September 20 – 22, 2017 | San Diego, CA

Sheraton San Diego Marina

Day One
Thursday 21 September, 2017

Day Two
Friday 22 September, 2017

07.00
Breakfast Briefing: The Advantages of an Integrated Supply Chain

  • Lisa McDermott Principal Scientist, Process and Analytical Development, MilliporeSigma
  • Jyothi Swamy Head of Global Marketing/ADC, MilliporeSigma

Synopsis

• Explore project accelerators of integrating your drug linker and ADC supply chain
• Enhance chemical understanding of your conjugate

Honorary Chair

08.00
Chair’s Opening Remarks

  • Scott Dylla Chief Scientific Officer, AbbVie-Stemcentrx

Optimization of ADCs: Maximize the Therapeutic Window

08.10
Chlorotoxin in Peptide Drug Conjugates: Improved Understanding of Tumor Targeting

Synopsis

• Chlorotoxin is a tumor targeting peptide that naturally occurs in scorpion venom and has proved efficacious in human glioma clinical trials
• Peptide Drug Conjugate (PDC) with chlorotoxin for tumor uptake and cryptophycin as warhead has a promising preclinical pharmacological profile
• Several proposed targets previously described for chlorotoxin do not align with observed PDC activity
• Comprehensive analysis of MoA of chlorotoxin reveals its true target which is distinct and separate from its toxic properties in venom

08.40
Explore Novel Preclinical Toxicity Models which Better Predict Clinical Safety & Efficacy

  • Jan Pinkas Executive Director, Pharmacology & Toxicology, ImmunoGen

Synopsis

• Improve understanding of driving mechanisms of off-target toxicities that drive MTD for most ADCs
• Design and develop novel preclinical animal models which look to improve the preclinical to clinical translation of ADCs
• Effectively use preclinical data to inform design of Phase I trial

09.10
Preclinical Development of Superior ADCs Incorporating Novel Linker & Warhead Designs

  • Gary Chen Chief Scientific Officer, Levena Biopharma

Synopsis

• Robustness of screening panel from antibody to ADC leads in 2 months, from target IND within 2 years
• Preclinical studies of several ADCs showing superior PK, PD and toxicity profiles
• Promise of multifunctional ADCs

09.40
Morning Refreshments & Networking

10.30
Explore Novel Tumor Associated Antigens

Chair: Tim Lowinger, Chief Scientific Officer, Mersana

10.30 Explore a Novel Screening Platform for Development of Antibody-Drug Conjugates Against Novel Targets

  • Discover a novel high-throughput screening approach which optimizes the selection of an antibody for a particular target, tumor type, linker and drug for ADC development
  • Hear an overview of what makes for an appropriate ADC target
  • Review preclinical development of an ADC using this novel screening approach

Maria Luz Jaramillo, Senior Research Officer & ADC Project Lead, National Research Council Canada

11.00 TCR-like Antibody-Drug Conjugates Media Killing of Tumor Cells with Low Peptide/HLA Targets

  • TCR-like antibodies and HLA-peptide targets
  • Low copy number
  • Internalization
  • Molecular interaction between antibody and HLA-peptide influences drug potency

Jon Weidanz, Associate Vice President for Research & Professor of Biology, The University of Texas at Arlington

11.30 Lunch & Networking

Lunch Seminar: Sciex

Improving ADC Targeting: Antibody Engineering & Application of Novel ADC Formats

13.00 Non-Natural Amino Acids for Simple & Efficient Production of ADCs

  • Discover novel NNAA’s bearing reactive functional groups
  • Examine NNAA reactive groups which can accommodate a wide variety of drug-linkers
  • Review NNAA’s being incorporated into antibodies and maintain reactivity after expression and purification
  • Antibodies bearing NNAA’s allow production of antibody drug conjugates in a one-step process
  • Gain insight which supports that NNAA ADCs exhibit similar, or better, stability and potency compared to thiol-linked ADCs

James Christie, Scientist, Antibody Discovery & Protein Engineering Department, MedImmune

13.30 Repurposing an Imaging Agent to Target a Bispecific Antibody for Prostate Cancer

  • Learn of a novel prostate specific membrane antigen (PSMA)-specific imaging agent “DUPA” and how it was exploited as the targeting agent of a bispecific antibody to treat prostate cancer
  • Explore how site-specific conjugation of the imaging agent was used to control the geometry and stoichiometry of the antibody conjugate, yielding a candidate with high potency and selectivity
  • Critically review data which supports the lead candidate completely eliminates tumors in mouse xenograft models using cell lines and patient-derived tumors from bone metastases

Travis Young, Principal Investigator, California Institute for Biomedical Research

10.30
Robustly Translate from In Vitro to In Vivo Development

Chair: Kurt Gish, Associate Director II, AbbVie

10.30 Further Advancements in the Development of Potent Maytansinoid Payloads and ADCs

  • Design and synthesis
  • In vitro cytotoxicity of cleavable/noncleavable ADCs and their payloads
  • ADC In vivo efficacy

Thomas Nittoli, Director, R&D Chemistry, Regeneron Pharmaceuticals

11.00 Predict In vivo Efficacy?

  • In vitro data with aCD70 ADCs utilizing different antibodies and drug linkers
  • Ex vivo plasma stability studies
  • In vivo PK studies
  • In vivo efficacy models

