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2019 AGENDA


  • Key Topics:

    • Discovery and Preclinical Science
    • Translational Science & Biomarkers
    • Bispecifics
    • Emerging Technologies

  • 7:45 am

  • Registration and Morning Coffee/Tea

  • 8:15 am

  • Co-Chair's Opening Remarks


    Ian McCaffery, PhD

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


    Omid Hamid, MD

    Chief, Translational Research and Immunotherapy / Director, Melanoma Therapeutics, The Angeles Clinic and Research Institute

  • 8:30 am

  • Opening Keynote: Hubble’s Constant for the Expanding Universe of Immunotherapy

    Drew Pardoll, MD, PhD

    Drew Pardoll, MD, PhD
    Director, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Professor of Oncology, Johns Hopkins University School of Medicine


  • Discovery, Preclinical Science and Bispecifics

    Plenary Chair:


    Omid Hamid, MD

    Chief, Translational Research and Immunotherapy / Director, Melanoma Therapeutics, The Angeles Clinic and Research Institute

  • 9:00 am

  • Preclinical Combinations with Bispecific T-cell engager (BiTE®) Immune-therapy and Translation to the Clinic

    This talk will focus on PD1 combinations including an update on Blincyto/Keytruda combination.

    Julie Bailis, PhD
    Principal Scientist, Oncology Research, Amgen

  • 9:20 am

  • Recombinant MVA an Immunotherapy for Cancer: More Than a Vaccine

    This talk will include preclinical data on Bavarian Nordic’s vaccine platform as a tool to modify the global immune response by encoding target antigens, encoding costimulatory molecules, and encoding cytokines. This allows one agent to be used that can solve many problems that otherwise are being addressed, clinically, by multiple agents. Instead of combining vaccine + cytokine + checkpoint, in turn may be able to repurpose vectors to give them either intravenously or intratumorally (or both) to modify the TME, active innate immune responses including NK cells, generate T cell activation peripherally and locally. Then, combine with checkpoint inhibitors and ADCC-inducing antibodies to drive potent anti-tumor effect. These findings will be translated  into various clinical trials in the next 6-18 months.


    Hubertus Hochrein, PhD
    VP, Head of Research, Bavarian Nordic

  • 9:40 am

  • Grand Opening of the Exhibit & Networking Café and Breakfast

  • 10:25 am

  • Updates on Bintrafusp alfa/M7824 Clinical Data

    This talk will provide an overview of the molecule Bintrafusp alfa/M7824 – an innovative, first-in-class bifunctional fusion protein composed of an anti–PD-L1 mAb fused with 2 extracellular domains of TGF-βRII (a TGF-β “trap”). The mechanism of action, pre-clinical and phase 1 studies of this molecule will be discussed as well as an overview of the next wave of clinical development.


    Laureen Ojalvo, MD, PhD

    Medical Director, EMD Serono

  • 10:45 am

  • Leveraging the Tumor Microenvironment for IO Therapy

    This talk will address agonistic strategies, T and NK cell redirection and the use of genetic/phenotypic associations to identify novel target space in IO.

    Kenneth Hance
    Kenneth Hance, PhD

    Senior Director, Head of Immune Biology, Immuno-Oncology & Combinations DPU, Oncology R&D, GSK

  • 11:05 am

  • Panel: Advancing Bispecifics for Combination Immunotherapy

    • What are the types of bispecifics and what are the limitations?
    • What are the toxicity related side effects?
    • What are the next steps/levels for bispecifics?
    • What does the future hold for bispecifics?

    Moderated by:

    Daniel Dan Chen
    Daniel Chen, MD, PhD

    Chief Medical Officer, IGM Biosciences

    Panelists:

    Julie Bailis, PhD
    Principal Scientist, Oncology Research, Amgen


    Rajkumar Ganesan, PhD

    Director, Bispecifics and CAR-T, Janssen Research & Development


    David Schaer, PhD

    Director, Translational Oncology Lead, Pfizer
  • 11:50 am

  • IO Novel Technologies

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

    Plenary Chair:

    Daniel Dan Chen
    Daniel Chen, MD, PhD

    Chief Medical Officer, IGM Biosciences


  • QuartzBio, part of Precision for Medicine


    Renée Deehan-Kenney, PhD

    VP, Computational Biology

    Invicro


    Ohad Ilovich, PhD

    Director, Translational Research

    Advaxis


    Joel R Hecht, MD

    Professor of Clinical Medicine, David Geffen School of Medicine / Director, Gastrointestinal Oncology ProgramUniversity of California Los Angeles (UCLA)(on behalf of Advaxis)

