Agenda 2018

  • 7:45 am

  • Registration and Breakfast

  • 8:30 am

  • Co-Chair’s Opening Remarks


    Axel Hoos, MD, PhD

    SVP, Oncology R&D, GSK


    Patrick Hwu, MD

    Head, Division of Cancer Medicine, Department Chair, Melanoma Medical Oncology Department Chair, Sarcoma Medical Oncology, MD Anderson Cancer Center

    Ian McCaffery new
    Ian McCaffery, PhD
    VP, Oncology Translational Science, Janssen Pharmaceuticals

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  • Preclinical Mechanistic Combinations Plenary Session

    Chaired by:

    Ian McCaffery new
    Ian McCaffery, PhD
    VP, Oncology Translational Science, Janssen Pharmaceuticals

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  • 8:45 am

  • IO Combinations with CAR-T Therapies

    Michael Kalos new
    Michael Kalos, PhD

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

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  • 9:05 am

  • Preclinical Evaluation of Combinations with Bispecific T-cell Engager (BiTE®) Antibody Constructs

    Julie Bailis, PhD
    Principal Scientist, Oncology Research, Amgen, Inc

  • 9:25 am

  • The Tumor Explant Model as a Model System to Understand Treatment Effects

    This talk will look at the infiltration of lymphocytes and cytokine/ chemokine profiles into the tumor and which drugs/drug combinations can drive that through a tumor explant model. This fully human, fully immunocompetent model system allows to monitor and understand the immediate effects of systemic treatments on the tumor and surrounding normal tissue.  This model to is used to identify mechanisms of response and resistance in tumor types.

    Dirk Jäeger
    Dirk Jäeger, MD

    Director, Medical Oncology, National Center for Tumor Diseases (NCT), University Medical Center Heidelberg

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  • 9:45 am

  • Model Systems for Studying Combinations

    Marcus Bosenberg
    Marcus Bosenberg, MD, PhD

    Professor, Dermatology and Pathology, Yale Cancer Center

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  • 10:05 am

  • Networking Break

  • 10:45 am

  • A Novel Approach to IO Combination Regimens and Multispecific Constructs

    In this talk, Dr Thomas Schuetz, CEO, Compass Therapeutics will present data from their proprietary Stitchmabs platform, a novel screening technology that enables high-throughput screens of bispecific and multispecific antibody constructs. Stichmabs has uncovered uniquely synergistic combinations of tumor targeted antibodies and agonists to NK cell activating receptors. We have developed these hits into bispecific monoclonal antibody drug candidates that are highly effective at mediating tumor cell killing by NK cells in vitro. These drug candidates are capable of killing tumor cell lines with high, medium, and low cell surface antigen expression.

    Thomas Schuetz

    Thomas J Schuetz, MD, PhD
    Co-founder and CEO, Compass Therapeutics

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  • 11:05 am

  • 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

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  • 11:25 am

  • Panel Discussion: Predicting IO Combination Success

    This panel will address how do we predict what is going to work and what is not going to work by looking at model systems and early translational clinical trials. Key questions include:

    • Where have there been successes and failures either in preclinical modeling or combinations that have been inferred from the clinic? 
    • What level of evidence should we be looking at from preclinical and phase1 trials that would inform future directions?
    • How can we learn from mechanisms of non response that can help design more intelligent combinations that targets the mechanisms of resistance?
    • Are there new clinical trial paradigms that might be developed that will allow us to fully understand mechanisms and inform combinations?
    • How can collaborations help maximize the learnings/data to help inform combinations?
    • Forward looking, what kind of technologies and model systems/approaches should the field be taking to develop further insights into convergent mechanisms of actions that might lead us to believe that specific combinations will be important?

    Moderator:

    Ian McCaffery new
    Ian McCaffery, PhD
    VP, Oncology Translational Science, Janssen Pharmaceuticals

    Panelists:

    Dirk Jäeger
    Dirk Jäeger, MD

    Director, Medical Oncology, National Center for Tumor Diseases (NCT), University Medical Center Heidelberg

    Marcus Bosenberg
    Marcus Bosenberg, MD, PhD

    Professor, Dermatology and Pathology, Yale Cancer Center

    Theresa LaVallee
    Theresa LaVallee, PhD

    Head of Translational Medicine and Regulatory Affairs, Parker Institute for Cancer Immunotherapy

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  • 12:10 pm

  • Lunch


  • Translational Science & Emerging Biomarkers Plenary Session

    Chaired by:

    Theresa LaVallee
    Theresa LaVallee, PhD

    Head of Translational Medicine and Regulatory Affairs, Parker Institute for Cancer Immunotherapy

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  • 1:10 pm

  • The Role of the Gut Microbiome in Response to Immunotherapy

    Major progress has been made in the treatment of cancer through the use of immunotherapy, however not all patients respond and new insights into mechanisms of response and resistance are critically needed. We studied the microbiome in patients with metastatic melanoma going onto immune checkpoint blockade, and demonstrated that responders to therapy had a higher diversity of the gut microbiome and compositional differences compared to non-responders. Importantly, this was associated with differences in anti-tumor immunity. Based on this and other data, efforts are ongoing to modulate the microbiome to enhance responses to immunotherapy – however complexities exist and will be discussed in this talk.