Lillian Skidmore, Associate Director, Translational Sciences, Ambrx

11.30 Lunch & Networking

Lunch Seminar: Sciex

From Bench to Bedside: Improve Preclinical to Clinical Translation

13.00 Anti-CD22 and anti-CD79b ADCs preferentially target proliferating B cells

  • PD biomarker strategy for B cell-targeted ADCs
  • PK/PD relationships of ADCs and their respective unconjugated mAbs
  • The differential effects of ADCs and mAbs on subsets of proliferating B-cells
  • The therapeutic value of these ADCs

Dongwei Li, Pharmacologist, Genentech

13.30 Establishing Workflows to Evaluate Payloads, Linker Drugs & ADCs early in Discovery to Enable Rapid Transition into Development

  • Screening strategies to quickly produce and evaluate consistent high-purity ADCs for early pre-clinical testing
  • Use of novel mass spec methods to characterize new payloads for consistency in product quality and assessment of stability
  • Applying high-throughput principles to early research conjugations to assess developability and future CMC robustness

Vikram Sisodiya, Associate Director, AbbVie-Stemcentrx

Optimize Clinical Trial Design

Chair: Kyle Holen, Executive Medical Director, AbbVie

10.30 Optimization of Dosing Schedule to Maximize Therapeutic Index of Highly Potent ADCs

  • Understand the pharmacokinetic drivers of safety and efficacy of ADCs in animals by leveraging preclinical models
  • Gain an overview of clinical data generated using alternative dosing schedules
  • Discover preclinical examples where animal models have been used to identify exposure response relationships that can inform
    clinical trial design

Mary Jane Hinrichs, Principal Toxicologist, MedImmune

11.00 Predicting Clinical Success of ADCs using a Mechanistic Modeling & Simulation Approach

  • Discover quantitative modeling and simulation approach to analyze data on 10 ADCs in patient trials or approved for
    oncology indications
  • Review how clinical efficacious dose was predicted from preclinical PK/PD studies and compared with clinical MTD, recommended Phase II and clinically approved doses
  • Explore Monte Carlo clinical trial simulations to predict objective response rate
  • Learn how to select the best ADC, to optimize clinical trial design and determine likelihood of success versus clinical standard of care

Alison Betts, Modelling & Simulation Leader & Associate Research Fellow, Pfizer

11.30 Lunch & Networking

Lunch Seminar: Sciex

Patient Stratification: Biomarkers & Companion Diagnostics

13.00 Blueprint for Robust Patient Selection & Mirvetuximab Soravtansine as a Case Study

  • Applying robust biology with the right ‘toolbox’
  • Advancing rapidly from POC to pivotal study
  • Lessons learned for successful CDx development

Angela Romanelli, Executive Director, Translational Medicine, ImmunoGen

13.30 Panel Discussion: Enhancing Clinical Success Through Biomarkers & Companion Diagnostic Development

  • Discuss tumor associated antigen expression as a key determination of response
  • Review progress in technological advances for developing diagnostic and companion diagnostics
  • What will the next 12 months hold to better identify responsive patient populations

Effectively Outsourcing ADC Manufacturing & Managing Complex Supply Chains

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

10.30 Intelligent Product Development to get Your ADC to the Clinic Quickly While Ensuring Commercial Final Product Stability

  • Understand the advantages of a lyophilized formulation for ADC final product
  • Describe possible phase 1 clinical presentations: liquid, frozen, or lyophilized
  • Regardless of the Phase 1 presentation, what formulation considerations are required to allow for development of a stable lyophilized final product?
  • What steps does early phase formulation development require?
  • Following success in the clinic, how can the product be further optimized to result in a stable, commercial product?

Wendy Saffell-Clemmer, Director, Research, Baxter BioPharma Solutions

11.00 Utilise Disposable Technologies for ADC Manufacturing

  • Understand how single use technologies can reduce upfront capital costs of establishing manufacturing processes and
    requirement for utilities such as cleaningplace reagents, water for injections and clean steam for equipment sterilization
  • Discuss the advantages of disposable technologies with design flexibility during development and scale-up
  • Lessons learned from Inotuzumab Ozogamicin

Tok Han, Director/TL, Pfizer

11.30 Lunch & Networking

Lunch Seminar: Sciex

Process Quality Control & Final Product Characterization

13.00 Development of Novel Drug-Linker Manufacturing Processes

  • Development of polymeric drug-linkers which enable high-DAR ADCs
  • Control of product heterogeneity
  • Ensuring batch-to-batch reproducibility

Michael Kaufman, Senior Vice President, CMC, Mersana Therapeutics

13.30 Session to be confirmed

14.00
Afternoon Refreshments & Networking

The Next Generation of Antibody-Drug Conjugates Coming of Age: Explore Promising Opportunities Beyond Oncology

15.30
Developing the Magic Bullet Outside Oncology: An Analytical Perspective

Synopsis

• Review the potential of developing ADCs for non-oncological indications
• Discover rationale for targeting Glucocorticoids to immune cells as antibody drug conjugates
• Explore the preclinical development, from an analytical perspective, of novel ADC targeting auto-immune disease

16.00
Preclinical ADME Characterization of THIOMABTM-Antibiotics Conjugates (TAC) to Support Clinical Development of TAC for treating StaphA Infectious Disease

  • Ben Shen Principal Scientist, Preclinical & Translational Pharmacokinetics & Pharmacodynamics, Genentech

Synopsis

• Rationales and biology of TAC development
• Challenges in conducting ADME studies
• In vitro and in vivo ADME data with TAC and its catabolites
• Implication and impact of ADME data on clinical development

16.30
Chair’s Closing Remarks

  • Scott Dylla Chief Scientific Officer, AbbVie-Stemcentrx