  • 12:30 pm

  • Networking Lunch and Partnering Meetings


  • Translational Science & Emerging Biomarkers

    Plenary Chair:


    Ian McCaffery, PhD

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

  • 1:30 pm

  • Panel: How AI, Machine Learning and Big Data are Used to Inform Combinations

    Led by:


    Matthew Albert, MD, PhD

    VP, Immunology & Infectious Diseases, Insitro

    Panelists:


    Edward Bowen

    VP, AI & Machine Learning, GSK


    Ryan Fukushima

    Chief Operating Officer, Tempus


    Renée Deehan-Kenney, PhD

    VP, Computational Biology, QuartzBio, part of Precision for Medicine

  • 2:15 pm

  • The Functional Capacity of Immune Cells as Measured by Single Cell Proteomics Predicts Clinical Outcome Across IO Therapies

    Using single cell proteomics to measure the functional capacity or ‘fitness’ of immune cells has correlated with and been predictive of  clinical outcome in CAR-T, TIL, Cancer Vaccine and Checkpoint Inhibitor therapy. This talk will review several of these data sets and discuss applications of IsoPlexis’ single cell technology.


    Will Singleterry, PhD

    Director of Business Development, IsoPlexis

  • 2:35 pm

  • Molecular Correlates of Response and Resistance to Atezolizumab+/- Bevacizumab in Untreated Metastatic RCC


    Mahrukh Huseni

    Scientific Manager, Genentech

  • 2:55 pm

  • Profiling the effect of Single Agent CPI versus Combinations Through Diverse Sampling and Personalized Tumor Histoculture

    This presentation will address how Mitra Biotech’s personalized, fully human, ex-vivo histoculture platform technology (CANScriptTM), which uses patient material (tumor, autologous ligands and PBMC) to explore the mechanism of action for novel agents and combinations, focusing on molecular and phenotypic effects was used to model the effect of immune-modulating drugs on the tumor microenvironment. The focus will be how quality control of experimental conditions can result in the generation of biological insights.


    Mark Paris, PhD

    Associate Director, Translational Applications, Mitra Biotech

  • 3:15 pm

  • Maximizing Immunotherapy Biomarker Discovery with a Multidimensional Tumor Immunogenomics Platform

    More accurate, predictive biomarker analysis may assist in the selection of effective combinatorial immunotherapy treatments for patients.  Additionally, the complexity of both the tumor and tumor microenvironment suggests a comprehensive approach is needed for robust characterization of the cancer ecosystem. The ImmunoID NeXT platform investigates key aspects of immuno-oncology; from elucidating mechanisms of tumor escape and detecting neoantigens, to identifying novel biomarker signatures and characterizing the immune repertoire. This presentation will focus on the current challenges facing investigators in immuno-oncological translational research including maximizing data generation from a single sample and the analysis of complex data.

    Erin_Newburn
    Erin Newburn, MS, PhD

    Associate Director, Field Applications Scientist, Personalis, Inc

  • 3:35 pm

  • Afternoon Networking Break and Partnering Meetings

  • 4:20 pm

  • Updates on PARP Inhibition


    Darren Hodgson, PhD

    Senior Principal Translational Scientist, Oncology iMED, AstraZeneca

  • 4:40 pm

  • How Biomarker Combinations are as Rational as IO Combinations

    The design of successful clinical strategies for therapeutic combinations has been hindered by the inability of single analyte biomarkers to deliver a comprehensive view of the immune system. Combination therapies require advanced methods for interrogating tumor immune composition and patient’s immune response. Early results with multidimensional biomarkers, driven by predictive immune modeling, are enabling higher predictive accuracy for better patient selection and more robust treatment decisions.


    Jon Armstrong

    Chief Scientific Officer, Cofactor Genomics

  • 5:00 pm

  • Panel: Next Generation Biomarkers

    • What’s the cutting edge thinking on biomarkers?
    • Predictive markers and what are they telling us about the biology?
    • What are the mechanisms of resistance/action?
    • How do you measure them like PD1 expression and PDL1 expression?
    • How much do you need to see in order to have confidence that that combination is going to work? With other agents that target other receptors, biomarkers could be a way to drive a patient stratification. Is that evolving in a positive way? Are we seeing novel things?
    • Beyond that are there emerging technologies? Can we detect from blood, biomarkers that will be able to enable clinical desire?
    • How are we using machine learning and AI to find additional insights?

