Cambridge Healthtech Institute’s 5th Annual

Immuno-Oncology Biomarkers

Patient Selection, Companion Diagnostics, and Immune Profiling

June 2-4, 2020


As pharmaceutical and biotechnology companies increase their investment in immuno-oncology programs to facilitate rapid development of novel immunotherapies, there is increasing pressure to discover and validate relevant biomarkers. Cambridge Healthtech Institute’s 5th annual Immuno-Oncology Biomarkers meeting will bring together biomarker experts from industry and academia to address rapid development of predictive and prognostic IO biomarkers, utility of these biomarkers in clinical trials, and their potential as companion diagnostics.

Final Agenda

Recommended Short Course*

SC3: Fit-for-Purpose Biomarker Assay Development – Performance Characterization and Validation to “Context of Use” - Detailed Agenda

*Separate registration required.

Tuesday, June 2

PATIENT SELECTION

Integration of precision medicine into clinical trials will provide better patient selection to maximize benefit to the trial participant and provide valuable information for the study sponsor. These sessions will cover novel trial designs, biomarker development strategies, and predicting response and resistance to treatment.


10:00 am Main Conference Registration Open

PRECISION MEDICINE IN ONCOLOGY

11:15 Chairperson’s Remarks

Tracy Lively, PhD, Chief, Diagnostics Evaluation Branch; Deputy Associate Director, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute

11:25 Precision Medicine Initiatives at the NCI

Lively_TracyTracy Lively, PhD, Chief, Diagnostics Evaluation Branch; Deputy Associate Director, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute

The development of predictive markers to guide the use of emerging therapeutic agents requires new approaches to both clinical trials and correlative laboratory science. This talk will present NCI’s experience with novel trial designs, including lessons learned from NCI MATCH, and additional approaches to more effective integration of biomarker development into cancer therapy trials.

11:55 Oncology Biomarker Development Strategies in Precision Therapies

Li_YanYan Li, PhD, Director, Oncology Biomarkers, Bayer U.S.

This presentation will discuss combining tissue and liquid biopsy to follow the patient’s tumor evolution and adding RNA gene expression profiling to DNA to expand clinical options for patients.

12:25 pm How to Catch Them All: Genomic Panels Big and Small

Morrissette_JenniferJennifer Morrissette, PhD, Director, Clinical CytoGenomics Laboratory, Associate Professor, Pathology, University of Pennsylvania

High volume clinical laboratories need to accommodate a variety of specimen types, qualities and quantities. This typically cannot be accomplished using a single method; we have validated a large hybrid-capture based panel and a small amplicon-based companion panel for low-input and/or low-quality DNA. This talk will discuss the decision making process for panel design, both inter- and intra-laboratory. The large panel includes content shared across multiple institutions which have decided to utilize similar methodologies allowing for cross-validation.

12:55 Transition to Lunch

1:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:30 Session Break

PREDICTIVE BIOMARKERS OF RESPONSE AND RESISTANCE

2:00 Chairperson’s Remarks

Hua Eleanor Yu, PhD, Billy and Audrey Wilder Endowed Professor; Co-Leader, Cancer Immunotherapeutics Program, City of Hope Comprehensive Cancer Center

2:05 PD-L1 Immunohistochemistry (IHC) as a Predictive Marker for the PD-1/PD-L1 Axis Blockade

Mino-Kenudson_MariMari Mino-Kenudson, MD, Professor, Pathology, Harvard Medical School

PD-L1 IHC is a globally accepted predictive biomarker for the PD-1/PD-L1 axis blockade and is now deployed in the most pathology laboratories. Although its appropriate implementation and interpretation are critical, it can be challenging due to the multiple antibody clones/platforms available and given the typically small samples provided. Thus, I will discuss important considerations on pre-analytical, analytical, and post-analytical aspects of PD-L1 IHC for lung cancer and other solid tumors.

2:35 Fatty Acid Oxidation Is a Biomarker for Breast Cancer Chemo-Resistance and CD8 T Cell Suppression

Yu_HuaHua Eleanor Yu, PhD, Billy and Audrey Wilder Endowed Professor; Co-Leader, Cancer Immunotherapeutics Program, City of Hope Comprehensive Cancer Center

We recently demonstrated a critical role of STAT3 in regulating lipid metabolism/fatty acid β-oxidation (FAO) to promote breast CSCs and cancer chemo-resistance. We further show that FAO in tumor CD8+ T effector cells is important for obesity-associated breast tumor progression. Moreover, PD-1 ligation in CD8+ T cells activates STAT3 to increase FAO, inhibiting CD8+ T effector cell functions. Therefore, FAO is a biomarker for breast cancer chemo-resistance and immunosuppression.

