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2019 Preliminary Agenda


  • Co-chair’s Opening Remarks


    James Gulley, MD, PhD

    Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute


    Axel Hoos, MD, PhD

    SVP, Oncology R&D, GSK


    Andrew Baum, MD

    Head of Global Healthcare, Managing Director, Equity Research, Citi


  • Discovery and Preclinical Science Plenary

    This plenary includes talks focused on tumor microenvironment changing technologies, pegylated cytokines and additional discovery and preclinical data.


  • Tumor Microenvironment Changing Technologies


  • IDO Inhibition Preclinical Updates


  • Blockade of the Adenosine Pathway: Preclinical, Translational and Clinical studies with CPI-444, an A2A Receptor Antagonist for Cancer Treatment

    Stephen B Willingham, PhD
    Senior Scientist, Corvus Pharmaceuticals


  • Update on Anti-CD73


    Ronald Herbst, PhD

    VP R&D, Head Oncology Research, Medimmune


  • Pegylated Cytokines


  • Update on IL-10


    Aung Naing, MD, FACP

    Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center


    Martin Oft, MD

    VP, Preclinical and Clinical Research, ARMO


  • NKTR-21: Accessing the IL-2 Pathway for Immune Oncology

    • Nektar’s polymer chemistry technology was used to create NKTR-214, a CD122-biased cytokine that targets the IL-2 pathway
    • NKTR-214 has drug-like properties far improved over the native IL-2 cytokine
    • Nonclinical studies validate NKTR-214 as an immune stimulating agent
    • Clinical results demonstrate systemic and intratumoral immune activation, and the ability to drive increased TIL and convert tumors from PD-L1 negative to positive
    • In combination with anti-PD-1, NKTR-214 shows broad activity across multiple tumor types, including PD-L1 negative and PD-L1 positive tumors


    Jonathan Zalevsky, PhD

    SVP, Research & Chief Scientific Officer, Nektar


  • Translational Science and Emerging Biomarkers Plenary Part I

    This plenary reports on translational data, biomarkers, companion diagnostics and additional applications to help predict responses to cancer immunotherapy.


  • Biomarker Signaling: Turning Cold Tumors Hot


    Priti Hegde, PhD

    Global Franchise Lead, Cancer Immunotherapy Biomarkers, Genentech


  • Prostvac and Lessons Learned About Therapeutic Cancer Vaccines


    James Gulley, MD, PhD

    Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute


  • Oncolytic Viruses: Promises, Problems & Solutions

    Oncolytic viruses (OV) are live viruses used as drugs. They can be many drugs in one because they stimulate multiple pathways leading to activation of innate and adaptive immunity in tumors and can be engineered to deliver multiple biological drugs like antibodies, cytokines, etc. However, unlike small molecules and biologics, the immune system is very good at clearing viruses. This session will provide data demonstrating how BeneVir’s OV hide from innate and adaptive immunity to enhance therapeutic efficacy.


    Matthew Mulvey, PhD

    CEO, BeneVir, a Janssen Pharmaceuticals Company


  • Data-Driven Case Studies by:

    Imaging Endpoints


    Ron Korn, MD, PhD

    Founder, Chairman and Chief Medical Officer, Imaging Endpoints

    Neogenomics


    Maher Albitar, MD

    SVP, Chief Medical Officer and Director of Research and Development, NeoGenomics Laboratories


  • Immunosequencing: Expanding Beyond MRD and Immuno-oncology

    This talk will briefly review the use of immunosequencing as a clinical diagnostic for monitoring patients with lymphoid malignancies and as an adjunct in the evaluation of cancer patients who might benefit or have benefited from immune-modulatory therapy. It will then describe new advances in the ability to define the target of a B- or T-cell based on knowledge of the primary nucleotide sequence(s) of its immune receptors. It will conclude with a description of current efforts to create a comprehensive “immunome” for any individual as a general assessment of health and disease status.


    Lanny Kirsch, MD

    SVP Translational Medicine, Adaptive Biotechnologies


  • Panel: Next Generation Biomarker and Companion Diagnostics for Predicting Response

    • How can biomarkers act as a tool for understanding the biology at a level that is sufficient for making decisions around combinations?
    • What are the potential biomarkers that can help predict if a patient will respond to combinations?
    • Once a biomarker is identified in terms of biology, been measured and the technology platform identified to meet those measures, how is the biomarker developed to the level of clinical grade that meets approval?
    • How do we validate diagnostics in IO/combinations?
    • How do you satisfy regulators?
    • Are there other biomarkers in development?
    • What are the implications for intervention?
    • Are biomarkers and companion diagnostics crucial for rational combination success?

    Moderator:


    Priti Hegde, PhD

    Global Franchise Lead, Cancer Immunotherapy Biomarkers, Genentech


  • IO Novel Technologies and Innovative Solutions Plenary

    This plenary showcases companies that have technologies and solutions that will help stakeholders in the IO field advance developments that provide treatment for cancer patients.

    We are currently accepting abstracts for companies seeking to present their technology or solutions in this quick-fire style plenary. Please email Geeta Bachani at Geeta@tcfllc.org for more information.