    Moderated by:


    Ian McCaffery, PhD

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

    Panelists:


    Paul Beresford, PhD

    Chief Business Officer, Biodesix

    Daniel Dan Chen
    Daniel Chen, MD, PhD

    Chief Medical Officer, IGM Biosciences


    Ohad Ilovich, PhD

    Director, Translational Research, Invicro


    Ruslan Novosiadly, MD, PhD

    Oncology Translational Medicine Team Lead, BMS


    Matthew Onsum, PhD

    Director, Head of Diagnostics, Analytics, and Biomarkers, Seattle Genetics

  • 5:45 pm

  • PD1 Resistance with a Multi-Omic Approach

    Anti-PD-1 therapy has transformed cancer care but most patients do not respond. It is increasingly clear that there will be no single biomarker of response to aPD-1, and that a multi-omic approach will be required. This talk will address:

    • Orthogonality and correlation of response biomarkers across histologies
    • Integration of multi-omic data sets for mechanistic insights into tumor immunobiology
    • The translational approaches to PD1 resistance program at the Parker Institute

    The focus throughout will be on leveraging molecular data for translational impact.

    Danny Wells
    Danny Wells, PhD

    Senior Data Scientist, Parker Institute for Cancer Immunotherapy

  • 6:05 pm

  • Annual Networking Reception

2019 AGENDA


  • Key Topics:

    • Next Generation Cell Therapy
    • Clinical Developments
    • Operationalizing Combinations
    • Business Aspects

  • 8:00 am

  • Morning Coffee/Tea

  • 8:20 am

  • Co-Chair's Opening Remarks


    Ian McCaffery, PhD

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


    Omid Hamid, MD

    Chief, Translational Research and Immunotherapy / Director, Melanoma Therapeutics, The Angeles Clinic and Research Institute


  • Next Generation Cell Therapy

    Plenary Chair:

    Michael Kalos new
    Michael Kalos, PhD

    VP, Immuno-Oncology and Oncology Cellular Therapies, Janssen Oncology

  • 8:30 am

  • Opening Keynote: Clinical Trials of Double Chimeric Antigen Receptor (CAR) T Cells and Engineered T Cell Combination Therapies

    Bruce Levine, PhD
    Barbara and Edward Netter Professor in Cancer Gene Therapy, Perelman School of Medicine, University of Pennsylvania

     

  • 9:00 am

  • Off-the-shelf CAR-engineered Cord Blood-Derived NK Cells for the Treatment of Cancer- The First-in-Human Trial

    Natural killer (NK) cells play critical roles in host defense against cancer. Our group within MD Anderson is exploring a number of avenues to enhance NK cell function against leukemia. These include novel strategies to expand off-the-shelf cord blood (CB) derived NK cells based on their co-culture with genetically-modified feeder cells that express membrane-bound cytokines and co-stimulatory molecules. To redirect NK cell specificity and enhance their in vivo persistence, we have successfully transduced expanded CB NK cells with a retroviral vector incorporating the genes for CAR-CD19, IL-15 and inducible caspase-9-based suicide gene (iC9). Data from a first-in-human Phase I/II clinical study to test the safety and efficacy of escalating doses of off-the-shelf iC9/CAR.19/IL-15 CB-NK cells in patients with relapsed or refractory B-lymphoid malignancies will be presented.

    Katy Rezvani, MD, PhD
    Katy Rezvani, MD, PhD

    Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine, MD Anderson Cancer Center

  • 9:20 am

  • Combination Strategies for CAR-T Therapies

    Cell therapy has revolutionized the field of oncology by presenting an alternate paradigm to engineer the immune system to target and eradicate cancer. While cell therapy has shown dramatic success in certain hematologic malignancies, considerable obstacles still remain for it’s full potential to be realized. In this presentation, we will provide overview strategies and approaches that have the potential to enhance the activity of cell-based therapies and lead to enhanced anti-tumor activity.