3:05 How to “Read” Immune Responses with Exosomes and Other EVs

Jones_JenniferJennifer Jones, MD, PhD, Investigator, Laboratory of Pathology; Head, Translational Nanobiology Section, Center for Cancer Research, NCI, NIH

Extracellular vesicles (EVs) are an area of substantial interest in the area of liquid biopsies. However, EV analyses are a frontier with few well-established roadmaps or guides. The pitfalls and potentials of EV studies will be discussed, and a framework for safely proceeding in this area will be presented.

3:35 Sponsored Presentation (Opportunity Available)

3:50 Sponsored Presentation (Opportunity Available)

4:05 Networking Refreshment Break and Transition to Keynote


PLENARY KEYNOTE SESSION

4:25 - 6:05 Driving Entrepreneurial Innovation to Accelerate Therapeutic Discoveries

The life sciences community has an unprecedented scientific arsenal to discovery, develop and implement treatments, cures and preventions that enhance human healthcare.

Moderator: Nadeem Sarwar, President, Eisai Center for Genetics Guided Dementia Discovery (G2D2), Eisai Inc.

Panelists: Anthony Philippakis, Chief Data Officer, Broad Institute; Venture Partner, GV

Barbara Sosnowski, Vice President and Global Head, Emerging Science & Innovation Leads, WWRDM, Pfizer

John Hallinan, Chief Business Officer, Massachusetts Biotechnology Council

6:05 Welcome Reception in the Exhibit Hall with Poster Viewing

7:10 Close of Day

Wednesday, June 3

IMMUNE PROFILING

Immune profiling promises to identify biomarkers that predict response to immunotherapy and to help monitor its progress. Understanding the tumor microenvironment and mechanisms of tumor immune evasion are the goal of this session.


7:30 am Registration Open and Morning Coffee

INTEGRATED IMMUNE PROFILING AND TUMOR MICROENVIRONMENT

8:10 Chairperson’s Remarks

Samir Hanash, MD, PhD, Director, McCombs Institute for Cancer Early Detection and Treatment, MD Anderson Cancer Center

8:15 Integrative Analyses of Environment, Microbiome, Immunity, and Tumor for Precision Oncology

Ogino_ShujiShuji Ogino, MD, PhD, MS, Professor of Pathology, Brigham & Women’s Hospital, Harvard Medical School; Professor, Epidemiology, Harvard T.H. Chan School of Public Health; Chief of Molecular Pathological Epidemiology (MPE) Program, Brigham & Women’s Hospital; Associate Member, Broad Institute of MIT and Harvard

The integrative field of immunology-MPE (molecular pathological epidemiology) is an emerging paradigm and can investigate influences of the exposome on tumor-immune interactions, thereby informing immunotherapy research. Using over 1500 colorectal cancer cases with rich data on immune response, whole exome sequencing, RNA-sequencing, tumor neoantigens, and clinical outcomes, proof-of-principle immunology-MPE studies have shown great promise for precision prevention and immuno-oncology.

8:45 The Tumor Immune Microenvironment of Pre-Malignant Lesion in the Pancreas

Thompson_ElizabethElizabeth Thompson, MD, PhD, Assistant Professor, Pathology and Oncology, The Johns Hopkins Hospital

While much work has focused on the tumor immune microenvironment of established cancers, little is known about the immune response to the earliest stages of tumor development. This talk will explore the immune microenvironment of neoplastic precursor lesions in the pancreas, focusing on pancreatic intraepithelial neoplasia and intraductal papillary mucinous neoplasms (IPMN) with emphasis on features predicting grade of dysplastic change and recurrence/progression to malignancies.

9:15 Immune Profiling in an Evolving Immune Oncology Landscape

Darrell Borger, PhD, Associate Director, Translational Sciences, Head, Integrated Translational Technologies, Oncology Drug Development Unit, Takeda Pharmaceuticals

9:45 How Biospecimen Sourcing Can Impact Your R&D Results

Vanessa Tumilasci, PhD, Commercial Director, Trans-Hit Bio

Biospecimen sourcing is becoming a challenge for many scientists who need to respect timelines for R&D plans as well as regulatory and ethical constraints. Are the scientists working with the samples aware of all the imperatives to obtain them; quality, respect of laws, ethics and regulations?

10:00 Sponsored Presentation (Opportunity Available)

10:15 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Molecular Signatures of Tumor Immune Evasion

Hanash_SamirSamir Hanash, MD, PhD, Director, McCombs Institute for Cancer Early Detection and Treatment, MD Anderson Cancer Center

A wide world of mechanisms leading to tumor immune evasion have emerged. Assessment of these mechanisms has relevance to immunotherapy applications.

