September 20 – 22, 2017 | San Diego, CA

Sheraton San Diego Marina

Day One
Thursday 21 September, 2017

Day Two
Friday 22 September, 2017

Honorary Chair

08.00
Chair’s Opening Remarks

  • Scott Dylla Chief Scientific Officer, AbbVie-Stemcentrx

08.10
Keynote – Antibody Drug Conjugates: Current Status & Future Directions

Synopsis

• Global overview of ADC development
• Critical review of current industry challenges for achieving optimum therapeutic window and therefore developing clinically effective ADCs
• Prediction of what the next 12 months hold for the field

08.40
Keynote – Development of Several Classes of DNA-Damaging ADCs

  • Puja Sapra Vice President & Chief Scientific Officer, Pfizer

Synopsis

  • From bench to bedside: explore the discovery and development Inotuzumab Ozogamicin
  • Preclinical development of novel DNA-damaging ADCs

09.10
Minimizing Off-Target Toxicity & Improve Targeting to Tumor Associated Antigens

  • Rakesh Dixit Vice President & Global Head , Biologics Safety Assessment, MedImmune

Synopsis

• Translational challenges to attaining desirable clinical therapeutic index
• Significance of both on and off-target toxicities
• Five rights in ADC that help reduce both on and off-target toxicities
• Translational approaches to rapid clinical development of ADCs

09.40
Speed Networking

10.30
Morning Refreshments

Optimize Payload-Linker Chemistry Design

Chair: Tim Lowinger, Chief Scientific Officer, Mersana Therapeutics

11.00 Antibody-Drug Conjugates with Pyrrole- Based KSP Inhibitors as Novel Payload Class

  • Inhibitors of kinesin spindle protein as ADC payloads
  • Exploration of appropriate sites for linker attachment and development of potent effector chemistries
  • Profile of active metabolites
  • Case study: KSPi ADCs targeting the TWEAK receptor

Hans-Georg Lerchen, Principal Scientist, Medicinal Chemistry, Bayer

11.30 ThioBridge™ as a Tool for the Design, Optimisation & Manufacture of ADCs

  • ThioBridge™ conjugation is a flexible approach for producing stable ADCs with defined location and extent of drug loading
  • The simple design of ThioBridge™ ADCs means they can easily undergo a systematic determination and optimization of their in vitro and in vivo biological properties
  • ThioBridge™ targets natural disulfides with highly reproducible conjugation profiles at milligram to gram scales
  • Abzena’s capabilities for design, optimization and manufacturing of ADCs

Matthew Bird, Team Leader, Abzena

12.00 PBD / ADC Update 2017

  • Why PBDs make good payloads
  • Clinical progress of ADCs
  • New PBD payloads

Phil Howard, CSO, Spirogen

12.30 Lunch & Networking

Lunch Seminar: Sartorius

Harness Next Generation Bioconjugation for More Stable Efficacious ADCs

13.30 Enabling the Next Generation of Calicheamicin-Based Antibody-Drug Conjugates

  • Presenting the design rationale for preparing aminohexose-linked calicheamicin linker-payloads
  • Disclosing the critical improvements in the chemistries of linker attachment and disulfide exchange that enabled the safe and efficient exploration of this new class of calicheamicin conjugates
  • Describing how the optimizations of conjugation chemistry, linker chemistry, and calicheamicin payload structure has provided ADCs with vastly improved potencies over traditional calicheamicin-based ADCs

Russell Dushin, Associate Research Fellow, Pfizer

14.00 Site-specific Conjugation: Improving Homogeneity & Other Druggability Properties of Antibody-drug Conjugates

  • Site-specific conjugation linkers lead to more homogeneous ADC products
  • More homogeneous ADCs have reduced toxicity and increased potency
  • Development of more potent ADC clinicalcandidate targeting HER2 positive breast cancer will also be discussed

Bruce Nianhe Han, Chief Scientific Officer, NewBio Therapeutics

14.30 Conjugation Development & Mechanistic Analysis of Disulfide-Linked THIOMAB™ Antibody-Drug Conjugates

  • Enabling and optimizing hindered direct disulfide conjugation to THIOMAB™ antibodies and other protein/peptide carriers
  • Impacts of hindered disulfide conjugation on stability and efficacy in vivo
  • Study of disulfide linker processing and trafficking in cells using FRET

Jack Sadowsky, Scientist, Protein Chemistry, Genentech

Minimize Off-Target Toxicity

Chair: Kurt Gish, Associate Director II, AbbVie

11.00 Characterization of Pharmacokinetic Properties of a Site-Specific Antibody Drug Conjugate Using Multi-Platform Bioanalytical Assays

  • Review a combination of five assays used to determine the concentration and in vivo stability of a site-specific antibody drug
    conjugate
  • A total antibody (ELISA), total conjugated antibody (LC-MS/MS), drug-antibody-ratio (LC-HR/MS), catabolite (LC-MS/MS) and anti-drug-antibody assay were developed to support an exploratory toxicology study in cynomolgus monkeys
  • The total conjugated antibody assay utilizes immuno capture and tryptic digestion and provides a highly reproducible DAR-biasfree assay
  • Drug antibody ratio measurements confirmed in vivo stability and no detectable concentrations of free drug were found in
    circulation

