Antibody-Drug Conjugates 2016: Perspectives & Opportunities - a Pipeline, Technology, Stakeholder & Business Analysis

Date: November 30, 2015
Pages: 470
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Publisher: La Merie Publishing
Report type: Periodicals
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ID: A64E78C3AA8EN
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This report describes and analyzes the situation of antibody-drug conjugates as of November 2015 regarding
  • ADC pipeline,
  • ADC technologies,
  • ADC stakeholders and
  • ADC business opportunities and commercial perspectives.
Although the initial enthusiasm about antibody-drug conjugates has made room for a more realistic understanding, the prospects for success of ADC drug candidates remain good and are based on a well-filled pipeline, increasing adoption of next generation ADC technologies, lessons learned from failures, a balanced mixture of stakeholders and a variety of options for funding of ADC developments. About 70 ADCs are in clinical and pre-IND stages of development and at least the same number of ADC programs are in preclinical R&D.

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For the first time in 2015, combined sales of the approved and marketed ADC products Adcetris and Kadcyla will surpass the sales limit of US$ 1 billion. The pipeline of ADCs and immunoconjugates in advanced clinical development gives the chance of approval of further ADCs in the near- and mid-term future. The clinical attrition rate of ADCs is lower, i.e. better, than that of conventional, naked antibodies in oncology. The availability of next generation ADC technologies allows to select case by case the appropriate linker and payload. Site-specific conjugation technologies with and without engineering of the antibody generate homogenous products. Novel payloads provide the basis for enhanced antitumor activity. Prodrug concepts and polymeric carrier systems may not only contribute to a higher therapeutic index, but also boost efficacy by targeted delivery of a higher number of payloads than in conventional ADCs. Competition by ADCs directed against the same target is relatively low, except for clinically and commercially validated Her2 which is ideal to validate new technologies. However, targets are still a bottleneck with the attractive consequence that companies with successful target identification capabilities are highly rewarded by investors and business partners.

Nearly all major pharma and biotech companies have ADC programs, although with different strategies of how to gain access to ADC technologies. Few have established proprietary in-house capabilities, most still rely on outside technology providers. However, the duopoly of conventional ADC technology providers is converting into a more differentiated, heterogenous field of ADC technologies and technology providers.

This report entitled „Antibody-Drug Conjugates 2016: Perspectives & Opportunities - a Pipeline, Technology, Stakeholder & Business Analysis“ is based on the analysis of more than 90 companies, more than 100 ADC drug profiles and more than 26 ADC technologies and components. Sources of information are provided by 274 scientific references and numerous non-scientific references, e.g. press releases, stock exchange disclosures, presentations, annual reports, fact sheets (with hyperlinks leading to source of information). The report also describes and analyzes business deals in the ADC field, e.g. collaboration and license agreements, mergers and acquisitions, financial transactions (divestments, public offerings, private equity and venture capital fund-raising).

Coverage of this ADC report:
  • Next-to-market ADCs
  • ADC Drug Profiles: clinical, pre-IND, preclinical
  • Target Competition by ADCs
  • ADC Development Failures
  • Conventional & Emerging ADC Technologies
  • Polymeric ADC Carriers
  • Novel ADC Payloads & Linkers
  • Site-specific ADC Conjugation Technologies
  • Major Pharma & Biotech Companies with ADC Programs
  • Small and Medium Biopharmaceutical Companies with ADC Programs
  • Integrated ADC Technology & Pipeline Companies
  • Companies with Linker, Payload, Carrier and Conjugation Technologies
  • Commercial Opportunities and Perspectives with ADCs
  • Commericalization of Approved ADCs
  • Fund-Raising for ADC Companies
  • Pharma-Biotech & Biotech-Biotech Collaboration & Licensing Agreements
1 EXECUTIVE SUMMARY

2 ADC PIPELINE ANALYSIS

2.1 Overview
2.2 Next-to-market ADCs
2.3 Next-to-market Immunoconjugates
2.4 ADCs in Early Clinical Development
2.5 ADCs in IND-Enabling Studies
2.6 ADCs in Preclinical R&D
2.7 Competition among ADCs for the Same Target
2.8 Discontinued ADCs and Clinical Attrition Rate

3 ADC TECHNOLOGY ANALYSIS

3.1 Overview
3.2 Conventional and Emerging ADC Technologies
3.3 Probodies and Novel Preclinical Stage Carriers
3.4 Carrier Systems
3.5 Site-Specific Conjugation Technologies with Antibody Engineering
3.6 Site-Specific Conjugation Technologies without Antibody Engineering

4 ADC STAKEHOLDER ANALYSIS

4.1 Major Pharma and Biotech Companies
4.2 Small and Medium Biopharmaceutical Companies
4.3 ADC Technology and Pipeline Companies
4.4 Companies with Novel Payload Technologies
4.5 Companies with Linker, Conjugation & Carrier Technologies
4.6 Companies with Alternative Targeting Moieties

5 ADC BUSINESS ANALYSIS

5.1 Overview of Commercial Opportunities and Perspectives with ADCs
5.2 Commercialization of Approved ADCs
5.3 Fund-Raising
5.4 Mergers and Acquisitions
5.5 Pharma – Biotech Collaboration & Licensing Deals
5.6 Biotech – Biotech Collaboration & Licensing Deals

