Monoclonal antibodies form the fastest growing segment of the pharmaceutical industry, with total annual sales expected to top $50 billion in the next four years.

Dallas, TX -- (SBWire) -- 04/18/2010 -- ReportsandReports announce it Will Carry the Preclinical Development of Monoclonal Antibodies and Related Biologicals: Emerging technologies and new therapeutic candidates Market Research Report in its Store.

Monoclonal antibodies form the fastest growing segment of the pharmaceutical industry, with total annual sales expected to top $50 billion in the next four years. 23 full-size monoclonal antibodies and three monoclonal antibody fragments have been launched so far, several having quickly reached ‘blockbuster status’ (annual sales of over $1 billion). Between 1995 and 2007, the number of monoclonal antibody-based drug candidates entering clinical trials more than tripled, and this expansion is continuing.

This report explains what monoclonal antibodies are, and why large pharmaceutical companies are investing so heavily both in developing such drugs internally and acquiring monoclonal antibody candidates from others. More than 80 popular and emerging technologies are named, explained and illustrated with original full-color diagrams.

The newest wave of drug candidates based on these technologies can be seen in more than 200 case studies, which identify every commercial company known to have carried out preclinical studies of therapeutic monoclonal antibodies in the last year. Finally, prospects and challenges for the future of this field are discussed, with opinions from scientific pioneers and industry leaders.

Key features of this report

• Illustrated ‘beginners guide’ to monoclonal antibodies: What they are, how they are made and why they hold such great promise for the treatment of disease.

• More than 80 descriptions of proprietary technologies currently in use around the world to select, produce and re-engineer monoclonal antibodies.

• More than 30 original, full-color diagrams illustrating the science and technology of monoclonal antibodies, both as they appear in nature and in the myriad new forms now being assessed in preclinical trials.

Scope of this report

• Understand the basic qualities of monoclonal antibodies and how these qualities translate into unique medical and commercial features for drug candidates.

• Appreciate the challenges and risks of monoclonal antibodies, as well as their promise.

• Assess promising new technologies for investment or in-licensing.

• Identify which companies are involved in this field, and what they are doing.

• Predict the kinds of drug that will enter clinical trials in the next 1-4 years and may reach the market in the next 5-10 years.

Key Market Issues

• New monoclonal antibodies can be used to target new disease processes that are not currently addressed by any other therapies, thereby accessing market areas with high unmet demand.

• The inherent specificity and predictability of monoclonal antibodies have been shown to shorten drug development times and increase rates of success in preclinical and clinical trials, relative to non-biological ‘small molecule’ drugs.

• High barriers to entry currently prevent many new companies from entering this field. The techniques now used to create, select and modify monoclonal antibodies for human therapeutic use are protected by intellectual property, which the originators defend vigorously. However, several early patents on fundamental techniques will expire very soon.

Key findings from this report

• Early challenges relating to immunogenicity, tissue penetration, administration and production of monoclonal antibodies are being addressed by myriad new technologies.

• The competitive benefits of identifying and addressing new therapeutic targets continue to provide incentives for new target selection and monoclonal antibody identification programs.

• Established techniques for ‘humanization’ of non-human monoclonal antibodies remain popular, despite the rise of newer ‘fully human’ monoclonal antibody technologies. This may be due to the robust nature of the earlier technologies and/or the imminent expiries of key patents.

• Genetic engineering methods and novel ‘host cell’ production systems are being used to optimize and modify functions of monoclonal antibodies. Proprietary platforms using these methods have been widely licensed to many of the major players in the biopharmaceutical industry.

Key questions answered

• What are monoclonal antibodies, and what can they do?

• Why are so many companies developing them as therapeutic agents?

• Which companies are currently working to validate and develop the latest generation of drug candidates based on monoclonal antibodies?

• What technological and regulatory challenges face these companies in developing such candidates and bringing drugs to market?

