Recent advances in cancer immunotherapy have generated excitement across all fields of oncology. However, the field is still experiencing a lack of predictive biomarkers and patient selection remains difficult. Challenges in discovering predictive biomarkers for cancer immunotherapy involve multiple cell types, multiple mechanisms of T-cell regulation, genetic heterogeneity of tumors, immune components, etc. Cambridge Healthtech Institute’s 3rd Annual Immuno-Oncology Biomarkers and Companion Dx conference program is designed to bring together clinical immuno-oncologists, researchers from pharmaceutical companies and laboratory medicine leaders to discuss the underlying mechanisms of cancer immunotherapy, its predictive biomarkers, as well as existing and emerging clinical assays aimed at improving patient outcomes.

Final Agenda

Monday, March 2

10:30 Conference Program Registration Open

ADVANCING PRECISION IMMUNO-ONCOLOGY

11:45 Organizer’s Opening Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute

11:50 Chairperson’s Remarks

Cecilia Schott, PharmD, MBA, Head, Precision Medicine Strategy, Oncology Business Unit, Novartis

11:55 From Exploratory Biomarker to Companion Diagnostics

Luciana Molinero, PhD, Senior Scientist, Oncology Biomarker Development, Genentech

The presentation will present the opportunities and challenges in developing impactful biomarker strategies for early clinical development of new immuno-oncology drugs. We will focus on the design of fit-for-purpose entry into human clinical trials, proof or dis-proof of mechanism of action, and optimal biological dose finding.

12:25 pm NEW: Emerging Trends and Technologies in Companion Diagnostics

George Green, PhD, Executive Director, Head, Pharmacodiagnostics, Bristol-Myers Squibb

Patient selection strategies, technology, and understanding of disease are evolving. For example, tumor mutational burden and gene expression profiling have not yet met early expectations, and combination strategies and monitoring in earlier indications appear promising. Sequencing is becoming standard, and use of plasma may improve its utility. Additionally, technological advancements such as digital imaging, artificial intelligence, and single cell sequencing are approaching practical use. Here, we survey these emerging trends and perspectives in companion diagnostics.

Presentation delivered via a live, interactive video conferencing platform.

12:55 Session Break

1:05 LUNCHEON PRESENTATION I: Circulating Stromal Cells Predict Clinical Response in the Immunotherapy Setting

Daniel L. Adams, Director, Clinical R&D, Creatv MicroTech Inc

Circulating stromal cells (CStC) act as a novel blood-based biomarker for immuno-oncology therapeutics. We will present the findings from a variety of IO clinical trials showing CStC’s ability to provide companion diagnostics and predict treatment response.

1:35 NEW: LUNCHEON PRESENTATION II: IVD Regulatory Landscape: What Challenges to Prepare for Before 2022

Ashleigh Dawley, RAC, Manager, Regulatory Affairs, Medical Device and Diagnostic Research, ICON plc

In vitro diagnostic (IVD) manufacturers are struggling to meet transition deadlines for the new European Union In Vitro Diagnostics Regulation. This regulation aims to ensure the safety and performance of devices. Yet, the increased responsibility on manufacturers to show that products meet the requirements has created challenges across the IVD lifecycle. The industry’s slow progress to meet the May 2022 deadlines will impact market access. Manufacturers will need a strategy to avoid product availability problems.

Presentation delivered via a live, interactive video conferencing platform.

2:05 Session Break

NEW FRONTIERS IN COMPANION DIAGNOSTICS IN ONCOLOGY AND IO

2:20 Chairperson’s Remarks

Ron Mazumder, PhD, MBA, Vice President, Oncology Biomarker Development & Companion Diagnostics, Genentech

2:25 Principals of Cell-Based Cancer Immunotherapy

Nicholas Restifo, MD, Executive Vice President for Research, Lyell Immunopharma, Inc.

Adoptive cell therapy (ACT) is a highly personalized cancer therapy that involves administration to the cancer-bearing host of immune cells with direct anticancer activity. ACT using naturally occurring or genetically engineered tumor-reactive lymphocytes has mediated durable, complete regressions in patients with melanoma and varieties of leukemias and lymphomas, as well as anecdotal but profound responses in patients with common epithelial cancers. The principals of cell-based therapies will be discussed.

2:55 NEW: How Biospecimen Sourcing Can Impact Your R&D

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?

3:10 NEW: Presentation to be Announced 

3:25 NEW: PANEL DISCUSSION: New Frontiers in Companion Diagnostics in Oncology and IO

Topics to be Discussed:

• New Biomarkers and Technologies
• T-Cell Receptor Sequencing
• Neoantigen Approaches
• Biomarkers for T Cell Therapy

Moderator: Ron Mazumder, PhD, MBA, Vice President, Oncology Biomarker Development & Companion Diagnostics, Genentech

Panelists: George Green, PhD, Executive Director, Head, Pharmacodiagnostics, Bristol-Myers Squibb

Nicholas Restifo, MD, Executive Vice President for Research, Lyell Immunopharma, Inc.