    Michael Kalos new
    Michael Kalos, PhD

    VP, Immuno-Oncology and Oncology Cellular Therapies, Janssen Oncology

  • 9:40 am

  • Networking Café, Morning Break and Breakfast, Partnering Meetings

  • 10:20 am

  • Multimodal T Cell Combinations for Cancer Therapy


    Dmitry Pankov, MD

    Head, Non-Clinical Combinations Oncology Cell Therapy, GSK

  • 10:40 am

  • High-Throughput Identification of Neoantigen-specific TCRs for Therapeutic Development

    The Adaptive Biotechnologies TruTCR™ discovery technology enables the screening and identification of naturally-occurring TCRs at extraordinary throughput and scale. The TruTCR approach leverages a novel, highly sensitive, multiplex approach, known as MIRA™(Multiplexed Identification of T-cell Receptor Antigen specificity), which combines deep sequencing with cellular immunology techniques to assess TCR specificity to large numbers of query antigens. More than 400 antigens are routinely and simultaneously queried using MIRA, and antigen-specific TCRs at frequencies as low as 1 in 10 million are identified. TCRs are then reconstructed by accurate high-throughput pairing of TCRA with TCRB chains using Adaptive’s pairSEQÒ technology. Select candidate TCRs undergo further profiling and characterization, including functional avidity, cytokine release, cytotoxicity and safety evaluations. Adaptive has identified and characterized several high avidity TCRs against clinically relevant cancer antigens and shared neoantigens. These TCRs demonstrate differentiated therapeutic potential that includes promising cytolytic activity and safety profile.


    Sharon Benzeno, PhD, MBA

    SVP, Drug Discovery, Adaptive Biotechnologies

  • 10:55 am

  • New Opportunities for Cell Therapy Combinations:

    • What are the new opportunities in cell therapy for combinations?
    • What the challenges are going to be with the microenvironment?
    • What is being done to engineer cell therapy?
    • How do you develop CARs and TCRs that deliver payloads?
    • How do you manufacture all of this beyond mouse models to figure out how to effectively do this in patients?
    • How do you actually go about designing trials and testing hypothesis?
    • How do you create the regulatory framework to do these types of studies?
    • How do you engage with regulatory agencies to get these things moving?
    Moderated by:

    Michael Kalos new
    Michael Kalos, PhD

    VP, Immuno-Oncology and Oncology Cellular Therapies, Janssen Oncology

    Panelists:


    Sharon Benzeno, PhD, MBA
    SVP, Drug Discovery, Adaptive Biotechnologies


    Chaohong Fan, MD, PhD

    Medical Officer, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research (CBER), FDA


    Bruce Levine, PhD

    Barbara and Edward Netter Professor in Cancer Gene Therapy, Perelman School of Medicine, University of Pennsylvania


    Mark Stewart, PhD

    VP, Science Policy, Friends of Cancer Research


    Bahram (Bob) Valamehr, PhD

    Chief Development Officer, Fate Therapeutics


  • Business Aspects for IO Combinations

    Plenary Chair:


    Asthika Goonewardene, MBA

    Senior Biotech Analyst, Bloomberg Intelligence

  • 11:40 am

  • Approaches to IO Combination Collaborations and Building on Existing Partnerships

    • How do you think about partnering strategically?
    • What are the innovative approaches?
    • How can partnerships evolve between pharma and biotech?
    • How can we as an industry consider those and improve on the process?
    • If we look beyond checkpoint inhibitors, where is the next wave and how does that influence approaches to collaborations?

    Moderated by:


    Anton Xavier, MSc, MBA

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

    Panelists:


    Madee Gooriah, PharmD

    Director of Oncology Search & Evaluation for Business Development, BMS


    Paul Stead, PhD

    VP, Business Development, Adaptimmune


    Loïc VINCENT, PhD
    VP, Immuno-Oncology & Cell Therapy Discovery, and Research Partnerships, Takeda


    Michael Woo, PharmD

    Head, Search & Evaluation, Immuno-Oncology; Business Development & Licensing, Novartis Institutes for BioMedical Research

  • 12:20 pm

  • Evaluating and Investing in IO Combinations

    This fireside chat brings together perspectives from VCs, Crossover and Public Market investors on the following:

    • How to evaluate the science and how to figure out who the winners are?
    • From an investment perspective, what are the technologies right now and what needs to develop to make them happen?
    • What science aspects and how much of it do investors at each stage require for decision making?