Table of Content:
Executive summary 16
An introduction to monoclonal antibodies 16
Identifying non-human monoclonal antibodies 17
Optimizing full-length antibodies 17
Fully human monoclonal antibodies 18
Antibody conjugates 19
Novel binding molecules derived from antibodies 20

Chapter 1 An introduction to monoclonal antibodies 22
Summary 22
Introduction 23
Antibodies in nature 23
Advantages of monoclonal antibodies as drugs 29
Target range 29
Predictability 30
Pharmacokinetics 30
Technology protection 30
Challenges and opportunities for the next generation of monoclonal antibodies 31
Target selection 31
Species specificity 33
Pharmacokinetics 34
Manufacture 34
Monoclonal antibody drugs already at market 35
Orthoclone OKT3 35
Remicade 36
Rituxan 36
Zenapax 37
Synagis 37
Humira 37
Vectibix 38
Simponi 38
Lucentis 38
Cimzia 39
Tysabri 39
Preclinical development of therapeutic drugs 40
Proof of concept 40
Safety profile 40
Conclusions 42

Chapter 2 Identifying non-human monoclonal antibodies 46
Summary 46
Introduction 47
Technology platforms 47
Hybridoma technology 48
RabMAbs 48
SLAM 48
Human Response Platform 49
DIAAD 49
ImmuneY2 50
iMAB 50
Fusion Expression Technology 51
ProMIS 51
AbScreen 51
AbProt 52
BioArctic platform 52
FunctionFIRST 52
Case studies 52
Abbott Labs 53
AbGenomics 53
Alethia 53
Amorfix 53
Arrowsmith Technologies 54
AVEO 55
BioSceptre 55
Canadian Bio Med Systems 55
Cangene 56
CellAct 56
CoGenesys 57
Crucell 57
CSL 58
Daewoong 58
DKFZ 58
Epitomics 59
Fusion Antibodies 59
Ganymed Pharmaceuticals 60
GeNeuro 60
Genitope 60
GSK 61
Heat Biologics 61
Immuno-Biological Labs 61
ImmunoGen 62
Immutep 62
InflaRx 63
Innate Pharma 63
Inotek 63
Intercell 64
LigoCyte 64
MedImmune 64
Morphotek 65
NeoGenix 65
Northwest Biotherapeutics 66
Novartis 66
Novo Nordisk 67
OncoMed 67
Perseis Therapeutics 67
Pfizer 68
Pharma Research Toronto 69
Prana Biotech 69
Quest PharmaTech 69
Recepta Biopharma 69
Receptor-Logic 70
Roche 70
Shanghai CP Guojian 71
Suzhou Stainwei Biotech 71
Therapure 71
ThromboGenics 71
Thrombotargets 72
Tolerx 72
Trillium 73
Vaccinex 73
Wilex 73
ZymoGenetics 74
Conclusions 81

Chapter 3 Optimizing full-length antibodies 84
Summary 84
Introduction 85
Technology platforms 86
Chimeric antibodies 86
CDR grafting 88
SMART 90
Superhumanisation 90
Framework Patching 91
Composite Human Antibody 91
ATLAb 92
Humaneering 92
MLG 93
DeImmunisation 93
Humanation 93
Human Engineering 94
FcX 94
The LEX System 94
Potelligent 94
Complegent 95
BestMAb 97
ImmunoBody 97
EB66 97
Synageva Expression Platform 98
XmAb 98
Sugar Engineered Antibodies 99
Wox 99
Case studies 101
Abbott Labs 101
Advanced Immune Therapeutics 102
Alder Biopharm 102
Alethia 103
Alexion 103
Antisoma 103
Arana 104
Attenuon 105
AVEO 106
BioArctic Neuroscience 106
Biogen Idec 106
Biolex 107
BioXell 108
China Synthetic Rubber Corp 108
CSL 108
CureTech 109
Direvo 109
DSX 109
Eli Lilly 110
Epitomics 110
Faron Pharm 110
Femta Pharm 110
Forerunner Pharma Research 111
Fusion Antibodies 111
Galaxy Biotech 112
Galileo Oncologics 112
Genentech 113
Glenmark 113
GlycoForm 114
Glycotope 114
ImmunoCellular Therapeutics 114
Immunomedics 115
Innate Pharma 115
InNexus Biotech 115
Intellect Neurosciences 116
Isu Abxis 116
Janssen Alzheimer Immunotherapy 116
KaloBios 117
Keel Pharm 117
LigoCyte 117
Lpath 117
Mabion 118
MacroGenics 118
MaimoniDex 119
MAT Biopharma 119
MedImmune 119
Medtronic 120
Micromet 120
NKT Therapeutics 120
Opsona 121
Percipio 121
Pharma Research Toronto 122
ProtAb 122
Scancell 123
Selexys 123
SinoMab Bioscience 124
Synageva 124
TaiMed 124
Trillium 125
United Biomedical 125
Vascular Pharm 125
VasGene 126
Vegenics 126
Vybion 126
Xencor 127
Conclusions 134