11:30 Multiplex Immunofluorescence Tyramide Signal Amplification and Multispectral Imaging Assay to Support Translational Oncology Studies

Parra_EdwinEdwin Roger Parra Cuentas, MD, PhD, Assistant Professor, Translational Molecular Pathology; Director of the Multiplex Immunofluorescence and Image Analysis Laboratory, MD Anderson Cancer Center

Multiplex immunofluorescence (mIF) has emerged in the last years as a very powerful tool to study tumor tissues. This revolutionary technology provides important visual techniques for tumor examination in formalin-fixed paraffin-embedded specimens to improve the understanding of the tumor microenvironment, promote new treatment discoveries, aid in cancer prevention, as well as allowing translational studies to be carried out.

12:00 pm Sponsored Presentation (Opportunity Available)

12:30 Transition to Lunch

12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:05 Session Break


PLENARY KEYNOTE SESSION

1:45 - 3:15

Lgr5 Stem Cell-Based Organoids in Human Disease

Clevers_HansHans Clevers, MD, PhD, Principal Investigator of Hubrecht Institute and Princess Máxima Center, CSO of HUB Organoids Technology

Organoid technology opens a range of applications in fields such as physiology, study of disease, drug development and personalized medicine. Human organoids represent excellent disease models, be it infectious, hereditary or malignant  Eventually, cultured mini-organs may be used to replace transplant organs from donors. I will describe how we originally created ‘mini-guts’ via 3D culture systems of stem cells of the small intestine and colon, and then expanded the technology to virtually all human organs.

Systematically Drugging Ras

Fesik_StephenStephen Fesik, PhD, Professor of Biochemistry, Pharmacology, and

Chemistry, Orrin H. Ingram II Chair in Cancer Research, Vanderbilt

University School of Medicine

K-Ras is a small GTPase that is mutated in pancreatic (90%), colon (50%), and lung (30%) carcinomas. Downregulation of activated Ras reverses the transformed phenotype of cells and results in the dramatic regression of tumors in murine xenograft models. Thus, K-Ras inhibition represents an attractive therapeutic strategy for many cancers. In this presentation, I will discuss our efforts to directly target Ras at two sites and target SOS, a molecular partner of Ras, with activators and inhibitors. 

3:15 Refreshment Break in the Exhibit Hall with Poster Viewing

BIOMARKERS FOR ONCOLOGY CLINICAL TRIALS

4:00 Chairperson’s Remarks

Samir Hanash, MD, PhD, Director, McCombs Institute for Cancer Early Detection and Treatment, MD Anderson Cancer Center

4:05 Presentation to be Announced

4:35 Overview of Genomic Biomarkers in Clinical Trials

Chetan Deshpande, Clinical Biomarker Assay Lead, Pfizer

Genomics biomarkers have been implemented routinely in clinical trials, especially in oncology, for exploratory endpoints. Over the last few years, molecular testing by NGS has been applied not only to understand the molecular mechanism of the underlying disease but also to gain insights into resistance mechanism. This presentation will review the current trends in implementing genomic biomarkers in oncology clinical trials.

5:05 Find Your Table, Meet Your Moderator

5:10 Roundtable Breakout Discussions - View Details

TABLE: Tumor Immune Microenvironment

Moderator: Elizabeth Thompson, MD, PhD, Assistant Professor, Pathology and Oncology, The Johns Hopkins Hospital

TABLE: Theranostics in Immuno-Oncology

Moderator: Michael Roehrl, MD, PhD, Director, Precision Pathology Center, Memorial Sloan Kettering Cancer Center; Associate Professor, Pathology and Laboratory Medicine, Weill Cornell Medicine

5:45 Reception in the Exhibit Hall with Poster Viewing

6:45 Close of Day

Thursday, June 4

COMPANION DIAGNOSTICS

The companion diagnostics session will cover biomarker discovery and assay development, patient selection strategies, and identifying biomarkers to monitor patients during treatment.


8:00 am Registration Open and Morning Coffee


PLENARY KEYNOTE SESSION

8:30 - 9:40 Applications of Artificial Intelligence in Drug Discovery – Separating Hype from Utility

Walters_PatrickPatrick Walters, PhD, Senior Vice President, Computation, Relay Therapeutics

Over the last few years, there has been tremendous interest in the application of artificial intelligence and machine learning in drug discovery. Ultimately, the success of any predictive model comes down to three factors: data, representation, and algorithms. This presentation will provide an overview of these factors and how they are critical to the successful implementation and deployment of AI methods.

