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
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MONDAY, October 23
9:00 am Registration & Morning Coffee
9:25 Chairperson's Opening Remarks
Sofie Pattijn, CTO, ImmunXperts
9:30 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 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
11:30 Bioassays for Checkpoint Inhibitors
Ulrike 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.
12:00 Building a Reporter Gene Bioassay
Platform for Single and Combination Immunotherapy Programs
Jey 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
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 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 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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