  • Financial and Commercial Implications Plenary

    This plenary features talks by VCs, Investors and Analysts on the IO landscape and delves deeper into the financial implications of the IPO Process for IO biotechs.


  • Financial Plenary Keynote Address


  • Investor Perspective on the IO Landscape

    This talk will provide a perspective on how long term investors in IO are looking at and evaluating the space including approaches and areas to concentrate on when funding innovation.


    Khalil Barrage

    Managing Director, Public Equity, Invus


  • IPO Process Panel

    This panel, moderated by Dr Andrew Baum, Citi, delves into discussion on the preparation of an IPO, straight licensing with the transition to a public company and decision making on prioritization within portfolios.

    Moderator:


    Andrew Baum, MD
    Head of Global Healthcare; Managing Director, Equity Research, Citi


  • Attendees will have the opportunity to network and schedule one-on-one partnering meetings during the networking luncheon and scheduled breaks.

2019 Preliminary Agenda


  • Co-chair’s Opening Remarks


    James Gulley, MD, PhD

    Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute


    Axel Hoos, MD, PhD

    SVP, Oncology R&D, GSK


    Andrew Baum, MD

    Head of Global Healthcare, Managing Director, Equity Research, Citi


  • Trends and Collaborations Plenary

    This plenary features reports from three major publications on the IO field including new innovations, trends, partnerships and the impact of investments driving collaborations.


  • BioCentury Report

    The BioCentury report will cover how companies and academic investigators are driving innovations within immuno-oncology, including new targets, modalities and technologies, to address some of the field’s biggest challenges.


    Simone Fishburn, PhD

    VP and Executive Editor, BioCentury & BioCentury Innovations


  • Bloomberg Intelligence Report


    Asthika Goonewardene, MBA

    Senior Biotech Analyst, Bloomberg Intelligence


  • Endpoints News Report

    The Endpoints News Report will review the build up of immuno-oncology over the past few years. With the large amount of money and the extraordinary numbers we have seen invested in the space, this talk will discuss what impact this may have on collaborations.


    John D Carroll

    Editor-in-Chief, Endpoints News


  • Business Development Plenary Hosted by Solebury Trout

    This plenary provides a recap of recent IO deal-making and includes perspectives from pharma and biotech along with investors on raising capital and other investment decision-making aspects throughout the development lifecycle.


  • Insights from Deal Trends: Betting on Tumor Immunology


    Jeffrey Bockman, PhD

    EVP, Oncology Practice, Defined Health


  • Raising Capital in the Current Market

    • How do you raise capital?
    • What goes into the financing in series A, B and E rounds?
    • Investors, how do you decide who to put funds toward?
    • How are these rounds getting done?

  • Executive Fireside Chats

    In this portion of the business development plenary, Solebury Trout presents two executive-level fireside chats. They include a spotlight discussion on novel technologies with an IO Biotech CEO and a deeper look into the business developments/investment decision making with a life sciences investment organization focused on IO.


  • Afternoon Breakout Sessions

    • Translational Science & Emerging Biomarkers Part II

      This session continues to focus on the biology and applications to help predict responses to immunotherapy.

    • HexaBody Technology To Enhance Antibody Therapeutics for a Broad Range of Applications in Cancer


      Tahamtan Ahmadi, MD, PhD

      SVP, Oncology and Translational Medicine, Genmab

    • ADC Mechanisms of Action Used to Inform Combinations

      Ian Pyrah, PhD
      VP Translational SciencesSeattle Genetics

    • Novel CARs for Solid Tumors: IL-13

      Sadik Kassim, PhD
      Chief Scientific Officer, Mustang Bio

    • Clinical Operations

      This session is designed for clinical trial operation executives who want to learn what it takes to execute an IO clinical trial. This is an excellent opportunity to walk through the building blocks of IO clinical trial operations and discuss pitfalls and lessons learned.

    • Genentech: An End-to-End Clinical Trial Operations Case Study

      In this talk, Genentech will walk the audience through their clinical trial operations strategy using case examples, identifying pitfalls that have been avoided and those that have been experienced and overcome in order to provide key learnings and help organizations both large and small navigate the operational minefield.

      Karen Dimick
      Karen Dimick
      Operations Program Leader – Cancer Immunotherapy Combinations Development- Oncology Global Product Development, Genentech

    • Multi-Dimensional Computation Analysis for IO

      This talk will address bringing together the data from the patient including their immune profile, imaging of the immune cells, genetic modifications, and applying AI and machine learning into multi-dimensional analytics and visualization. Applying multi-dimensional analytics could really inform where you need to be going next with the data, with the molecules and with IO combinations.

    • Operational Collaborations Between Multi-stakeholders

      • What does the collaboration look like from an operational standpoint? What has worked and what hasn’t?
      • Overcoming site hurdles in regard to data entry, data capture, site education
      • Back end data analysis challenges as a result of expanding data collection and CRS questions/inquiries that we are asking on a lot of these immune studies.

  • IO Imaging Aspects Plenary

    This plenary includes imaging data and methods to further monitor the immune system and provides informative approaches that can assist in the assessments of IO therapies.


