Archive for July 5th, 2010

Preclinical development of monoclonal antibodies and Biologicals: new technologies and new cancer treatments

Monoclonal antibodies are the segment of the pharmaceutical industry, with annual income expected dollars over the next few years up four. antibodies power 23 full-size monoclonal and three fragments of monoclonal antibodies were derived much more swiftly achieve blockbuster position (annual income of over € bn). Between 1995 and 2007, indicating the number of drug candidates monoclonal antibody-based clinical trials more than tripled, and this expansion continues.

This report explains that the monoclonal antibody, and why the huge pharmaceutical companies as major investments in both internal drug development and acquisition of other monoclonal antibody candidates. More than 80 favourite and new technologies are identified, explained and illustrated with original drawings in color.

The last wave of drug candidates based on these technologies can, in more than 200 case studies, which are all commercial enterprises known in preclinical studies of therapeutic monoclonal antibodies in the last year conducted a piece of identity. Finally, prospects and challenges for the future of this area are discussed, with comments from the pioneers of science and industry leaders.

The main features of this report

• Beginners illustrated guide “to monoclonal antibodies. What they are, how they are doing and why they hold so much promise for disease treatment

• More than 80 descriptions of patented technology being used worldwide to produce and re-engineered monoclonal antibodies.

• Over 30 original scales colors, where science and technology of monoclonal antibodies, as they were both in nature and in countless new forms currently in preclinical studies.

think about this report

• Understanding basic properties of monoclonal antibodies and how these qualities translate into one-of-a-kind functions for medical and commercial product candidates.

• Enjoy the challenges and risks of monoclonal antibodies as well as its promise.

• To evaluate promising new technologies for investment or licensing.

• Identify businesses in this area involved, and what they do.

• E-type drug use, clinical trials in the next 1-4 years in power and can reach the market in the next 5-10 years.

is the key market questions

• New monoclonal antibodies, new disease processes, which is not currently addressed by other therapies targeting the areas of access to markets with high demand.

• The inherent specificity and predictability of monoclonal antibody has been shown to reduce drug development and increase the success rate of pre-clinical and clinical versus non-organic “small molecule” drugs.

prevent barriers to entry are now many new companies entering the area. The techniques used this day to create, edit or choose monoclonal antibodies for therapeutic use rights are fortified by intellectual property rights, the authors defend vigorously protected. However, some patents from the beginning of the basic techniques very soon.

The main conclusions of this report

• Early challenges immunogenicity, tissue penetration, management and production of monoclonal antibodies to treat the new technologies.

• The competitive advantage to refer and address new therapeutic targets continue to attract new target selection and finding of monoclonal antibodies offer programs.

• Implementation techniques for “humanizing” the favourite non-human monoclonal antibody as before, despite the current rise of “fully human” monoclonal antibody technologies. This might be due to the robustness of the technology early and / or the immediate process of key patents.

• The methods of genetic engineering and novel host cell systems of production “will optimize and alter the functions used by monoclonal antibodies. Proprietary platforms of these methods have been widely licensed to many the main players in the biopharmaceutical industry.

Key issues answered

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

• Why so many companies developed as therapeutic agents

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

• What are the technological and regulatory challenges that companies in the development of these candidates, and market drugs

Index:

Summary 16

An introduction to the monoclonal antibody 16

not refer human monoclonal antibody-17

optimize long-term antibody 17

human monoclonal antibody 18

conjugated antibody-19

20-binding antibody molecules Novel p derived

Chapter 1 Introduction to the monoclonal antibody 22

Summary 22

Introduction 23

antibodies in kind 23 benefits

monoclonal antibodies as drugs 29

target range of 29

predictability 30

Pharmacokinetics 30 30

Challenges and opportunities for the next generation of monoclonal antibodies 31

Target Selection 31

33 species specificity

Pharmacokinetics 34

Make 34

monoclonal antibody drugs already on the 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