    Jennifer Wargo, MD

    Associate Professor, Surgical Oncology and Genomic Medicine, MD Anderson Cancer Center

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  • 1:30 pm

  • IO Combinations Based on Tumor Mutation Analysis

    Although regimens containing PD1/PD-L1 blocking agents have significantly improved survival in first- and second-line non-small cell lung cancer (NSCLC), some treated patients do not respond. A deeper understanding of mechanisms of resistance to PD-(L)1 blockade is needed to improve therapeutic decisions. We will provide examples of how genomic analyses may help to identify mechanisms of resistance and guide rational combination approaches.

    Maria Jure Kunkel
    Maria Jure-Kunkel, PhD

    Director, Immuno-Oncology Translational Medicine, Medimmune

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  • 1:50 pm

  • Demystifying Tumor Immunogenomics: Key Challenges and Solutions

    Advances in immuno-oncology research have led to promising results with NGS-guided analysis for sensitive neoantigen identification as well as for the discovery of novel biomarkers. However, standard approaches suffer from limitations. Personalis addresses these issues using its proprietary ACE ImmunoID platform, which combines augmented exome and transcriptome sequencing with advanced analytics. We’ll share data that demonstrates the technical characteristics with an overview of the analytical validation, bioinformatics pipeline, neoantigen prediction and immunogenomics reporting capabilities.  Additionally, we will be sharing a case study demonstrating ACE ImmunoID’s further utility in biomarker discovery through identifying methods of tumor escape in patients treated with checkpoint modulators.

    Erin_Newburn
    Erin Newburn, PhD

    Associate Director, Field Application Scientist, Personalis Inc

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  • 2:10 pm

  • Predictive Biomarkers of Clinical Response Reveal Synergy Mechanisms Between Combination Immunotherapies Using Single Cell Proteomics

    This talk will provide data that demonstrates how:

    • Polyfunctional Strength (the secretion of two more cytokines per cell, where the cytokine secretion intensity is tied to the cell which produced it) is a more accurate predictor of clinical outcome than flow cytometry, bulk protein analysis or gene array
    • Single Cell Functionality has correlated with Objective Response across IO: CAR-T with Kite Pharma, Checkpoint Inhibitors and Cancer Vaccines
    • Polyfunctionality of CD4+ T-cells is a predictor of Overall Survival of patients treated with the GVAX Vaccine where post- versus pre-vaccination fold-change of the polyfunctional strength index associated with patient overall survival (P = 0.001).


    Will Singelterry, PhD

    Associate Director, Business Development, IsoPlexis

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  • 2:25 pm

  • TCR Sequencing as a Predictive Biomarker of Response in IO

    • The Adaptive Biotechnologies immunosequencing technology platform combines bias-controlled multiplex PCR amplification with high-throughout sequencing and sophisticated bioinformatics.
    • Adaptive’s immunoSEQ TCRB Assay is being incorporated as a novel immune molecular biomarker with potential predictive value in response to diverse immunomodulatory agents in different tumor types.
    • This presentation will demonstrate use of the TCRB Assay to profile, track and monitor T cell receptor (TCR) repertoire changes in patients with solid tumors. The accurate quantitation of TCR density and clonality from either tumor tissue or blood samples informs immune repertoire dynamics with meaningful clinical implications.


