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


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


Table Of Contents

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

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


0          Abbreviations


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 Randamp;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 andamp; 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 andamp; Licensing Deals

5.6       Biotech - Biotech Collaboration andamp; 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 andamp; Pipeline Companies

7.4       ADC Payload Companies

7.5       ADC Linker, Carrier andamp; 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:


10        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 Randamp;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 andamp; Biotech

Table 11: Targets of Clinical Stage ADC Molecules in Development at Major Pharma andamp; Biotech

Table 12: Technology Licenses for ADCs by Major Pharma andamp; Biotech

Table 13: New ADC Technology Partners of Big Pharma Companies

Table 14: Number of ADC Molecules in Development at Small andamp; Medium Biopharmaceutical Companies

Table 15: Targets and Origin of ADCs at Small andamp; 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 andamp; Conjugation Technologies

Table 22: Companies with Linker, Carrier andamp; 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: AbbVieandrsquo;s ADC Pipeline

Table 37: Amgenandrsquo;s Clinical ADC Pipeline

Table 38: Astellas Pharmaandrsquo;s ADC Pipeline

Table 39: AstraZenecaandrsquo;s Pipeline of PBD and Tubulysin ADCs

Table 40: Bayerandrsquo;s ADC Pipeline

Table 41: Novartis ADC Pipeline

Table 42: Pfizerandrsquo;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 Biosciencesandlsquo; ADC Pipeline

Table 48: ADC Pipeline of Celldex Therapeutics

Table 49: Genmabandlsquo; ADCs in development

Table 50: ADC Pipeline of Oxford BioTherapeutics

Table 51: Preclinical ADC Pipeline of Oxis Biotech

Table 52: Ambrxandlsquo; ADC Pipeline

Table 53: ImmunoGenandrsquo;s in-house ADC Pipeline

Table 54: ImmunoGenandrsquo;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: Immunomedicsandlsquo; Clinical ADC Pipeline

Table 58: Sales of Adcetris

Table 59: Seattle Geneticsandlsquo; Adcetris Pipeline of Additional Indications

Table 60: Seattle Geneticsandlsquo; in-house ADC Pipeline

Table 61: Seattle Geneticsandlsquo; Collaborator ADC Pipeline

Table 62: Discontinued ADCs Based on Technology from Seattle Genetics

Table 63: Stemcentrxandlsquo; Discovered ADC Programs in Clinical Development

Table 64: Centroseandlsquo;s EDC Pipeline

Table 65: Mersanaandrsquo;s Proprietary Fleximer ADC Pipeline

Table 66: Sorrentoandrsquo;s Proprietary ADC Pipeline

Table 67: Angiopepandrsquo;s Oncology Pipeline

Table 68: Endocyteandrsquo;s Pipeline of Small Molecule Drug Conjugates (SMDCs)


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