Immuno-Oncology Xchange
East Coast 2021
May 25 & 27

Agenda
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Welcome to hubXchange’s virtual East Coast Immuno-Oncology Xchange 2021, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in developing immuno-oncology therapies. 
Discussion topics will cover Immune Biomarkers & Translational Research, Preclinical Research, Clinical Development, Cell Therapies and Next-Generation Therapies.
Take advantage of this unique highly interactive meeting format designed for maximum engagement, collaboration and networking with your peers.

Immune Biomarkers & Translational Research

Time
Titles and Bullets
Facilitator
DAY 1 (May 25, 2021) 
8:30am – 9:00am

Opening Address & Keynote: Accelerating tissue biomarker discovery with multiplex immunofluorescence assays, Florian Leiss, Vice President, Digital Health, Ultivue
9:10 – 10:10am
Novel biomarkers strategies to illuminate insights into the TME
  • Exploring the dynamic nature of the TME
  • The need for new biomarker discovery and development
  • Harnessing the ability to derive more meaningful information from precious tissue samples
  • Novel strategies for advanced image analysis

Vice President, Digital Health Strategies
Ultivue

Florian Leiss is VP Digital Health Strategies at Ultivue. He is responsible for digital and data-driven offerings and image analysis. Florian has been working for the 10+ years in software development for healthcare to make AI-powered CDx in oncology a reality, to support radiologists with routine reporting, or to empower pathologists with image analysis at AstraZeneca, Smart Reporting and Definiens. He holds PhDs in neuroscience and philosophy.

10:10 – 11:00am
BREAK
11:00 – 11:30am
1-2-1 Meetings

11:30am – 12:00pm
1-2-1 Meetings

12:00 – 1:00pm
BREAK
1:00 – 1:30pm
1-2-1 Meetings
1:40 – 2:40pm
Predicting patient responses to Immune Checkpoint Inhibitors
  • Few pre-clinical models available to test predictive biomarker hypotheses early during drug discovery
  • Default is often to use the target itself as the best predictive biomarker, is it the best choice?
  • Frequency of target expression can be derived from multiple sources, but there is no clear link between target expression and potential for response
  • Extensive clinical experience is still required to identify best predictive biomarkers and their appropriate cut-offs

Senior Director, Global Head, Clinical Biomarker Strategy
EMD Serono

Isabelle has extensive experience and expertise in IO drug discovery and development with current focus in clinical biomarkers and companion diagnostics. Isabelle was in charge of developing the small molecule IO pipeline at Bristol Myers Squibb in 2014/2015. She has since joined EMD Serono as Global Head of Clinical Biomarker Strategy where she leads a Team which supports IO, Oncology and Immunology products in the pipeline. She has also led the clinical biomarker and patient selection strategy and is co-author on several publications for a bi-functional IO molecule, bintrafusp alfa, under development at EMD Serono.

DAY 2 (May 27, 2021)
8:30 – 9:00am
Keynote Presentation
9:10 – 10:10am
Integrating biomarker data and clinical response data from IO based clinical trials
  • How do we optimize early stage clinical study design for exploratory biomarker development?
  • How do we take advantage of peripheral immune components (autoantibodies, exosomes, T cell markers, etc.) to understand the tumor immune micro-environment?
  • Current diagnostic criteria in cancer immunotherapy doesn’t accurately identify subjects likely to respond.  How do we use what’s available develop rational combination therapies with other immunotherapies or chemotherapies? 

Director, Translational Biology
Macrogenics

Patrick Kaminker is an industry scientist that received his degree in Pharmacology from the University of Kentucky. After focusing his postdoctoral studies on the intersection of telomeres with aging and cancer in Dr. Judy Campisi’s lab at the Lawrence Berkeley National Labs he joined the Buck Institute for Age Research. Dr. Kaminker then spent several years at Celera and Human Genome Sciences in the pursuit of novel targeted cancer therapies. He took an interest in translational research while at Human Genome Sciences while looking for biomarkers associated with TRAIL agonists and how a certain population had shown durable anti-tumor activity associated with certain immune signatures. Since that time, he has been focused on the translational aspects of multiple classes of therapeutics including: epigenetic modifiers, antibody-drug conjugates, and recently cancer immunotherapies and currently runs the translational group at Macrogenics.

