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2019 Agenda - Follow us on Twitter @IO360Summit

  • 7:30 am

  • Registration

  • 8:15 am

  • 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

  • 8:30 am
    - 11:20 am

  • 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


  • Morning Networking Break


  • 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-214: 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

  • 11:20 am
    - 3:30 pm

  • 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.

    Plenary Chair:


    Priti Hegde, PhD

    Global Franchise Lead, Cancer Immunotherapy Biomarkers, Genentech


  • Plenary Keynote: 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


  • Key Central Laboratory Capabilities to Enable Successful Immuno-Oncology Clinical Development

    This talk will provide an overview of central laboratory capabilities that deliver mechanistic and predictive biomarker data to support decision making for Immuno-Oncology Clinical Development.

    Patrice Hugo
    Patrice Hugo, PhD

    Chief Scientific Officer, Q² Solutions


  • Lunch


  • 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


  • Modeling the Effect of Checkpoint Inhibition on the Tumor Microenvironment Using A Personalized Ex Vivo Histoculture Approach

    Delineation of the intra-tumor microenvironment in a dynamic, spatio-temporal setting is critical for investigating the activity and efficacy of candidate oncology drugs. The majority of solid cancers contain unorganized, highly-complex microenvironment wherein a dysregulated phenotypic impacts treatment outcomes at a personalized level.  Mitra Biotech developed and validated a personalized, fully human ex-vivo histoculture platform technology (CANscript™) using patient material (tumor, autologous ligands and immune cells) to explore the effect of a variety of drug classes on individual tumor compartments and across the phenotype of the sample (Nat Comm., 6:6169:1-14 2015).  With respect to immune-modulating agents, we have investigated the effect of innate and adaptive targets on immune contexture.  This session will review Mitra’s strategy for histoculture and explore data from internal and client studies as a means of understanding the strengths and weaknesses of our approach.


    Mark Paris, PhD

    Associate Director, Translational Applications, Mitra Biotech


  • 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

    Panelists:


    Daniel Chen, MD, PhD

    Chief Medical OfficerIGM Biosciences

    Theresa LaVallee
    Theresa LaVallee, PhD
    Head of Translational Medicine and Regulatory AffairsParker Institute for Cancer Immunotherapy

    Ian McCaffery new
    Ian McCaffery, PhD

    VP and Head of Oncology Translational ResearchJanssen Research and Development


    David Messina, PhD

    COO, Cofactor Genomics


  • Afternoon Networking Break

  • 4:10 pm
    - 5:10 pm

  • 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.
  • 5:10 pm
    - 6:30 pm

  • 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.

    Plenary Chair:


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


  • 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


  • Monetizing Science: Turning an Asset into Value through IPOs

    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

    with


    David Epstein, MBA

    Executive Partner, Flagship Pioneering


    Dan Passeri, MSc, JD

    President and Chief Executive Officer, Cue Biopharma


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

2019 Agenda - Follow us on Twitter @IO360Summit

  • 7:30 am

  • Registration

  • 8:20 am

  • 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

  • 8:30 am
    - 9:30 am

  • 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


  • Morning Networking Break

  • 10:10 am
    - 12:30 pm

  • 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

    This talk will look at deal-making and investments in the I-O space to see what can be learned about the expanding and shifting landscape of BioPharma and investor interest by examining who is placing what kinds of bets on which targets and modalities, at what stage and with what terms. Additional topics include:

    • Where are the next big paradigm shifts going to be? 
    • Where is the next great target that will supersize foundational checkpoint therapy?


    Jeffrey Bockman, PhD

    EVP, Oncology Practice, Defined Health


  • IO Partnering Strategies In an Increasingly Complex Environment

    In this panel, large pharma and biotech business development leads discuss decision-making when it comes to partnering and collaborations in today’s IO environment.

    • What is the current nature and types of partnerships being done in IO?
    • Is dealmaking and partnerships evolving due to the need for IO combinations? How so?
    • What is the balance between in house R&D and external innovation in IO?
    • What is the decision making regarding exclusive licensing and “no strings attached” partnerships?


    Emmett Schmidt, MD, PhD
    Scientific Associate VP; Lead, External Collaborations Project Team, Merck Research Labs


    Anton Xavier, MBA

    Assistant Director, Technology and Business Development, New York State Center for Biotechnology


  • Fund Raising in the Current IO Space

    This panel, designed for small and emerging biotechs, will address the following questions on fund raising in today’s competitive market.

    • How do you raise capital?
    • How do you interact with your shareholders?
    • How do you maintain visibility in the market?
    • How do you entice investors and such to be part of your IPO?
    • How do you move forward if you have a short term investor rather than a long term investor?
    • How do you differentiate yourself from other IO companies?