6 ADC DRUG PROFILES

6.1 Clinical Stage ADC Drug Profiles
6.2 Pre-IND and Preclinical Stage ADC Drug Profiles
6.3 Immunoconjugate Drug Profiles
6.4 Discontinued ADC Drug Profiles

7 ADC COMPANY PROFILES

7.1 Major Pharma and Biotech Companies
7.2 Small and Medium Biopharmaceutical Companies
7.3 ADC Technology & Pipeline Companies
7.4 ADC Payload Companies
7.5 ADC Linker, Carrier & Conjugation Technology Companies
7.6 Companies with Alternative Targeting Moieties

8 REFERENCES

9 ADDENDUM

9.1 Addendum 1: ADCs in Advanced Clinical Development
9.2 Addendum 2: ADCs in Early Clinical Development
9.3 Addendum 3:
9.4 Addendum 4:

LIST OF TABLES

Table 1: Overview of Development Stages of ADCs
Table 2: Characteristics of Next-to-Market ADCs in Advanced Clinical Development
Table 3: Next-to-Market Immunoconjugates
Table 4: Characteristics of ADCs in Early Clinical Development
Table 5: Characteristics of ADCs in IND-Enabling Studies
Table 6: Characteristics of ADCs in Preclinical R&D
Table 7: Target Competition of ADCs
Table 8: Overview of ADCs Discontinued from Clinical Development
Table 9: Reasons for failure of ADCs compared with naked antibodies
Table 10: Number of ADC Molecules in Development at Major Pharma & Biotech
Table 11: Targets of Clinical Stage ADC Molecules in Development at Major Pharma & Biotech
Table 12: Technology Licenses for ADCs by Major Pharma & Biotech
Table 13: New ADC Technology Partners of Big Pharma Companies
Table 14: Number of ADC Molecules in Development at Small & Medium Biopharmaceutical Companies
Table 15: Targets and Origin of ADCs at Small & Medium Biopharma
Table 16: Novel ADC Technology In-Licensed by Biopharma Companies
Table 17: Technology Used in ADC Molecules in Development at ADC Technology Companies
Table 18: Number of ADC Molecules in Development at ADC Technology Companies
Table 19: Targets of ADC Molecules in Development at ADC Technology Companies
Table 20: Companies with Novel Payload Technologies
Table 21: Overview of Companies with Linker, Carrier & Conjugation Technologies
Table 22: Companies with Linker, Carrier & Conjugation Technologies
Table 23: Companies with Alternative Targeting Moieties
Table 24: Fund-Raising by ADC Technology and Product Companies in 2014 and 2015
Table 25: Agreements between pharma and biotech companies for ADCs 2014-2015
Table 26: Agreements between biotech and biotech companies for ADCs 2014-2015
Table 27: Clinical Studies with ABT-414
Table 28: Sales of Adcetris
Table 29: Phase III Clinical Studies with Adcetris
Table 30: Actively Recruiting Phase II Clinical Studies with Adcetris
Table 31: Clinical Studies with CDX-011
Table 32: Clinical Study Program of BT062
Table 33: Advanced Phase Clinical Studies with Kadcyla
Table 34: Phase Ib/II Studies with Polatuzumab Vedotin
Table 35: Interim phase II efficacy results of IMMU-132
Table 36: AbbVie’s ADC Pipeline
Table 37: Amgen’s Clinical ADC Pipeline
Table 38: Astellas Pharma’s ADC Pipeline
Table 39: AstraZeneca’s Pipeline of PBD and Tubulysin ADCs
Table 40: Bayer’s ADC Pipeline
Table 41: Novartis ADC Pipeline
Table 42: Pfizer’s Clinical Stage ADC Pipeline
Table 43: Roche Pipeline of Clinical Stage ADCs
Table 44: Roche ADCs Discontinued from Clinical Development
Table 45: Sanofi Clinical Stage ADC Pipeline
Table 46: ADC Pipeline of ADC Therapeutics
Table 47: Asana Biosciences‘ ADC Pipeline
Table 48: ADC Pipeline of Celldex Therapeutics
Table 49: Genmab‘ ADCs in development
Table 50: ADC Pipeline of Oxford BioTherapeutics
Table 51: Preclinical ADC Pipeline of Oxis Biotech
Table 52: Ambrx‘ ADC Pipeline
Table 53: ImmunoGen’s in-house ADC Pipeline
Table 54: ImmunoGen’s Partnered ADC Programs in Clinical Development
Table 55: Discontinued Clinical Stage ADCs with ImmunoGen Technology
Table 56: Reasons for Failure of TAP-based ADCs Compared with Naked Antibodies
Table 57: Immunomedics‘ Clinical ADC Pipeline
Table 58: Sales of Adcetris
Table 59: Seattle Genetics‘ Adcetris Pipeline of Additional Indications
Table 60: Seattle Genetics‘ in-house ADC Pipeline
Table 61: Seattle Genetics‘ Collaborator ADC Pipeline
Table 62: Discontinued ADCs Based on Technology from Seattle Genetics
Table 63: Stemcentrx‘ Discovered ADC Programs in Clinical Development
Table 64: Centrose‘s EDC Pipeline
Table 65: Mersana’s Proprietary Fleximer ADC Pipeline
Table 66: Sorrento’s Proprietary ADC Pipeline
Table 67: Angiopep’s Oncology Pipeline
Table 68: Endocyte’s Pipeline of Small Molecule Drug Conjugates (SMDCs)
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