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

September 2011 | 274 pages | ID: A73BDEAEFBAEN
La Merie Publishing

Abstracts

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

Contents

trong>1. ABBREVIATIONS

2. OVERVIEW

3. EXECUTIVE SUMMARY

4. DRUGS AND LINKERS USED IN ANTIBODY-DRUG CONJUGATES

5. ANTIBODIES USED IN ANTIBODY-DRUG CONJUGATES

6. ANALYSIS OF STAKEHOLDERS IN ANTIBODY-DRUG CONJUGATES

7. CLINICAL VALUE OF ANTIBODY-DRUG CONJUGATES

8. R&D PIPELINE ANALYSIS OF ANTIBODY-DRUG CONJUGATES

9. COMMERCIAL VALUES OF ANTIBODY-DRUG CONJUGATES

10. COMPANY PROFILES

Abbott
Aeterna Zentaris
Allozyne
Alpha Cancer Technologies
Ambrx
Amgen
Amunix
Anaphore
Astellas Pharma (Agensys)
AstraZeneca (MedImmune)
Bayer Healthcare Pharmaceuticals
Biogen Idec
Biotest
Bristol-Myers Squibb (Medarex)
Celldex Therapeutics
Centrose
Daiichi Sankyo
Genmab
GlaxoSmithKline
ImmunoGen
Immunomedics
Merrimack Pharmaceuticals
Mersana Therapeutics
Millennium: The Takeda Oncology Company
Nerviano Medical Sciences
Novartis
Pfizer (Wyeth)
PharmaMar
Philogen
Progenics Pharmaceuticals
Roche (Genentech)
Sanofi
Seattle Genetics
Spirogen
Sutro Biopharma
Synthon (Syntarga)
Tactic Pharma (Attenuon)
Wilex (Heidelberg Pharma)
References

Tables

TABLES

Table 1 Characterization of Antibody-Drug Conjugates
Table 2 Drugs in Use for Antibody-Drug Conjugates
Table 3 Seattle Genetics ADC Technology Licensing Agreements
Table 4 Immunogen ADC Technology Licensing Agreement
Table 5 Antibody-Drug Conjugates in IND and Clinical Stages
Table 6 Linkers in Use for Clinical-Stage Antibody-Drug Conjugates
Table 7 Advantages and Disadvantages of Linkers and Cytotoxic Drugs
Table 8 Companies Active in R&D of New Cytotoxic Drugs for ADCs
Table 9 Companies Active in R&D of New Linkers for ADCs
Table 10 Immunogenicity of Antibody-Drug Conjugates
Table 11 Number of drug molecules per antibody
Table 12 Activities of Companies in the ADC Field
Table 13 Strengths & Weaknesses of Integrated ADC Technology & Product Companies
Table 14 Emerging ADC Technology Companies
Table 15 Immunoconjugate & Alternative ADC Companies
Table 16 Reasons for Discontinuation of Clinical Stage Antibody-Drug Conjugates
Table 21 Main Clinical Trials with T-DM1 in Metastatic Breast Cancer
Table 18 Clinical Results of phase I/II stage Antibody-Drug Conjugates
Table 19 Antibody-Drug Conjugates in Non-Clinical Development and Preclinical R&D
Table 20 Antibody-Drug Conjugates Discontinued in Clinical Stages
Table 21 Targets of Antibody-Drug Conjugates
Table 22 Immunoconjugates with Non-Antibody Targeting Moiety

EXECUTIVE ADC PROFILES

AEZS-108
AGS-16M8F
ASG-5ME
ASG-22ME
BAY 79-4620
BAY 94-9343
BIIB015
BT-062
CR011-vcMMAE
CR014-vcMAE
hRS7-SN-38
IMGN388
IMGN529
IMGN853
IMGN901
Inotuzumab ozogamicin
Labetuzumab-SN-38
LIV-1 ADC
MDX-1203
MDX-1204
MEDI-547
Milatuzumab-doxorubicin
MM-302
PSMA-ADC
RG7596
SAR3419
SAR566658
SGN-19A
SGN-35
SGN-75
Trastuzumab-DM1

RELATED COMPANIES

Abbott
Aeterna Zentaris
Allozyne
Alpha Cancer Technologies
Ambrx
Amgen
Amunix
Anaphore
Astellas Pharma (Agensys)
AstraZeneca (MedImmune)
Bayer Healthcare Pharmaceuticals
Biogen Idec
Biotest
Bristol-Myers Squibb (Medarex)
Celldex Therapeutics
Centrose
Daiichi Sankyo
Genmab
GlaxoSmithKline
ImmunoGen
Immunomedics
Merrimack Pharmaceuticals
Mersana Therapeutics
Millennium: The Takeda Oncology Company
Nerviano Medical Sciences
Novartis
Pfizer (Wyeth)
PharmaMar
Philogen
Progenics Pharmaceuticals
Roche (Genentech)
Sanofi
Seattle Genetics
Spirogen
Sutro Biopharma
Synthon (Syntarga)
Tactic Pharma (Attenuon)
Wilex (Heidelberg Pharma)