  • The RatIOnal Investor: Understanding IO Investment Decisions

    • To what extent are big rounds of financing sustainable in the future?
    • What is the trigger for why it is sustainable or not?
    • How do you decide who to put new funds towards?


    Tom Brakel, MD

    Senior Portfolio Manager/ Senior Investment AnalystFederated Global Investment Management Corporation


  • Executive Fireside Chat

    This fireside chat, presented by Solebury Trout with the CEO of Forbius, will discuss lessons learned from their IPO journey.


    Ilia Tikhomirov, MBA

    President and CEO, Forbius (Formulation Biologics)


  • Lunch


  • Keynote: Evolving I-SPY 2 to Optimize Breast Cancer Outcomes

    In this talk, founder and co-principal investigator of I-SPY 2, Dr Laura Esserman, shares the remarkable progress achieved by the I-SPY 2 clinical trials in improving the outcomes of breast cancer. Dr Esserman will also share how I-SPY 2 is impacting far beyond breast cancer by increasing efficiencies that promise to accelerate the development and delivery of more effective therapies for other cancer types and a range of other diseases.


    Laura Esserman, MD, MBA

    Director, UCSF Carol Franc Buck Breast Cancer Center; Alfred A. de Lorimier Endowed Chair in General Surgery; Professor of Surgery and Radiology, UCSF

  • 1:50 pm
    - 4:40 pm

  • 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.

      Plenary Chair:

      Ian McCaffery new
      Ian McCaffery, PhD

      VP and Head of Oncology Translational Research, Janssen Research and Development


       

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

      • Introduction to hexabody platform technology as well as related Hex Select platform technologies
      • Preclinical data to support the idea of hexamerization to lead to enhanced CDC, or stable cross-linking,
      • Clinical vignette from GenMab’s DR5/Dr5 hexabody program, currently in the clinic, which serves as clinical validation of hexabody platform


      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

    • Cofactor Genomics Case Study


      Jarret Glasscock, PhD

      CEO, Cofactor Genomics

    • Afternoon Networking Break

    • Novel CARs for Solid Tumors: IL-13

      Sadik Kassim, PhD
      Chief Scientific Officer, Mustang Bio

    • Clinical Operations for IO Trials

      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.

      Plenary Chair:


      Jacqueline Karmel
      Principal Director Scientific Collaborations, Roche


       

    • 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

    • Afternoon Networking Break

    • Operational Collaborations and Data Management Between Multi-stakeholders

      This panel will address the operational challenges with obtaining IO data and the utilization of IO data to advance science. Key discussion points include:

      • Aggregating data across trials and centers
      • Obtaining associated clinical data from academic studies and combine it with data from other studies
      • Obtaining secondary data analysis which brings in new channels of research on top of the primary analysis
      • How to best to leverage all the operational data to drive the types of activities required to start trials, to know where we are and to be able to manage risks


      Adriana Comprelli
      Head, Clinical Operations, Early Assets & Clinical Pharmacology, BMS


      Jacqueline Karmel
      Principal Director Scientific Collaborations, Roche

  • 4:40 pm
    - 6:25 pm

  • 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.

    Plenary Chair:


    Andrea Perrone, MD

    Head of Clinical Imaging, Translational Medicine, Merck


  • Whole Body PDL1 PET

    David Leung
    David Leung, MD, PhD

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


  • More Information in the Image: Radiomics, Kinetics, and AI


    Lawrence Schwartz, MD

    Chief, Radiology Service, Columbia University Medical Center


  • 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 Agenda - Follow us on Twitter @IO360Summit

  • 7:45 am

  • Registration

  • 8:20 am

  • 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

  • 8:30 am

  • 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

     

  • 9:10 am
    - 12:45 pm

  • 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


  • Morning Networking Break


  • 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.


  • CAR-T Clinical Developments

    Michael Kalos new
    Michael Kalos, PhD
    VP, Immuno-oncology & Oncology Cellular Therapies, Janssen Oncology

  • Improving CAR-T Accessibility through Next Generation Technologies

    The pipeline of adoptive T-cell therapies and other cell based immuno-oncology programs continues to expand with a number of modifications and improvements to the first generation programs. These platforms include improved specificity and delivery — including non-viral platforms, targeting of multiple antigens, editing constructs, and a variety of strategies to address toxicity and the tumor microenvironment. This panel of experts will consider the major technical and clinical improvements to cell based IO therapeutics that will lead to more durable therapies and the ability to treat both liquid and solid tumors. 

    Moderated by:


    Morrie Ruffin

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


  • Lunch

  • 1:40 pm
    - 4:00 pm

  • 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.