The preclinical development of therapeutics 40

p Proof of Concept 40

Security Profile 40

42

Chapter 2: Identification of non- human monoclonal antibody-46

Summary 46

Introduction 47

Technology Platforms 47

Hybridoma 48

RabMAbs 48

SLAM 48 </p

> Platform answer man 49

DIAAD 49

ImmuneY2 50

IMAB 50

Fusion Expression Technology 51 </p

Wed ProMIS 51

AbScreen 51

AbProt 52

BioArctic platform 52

FunctionFIRST 52> </p 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

Sea 57

Crucell 57

CSL 58

Daewoong 58

DKFZ 58

Epitomics 59

Antibody Fusion 59

Ganymed Pharmaceuticals 60

GeNeuro 60

Genitope 60

GSK 61

61

Immuno-Biological Laboratories, 61

ImmunoGen 62

Immutep 62

InflaRx 63

Innate Pharma

63

Inotek 63

Intercell 64

LigoCyte 64

MedImmune 64

Morphotek 65

NeoGenix 65

Biotherapeutics Northwest 66

Novartis 66

Novo Nordisk 67

OncoMed 67

Therapeutics 67

Pfizer 68

Pharma Research of Toronto 69

Biotech 69

69

Biopharma Recepta 69

70

Roche 70

Shanghai CP Guojian 71 Stainwei 71

Thera Pure 71

ThromboGenics 71

Thrombotargets 72

Tolerx 72

Trillium 73

Vaccinex 73

Wilex 73

ZymoGenetics 74

Conclusions 81

Chapter 3 Optimization of long-term antibody 84

Summary 84

Introduction 85

Plates technological platforms 86

chimeric antibodies 86

CDR-grafting 88

SMART 90

Superhumanisation 90

Patching Frame 91

Composite Human Antibodies 91

Atlab 92

Humaneering 92

MLG 93

DeImmunisation 93

Humana 93

Engineering man 94

FCX 94

Lex system 94

POTELLIGENT 94

Complegent 95

BestMAb 97

ImmunoBody 97

EB66 97

Platform expression Synageva 98

XmAb 98 p Engineered Antibody 99

Wox 99 Wed case 101

Abbott Labs 101

Advanced immunotherapy 102

Alder Biopharm 102

Alethia 103

Alexion 103

Antisoma 103

Arana 104

mitigate 105

AVEO 106

Neuroscience BioArctic 106

Biogen Idec 106

Biolex 107

BioXell 108

China Synthetic Rubber Corp. 108 108

CSL

CureTech 109

Direvo 109

DSX 109

Eli Lilly 110

Epitomics 110

Faron Pharm

110

Pharm Femta 110

Forerunner Pharma Research 111

Antibody Fusion 111

Galaxy Biotech 112 </

p> Wed uranologist Oncologic 112

Genentech 113

Glenmark 113

glycoform 114

glycotope 114> </p ImmunoCellular Therapeutics 114

Immunomedics 115

Innate Pharma 115

InNexus Biotech 115

Intellect Neurosciences Isu 116

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 Search Toronto 122

ProTAB 122

Scan Cell 123

seleXys 123

Bioscience SinoMab 124

Synageva 124

TaiMed 124

Trillium 125

Biomedical United 125

Vascular 125

VasGene 126

Vegenics

126

Vybion 126

Xencor 127

Conclusions 134

Chapter 4 fully human monoclonal antibody 138

Summary 138

Introduction 139

139 technology platforms

phage-display-139

MBAS 141 p SAMC 142

HuCAL 142

isolated from these 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

platforms Viventia 147

natural human antibodies 148

MabIgX 148

Reverse Translational Medicine 148

I STAR-149

instead of cells 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 </p

> Wed Crucell 160

GSK 160

HuMAb 160

Antibodomics human 161

Humanyx 161

Ibio 162

ImClone 162

IMED Therapeutics 163

Immune System 163

IQ Therapeutics 164

Kenta Biotech 164

Kyowa Hakko Kirin 165

MabVax 165

Mapp Biopharmaceutical 166

Medarex 166

MedImmune 167

Merck & ; Co 168

Micromet 169 169

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

Thera Clone 177

Trellis Bioscience 178

U3 Pharma 178

Vaccinex 179

Vegenics 179

Wed Xoma 180

Conclusions 189

Chapter 5 antibody conjugated 192 </ / p> Summary 192

Introduction 193

193 technology platforms

Antibody drug conjugate 193

antibodies payload 195

This Probo 195

Antibody Cloaking 197

targeted photodynamic therapy 197