    Moderated by:


    Asthika Goonewardene, MBA

    Senior Biotech Analyst, Bloomberg Intelligence

    Fireside Guests:


    Christiana Bardon, MD

    Managing Director, Burrage Capital / MPM Capital Oncology Impact Fund

    Carlo Rizzuto
    Carlo Rizzuto, PhD

    Partner, Versant Ventures

  • 1:00 pm

  • Networking Lunch and Partnering Meetings


  • IO Clinical Combinations and Operations

    Plenary Chair:

    Emmett Schmidt
    Emmett Schmidt, MD, PhD

    Scientific Associate VP of Clinical Oncology & Lead, External Collaborations Project Team, Merck Research Labs

  • 2:00 pm

  • Addressing Operational Challenges of Multi-therapy Combination Studies

    This panel, led by Andy Lee, SVP, Head of Global Clinical Trial Operations, Merck will address the philosophy and pragmatics of synergistic therapies in combination trials. Key talking points include:

    • How do you source the material, manage the expiry dates and acquire them in different countries? 
    • How do you set up a trial?  
    • What’s the difference between doing your own combinations vs doing a study with an external collaborator?
    • How do you go about contracting, deciding systems and processes, etc
    • Insourcing vs outsourcing: How do you work with two different sponsor’s drugs and products?
    • How do you set up your workforce that you firewall?
    • Once the study is going, how do you manage the safety when you have two different combinations?
    • How do you report the safety to different sponsors?
    • How do you update and manage the informed consent?
    • How do you run two studies together with competing sites and firewalling, etc?

    Moderated by:

    Andy Lee
    Andy Lee

    SVP, Head of Global Clinical Trial Operations, Merck

    Panelists:

    Carol Haddad
    Carol Haddad
    Executive Director, CSSM Oncology, GCTO, Merck

    Gretchen Hurst
    Gretchen Hurst

    Director, Oncology Project Leadership, IQVIA


    Ron Korn, MD, PhD

    Founder, Chairman and CMO, Imaging Endpoints


    Beth Metzheiser

    Head of Clinical Operations, Hematology and CRO Collaborations, BMS

  • 3:15 pm

  • Pembrolizumab as a Foundational Partner for Combination Immune-Oncology Drug Development

    There are quite a number of evolving data sets which help inform the direction of combination therapy. This talk addresses:

    • The foundational nature of PD-1 antibodies as combination partners
    • The utility of precision based tools for suggesting potential combinations
    • Emerging data which are exemplars of the approach including:
      • Chemo-combinations
      • TKI-combinations
      • IO-IO combinations


    Roy Baynes, MD, PhD
    SVP & Head, Global Clinical Development, Chief Medical Officer, Merck Research Laboratories

  • 3:35 pm

  • Emerging Results in the IO Field on PD1 Checkpoint Inhibitor Combination Therapy

    In this talk, Dr Emmett Schmidt will share data he has compiled based on 300 clinical trials that include emerging response data. As a result of this analysis, Dr Schmidt found that most clinical combinations are showing combination activity above the equivalent monotherapy activity of the PD-1 combination agent. He will offer an approach to the analysis of “synergy” based on a recent review article. At this time, this analysis does not detect evidence for mathematical synergy in current PD-1 pathway inhibitor combination trials.

    Emmett Schmidt
    Emmett Schmidt, MD, PhD

    Scientific Associate VP of Clinical Oncology & Lead, External Collaborations Project Team, Merck Research Labs

  • 3:55 pm

  • Bempegaldesleukin (NKTR-214): Harnessing the IL-2 pathway in combination immunotherapies

    • Bempegaldesleukin: Structure and function of an engineered IL-2 cytokine prodrug providing sustained IL-2Rβγ-biased signaling
    • Preclinical PK, PD, MOA and combination with PD-1 checkpoint inhibition
    • Clinical PK, PD, clinical response data and biomarkers in patients with melanoma and bladder cancer
    • Combinations under investigation


    Willem Overwijk, PhD

    VP, Oncology Research, Nektar Therapeutics

  • 4:15 pm

  • Taking a “Toll” on Cancer: Combination Strategies with TLR9 to Overcome Immunotherapy Resistance

    • Tilsotolimod: Creating a beneficial tumor microenvironment by engaging innate immune pathways
    • Clinical translation of the MOA in patients with melanoma and refractory solid tumors
    • Improving clinical outcomes in PD-1 refractory metastatic melanoma
    • Combination strategies beyond melanoma

    Srinivas Chunduru
    Srinivas K Chunduru, PhD
    VP, Translational Medicine, Idera Pharmaceuticals

  • 4:35 pm

  • Clinical Updates on Vemurafenib + Cobimetinib + Anti-PDL1


    Justine Cohen, DO

    Oncologist, Center for Melanoma, Massachusetts General Hospital

  • 4:55 pm

  • Conference Concludes