The New Generation of Antibody Therapeutics: Current Status and Future Prospects - Overview

NEW YORK, July 5, 2012  /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

The New Generation of Antibody Therapeutics: Current Status and Future Prospects - Overview

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Antibody sales are predicted to reach $50 billion this year. This Insight Pharma Report focuses on recent developments in the therapeutic antibody field and new technologies built on the foundations of previously successful and unsuccessful strategies. Following a review of the business environment and market forces, this report examines:

The state of the art, and the needs and direction, of antibody technology todayAntibody conjugates and other payloads: construction, clinical development, and corporate activityMultispecific and multifunctional antibodies: construction, clinical development, and corporate activityDevelopment of biosimilars and biobetters: commercial and regulatory issuesAdvances in product development technologies and overcoming biomanufacturing challengesIP challenges, deal structures, mergers and acquisitionsMarketed and clinical pipeline products, current status and future forecastStrategies, technologies, and pipelines of selected new-generation antibody companiesFuture potential impact of systems biology and nanotechnologyStrategic issues, economic outlook, and opportunities for future productsInsights from thought leaders interviewed for this reportThe commercial clinical pipeline for antibodies is growing at a rate of 50–55 new mAbs per year. Today, about 314 mAb products are in clinical trials worldwide. The New Generation of Antibody Therapeutics: Current Status and Future Prospects reviews antibodies in clinical development, profiles selected companies that may contribute to the next generation of cutting-edge antibody technology, and discusses notable collaborations within the antibody industry.

A number of immunotoxins currently in clinical trials are antibody-based reagents. As discussed in this Insight Pharma Report, a number of targets, drugs, and linkers are being evaluated. The last few years have seen striking improvements in the development of antibody-drug conjugate technology; it is clear that in the next few years a wave of such products will gain approval. Firms that profess expertise in the synthesis of immunoconjugates are discussed in this report.

Bispecific antibodies present unique possibilities for disease treatment. There is substantial interest in bispecific antibodies as a means to overcome some of the shortcomings of conventional recombinant antibodies that have slowed their successful performance and prevented FDA approval. Today, numerous bispecific antibodies are in clinical trials and may provide a new generation of antibody technologies. This Insight Pharma Report profiles selected bispecific antibody companies and cutting-edge concepts in bispecific antibody development.

The New Generation of Antibody Therapeutics: Current Status and Future Prospects discusses recent developments in bioprocessing relevant to the needs of the antibody sector. Also discussed are biosimilar antibody drugs, which are the subject of much interest with many patent expirations taking place. While the FDA has yet to approve a biosimilar, many large companies have been moving forward aggressively on such products. We review challenges and opportunities, commercial development and the marketplace, as well as regulatory issues concerning biosimilars.

Predictions for the future of cutting-edge antibody technologies are that robust growth will continue despite the many roadblocks and uncertainties in the overall picture of drug development. While the market will continue to be dominated by whole antibody molecules, it is anticipated that bispecific antibodies and antibody-drug conjugates will be a growing component of the overall market.

About the Author

K. John Morrow, Jr., PhD, is a writer and consultant for the biotechnology industry. He obtained his PhD in genetics from the University of Washington in Seattle, and completed his training with post-doctoral studies in Italy at the Universitá di Pavia and in Philadelphia at the Fox Chase Cancer Institute. He has held faculty positions at the University of Kansas and at Texas Tech University Health Sciences Center. His writings include over 200 peer-reviewed journal papers, non–peer-reviewed coverage of the biotechnology industry, books, and marketing reports. A number of companies, including Meridian Bioscience, Affitech, Henderson-Morley Biotechnology, Brandwidth Communications, and Emergent Technologies have taken advantage of his consultancy services, provided through Newport Biotechnology Consultants. He resides in Newport, KY.

Chapter 1

1.1. Introduction

A Long History of Biotherapeutics

The Rise of Antibodies

The FDA Approval Process

Is the FDA Moving Too Slowly?

Cost Factors in Antibody Therapeutics

1.2. Current Products

Avastin (bevacizumab)

Cimzia (certolizumab pegol)

SIMPONI (golimumab)

ILARIS (canakinumab)

STELARA (ustekinumab)

ARZERRA (ofatumumab)

Prolia (denosumab)

Actemra (tocilizumab)

Benlysta (belimumab)

YERVOY (ipilimumab)

ADCETRIS (brentuximab)

1.3. Business Environment and Market Forces

World Economic Outlook

Economic Outlook for Antibody Technologies

Drug Development Costs

1.4. Opportunities for Future ProductsAntibodies in Development

Phase III Antibody Studies

Elotuzumab

Naptumomab estafenatox

AMG 386

Itolizumab

Factor VIII-Fc and Factor XI-Fc

CINQUIL (reslizumab)