AlbudAb 198

hyFc 198

ligand traps 198

CovX-body 200

dynamic linking 200

LEC technology 200

Case Studies 201

ALGETA 201

Aphios 201> </p Technologies ArmaGen

201

Medical Center Asan 202 Bayer

Schering 202

Beijing ABT 203

Biogen Idec 203 </p

> Wed biotransformations 203

Boehringer Ingelheim 204

Celldex 204

Cytoguide 205

CytomX 205> </p Dompé 206

EnGeneIC 206

FDA 206

Forerunner Pharma Research 207

Oncologic uranologist 207

Genentech 207

Genexine 208

ImmunoGen 208

Immunomedics 209

InNexus Biotech 210

Medarex 210

MedImmune

211

Merrimack 211

Morphotek 212

Mycenax 212

212 NCI

Oncaidia 213

oncotherapy Science 213

Panacea 214

Peregrine 214

Pfizer 214

Pivotal BioSciences 215

Seattle Genetics 215

Symphogen 215

216

Viventia 216 222

Chapter 6 new molecules of antibody binding 224 </> p / derivatives

Summary 224

Introduction 225

226 technology platforms

Fab 226

TetraMABs 227

scFv 227

Immuna 228

[scFv] 2228

BiTE 229 </p Avibodies My 230

TandAb 233

Flexi Body 234

V-NAR 234

Nanobodies 236

p domain antibodies> 238

heteropolymer 242

UniBody 243

field of anti-trade 244

246 SMIP> </p SCORPION 247

DVD-Ig-248

249 case studies

Abbott Labs 249

Ablynx 249

Adaltas 250

Affimed 250

Avipep 251

Beijing ABT 251

Biogen Idec 252

Calmune 252

Elusys 253

ESBATech 253

253

glycotope 254

GSK 254

Inmunova 255

256

Micromet 256 257

PharmAbcine 257

Trubion 257

Suzhou Stainwei Biotech 258

Taligen 259

Vegenics 259

Conclusions 264

Research Methodology Primary

266

Glossary 267

278 Index

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Information Technology

IT defines as Information Technology, IT is consists of study, design, advance development, accomplishment, support or administration of personal foundation information system, mostly software application and personal hardware. Information technology works with the use of electronic personal and personal software to renovate, defend, development, and broadcast and other information.

Information technology has overstuffed to cover many features of computing and technology, and this word is more familiar than ever before. Information technology subject can be quite large, encompassing many fields. IT professionals perform different types of responsibilities that range from installing applications to designing complex personal networks. IT professional’s responsibilities are data management, networking, database, software design, personal hardware, management and administration of whole system. IT (Information Technology) is combined word of personal and communications or “InfoTech”. Information Technology illustrates any technology which helps to manufacture, manipulate, accumulate, communicate or broadcast information.

Information Communications Technology (ICT):- ICT term comprises the entire technology for communication of advance information. It includes any intermediate to record information by paper, attractable disk or tape, pen, optical disks, flash memory, CD/DVD etc. and also ICT technology used for broadcasting information by television, radio, microphone, loudspeaker and cellular phones. Information technology transfer information with the help of satellite system and intercontinental cables. Defiantly IT has developed into a type of a hub for communicating information.

Informative modeling: – it is an interdisciplinary myth for connecting information technologies field with architectural examination and modeling. IM aspires at improving the way evidences and information about architectural objects developed throughout time can be demonstrated. IM applies for studying of historic architecture, and objects been broadly transformed.

