Antibody-Drug Conjugates 2011 - real breakthrough still to come. A Technology, Stakeholder and R&D Pipeline Analysis

Sep 29, 2011, 06:10 ET from Reportlinker

NEW YORK, Sept. 29, 2011 /PRNewswire/ announces that a new market research report is available in its catalogue:

Antibody-Drug Conjugates 2011 - real breakthrough still to come. A Technology, Stakeholder and R&D Pipeline Analysis

Product description

This report "Antibody-Drug Conjugates 2011 – real breakthrough still to come: A Technology, Stakeholder and R&D Pipeline Analysis" published in September 2011 provides the most complete compilation of information about antibody-drug conjugate (ADC) companies, technologies and products in R&D. A comprehensive analysis of the state of the art and key trends guides the reader through this complex subject. Stakeholders in the field of antibody-drug conjugates are analysed and their contribution to the growth ADC technology and products is assessed. A critical appraisal of the clinical results of active and discontinued ADC projects and products is provided. ADC technologies and products are challenged for their commercial value and growth potential.

Scope of the report

-Drugs and Linkers Used in Antibody-Drug Conjugates

-Antibodies Used in Antibody-Drug Conjugates

-Analysis of Stakeholders in Antibody-Drug Conjugates

-Clinical Value of Antibody-Drug Conjugates

-R&D Pipeline Analysis of Antibody-Drug Conjugates

-Commercial Values of Antibody-Drug Conjugates

-Company Profiles

-Executive ADC Profiles

The recent approval of Seattle Genetics' antibody-drug conjugate Adcetris has raised great enthusiasm among stakeholders in this field. Accelerated approval was based on stunning tumor response rates in relapsed Hodgkin's lymphoma and anaplastic large cell lymphoma. Analysts expect strong sales of the expensive therapy. However, the FDA request post-approval studies showing that the high response rates translate into improved survival and that the clinical benefit seen in a small study population of 160 patients can be confirmed in a larger population. Although these data do not have to delivered before 2018, Genentech will be the next company after Wyeth (now Pfizer) to come up with survival data of its solid tumor ADC trastuzumab emtansine expected for 2012-2014. So far, only two controlled studies with ADC compounds have been published: one with Mylotarg failed to show a survival benefit, but t-DM1 pleased with an improved safety profile versus the combination of naked antibody with systemic chemotherapy

Results of early stage clinical trials of a number of ADC projects promise anti-tumor activity in hematologic malignancies as well as in solid tumors, but also dose-limiting toxicities which still narrow the therapeutic window for the currently used drugs and linkers. Nevertheless, about half of the currently clinical stage ADC projects entered clinical development within the last year indicating a high interest in the industry which also is reflected by the numerous licensing deals of the technology providers with pharmaceutical and biotech companies. The attrition rate of ADC development projects so far is well within the rate in oncology, or even better. However, ADC technologies still can be improved and candidates are emerging but need more time for validation and maturation.

Features and Benefits

-Understand available drug-linker technologies

-Identify key trends of novel ADC concepts and drug-linker technologies

-Understand the complexity of the chemistry, manufacturing and control of ADC products and which approaches can taken to reduce it

-Perceive a realistic target profile of current ADC compounds and how it can be improved;