Obinutuzumab

Bosatria (mepolizumab)

Necitumumab

Ramucirumab

Epratuzumab

Tabalumab

Solanezumab

Farletuzumab

Secukinumab

Vedolizumab

Bapineuzumab

Inotuzumab (CMC-544)

Sarilumab

Zanolimumab (HuMax-CD4)

Girentuximab

Otelixizumab

Other Antibodies in Earlier Stages of Development

IL-1–Blocking Therapies

Adimab Antibodies: MM-151

Daratumumab

Alzheimer's Disease: Therapeutic Antibodies

A Delivery Strategy That Overcomes the Blood-Brain Barrier

A New Trial Will Follow Progression from the Preclinical State to Expression of the Full-Blown Disease

New Antibody Selection Technologies

Novartis and AnaptysBio

Ylanthia (MorphoSys)

Small Engineered Bispecific Antibodies

Improving Efficacy and Druggability of mAbs

A New Yeast Display Technology

1.5. Summary, Objectives, and Outlook

Chapter 2

2.1. Past and Present

2.2. General Methodology of Construction

2.3. Notable Antibody-Toxin Conjugates

AGS-16M8F

AGS-5ME

Glembatumumab Vedotin-Auristatin E

Ontak/DT

Trastuzumab-Emtansine

Lorvotuzumab-Mertansine (IMGN901)

Cintredekin Besudotox

MR1-1–PE

MEDI547-mcMMAF

CAT-8015–PE

BL22-PE

LMB-2–PE

SS1P-PE

Inotuzumab-Ozogamicin

PSMA ADC/PSMA ADC-Auristatin E

SAR-3419

Brentuximab-Vedotin

2SGN-75–Auristatin F

HuM195/rGel-rGelonin

RFT-5–dgA

Moxetumomab Pasudotox (CAT-8015–PE38)

CDX-011

2.4. Clinical TrialsHuM-195/rGel: A Unique Immunoconjugate

2.5. Commercial Development

Aldevron (Formerly GENOVAC)

GenScript

Maine Biotechnology Services

Ambrx

Seattle Genetics

Genentech

Philogen

2.6. Summary and Future Directions for Antibody-Drug Conjugates

Chapter 3

3.1. Challenges and Opportunities

3.2. The Rundown on Bispecific Antibody Companies Ablynx

Affimed

Fresenius

MacroGenics

Merrimack

Micromet

Pfizer

Sanofi

Trion

Zyngenia

3.3. Methods of Construction

3.4. Recombinant Polyclonal Antibodies

3.5. Anti-Angiogenic Antibodies: Boom or Bust

3.6. Challenges and Opportunities in Immunocytokines

Provenance

3.7. Cutting-Edge Concepts in Bispecific Antibody Development

DuoBody Technology

Chemically Programmed Antibodies: CovX

3.8. Summary and Conclusions

Chapter 4

4.1. Biosimilars: Challenges and Opportunities

An Uncertain Period

A Rundown on Biosimilars

Will Biosimilar Cost Savings Materialize?

4.2. Commercial Development and Marketplace

4.3. Role of the EMA and FDA in Approval and Regulation of Biosimilars

EU Initiative

Canadian Biologics Regulatory Guidelines

US Regulation and the Affordable Healthcare Act

4.4. Biobetters: Unique Products or Improved Biosimilars?

Chapter 5

5.1. Overview

5.2. Biomanufacturing Challenges

5.3. Overview of Bioprocessing Technology

Escherichia coli

Other Bacterial Hosts

Yeast

Saccharomyces cerevisiae

Pichia pastoris

Insect Cells

Dictyostelium discoideum

5.4. Downstream Processing: Improvements in Product Purification

5.5. New Emerging TechnologiesMore and Better Disposables

Dealing with Inclusion Bodies

Modifying Proteins to Improve Their Stability

New Wrinkles in Bioprocessing

Wanted: Very Rapid Micropurification Strategies

Non-Natural Amino Acids

Improvements in Product Purification from Plant Material

5.6. Failed Technologies and Lessons LearnedFailed Therapeutics

Inclusion Bodies

Host Cell Proteases, Endotoxins, and Pyrogens

Chapter 6

6.1. IP Thicket for Biosimilars

6.2. Collaboration and Partnering

Symphogen

Activartis Biotech

MorphoSys

ImmunGene

BioInvent

Eli Lilly

Apexigen and Gansu Duyiwei Biological Pharmaceutical

GlaxoSmithKline-Tolerx Collaboration

6.3. Mergers and Acquisitions

Bristol-Myers Squibb Completes Acquisition of Inhibitex

Biogen Idec to Pay Up to $562.5 Million for Stromedix

Sanofi Signs Rare Disease Pact with CRG

Illumina Rejects Roche Tender Offer

Chapter 7

7.1. Marketed Products: Current Status and Future Forecast

7.2. Clinical Development: Lessons Learned From Successes and Failures

7.3. The Centocor Experience with Centoxin

Chapter 8

8.1. Overview

MacroGenics

Micromet

Bicycle Therapeutics

8.2. Business Strategy

8.3. Technology and Product PipelineZyngenia

Philogen

T2 Biosystems

Molecular Partners

Tolerx

Crescendo Biologics

Haptogen

Trion, MacroGenics, and Micromet

Chapter 9

9.1. Outlook for the Future

Why Do Antibodies Fail?