  • Whole Body PDL1 PET

    David Leung
    David Leung, MD, PhD

    Medical Director, Oncology Imaging, Exploratory Clinical & Translational Research, BMS


  • Radiomics as a Tool to Look for Trends and Predictive Features for Efficacy in Trials


  • Regulatory Perspective: Imaging and Immuno-Oncology Trends


  • Imaging Evaluation for Immuno-oncology Protocols at the Site Level

    This joint presentation addresses how site performs clinical trials from a radiology and PI perspective and the challenges.


    Kelie Luby

    VP, Clinical Trials Software, Mint Medical


  • 5th Annual Networking Reception


  • Attendees will have the opportunity to network and schedule one-on-one partnering meetings during the networking luncheon and scheduled breaks.

2019 Preliminary Agenda


  • Co-chair’s Opening Remarks


    James Gulley, MD, PhD

    Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute


    Axel Hoos, MD, PhD

    SVP, Oncology R&D, GSK


    Andrew Baum, MD

    Head of Global Healthcare, Managing Director, Equity Research, Citi


  • Combining IO Modalities In a Cost Effective, Patient Beneficial Manner that Unfolds in Our Lifetime

    The hardest thing to figure out now is what combinations make the most sense in which patients and how to combine all these emerging modalities in a way that is cost effective, benefits patients and unfolds in our lifetime. There are hypothesis on what technologies should be explored together. Very few companies have all the relevant skills, reagents or product candidates in one setting, so it requires collaboration to  generate the most powerful combinations. This overview talk, followed by a panel will delve into the following:

    • What is the underlying pathobiology and how it is similar from patient to patient and how it is different in individuals?
    • What interventions make the most sense and how to get the right patient into the studies to test your hypothesis?
    • How do you connect modalities such as cell therapies and immune-module antibodies?
    • How do you explore potential meaningful combinations before you have approved agents where you can tap into other products?

    Moderator:


    Robert Stein, MD, PhD

    Senior R&D Advisor, Agenus

    Panelists:


    Jeffrey Bockman, PhD

    EVP, Oncology Practice, Defined Health


    Mark Simon, MBA

    Partner and Co-founder, Torreya Partners

     


  • Next Generation Cell Therapy Plenary

    This new plenary for 2018 features talks on emerging cell therapy approaches, optimization,  manufacturing and engineering CAR-Ts and the future outlook of cell-based therapies.


  • CAR-T Therapy for Cancer: Optimization Through Engineering T-cells or Combinations

    This talk will focus on the next steps for CAR-T therapy for cancer, discussing the novel approaches that are being developing in Dr Carl June’s lab including CAR-T combinations with small molecules and gene-editing.


    Marco Ruella, MD

    Assistant Professor and Scientific Director Lymphoma Program, Division of Hematology and Oncology, Department of Medicine and Center for Cellular Immunotherapies (CCI), Perelman School of Medicine, University of Pennsylvania


  • Allogeneic Approaches in Cell Therapy


  • Update on NY-ESO


    Cedrik Britten, MD

    Head, Cell Therapy, GSK


  • CAR-T Cell Manufacturing

    There is a debate between allogeneic and autologous approaches for manufacturing of CAR-T cells. It would be ideal to optimise the process and take the cells out of the patient but the turnaround time is over 4 weeks. This case study provides examples and data on how to effectively take the cells out of the patient with a quick turnaround that is beneficial.


  • Next Generation CAR-T and Cell-Based Immunotherapies

    This panel will address the scalability, challenges, emerging approaches and the future outlook of cell-based therapies.

    • Can the adoptive cell therapy technology meet the high expectations?
    • Are the toxicities telling us we are not ready?
    • How do we scale T-cell therapy and what are the plans for getting the therapy into all the patients who need it?
    • What combination therapy should be given with T-cell therapy?
    • How is cell-based immunotherapies changing the industry?

    Moderated by:


    Morrie Ruffin

    Founder and Managing Director, Alliance for Regenerative Medicine (ARM)


  • IO Clinical Developments Plenary

    This plenary provides progress reports on recent IO clinical data across indications.


  • MSI Case Study: Investigator/Industry Collaboration that led to the FDA’s 1st Tumor Agnostic Label Approval

    This multi-stakeholder talk will share the science of MSI and the journey of how MSI became the first tumor agnostic label approval. The objective is to demonstrate how effective the therapies are in MSI so it can help others design programs using tumor agnostics because the precedent is there.


    Eric Rubin, MD

    VP, Global Clinical Oncology, Merck Research Laboratories


  • Preclinical and Early Clinical Experience with ADU-S100/MIW815, a first-in-class STING Agonist for the Treatment of Cancer


    Andrea van Elsas, PhD

    Chief Scientific Officer, ADURO


  • Update on BCMA BiTE and AMG 330


    Tara Arvedson, PhD

    Director, Oncology Research, Amgen


  • Latest Clinical Data on T-Cell Bispecifics

    Speaker TBA, ImmunoCore


  • Attendees will have the opportunity to network and schedule one-on-one partnering meetings during the networking luncheon and scheduled breaks.