Richard Bourgon, PhD, Director, Senior Scientist, Oncology Bioinformatics, Genentech

Mahesh Yadav, PhD, Scientist, Oncology Biomarker Development, Genentech

4:25 Refreshment Break and Transition to Plenary Keynote

PLENARY KEYNOTE SESSION

(please see Keynote pages for details)

4:35 Welcome Remarks

Cindy Crowninshield, RDN, LDN, HHC, Executive Event Director, Cambridge Healthtech Institute

4:45 PLENARY KEYNOTE INTRODUCTION

Thomas Westerling-Bui, PhD, Senior Scientist, Regional Business Development, Aiforia

5:00 PLENARY KEYNOTE PRESENTATION: High-Performance Medicine

Eric Topol, MD, Founder and Director, Scripps Research Translational Institute (SRTI); Author, Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again

6:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

7:30 End of Day

Tuesday, March 3

7:30 am Registration Open and Morning Coffee

TECHNOLOGY, IMPLEMENTATION STRATEGIES AND CASE STUDIES

8:00 Organizer’s Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute

8:05 Chairperson’s Remarks

8:10 NEW: Liquid Biopsies for Precision Medicine in Cancer Treatment   

Walter Koch, PhD, Vice President, Global Research, Roche Molecular Systems

8:40 Biomarkers in the Era of Immuno-Oncology: Update on Keytruda and Combinations

Andrea Webber, PhD, Assistant Head, Clinical Biomarkers in Translational Oncology, Merck & Co., Inc.

This talk will discuss the evolving landscape of biomarkers in the field of immuno-oncology, on immunohistochemistry and genomic approaches, for both immune-checkpoint single-agent treatments and combination therapies.

Presentation delivered via a live, interactive video conferencing platform.

9:10 An Introduction to Chip Cytometry: Bridging the Gap Between Pathology and Flow Cytometry

Spencer Schwarz, Field Application Specialist, Canopy Biosciences

Chip cytometry is a mature and flexible methodology combining the multi-dimensionality and single-cell discrimination of flow cytometry with the spatial and morphology information of pathology. Flow cytometry provides high-dimensional biomarker information resolved at the single-cell level. Yet flow’s destructive sampling omits morphological and spatial relationship information. Conversely, pathology provides spatial and cell morphology information, but prohibits high-dimensionality biomarker interrogation. Chip cytometry intersects these methods, providing a complete and precise picture of proteomic expression.

9:40 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

NEOANTIGEN APPROACHES

10:40 Neo Approaches to Cancer Vaccines

Mahesh Yadav, PhD, Scientist, Oncology Biomarker Development, Genentech

Better clinical response to immunotherapy in cancers with high mutational burden suggests a potent role for tumor-specific neoantigens in driving tumor-specific T cell responses, thus making them an ideal candidate for cancer vaccination. With recent advances in genomic technology it is now possible to identify mutations in an individual patient’s tumor that could be targeted by a vaccine. I will discuss the opportunities and challenges of targeting neoantigens for personalized cancer vaccines in human cancers.

11:10 Computational Characterization of Tumor Neoantigens for Individualized Immunotherapy and Biomarker Applications

Richard Bourgon, PhD, Director, Senior Scientist, Oncology Bioinformatics, Genentech

Multiple lines of evidence implicate “neoantigens” as the targets of anti-cancer T cell responses, with the most tractable examples being somatic, non-synonymous mutations. Some common, recurrent mutations are immunogenic, but most neoantigens arise from passenger mutations which are unique to each patient, making individualized therapeutic approaches an attractive option. In this session, we will examine bioinformatics algorithms for identifying neoantigen candidates with the greatest immunogenic potential.

11:40 Utilizing the Next Generation Single Cell Sorter, DEPArray

Jennifer Davids, Director, Field Scientific Support, Menarini Silicon Biosystems

11:55 Blood- and Urine-based Liquid Biopsy Solutions for Tumor Mutation Burden (TMB) and Minimal Residual Disease (MRD) in Clinical Trials

Shidong Jia, Founder & CEO, Predicine Inc.

This talk will present the development and clinical application of blood- and urine-based liquid biopsy solutions using cell-free tumor-derived DNA (cfDNA) and RNA (cfRNA). Case studies to be discussed include cfDNA-based TMB and MRD profiling, cfRNA-based splicing and fusion profiling, and clinical lab solutions for global clinical trials in the US, EU, APAC including China.