Matthew Meyers, Scientist, Celgene

11.30 On-Target Toxicity with ADCs: Species- Specific Toxicity & Preclinical to Clinical Translation

  • Improve understanding of target mediated toxicity
  • Two case examples of on-target toxicity
  • Explore why on-target toxicity was noted in rat but not cynomolgus monkey
  • Understand why the cynomolgus monkey was not predictive of clinical adverse events that were consistent with target-mediated
    toxicity

Anu Conor, Safety Assessment Expert, Preclinical Safety Group, Novartis

12.00 Developing & Manufacturing ADCs of the Next Generation & its Application in Cancer Targeted Therapy

  • ADC Platform still is a powerful option to increase efficacy of a antibody
  • Cysteine conjugation is better than lysine conjugation
  • Thiol-Covalent Conjugation increases ADC stability and efficacy
  • Conjugation Technology plays a key role in a successful ADC outcome

Andrew Huang, Chief Scientific Officer, Mabplex

12.30 Lunch & Networking

Lunch Seminar: Sartorius

Practical Lessons Learned from Preclinical ADC Development

13.30 Immunogenicity of Antibody Drug Conjugates

  • Importance of ADC Immunogenicity risk assessment including specific risk factors and potential clinical consequence of
    adaptive immune response to ADCs
  • Current industry standards for the characterization of ADC immunogenicity response
  • Learn tiered testing approach and bioanalytical strategies to help understand the immunogenic behaviour of ADC
    candidates
  • Key considerations and mitigation strategies to overcome bioanalytical challenges in developing and validating immunogenicity assays for ADCs

Seema Kumar, Associate Director, EMD Serono

14.00 Development & Translational Application of Integrated Mechanistic Model of ADC Pharmacokinetics

  • ADCs are often produced and administered as a mixture of conjugated antibodies with different drug to antibody ratios (DAR)
    resulting in complex and heterogeneous disposition kinetics
  • Learn of a mechanism-based translational model that describes and predicts the complex pharmacokinetic (PK) behaviour of
    ADCs in preclinical species and in patients
  • Discover an approach which incorporates known mechanisms of ADC disposition including explicit representation of all
    DAR species, DAR-dependent sequential deconjugation and DAR-dependent antibody/ ADC clearance

Siddharth Sukumaran, Drug Development Scientist, Genentech

14.30 Characterization of Peak Profiles in Quality Indicating Assays

  • More details to follow 

Allan Davidson, Analytical Development Manager, Piramal

Review Learnings from ADC Clinical Development

Chair: Kyle Holen, Executive Medical Director, AbbVie

11.00 Review of the ADC Clinical Pipeline

  • Update on the key movements in the clinic
  • Insight into the rapidly evolving pipeline
  • Analysis of novel clinical ADCs

Heather Donaghy, Research Analyst, Beacon, Hanson Wade

11.30 Clinical & Preclinical Update of Topoisomerase I inhibitor, Exatecan Derivativebased ADCs (DXd-ADC)

  • Clinical efficacy of DS-8201, a novel HER2-targeting DXd-ADC
  • Preclinical update of DS-8201 in IO combination
  • Preclinical efficacy of U3-1402, a novel HER3-targeting DXd-ADC
  • Explore application of DXd-ADC technology

Kiyoshi Sugihara, Senior Researcher, Biologics & Immuno-Oncology Laboratories, Daiichi
Sankyo

12.00 Preclinical Evaluation Of ABBV-838, A First- In-Class Anti-CS1 Antibody-Drug Conjugate for the Treatment of Multiple Myeloma

  •  Potent tumor growth inhibition, including regressions and cures, was observed in multiple xenograft models of myeloma
    following a single dose of ABBV-838
    In preclinical xenograft models, ABBV-838 enhanced the anti-tumor efficacy when combined with pomalidomide or bortezomib compared to that seen with either agent alone
  • An additional process step was added to enrich for those antibodies containing primarily 2 molecules of MMAE
  • This “E2” format was able to deliver more conjugated MMAE in preclinical safety studies than a “DAR4” format and had equal or better efficacy when normalised by conjugated MMAE dose
  • ABBV-838 is currently being investigated in a Phase 1 first-in-human safety study

Kurt Gish, Associate Director II, AbbVie

12.30 Lunch & Networking

Lunch Seminar: Sartorius

Clinical Update from Next Generation Phase I Novel ADCs

13.30 Preliminary Clinical Validation of a Novel ADC, AbGn-107, for the Treatment of Gastrointestinal Tumors

  • Development concept and characteristics of AbGn-107
  • Safety evaluation in non-human primate
  • Preliminary clinical observation in advanced GI tumor patients