-Understand which tumor antigens are targeted by ADCs and their role

-See which companies can provide solutions

-Understand the commercial value of ADC technologies and ADC products

Table of Contents

1. Abbreviations 6

2. Overview 7

3. Executive Summary 8

4. Drugs and Linkers Used in Antibody-Drug Conjugates 9

5. Antibodies Used in Antibody-Drug Conjugates 20

6. Analysis of Stakeholders in Antibody-Drug Conjugates 24

7. Clinical Value of Antibody-Drug Conjugates 30

8. R&D Pipeline Analysis of Antibody-Drug Conjugates 35

9. Commercial Values of Antibody-Drug Conjugates 38

10. Company Profiles 40

Abbott 40

Aeterna Zentaris 40

Allozyne 42

Alpha Cancer Technologies 43

Ambrx 43

Amgen 43

Amunix 45

Anaphore 46

Astellas Pharma (Agensys) 46

AstraZeneca (MedImmune) 49

Bayer Healthcare Pharmaceuticals 50

Biogen Idec 52

Biotest 53

Bristol-Myers Squibb (Medarex) 54

Celldex Therapeutics 57

Centrose 60

Daiichi Sankyo 61

Genmab 62

GlaxoSmithKline 62

ImmunoGen 63

Immunomedics 75

Merrimack Pharmaceuticals 79

Mersana Therapeutics 80

Millennium: The Takeda Oncology Company 82

Nerviano Medical Sciences 84

Novartis 84

Pfizer (Wyeth) 85

PharmaMar 91

Philogen 92

Progenics Pharmaceuticals 92

Roche (Genentech) 94

Sanofi 103

Seattle Genetics 107

Spirogen 116

Sutro Biopharma 117

Synthon (Syntarga) 118

Tactic Pharma (Attenuon) 119

Wilex (Heidelberg Pharma) 120

References 123

Tables 159

Table 1 Characterization of Antibody-Drug Conjugates 159

Table 2 Drugs in Use for Antibody-Drug Conjugates 159

Table 3 Seattle Genetics ADC Technology Licensing Agreements 10

Table 4 Immunogen ADC Technology Licensing Agreement 162

Table 5 Antibody-Drug Conjugates in IND and Clinical Stages 164

Table 6 Linkers in Use for Clinical-Stage Antibody-Drug Conjugates 166

Table 7 Advantages and Disadvantages of Linkers and Cytotoxic Drugs 12

Table 8 Companies Active in R&D of New Cytotoxic Drugs for ADCs 14

Table 9 Companies Active in R&D of New Linkers for ADCs 15

Table 10 Immunogenicity of Antibody-Drug Conjugates 20

Table 11 Number of drug molecules per antibody 21

Table 12 Activities of Companies in the ADC Field 24

Table 13 Strengths & Weaknesses of Integrated ADC Technology & Product Companies 25

Table 14 Emerging ADC Technology Companies 27

Table 15 Immunoconjugate & Alternative ADC Companies 28

Table 16 Reasons for Discontinuation of Clinical Stage Antibody-Drug Conjugates 30

Table 21 Main Clinical Trials with T-DM1 in Metastatic Breast Cancer 171

Table 18 Clinical Results of phase I/II stage Antibody-Drug Conjugates 34

Table 19 Antibody-Drug Conjugates in Non-Clinical Development and Preclinical R&D 172

Table 20 Antibody-Drug Conjugates Discontinued in Clinical Stages 179

Table 21 Targets of Antibody-Drug Conjugates 36

Table 22 Immunoconjugates with Non-Antibody Targeting Moiety 181

Executive ADC Profiles 182

AEZS-108 182

AGS-16M8F 185

ASG-5ME 186

ASG-22ME 188

BAY 79-4620 189

BAY 94-9343 191

BIIB015 192

BT-062 195

CR011-vcMMAE 199

CR014-vcMAE 202

hRS7-SN-38 203

IMGN388 205

IMGN529 207

IMGN853 210

IMGN901 212

Inotuzumab ozogamicin 219

Labetuzumab-SN-38 225

LIV-1 ADC 227

MDX-1203 228

MDX-1204 230

MEDI-547 231

Milatuzumab-doxorubicin 233

MM-302 236


RG7596 241

SAR3419 244

SAR566658 247

SGN-19A 249

SGN-35 250

SGN-75 261

Trastuzumab-DM1 264

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Biopharmaceutical Industry: Antibody-Drug Conjugates 2011 - real breakthrough still to come. A Technology, Stakeholder and R&D Pipeline Analysis

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Nicolas Bombourg
US: (805)652-2626
Intl: +1 805-652-2626

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