Technical support: – it is a range of services which has provided by technology products as mobile cell phone, TV and personal or electronic & mechanical gadgets. Technical services attempt to assist the individual resolve specific problems with the product. Somewhat that offering training, support services and other customization.

Most of the companies advocate technical support on behalf of the products, either they are freely acquirable or for a pay. Technical support can be conveyed by the telephone or with the help of various channels like e-mail or a website. Major organizations having frequently internal technical service acquirable to staff for pc related problems. Also world wide web is the ideal place to convey your problem in form of message and it’s freely acquirable for tech support, where many of experienced users might advice and assistance you.

Yissum And Technology Transfer At The Hebrew University Of Jerusalem

Yissum, the Technology Transfer Company of the Hebrew University of Jerusalem, aims to promote the transfer of Hebrew University technology for the benefit of society, while maximizing returns to support research, education and scientific excellence.

Founded in 1964, Yissum is one of the first technology transfer companies worldwide – second only to the Weizmann Institute’s Yeda, founded in 1959, and many years senior to most American universities – which began their Technology Transfer Services activities following the Baye-Dole Act of 1980; European universities, which typically began these activities in the 1990’s and Japan, which only began in 1998.

Yissum provides the interface between the university’s researchers and industry, including:

· Licensing out of new technologies

· Creation and support of spin-off companies

· Industry-sponsored academic research

· Scientific services

These years of experience have borne fruit, as Yissum’s revenues place it among the top 15 universities worldwide. Close to $1 billion worth of products based on Hebrew University technology are sold worldwide annually. Yissum’s 2005 revenues were $35 million, of which $23. 5 million in royalties Through its efforts in securing industry-sponsored research and other funding, Yissum contributes some 10% of the Hebrew University’s research budget, making the institution a true Technology Transfer University.

Charged with the endorsement and commercialization of the university’s intellectual property, Yissum has generated over 1,500 patent families over the past 20 years alone, of which 750 are currently active, including 250 which are licensed. In addition, Yissum holds equity in over 50 companies. In 2007, Yissum received 121 disclosures, submitted 91 patent applications and was allowed 59 new patents worldwide.

On the commercialization side, over 400 projects were handled in 2007 and 418 agreements were signed, including 33 license and option agreements.

Yissum enjoyed the first Initial Public Offering of one of its companies on the Tel Aviv stock exchange in December 2005 when NasVax Ltd. , based on technology from Prof. Chezy Barenholz, was successfully floated. The company now has $10 million in the bank and is in clinical trials with its influenza vaccine. This is not the first commercial success for Prof. Barenholz, who is also the developer of Doxil™, sold by Johnson & Johnson (through its acquisition of Alza) in the United Says and Schering Plough (under the trade study Caelyx™) internationally. Doxil™ enjoyed worldwide income of over $400 million in 2005.

Yissum, through the creation of Atox Bio Inc. , was also chesty to sponsor the submission to the NIH of a allow application by Prof. Raymond Kaempfer, who successfully received US$ 5. 6 million for the biodefence applications of super-antigens. Yissum continues to support AtoxBio as it develops other applications of Prof Kaempfer’s technology.

BioCancell Inc. , which was highlighted in last year’s report, successfully raised over US$3 million from private investors and the Hebrew University’s pension fund (as an independent investor), and successfully began clinical trials with its H19-based therapy in patients suffering from bladder cancer.

Following a change of management at the end of 2005, Yissum has announced some organizational changes aimed at providing the university’s researchers with better, more focused service. In addition, Yissum is in the process of simultaneously identifying the university’s Top 30 most commercially-attractive projects, and at the same time raising funds to invest in taking these projects through the proof-of-principle phase in order to achieve significantly higher valuations and much better terms for commercialization. 2006 promises to be an exciting year for Yissum.

Yissum is the Technology Transfer Company of the Hebrew University of Jerusalem. Over the past 40 years, Yissum has allowed more than 400 technology licenses and is responsible for commercializing successful products that generate almost $1 billion in worldwide income each year.