12:10 pm Session Break

12:20  LUNCHEON PRESENTATION: Searching for the Next PD-L1 Caliber Companion Dx Assay? Follow These Steps

Frank Lynch, PhD, Executive Vice President, IHC Services, Discovery Life Sciences (legacy QualTek Molecular Laboratories)

Navigating the path to developing Companion Diagnostics in Immuno-Oncology can be challenging.  This presentation will discuss the approach to developing high quality prototype companion Dx IHC assays and their utility in patient selection and potential pivot to a Companion Dx approach.

1:20 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

2:00 Breakout Discussions in the Exhibit Hall (please click hereXXXXXXXXXXXXX for details)

3:00 Transition to Keynote Session

KEYNOTE SESSION

3:15 Organizer’s Remarks

Christina Lingham, Executive Director, Conferences and Fellow, Cambridge Healthtech Institute

3:20 Keynote Introduction

Allison Mallory, PhD, Director, R&D Molecular Biology, Stilla Technologies

3:35 What Does the New Era of Genomic Medicine Look Like? Effects on Patient Care, Therapeutics, and Diagnostics

20 years after the completion of the first draft of the Human Genome Project, there is compelling evidence of genomics delivering the rich promise of precision medicine. There have been major advances in the throughput and affordability of genome sequencing, enhanced tools for genome analysis and interpretation, new paradigms for therapeutics and strong signs of clinical benefit using genome editing. But major challenges remain. In this special plenary roundtable, three established pioneers of genomic medicine – David Haussler, Stephen Kingsmore, and Liz Worthey – offer their insights on the extraordinary advances in genomic medicine over the past 1-2 decades and share their hopes and concerns for the future of our field.

Moderator: Kevin Davies, PhD, Executive Editor, The CRISPR Journal, Mary Ann Liebert, Inc.

Panelists: Stephen Kingsmore, MD, DSc, President/CEO, Rady Children’s Institute for Genomic Medicine

David Haussler, PhD, Investigator, Howard Hughes Medical Institute; Distinguished Professor, Biomolecular Engineering, University of California, Santa Cruz; Scientific Director, UC Santa Cruz Genomics Institute; Scientific Co-Director, California Institute for Quantitative Biosciences (QB3)

Elizabeth Worthey, PhD, Director, Genomic Medicine, University of Alabama, Birmingham School of Medicine

4:50 Spring Fling Celebration in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

6:00 End of Day

Wednesday, March 4

6:45 am Registration Open

7:00 BREAKFAST PANEL DISCUSSION: The Time is NOW: Creating Meaningful Change for Women in the Workplace (Sponsorship Opportunity Available)

(please see Women in Science page for details)

Moderator: Robin Toft, Author of WE CAN, The Executive Woman’s Guide to Career Advancement; Founder and Chairman, Toft Group Executive Search

Panelists: Camille Samuels, MBA, Partner, Venrock

Paul Hastings, President and CEO, Nkarta Therapeutics, Inc

Teresa L. Wright, MD, Staff Physician, Medicine, San Francisco Veterans Administration

BIOMARKER-DRIVEN clinical STUDIES IN ONCOLOGY AND IO

8:00 Organizer’s Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute

8:05 Chairperson’s Remarks

Thomas O’Brien, PhD, Director, Translational Oncology, Global Product Development, Pfizer Oncology

8:10 Biomarker-Driven Strategies to Combat Resistance to Immuno-Oncology Agents

Thomas O’Brien, PhD, Director, Translational Oncology, Global Product Development, Pfizer Oncology

Next-Generation Sequencing and Liquid Biopsies offer exciting novel opportunities to bring innovative drugs to patients. But these opportunities do not come without challenges and will need to be resolved, particularly when looking at genomic signatures, such as Tumor Mutational Burden.

8:40 Biomarker-Assisted Targeted Therapy – RET and BTK Inhibitors in Personalized Medicine

Narasimha Marella, PhD, Director, Biomarker Operations, Loxo Oncology, Inc.

Genomic alterations in the RET kinase lead to overactive RET signaling and uncontrolled cell growth. LOXO-292 is an oral and selective investigational drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas. The long-term efficacy has been limited by acquired resistance and intolerance. LOXO-305 was designed to reversibly bind BTK and preserve activity in the presence of C481 acquired resistance mutations. Both therapies are currently being studied in global Phase I/II clinical trials.

9:10 Biomarkers Predicting Response to Neoadjuvant Immunotherapy in the Early-Stage Breast Cancer Setting: Lessons from the I-SPY 2 TRIAL

Denise Wolf, PhD, Senior Bioinformatics Scientist, Department of Laboratory Medicine, University of California, San Francisco

I-SPY 2, a phase 2 adaptive neoadjuvant trial in high-risk breast cancer, evaluates novel agents added to standard chemotherapy. In addition to efficiently evaluating agent/subtype pairs, I-SPY 2 is biomarker-rich: samples are profiled for mRNA; protein; mutations; and immune cell subpopulations using multiplex immunofluorescence (mIF). Here we present immune-related expression signatures, proteins, and mIF as predictors of response to pembrolizumab, which graduated for efficacy in TN and HR+HER2- patients.