    Erik Yusko, PhD

    Senior Manager, Computational Biology, Adaptive Biotechnologies

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  • Operationalizing Combinations Plenary

    Chaired by:


    Jacqueline Karmel

    Principal Director Scientific Collaborations, Roche

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  • 2:40 pm

  • Collaborations that Drive Combination Activities: The Science and Operations

    In this session, Merck clinical operation leaders address the operational considerations of combination studies. This includes:

    • What it takes to run combination studies from an operational standpoint
    • Creating drug sourcing activities, safety and quality agreements and with partnering pharma companies
    • Managing startup activities such as investigator brochures, risk language around combinations and a managing the safety along the way
    • Addressing drug procurement aspects and maintaining those quality aspects of bringing the combinations to the studies


    Ruth Rutledge

    Director, Women’s Cancer Lead, Clinical Sciences and Study Management, Oncology Clinical Development, Merck Research Labs  

    Carol Haddad
    Carol Haddad

    Director, Global Clinical Supply Planning, Merck Research Labs

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  • 3:10 pm

  • Novel Platform Trial Design

    Novel-novel combinations platform trials offer the opportunity to efficiently evaluate and screen out for important new therapies in a standing clinical trials infrastructure. They also offer other efficiencies by use of statistical modeling to formally leverage both historical information and concurrent information in related populations. This talk will describe the various operational and statistical aspects of platform trials for novel-novel combinations in oncology.

    Ohad Amit
    Ohad Amit, PhD

    Senior Director, Head of Clinical Statistics, GSK

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  • 3:30 pm

  • Networking Break

  • 4:15 pm

  • Regulatory Framework for Investigating & Approving Combinations

    This talk will focus on the FDA guideline on novel-novel combinations and its application including existing approvals and future expectations.

    Adnan Jaigirdar
    Adnan Jaigirdar, MD

    Medical Officer, Oncology Branch; Division of Clinical Evaluation, Pharmacology and Toxicology; Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, FDA

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  • 4:35 pm

  • Efforts to Harmonize Predictive Biomarkers

    In this talk, Dr Sacha Gnajtic, Icahn School of Medicine at Mt. Sinai will address the following:

    • What’s the scope of assays that we can think about?
    • How to go about getting them ready for usage in a multi-center fashion?
    • How to prepare biomarkers so the analytic validation efforts are making them as reproducible and robust as possible while maintaining innovation?
    • What efforts are being done to ensure results are being compared across sites?


    Sacha Gnjatic, PhD

    Associate Professor, Tisch Cancer Institute, Hematology/Oncology, ImmunologyIcahn School of Medicine at Mount Sinai

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  • 4:55 pm

  • Panel Discussion: The Operational Challenges of IO Combination Trials

    The complexities of doing combination clinical trials are huge. This panel will address:

    • How do you do clinical trials with different companies products?
    • How do you divide the roles and responsibilities?
    • How do you coordinate the supply chain with multiple investigational products?
    • What are the thresholds?

    Moderator:


    Jacqueline Karmel

    Principal Director Scientific Collaborations, Roche

    Panelists:


    Michel Azoulay, MD, MBA

    Clinical Operations Strategy & Collaborations, Sanofi


    Adriana Comprelli

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

    Carol Haddad
    Carol Haddad

    Director, Global Clinical Supply Planning, Merck Research Labs

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  • IO Emerging Technologies & Innovative Solutions

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

    Chaired by:


    Axel Hoos, MD, PhD

    SVP, Oncology R&D, GSK

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  • 5:40 pm

  • Exicure

    David Giljohann 2017
    David Giljohann, PhD

    CEO

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  • 5:50 pm

  • nanoString Technologies

    alessandra cesano
    Alessandra Cesano, MD, PhD
    Chief Medical Officer

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  • 6:00 pm

  • Inovio

    Jeffrey Skolnik
    Jeffrey Skolnik, MD
    VP, Clinical Development

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  • 6:10 pm

  • BeiGene

    Lusong Luo
    Lusong Luo, PhD
    SVP & Head of External Innovation

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  • 6:20 pm

  • Networking Reception

Agenda 2018

  • 8:15 am

  • Registration and Breakfast

  • 8:45 am

  • Co-Chair’s Opening Remarks


    Axel Hoos, MD, PhD

    SVP, Oncology R&D, GSK


    Patrick Hwu, MD

    Head, Division of Cancer Medicine, Department Chair, Melanoma Medical Oncology Department Chair, Sarcoma Medical Oncology, MD Anderson Cancer Center

    Ian McCaffery new
    Ian McCaffery, PhD

    VP, Oncology Translational Science, Janssen Pharmaceuticals


  • Emerging Clinical Combinations Plenary Session

    Chaired by:

    Roy Baynes new
    Roy Baynes, MD, PhD

    SVP, Global Clinical Development, Merck Research Labs

  • 8:55 am

  • PD-1 Antibody Based Immuno-oncology Novel Combinations Across Indications

    After establishing PD-1 antibody monotherapy activity, enabled by precision medicine,  across multiple cancer types and lines of treatments study of combination therapies across multiple indications is suggesting significant promise. The data thus far suggest the PD-1 antibody is both broad spectrum across tumors and foundational to the combination approach. Novel combinations include those with standard therapies (e.g. chemotherapy), with targeted therapies, with other immune modulators and with tumor vaccines or oncolytic viruses.