9:40 Coffee Break in the Exhibit Hall with Poster Viewing

IO BIOMARKERS FOR PATIENT SELECTION AND CLINICAL TRIALS

10:25 Chairperson’s Remarks

Michael Roehrl, MD, PhD, Director, Precision Pathology Center, Memorial Sloan Kettering Cancer Center; Associate Professor, Pathology and Laboratory Medicine, Weill Cornell Medicine

10:30 Deep Proteome-Based Theranostics in Immuno-Oncology

Roehrl_MichaelMichael Roehrl, MD, PhD, Director, Precision Pathology Center, Memorial Sloan Kettering Cancer Center; Associate Professor, Pathology and Laboratory Medicine, Weill Cornell Medicine

Steering the patient’s own immune system to fight cancer is a promising direction. However, identifying which patients benefit from such therapies and distinguishing which tumors may be more or less susceptible to immunological attack remain great challenges. We describe deep proteomic approaches to identify novel biomarkers that risk-stratify patients and that could be used to monitor patients before, during, and after IO therapy.

11:00 Patient Selection Strategies during Early Clinical Development – The Use of Big Data to Select Patient Populations

Brockstedt_DirkDirk Brockstedt, PhD, CSO, RAPT Therapeutics


11:30 Biomarkers for Cancer Immunotherapy and Cellular Therapy Selection and Treatment Monitoring

Weiss_GlenGlen Weiss, MD, MBA, Senior Medical Director, Unum Therapeutics

While several monoclonal antibody immunotherapies and cellular therapies are clinically available to treat advanced cancers, only a minority of patients treated with these agents experience impressive durable responses. How are these therapies selected and how is efficacy monitored? This presentation will highlight current data on biomarkers being used and evaluated for treatment selection and monitoring.

12:00 pm Sponsored Presentation (Opportunity Available)

12:30 Transition to Lunch

12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:05 Dessert and Coffee Break in the Exhibit Hall with Poster Viewing

BIOMARKER DISCOVERY AND ASSAY DEVELOPMENT FOR ONCOLOGY AND IMMUNO-ONCOLOGY

2:00 Chairperson’s Remarks

Michael Roehrl, MD, PhD, Director, Precision Pathology Center, Memorial Sloan Kettering Cancer Center; Associate Professor, Pathology and Laboratory Medicine, Weill Cornell Medicine

2:05 Maximizing the Return on Clinical Samples: Considerations for IO Discovery Biomarker Analysis

Donahue_AmberAmber Donahue, PhD, Senior Manager, Biomarker Clinical Assay Lead, Oncology Clinical Assay Group, Pfizer

Clinical samples are precious and generally limited. There are ways to stretch specimens further, such as aliquoting, or provision of extracted nucleic acid or even data rather than FFPE sections to analyzing laboratories. However, there are considerations necessary to this approach, including careful specimen tracking, freeze/thaw stability, fit-for-purpose cross-validation, and assay limitations.

2:35 Molecular Cytometry: Application to Immuno-Oncology and Possibilities for Precision Oncology

Chattopadhyay_PratipPratip Chattopadhyay, PhD, Associate Professor, Pathology, Isaac and Laura Perlmutter Cancer Center, NYU-Langone Medical Center


3:05 PANEL DISCUSSION: Integrated Biomarker Approaches

Coverage includes:

  • Integrating genomics, genetics, proteomics, post-translational modifications, molecular histology and other data for biomarker discovery
  • Informatics tools and data requirements for biomarker identification
  • Translational approaches for biomarker discovery, qualification and clinical development
  • High-throughput biomarker analysis and data generation
  • Integrated biomarker approaches for disease progression monitoring and predicting response to therapy

Call_KatherineModerator: Katherine Call, PhD, Senior Director, Head, Proteogenomics, Sanofi Translational Sciences


Panelists:

Baratta_MikeMichael Baratta, BA/MCAHPM, Scientific Director and Chief of Staff, Clinical Biomarker Development Innovation, Takeda


Chattopadhyay_PratipPratip Chattopadhyay, PhD, Associate Professor, Pathology, Isaac and Laura Perlmutter Cancer Center, NYU-Langone Medical Center


Amber Donahue, PhD, Biomarker Clinical Assay Lead, Oncology Clinical Assay Group, Pfizer

 

Emily Thrash, PhD, Scientist, Center for Immuno-Oncology, Immune Assessment Laboratory, Dana-Farber Cancer Institute

 

3:35 Close of Conference