Naked or Nattily Dressed: Which Is Best?

Escape from the Valley of Death

Next Five Years

Alternative Affinity Tools

Technologies, 10 Years Plus

Intracellular Immunity

Demands, Needs, Directions

New Target Search

Cost Containment

We Need to Quit Overpromising

Systems Biology Is Not the Holy Grail

There Are No Surprises

9.2. Systems Biology and Design of Innovative TherapiesBuilding More Antibodies

Future of the Proteome

Systems Biology Companies

9.3. Immunotherapeutics and Vaccines

9.4. Impact of Nanotechnology in Antibody Therapeutics Development

Magnetic Nanoparticles

Antibody-Conjugated Nanoparticles

Nanodelivery Systems for Antibodies

Nanotechnology and Regulatory Concerns

ReferencesAppendix List of ConsultantsCompany Index FIGURES

Figure 1.1. A Slow Rate of Approval for Antibodies Figure 1.2. Structure of the Akt MoleculeFigure 1.3. Anti-TNF Agents Infliximab, Adalimumab, and Certolizumab Pegol Figure 1.4. STELARA Molecule Figure 1.5. Zoledronic AcidFigure 1.6. Global GDP Growth Figure 1.7. R&D Expenditures Continue an Upward Trend, While Approval Rates Keep Dropping Figure 1.8. CD38 MoleculeFigure 1.9. Structure of the Three-Helical Albumin-Binding Domain (ABD) from Streptococcal Protein G (PDB: 1GJT)Figure 2.1. Chemical Structures of mAb-Drug ConjugatesFigure 2.2. An Antibody-Drug ConjugateFigure 2.3. Denileukin Diftitox (Ontak)Figure 2.4. Recombinant Immunotoxin BL22 and LMB-2Figure 2.5. How the PSMA ADC Works Figure 3.1. A Conventional Antibody and Its Derived FragmentsFigure 3.2. The Scaffold Antibody and the Bispecific CVX-241 AntibodyFigure 3.3. Structure and Size Comparison of Tetravalent Antibodies and Native Divalent Antibodies With Western Blot Analysis of the Purified Anti-CD20 mAbs Separated by SDS-PAGEFigure 3.4. Symphogen's Sym004 mAb Mixture Enables Novel Mechanism of ActionFigure 3.5. Peregrine Clinical Trials in ProgressFigure 8.1. Display of Philogen Technology Figure 8.2. Iron Oxide Nanoparticles (Orange) Coated With a Dextran Polymer and Bound to a Detector AntibodyFigure 8.3. A 4-Repeat DARPin Molecule Figure 9.1. Outline of the Immune Surveillance Theory Figure 9.2. Mechanism of Action of Whole IgG mAbsFigure 9.3. Antibody Fab Fragments Complexed with Peptide Epitopes Figure 9.4. Structure of the Armadillo Repeat Region of Beta-Catenin Figure 9.5. A Biosensor Platform Figure 9.6. Honeycombed Particles Filled with Cancer Drugs Act like Time-Release Capsules at Tumor Site

TABLES

Table 1.1. FDA-Approved Recombinant AntibodiesTable 1.2. Costs of the Most Expensive Drugs Table 1.3. Various Estimates of Pharma SalesTable 1.4. Phase III Antibody TrialsTable 1.5. IL-1–Blocking Therapies Marketed or In Development for the Treatment of Autoimmune DisordersTable 1.6. Many Antibodies Are Directed Against the Same Target Table 2.1. Immunotoxins: Current Status of Clinical TrialsTable 3.1. Bispecific Antibodies in Clinical Trials Table 4.1. EMA-Approved BiosimilarsTable 5.1. Non-Microbial Protein Production PlatformsTable 5.2. Important Approved Therapeutic Protein-Based Products From E. coli Table 5.3. Various Polishing OptionsTable 6.1. Notable Antibody CollaborationsTable 9.1. Properties of Affinity Molecules Table 9.2. Systems Biology CompaniesTable 9.3. Antibodies Against Infectious Disease Agents in Current Trials

To order this report:Biopharmaceutical Industry: The New Generation of Antibody Therapeutics: Current Status and Future Prospects - Overview

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