Cambridge Healthtech Institute’s Inaugural Symposium

Bioassays for Immuno-Oncology

Biological Assay Selection, Development, and Standards to Ensure FDA Approval of Novel Immunotherapies

October 23, 2017 | The Westin Alexandria | Washington, DC

 

Biological assays demonstrating drug characteristics such as potency, mechanism-of-action, and stability, are one of the most critical components of an FDA biologic submission. However, with more complex mechanisms-of-action, immunotherapies add a layer of difficulty to bioassay selection and development. At Cambridge Healthtech Institute's Inaugural Bioassays for Immuno-Oncology symposium, experts in bioassays for immuno-oncology therapies will discuss selection, development, and standards for bioassays and immunoassays. Special attention will be given to understanding the mechanism-of-action for immunotherapies, whether they be antibody- or cell-based. Overall, this one-day immersive symposium will outline a product life cycle approach for developing and implementing biological assays from preclinical studies to clinical development.

Final Agenda

MONDAY, October 23

9:00 am Registration & Morning Coffee

PRECLINICAL BIOASSAYS

9:25 Chairperson's Opening Remarks

Sofie Pattijn, CTO, ImmunXperts

Sofie_Pattijn9:30 KEYNOTE: In vitro Bioassays to Accelerate Immuno-Oncology Drug Development

Sofie Pattijn, CTO, ImmunXperts

Early evaluation of the effectiveness of candidate therapeutics and combination therapies can be done using mouse models and in vitro bioassays with mouse or human immune cells. The use of customized in vitro assays supports the candidate selection and functionality testing of new oncology leads.

10:00 Measurement of Fc Effector Function Using Binding Assays for Product Characterization

LeeAnn_MachieskyLeeAnn Machiesky, Scientist, MedImmune

Measuring Fc effector functions is important for antibody product characterization. As an alternative to cell-based assays, surface plasmon resonance (SPR)-based assays are useful and sensitive methods for assessing the binding affinity of the Fc to a panel of Fcγ receptors including FcRn. The talk will discuss the application of SPR assays for measuring Fc binding of different antibody subtypes, varying glycosylation levels and those with point mutations.

10:30 Networking Coffee Break

11:00 Late Breaking Presentation

UNDERSTANDING MECHANISM-OF-ACTION

11:30 Bioassays for Checkpoint Inhibitors

Ulrike_HerbrandUlrike Herbrand, Ph.D., Scientific Supervisor, Research & Development, Biosafety & Bioassay Services, Charles River Labs

Immune checkpoint therapy, which targets regulatory pathways in T cells to amplify antitumor immune responses, has been a game-changer in the treatment of some cancers. Bioassays to monitor immune responses are extremely challenging if the assay is designed based on primary cells to mimic the in vivo mechanism of action (MoA) in an in vitro approach. Surrogate assays reflect the MoA in a much less variable format, thereby allowing these assays to be used in GMP bioactivity testing. Surrogate assays are stability-indicating and suitable for biosimilarity assessment.

Promega BLACK12:00 Building a Reporter Gene Bioassay Platform for Single and Combination Immunotherapy Programs

Jey_ChengJey Cheng, Ph.D., R&D Group Leader, Bioassay Development, Promega

 
 
 
 

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Session Break

CLINICAL STAGE ASSAYS

1:55 Chairperson's Remarks

Steven J. Kussick, M.D., Ph.D., CMO, Director, Contract Research and Flow Cytometry, PhenoPath Laboratories; Clinical Assistant Professor, Laboratory Medicine, University of Washington

2:00 Flow Cytometric Assessment of Therapeutic Targets and Immune Responses in Immuno-Oncology

Steven_KussickSteven J. Kussick, M.D., Ph.D., CMO, Director, Contract Research and Flow Cytometry, PhenoPath Laboratories; Clinical Assistant Professor, Laboratory Medicine, University of Washington

This presentation will have two major components: 1) description of 10-color flow cytometry-based strategies for identifying and quantifying potential therapeutic targets on hematopoietic cancers including lymphoma, leukemia, and myeloma, with a review of receptor occupancy assessment in the presence of specific targeted therapies, and 2) description of 10-color flow cytometry-based approaches to comprehensive immune cell phenotyping, to assess global patient responses to immune checkpoint inhibitors and other immunomodulatory agents.

2:30 PD Analysis of MET Signaling in Fixed Tissue Specimens by Quantitative Multiplex Immunofluorescence and Concordance with Extraction Assays

Tony_NavasTony Navas, Ph.D., Senior Scientist, Clinical Pharmacodynamic Biomarkers Program, Applied/Developmental Research Directorate, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research

Development of immunofluorescence assays for phosphorylated TK biomarkers in tumor biopsies is hindered by factors including stability of phospho-epitope and specificity/sensitivity of signal detection. This talk will discuss development of phospho- and total MET IFA in FFPE tissues and its correlation with ELISA assays in extracted tissue samples. This talk will also discuss the specific quantitation of MET biomarkers localized either in the plasma membrane or nucleus in tissue sections.

3:00 Featured Poster: International Standards for the Biological Activities of Monoclonal Antibodies: Development of the First WHO International Standard for Rituximab

Sandra Prior, Ph.D., Senior Scientist, Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)

Biotherapeutic monoclonal antibodies (mAb) are produced in biological systems and by their very nature are heterogeneous and complex products. Critical quality attributes are carefully controlled during development as they intrinsically relate to a product's biological activity and safety profile. With the patent expiration on some of the earlier innovator products, the development of biosimilar mAbs is expected to rapidly widen market competition and patient accessibility to these important medicines. Exhaustive pre-clinical comparability studies between the biosimilar and the innovator reference medicinal product (RMP) are used to assess product micro-heterogeneities which are recognized and built into the biosimilarity concept. To date 6 biosimilar mAbs have been approved in Europe and the number of products is rapidly increasing. While stringent regulatory pathways are in place, the mAb biosimilar market is in its infancy and the impact of potential product drift in a multi-product market remains unknown. Thus it is imperative that continuous efforts are directed to support current controls to ensure confidence in the quality and consistency of these products over time. The World Health Organisation (WHO) has recognised the global need for the standardisation of biotechnology products over concerns on their quality, efficacy and safety. In particular WHO has recently endorsed the development of public bioactivity international standards for mAbs. These reagents would have the unique application in the calibration of bioassays and local standards by defining international units of bioactivity. With this aim, we have developed the first WHO international potency standard for rituximab and assessed its suitability in a multicentre international collaborative study. Our results suggest that the rituximab international standard improves bioassay data harmonisation and highlights how these reagents may help in ensuring product consistency over time promoting market confidence and patient accessibility. However, the role of this new class of standards should be clearly distinguished from that of the RMP in defining biosimilarity.

3:30 Networking Refreshment Break


 

4:00 Closing Panel Discussion: Challenges in Bioassay Design for Immuno-Oncology

Moderator:
Steven J. Kussick, M.D., Ph.D., CMO, Director, Contract Research and Flow Cytometry, PhenoPath Laboratories; Clinical Assistant Professor, Laboratory Medicine, University of Washington

  • Bioassays for determining immune response
  • Assay design
  • Drug development assays
  • Flow-cytometry cased assays

Panelists: 

Ulrike Herbrand, Ph.D., Scientific Supervisor, Research & Development, Biosafety & Bioassay Services, Charles River Lab 

Tony Navas, Ph.D., Senior Scientist, Clinical Pharmacodynamic Biomarkers Program, Applied/Developmental Research Directorate, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research

Sofie Pattijn, CTO, ImmunXperts

5:00 Close of Symposium

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