10:20 – 11:00am
BREAK
11:00 – 11:30am
1-2-1 Meetings
11:30am – 12:00pm
1-2-1 Meetings
12:00 – 1:00pm
Break

1:00 – 1:30pm

Poster Session: In vitro killing assays for immuno-oncology candidates

The need to better understand the tumour microenvironment (TME) dictates the characterization of the cell types involved, the roles they play and how they respond to treatment. To develop better cancer immunotherapies, in vitro primary immune cell bioassays offer an early assessment of their effects on the various players of the TME.
Cytotoxic cells are key players in the anti-tumour immune response. CD8+ T cells, also known as cytotoxic T lymphocytes, recognize and kill cells presenting antigens bound to MHC class I molecules, such as neoantigen present on the tumour cells.
Activation of CD8+ T cells requires at least two signals from antigen presenting cells: binding of their T cell receptor (TCR) to the appropriate peptide presented on MHC I and co-stimulation by B7 binding to CD28. However, tumour environment developed different mechanisms to reduce this immune cell killing such as checkpoint inhibitors expression. In that case, the immune system will be dampened. A second type of cytotoxic cells, named Natural killer cells, are an innate immune cell type that plays an important role in anti-cancer immunity. NK cells target cells lacking MHC I expression, including cancer cells that have lost expression of MHC I. NK cells induce apoptosis in cancer cells via release of perforin and granzymes from granules, like CD8+ T cells. But here too, NK cells can be broken down by the tumour cells, notably by the PD1/PDL1 interaction.
Increasing their efficacy as a therapeutic strategy has made the development of new therapeutics enhancing their anti-tumour response a priority. Those new therapeutics can have several shapes. The Antibody-dependent cell-mediated cytotoxicity (ADCC) activity of the IgG1 isotypes is one of the mechanisms that can be applied by immunoglobulin-based therapeutics. Another way to increase the killing of cancer cells is to target tumour antigens expressed by those cells using for example bispecific molecules that will enhance on the other side the T cell activation.
Using primary immune cells, in vitro bioassays were developed to better screen the potential effect of new therapeutics on immune cell killing activity. Their ability to increase or induce a cytotoxic activity and facilitate the anti-tumour immune response can as a result be assessed early in the drug development process.

1:00 – 1:30pm

Poster Session: Higher yields from limited or scarce samples – A more efficient technology for nucleic acid purification 

Use of various genomics techniques, including NGS, to identify and characterize biomarkers relies on an efficient extraction of nucleic acid from biological samples. Poor or inefficient extractions from rare or limited samples, such as tumor biopsies or small cell populations, can prohibit the number or types of assays that can be performed on each sample, and therefore limit the information obtained from each sample. Most conventional technologies for the extraction and purification of nucleic acid for genomics analyses rely on the principle of solid phase extraction, an inefficient multistep workflow that carries a risk of nucleic acid loss or damage at several steps.

The Ionic® Purification System enables a simple, automated workflow to extract and purify nucleic acids with dramatically increased yields and quality from a wide range of sample types, including formalin-fixed paraffin-embedded (FFPE) tissues and low numbers of cultured or sorted cells. Nucleic acids are isolated in their natural, native form using the company’s core isotachophoresis technology. Since isolation occurs without binding and stripping nucleic acid from a fixed surface, nucleic acid loss and fragmentation are minimized, and purification induced bias is eliminated.

1:40 – 2:40pm

Decoding the immune system to uncover novel biomarkers to support the development of more efficacious therapies
  • How do we assess the response to an IO therapy within a patient?  What is the best timing?  What tissues are the best to assess?
  • How do we understand how an IO drug works and which patients would benefit most form that drug?
  • How can we show that an IO drug differentiate from SOC and other IO drugs to ensure maximal impact for patients?
  • How can we test and confirm IO drug mechanisms of action before going into the clinic when the models are challenging?

Head, Immuno-Oncology Biology & Translation
Takeda Oncology

Katherine Seidl is currently Head of Immuno-Oncology Biology and Translation at Takeda Oncology. Prior to this she was the VP of Immunology, Research and Development, at SQZ Biotech. Katherine earned a Ph.D. in Genetics from Stanford University and completed her postdoctoral training at Harvard Medical School. A 15+ year career in drug discovery and development followed including Director of Immunotherapy at bluebird bio, Cambridge, MA. Katherine has worked at Novartis Institute of Biomedical Research in Switzerland and Cambridge, MA as a Group Leader in the departments of Oncology and Autoimmune, Transplantation and Inflammation. Previous experience in pre-clinical and translational research include Diamed, Wyeth, and Pfizer.

Portrait picture of Katherine Seidl
2:40 – 2:45pm
Closing Address

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