9:40 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

CIRCULATING BIOMARKERS IN IMMUNO-ONCOLOGY

10:40 The Wide World of Liquid Biopsy-Based Biomarker for Cancer Immunotherapy

Sam Hanash, MD, PhD, Director, McCombs Institute for Cancer Detection and Treatment, University of Texas MD Anderson Cancer Center

Multiple circulating biomarkers that have the potential to serve as predictive prognostic biomarkers to guide cancer immunotherapy are currently being pursued. These include tumor-derived microvesicles, soluble immune proteins, and metabolites. The current opportunities and challenges will be presented.

11:15 NEW: Blood-Based Biomarkers in Immuno-Oncology

Jonathan Baden, MS, Director, Pharmacodiagnostics, Bristol-Myers Squibb

Blood is accessible with minimally invasive and cost-effective methods, so it has always been considered an attractive source of biomarkers. With rapid technological advancements circulating tumor DNA (ctDNA), in particular, has become an invaluable diagnostic material with multiple potential applications across the disease continuum. Here, we review the recent findings on ctDNA to aid in patient selection and disease monitoring from an immuno-oncology perspective, and we discuss potential future directions.

Presentation delivered via a live, interactive video conferencing platform.

11:50 NEW: Characterizing the Bone Marrow Immune Contexture of Acute Myeloid Leukemia Using MultiOmyx^TM

Qingyan (Sandy) Au, PhD, Principal Scientist, Pharma Services, NeoGenomics Laboratories, Inc.

Bone marrow (BM) constitutes the home niche for leukemia cells in AML. Emerging data indicates BM’s crucial role in cancer development. MultiOmyx IF assay was used to characterize the BM immune contexture of AML. Direct assessment of immune phenotypes by MultiOmyx enables understanding of the immune landscape in AML.

12:15 pm NEW: Combining Cell Harvesting and Imaging Technologies for CTC Liquid Biopsy Sample-to-answer Analysis

Anne-Sophie Pailhes-Jimenez, R&D Group Leader, Cell Biology, Imaging, ANGLE Ltd

Alan Schwebel, President, CEO, BioView Ltd 

Circulating Tumor Cells provide access to protein and genetic information on patient cancer through a simple blood draw. Here we share the combination of ANGLE’s Parsortix® system for CTC harvesting with BioView’s automated CTC cell imaging and analysis scanner to deliver robust workflow to support the drive towards precision medicine.

12:40 Session Break

12:50 PRECISION HEALTH LUNCHEON PRESENTATION: Validation of A Next Generation Sequencing Gene Panel for Detection of Variants in Plasma Total Nucleic Acid

Xin-Xing Tan, PhD, Principal Scientist, Molecular, NeoGenomics Laboratories, Inc.

Liquid biopsy next generation sequencing (NGS) gene panel assays provide a powerful non-invasive tool to detect tumor-derived variants for clinic diagnostics in a massively parallel manner. We present here a NGS assay designed specifically for liquid biopsy clinical applications, and its analytical and clinical validation to assess accuracy, specificity, sensitivity, repeatability, and reproducibility, etc.

1:20 Refreshment Break in the Exhibit Hall with Last Chance Poster Viewing, Speed Networking, Book Signing, and Meetup Group

FEATURED SESSION: DATA STRATEGIES FOR GENOMICS

2:00 Chairperson’s Remarks

Geraldine A. Van der Auwera, PhD, Director of Outreach and Communications, Data Sciences Platform, Broad Institute

2:05 NEW: Fake It ‘til You Make It (Reproducible): Synthetic Data Resources for Genomics

Geraldine A. Van der Auwera, PhD, Director of Outreach and Communications, Data Sciences Platform, Broad Institute

The computational reproducibility of published biomedical research is limited by data access restrictions, affecting not just researchers who wish to reuse published analysis code, but also tool developers and educators who lack suitable example data for testing and training. We present: 1) a prototype pipeline that wraps established open-source data simulation tools to generate publicly shareable synthetic sequence data at any scale; and 2) a plan to develop community resources.

2:35 Drug Targets with Genomic Support: A Genomics-based Strategic Framework for Improving Target Discovery and Accelerating Drug Development

Justin Wade Davis, PhD, ACOS Research Fellow, Director, Computational Genomics, Genomics Research Center (GRC), AbbVie

Despite strong vetting for disease activity, only 10% of candidate new molecular entities in Ph1 clinical trials are approved. Analyzing historical data, Nelson et al. 2015 concluded pipeline drug targets with human genetic evidence of disease association are twice as likely to lead to approved drugs. We extend this using updated data, test prospectively whether genetic evidence predicts future successes, and introduce statistical models adjusting for target and indication-level properties.

3:05 Close of Conference