    Roy Baynes new
    Roy Baynes, MD, PhD

    SVP, Global Clinical Development, Merck Research Labs

  • 9:15 am

  • Immunotherapy Combinations with PARP Inhibitors

    Lauren Byers
    Lauren Byers, MD

    Associate Professor, Thoracic/Head and Neck Medical Oncology, MD Anderson Cancer Center

  • 9:35 am

  • Overcoming the Resistance to Immune Checkpoint inhibitors via Rational Combination of Immunotherapy

    • Preclinical studies to provide rationale for the combination Immunotherapy
    • Design and develop science-driven clinical studies of combination Immunotherapy
    • Biomarker analysis on the specimens from clinical trials of combination Immunotherapy


    Lei Zheng, MD, PhD

    Associate Professor of Oncology, Johns Hopkins Medicine

  • 9:55 am

  • Networking Break

  • 10:35 am

  • IDO Inhibition Combination Trial Perspectives: Epacadostat + Pembrolizumab for Melanoma

    This talk will consist of two parts. In part one, Incyte will share the clinical data and full analysis on pembrolizumab in combination with epacadostat for Melanoma.  In part two, Dr Jason Luke, University of Chicago, will address the mechanisms of why people thought it should work, why it has not and what can be learned moving forward. There will be 10 minutes at the end of the 2-part talk for Q&A.


    Lance Leopold, MD

    Group VP Clinical Development, Immuno-OncologyIncyte Corporation


    Jason Luke, MD

    Assistant Professor, Medicine, Melanoma and Developmental Therapeutics Clinics, University of Chicago

  • 11:15 am

  • Update on CD40 Cancer Therapeutics

    Most tumors are unresponsive to immune checkpoint blockade, especially if deep immunosuppression in the tumor develops prior to and prevents T cell immunosurveillance. Failed or frustrated T cell priming often needs repair before successful sensitization to PD-1/PD- L1 blockade. CD40 activation plays a critical role in generating T cell immunity, by activating dendritic cells, and converting cold tumors to hot. In preclinical studies, agonistic CD40 antibodies demonstrate T cell-dependent anti-tumor activity, especially in combination with chemotherapy, checkpoint inhibitory antibodies, and other immune modulators. With the advent of multiple CD40 agonists with acceptable single-agent toxicity, clinical evaluation of CD40 combinations has accelerated. This talk will provide an update on CD40 cancer therapeutics.


    Robert Vonderheide, MD, DPhil

    Director, Abramson Cancer Center of the University of Pennsylvania; Hanna Wise Professor in Cancer ResearchUniversity of Pennsylvania Perelman School of Medicine
     

  • Emerging Data Combinations in Clinical Trials Plenary Session

    Chaired by:


    Daniel Chen, MD, PhD

    Chief Medical Officer, IGM Biosciences

  • 11:35 am

  • Novel Approaches to Engineered Cancer Immunotherapy

    In 2018, advances in therapeutic technologies are changing the options available for cancer immunotherapy. From engineered large molecules, to protein modification techniques, from cellular immunotherapy to personalized cancer vaccines, how we approach therapeutics is broader than ever. Objectives for engineered cancer immunotherapy approaches, techniques and emerging clinical data will be presented.


    Daniel Chen, MD, PhD

    Chief Medical Officer, IGM Biosciences

  • 11:55 am

  • Lymphocytes as a Drug for the Treatment of Metastatic Cancer

    In this talk, Dr Steven Rosenberg, Chief, Surgery Branch at the National Cancer Institute, will discuss cancer immunotherapy using the adoptive cell transfer of autologous lymphocytes with antitumor activity with an emphasis on the identification of T-cells that recognize the products of mutations unique to the individual patient’s cancer.


    Steven Rosenberg, MD, PhD

    Chief, Surgery Branch, National Cancer Institute

  • 12:15 pm

  • Panel Discussion: Scalability of T-Cell Therapy

    • What is the scalability of T-cell therapy?
    • How do we scale T-cell therapy and what are the plans for getting the therapy into all the patients who need it?
    • How are we going to scale neo-antigen specific therapy if this is going to be novel to each patient?
    • How do we deal with resistance to T-cell therapies?
    • When should patients get TILs vs when they should get other therapies?
    • Do we need to alter the microenvironment to maximize these therapies?
    • What combination therapy should be given with T-cell therapy?
    • Will T-cell therapy lead to epitope spreading?