Ron Lin, Chief Scientific Officer, AbGenomics

14.00 Developing Potent & Selective Miniaturized Conjugates for the Treatment of Patients with Solid Tumors

  • Pentarins™ are potent and selective miniaturized conjugates uniquely designed to drive efficacy through deep and rapid
    penetration into solid tumors resulting in sustained payload accumulation and cancer cell death
  • PEN-221 is a novel cancer therapeutic that is highly selective for the somatostatin receptor that is in a Phase 1/2a clinical trial. PEN-221 is being developed to treat patients with neuroendocrine cancers including small cell lung cancer
  • PEN-866 is highly selective for Heat Shock Protein 90 (HSP90) and has demonstrated complete and durable tumor regressions in xenograft models of small-cell lung cancer, pancreatic cancer, ovarian cancer and sarcoma

Richard Wooster, Chief Scientific Officer, Tarveda Therapeutics

14.30 XMT-1522 & XMT-1536: The Next Generation of Novel ADCs

  • Discovery and translational development of novel ADCs targeting HER2 and NaPi2b
  • Increased efficacy and broader anti-tumor activity of the Dolaflexin ADC platform
  • Decreased free drug toxicity of the novel DolaLock auristatin payload

Don Bergstrom, Chief Medical Officer, Mersana Therapeutics

Scale Up from Clinical to Commercial ADC Manufacturing

Chair: Tony Cano, Senior Director, Process Development, AbbVie-Stemcentrx

11.00 Panel Discussion: Manufacturing & Analytical Challenges in the GMP Manufacture of ADCs

  • Single-use challenges and solutions for manufacturing of ADCs
  • Analytical control systems for ADCs: Where and how to control your CQAs. Use of mass spectrometry in process development and
    release testing
  • Influence of raw material sourcing on product quality
  • Supply chain management, harmonization of manufacturing services, insourcing vs. outsourcing, how to ensure successful tech
    transfer

Robert Bayer, Director, Althea

11.30 Regulatory Perspective: Drug Linker Intermediate, Drug Linker in ADC & IND & BLA Reviews

  • Manufacturing process and controls
  • Starting materials and intermediates
  • Characterization and specifications, quality controls of drug-linker in ADC, conjugation and purification process

Xiao Hong Chen, Quality Assessment Lead, FDA

12.00 Challenges in ADC Manufacturing, from Conjugation to Fill-Finish

More details to follow

Giorgio Salciarini, Technical Business Development Manager, BSP Pharmaceuticals

12.30 Lunch & Networking

Lunch Seminar: Sartorius

Develop Reproducible & Scalable Processes

1.30 Novasep’s Integrated Solutions for ADCs

  • Simplifying the supply chain through an integrated offer
  • Design considerations of a dedicated conjugation facility
  • DOE applied to conjugation challenges

Francois D’Hooge, Head, Bioconjugation, Novasep

2.00 Antibody Drug Conjugates: Process Development & Analytical Considerations

  • This presentation will focus on process development and analytical considerations for ADCs followed by a case study on a 2-step
    lysine based random conjugation process
  • Hear about work to understand the stability and reactivity of the key thiolated antibody intermediate, which was paramount to
    enabling successful scale up of this process
  • Review a case study which focuses on the use of key analytical techniques to develop a deeper understanding of the conjugate and to assess batch to batch reproducibility

Michael Hay, Senior Research Investigator, Bristol-Myers Squibb

2.30 Developing & Manufacturing Next Generation Bioconjugates

  • Approaches for scaling-up ADCs and other types of bioconjugates
  • Case studies and practical solutions will be presented

Laurent Ducry, Leader & Head of Bioconjugates, Lonza

15.00
Afternoon Refreshments & Networking

16.30
5 Minute Short-Fire Poster Presentation Talks

Synopsis

Capturing the scientific highlights of the World ADC San Diego Poster Session. The Short-Fire Presentation talks will put the spotlight on five exceptional posters
from the Scientific Poster Session (Thursday 21).

Discover Next Generation ADCs

17.00
Next Generation Antibody-Drug Conjugates

Synopsis

• Exploration of novel cytotoxic ADC payloads
• Increasing molecular understanding of payload and linker function
• Identification of ADC payloads that are not highly cytotoxic

17.30
Antibody Targeted Amanitin Conjugates (ATACs): Expanding the ADC Landscape With a New Payload Targeting RNA Polymerase II

Synopsis

• Supply of amanitin by chemical synthesis
• Technology improvements to enhance the therapeutic index of ATACs
• Proprietary ATAC projects for clinical development
• Assessing potential biomarkers for patient stratification

18.00
The Resistible ADC – Let Us Count the Ways

  • David Tice Director, Research & Development, MedImmune

Synopsis

• ADCs are multicomponent drugs with complex mechanisms of action
• This will be exemplified with a description of a novel clinical phase ADC
• Due to the high degree of complexity with ADCs, tumors can use multiple approaches to survive attack including but not limited to loss of target, altered trafficking, modulation of drug pumps and other specific mechanisms depending on the class of drug.

18.30
Chair’s Closing Remarks

  • Scott Dylla Chief Scientific Officer, AbbVie-Stemcentrx