule Type, H2 2016 49

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Dormant Projects, H2 2016 170

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Discontinued Products, H2 2016 171

List of Figures

List of Figures

Number of Products under Development for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer), H2 2016 11

Number of Products under Development for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) – Comparative Analysis, H2 2016 12

Number of Products under Development by Companies, H2 2016 13

Number of Products under Investigation by Universities/Institutes, H2 2016 15

Comparative Analysis by Late Stage Development, 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 39

Number of Products by Top 10 Targets, H2 2016 40

Number of Products by Stage and Top 10 Targets, H2 2016 40

Number of Products by Top 10 Mechanism of Actions, H2 2016 43

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 43

Number of Products by Routes of Administration, H2 2016 46

Number of Products by Stage and Routes of Administration, H2 2016 46

Number of Products by Top 10 Molecule Types, H2 2016 48

Number of Products by Stage and Top 10 Molecule Types, H2 2016 48

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