    Moderator:


    Patrick Hwu, MD

    Head, Division of Cancer Medicine, Department Chair, Melanoma Medical Oncology Department Chair, Sarcoma Medical Oncology, MD Anderson Cancer Center

    Panelists:


    Rafael Amado, MD

    Chief Medical OfficerAdaptimmune


    Maria Fardis, PhD

    President & CEO, Iovance Biotherapeutics


    Steven Rosenberg, MD, PhD

    Chief, Surgery Branch, National Cancer Institute


    Roger Sidhu, MD

    VP, Clinical Development, Kite, a Gilead Company
  • 1:00 pm

  • Lunch


  • Business Aspects Plenary Session

    Chaired by:


    Paul Stead, PhD, MBA

    VP, Business Development, Adaptimmune

  • 2:00 pm

  • Executive Fireside Chat: Partnership Deals and Combination Strategies

    In this fireside chat, Dr Emmett Schmidt of Merck Research Labs, joins us via phone to share Merck’s journey with collaborations and partnerships, specifically addressing the following:

    • What is Merck’s approach to combinations?
    • How does Merck choose combinations with Keytruda?
    • How does Merck select combinations to move forward with when there are hundreds of requests?
    • What has the journey of Merck’s collaborations been like, including successes and some that might not be so successful and how has that helped in collaboration decision making?
    • How does Merck approach business deals?


    Emmett Schmidt, MD, PhD

    Scientific Associate Vice President; Lead, External Collaborations Project TeamMerck Research Laboratories

    with Moderator:


    Mark Simon, MBA

    Partner and Co-founder, Torreya Partners

  • 2:30 pm

  • Panel: IO Combination Deals and Partnerships

    • What is the nature/landscape of the deals being done in combinations? (IO and non IO)
    • Who is doing them, what are they like, and are there any changes in the nature of the dealmaking that is occurring within IO because of the need for combinations?
    • Are the recent failures changing the nature of the partnering relationships? Is that changing the way people are thinking when it comes to funding at the early stage?
    • What is shaping the evolving nature or actual deal terms from the spectrum of collaboration through licensing to full sharing between biotech and pharma?

    Moderator:


    Jeffrey Bockman, PhD

    EVP, Oncology Practice Head, Defined Health

    Panelists:


    Robert Ang, MD

    Chief Business Officer, Neon Therapeutics


    Paul Stead, PhD, MBA

    VP, Business Development, Adaptimmune


    Robert Stein, MD, PhD

    Senior R&D Advisor, Agenus


    Michael Woo, PharmD

    Director, Search & Evaluation, Business Development & Licensing, Novartis Institutes for BioMedical Research (NIBR)

  • 3:15 pm

  • Afternoon Break

  • 3:30 pm

  • Panel: Investment Strategies Driving IO Combinations

    • What are the types of investments that will enable combinations? (ie: early mechanisms and novel platforms; pharma/biotech partnerships)
    • From an investment perspective, how do you identify what is coming up the pipeline? With all the combination studies out there, how do you get behind the right combination?
    • How do investors make the decision to invest in a seed round, series A of a novel mechanism or platform that is more likely to be useful in combination, or licensing assets?
    • Are we emphasizing too much on the adaptive immune system or should we look at innate immune system?
    • Given all the recent IPOs are we getting a bit too exuberant?

    Moderator:


    Asthika Goonewardene, MBA

    Senior Biotech Analyst, Bloomberg Intelligence

    Panelists:

    Jonathan Fassberg
    Jonathan Fassberg

    Co-CEO, Solebury Trout


    Michael King Jr

    Entrepreneur in Residence, Fortress Biotech


    Mark Simon, MBA

    Partner and Co-founder, Torreya Partners

  • 4:15 pm

  • Panel: Assessing Value & Market Access Implications of Immuno-Oncology Combination Therapies

    • How do we think about the value?
    • How is the IO market access landscape evolving?
    • Where are we now in terms of payer management?
    • What is the impact of reimbursement challenges?
    • What does the future payer initiatives look like?
    • What pricing strategies/reimbursement models are there to help address the issues?
    • What can we demonstrate and communicate value to payers for optimal reimbursement/market access?

    Moderator:


    Michael DeRidder, PhD

    Head, Commercial Strategy, Oncology Cell Therapy, GSK

    Panelists:

    Amanda Bruno
    Amanda Bruno, PhD

    Head, Value Evidence & Outcomes, OncologyGSK


    Lindee Goh, PhD

    Partner, Tapestry Networks


    Roger Longman

    CEO, Real Endpoints


    Ed Saltzman

    President and Founder, Defined Health

  • 5:00 pm

  • End of Conference