Chapter 4 Fully human monoclonal antibodies 138
Summary 138
Introduction 139
Technology platforms 139
Phage display 139
MBAS 141
CBAS 142
HuCAL 142
MAbstract 142
ActivMAb 143
Adimab platform 143
XenoMouse 143
UltiMAb 145
VelocImmune 145
Open Monoclonal Technology 146
Xenerex 146
SEBVI 147
Cloning the Human Response 147
Viventia platforms 147
Natural Human Antibodies 148
MabIgX 148
Reverse Translational Medicine 148
I-STAR 149
CellSpot 149
iBioLaunch 149
Case studies 150
Adimab 150
Acorda Therapeutics 150
Affitech 151
Agensys 153
Alopexx 153
AstraZeneca 154
BioFactura 155
Biotherapix 156
CellAct 156
Celldex 156
Centocor 157
Crucell 158
CSL 158
Dyax 158
Emergent BioSolutions 158
Functional Genetics 159
GenMab 159
Crucell 160
GSK 160
Humabs 160
Human Antibodomics 161
Humanyx 161
iBio 162
ImClone 162
IMED 163
Immune System Therapeutics 163
IQ Therapeutics 164
Kenta Biotech 164
Kyowa Hakko Kirin 165
MabVax 165
Mapp Biopharmaceutical 166
Medarex 166
MedImmune 167
Merck & Co 168
Micromet 169
MorphoSys 169
NatImmune 170
Neurimmune 170
NovImmune 170
Novo Nordisk 171
Omeros Corp 172
Oncaidia 172
OncoMed 172
Oxford BioTherapeutics 173
Panacea 173
Patrys 174
Peregrine 175
PharmAbcine 176
sanofi-aventis 176
Theraclone 177
Trellis Bioscience 178
U3 Pharma 178
Vaccinex 179
Vegenics 179
Xoma 180
Conclusions 189

Chapter 5 Antibody conjugates 192
Summary 192
Introduction 193
Technology platforms 193
Antibody Drug Conjugate 193
Targeted Antibody Payload 195
Probodies 195
Antibody cloaking 197
Targeted Photodynamic Therapy 197
AlbudAb 198
hyFc 198
Ligand traps 198
CovX-Body 200
Dynamic Cross-Linking 200
LEC technology 200
Case studies 201
Algeta 201
Aphios 201
ArmaGen Technologies 201
Asan Medical Center 202
Bayer Schering 202
Beijing ABT 203
Biogen Idec 203
BioTransformations 203
Boehringer Ingelheim 204
Celldex 204
Cytoguide 205
CytomX 205
Dompe 206
EnGeneIC 206
FDA 206
Forerunner Pharma Research 207
Galileo Oncologics 207
Genentech 207
Genexine 208
ImmunoGen 208
Immunomedics 209
InNexus Biotech 210
Medarex 210
MedImmune 211
Merrimack 211
Morphotek 212
Mycenax 212
NCI 212
Oncaidia 213
OncoTherapy Science 213
Panacea 214
Peregrine 214
Pfizer 214
Pivotal BioSciences 215
Seattle Genetics 215
Symphogen 215
Transgene Biotek 216
Viventia 216
Conclusions 222

Chapter 6 Novel binding molecules derived from antibodies 224
Summary 224
Introduction 225
Technology platforms 226
Fab 226
TetraMABs 227
scFv 227
Immuna 228
[scFv]2 228
BiTE 229
Avibodies 230
TandAb 233
Flexibody 234
V-NAR 234
Nanobody 236
Domain Antibodies 238
Heteropolymer 242
UniBody 243
Domain Exchanged Antibodies 244
SMIP 246
SCORPION 247
DVD-Ig 248
Case studies 249
Abbott Labs 249
Ablynx 249
AdAlta 250
Affimed 250
Avipep 251
Beijing ABT 251
Biogen Idec 252
Calmune 252
Elusys 253
ESBATech 253
Galileo Oncologics 253
Glycotope 254
GSK 254
Inmunova 255
MAT Biopharma 256
Micromet 256
Novartis 257
PharmAbcine 257
Trubion 257
Suzhou Stainwei Biotech 258
Taligen 259
Vegenics 259
Conclusions 264
Appendix 266
Primary research methodology 266
Glossary 267
Index 278

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