Cambridge Healthtech’s 3rd Annual
Emerging Technologies and Biomarkers for Cancer Immunotherapy
Next Generation of Immuno-Oncology Biomarkers
August 20-21, 2019
Novel biomarkers are needed to guide cancer immunotherapy and combinations in clinical trials and patient care settings. Discovery and development of predictive biomarkers in immune-oncology have proven to be difficult because of the complexity of the
immune response and tumor biology. Combination therapy approaches add another level of complexity and require multiple and multiplexed biomarkers to predict patient’s response. Cambridge Healthtech Institute’s Third Annual Emerging Technologies
and Biomarkers for Cancer Immunotherapy is designed to feature cutting edge technologies and their applications for new immune-oncology biomarkers discovery and validation.
Final Agenda
Recommended Short Courses*
Franklin/McPherson
SC3: Emerging Applications of ctDNA
John Simmons, PhD, Vice President, Translational Medicine, Personal Genome Diagnostics
This short course will cover cutting edge applications and clinical trials that use ctDNA for monitoring, minimal residual disease, and plasma tumor mutation burden. The background basics, the technologies, the clinical evidence out there so far, and
the highlights of the prospective designs that are underway will be discussed.
SC5: Tumor Mutation Burden: Unloading the Latest Challenges and Developments
Susan J. Hsiao, MD, PhD, Assistant Professor, Pathology and Cell Biology, Columbia University Medical Center
Larissa V. Furtado, MD, Medical Director, Molecular Oncology, ARUP Laboratories; Associate Professor of Pathology, University of Utah School of Medicine
Ahmet Zehir, PhD, Director, Clinical Bioinformatics, Memorial Sloan Kettering Cancer Center
In this short course, we will review the current state of the field for tumor mutational burden (TMB), a biomarker predictive of response to immunotherapy agents. This course will cover concepts including the clinical utility of measuring TMB, technical
considerations and challenges in validating and measuring TMB in a clinical laboratory, issues surrounding clinical TMB interpretation, and future directions and applications of TMB testing.
*Separate registration required.
TUESDAY, AUGUST 20
7:30 am Registration and Morning Coffee
8:30 Chairperson’s Opening Remarks
Omar Laterza, PhD, DABCC, Executive Director, Molecular Biomarkers and Diagnostics, Merck & Co., Inc.
8:40 Biomarkers in Early Clinical Development of Immuno-Oncology Drugs
Omar Laterza, PhD, DABCC, Executive Director, Molecular Biomarkers and Diagnostics, Merck & Co., Inc.
Biomarkers play a critical role in the early clinical development of novel Immuno-Oncology compounds, including in the assessment of target engagement, pharmacodynamic response, verification of the hypothesized mechanism of action, identification of safety
signals and getting an early read into potential predictive biomarkers. This information is important in decision making in dose selection, prioritization of assets, acceleration of programs and go/no-go decisions. In this session, case studies of
how biomarkers are used in decision making for early Immuno-Oncology programs will be presented, including considerations for the analytical validation of biomarker assays.
9:10 Highly Multiplex Quantification of Immunomodulatory Proteins in Blood and the Tumor Microenvironment
Amanda
Paulovich, MD, PhD, Full Member & Aven Foundation Endowed Chair, Clinical Research Division, Fred Hutchinson Cancer Research Center; Professor, Division of Oncology, Department of Medicine at the University of Washington School of Medicine
Novel assays are being developed to quantify ~100 immunomodulatory proteins. Assay targets were selected by key stakeholders in the immuno-oncology space. All assays will be based on monoclonal antibodies incorporated into the NextGen immuno-multiple
reaction monitoring platform. This next generation protein quantification platform is a highly attractive complement to current immunoassay platforms given its high specificity, quantitative precision, and ability to quantify large panels of proteins
in a multiplex manner.
9:40 CO-PRESENTATION: Single-Cell Imaging Technologies and Transcriptomic Approaches to Guide the Development of Tumor Immunotherapies
Andrea
Pomerantz, Investigator III, Microscopy and Biophotonics (MiBs), Analytical Sciences and Imaging, Novartis Institutes for Biomedical Research, Inc.
Tingyu Liu, PhD, Postdoctoral
Scholar, Exploratory Immuno-Oncology, Novartis Institutes for BioMedical Research, Inc.
In support of the development of new immunomodulatory therapies at NIBR, we are implementing multiple single-cell analyses including microfluidic and confocal imaging assays for interrogating single immune cell / target cell interaction dynamics.
To better understand the heterogeneity and functional alterations of tumor infiltrating lymphocytes, we are also performing single-cell RNA sequencing on lymphocytes extracted from primary human tumors. Collectively, these single-cell approaches
provide powerful tools to investigate tumor infiltrating lymphocyte heterogeneity while helping to identify novel targets to improve tumor immunotherapy.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:55 NEW: Chairperson’s Remarks
Scott Ely, MD, MPH, Director, Pathology, Bristol-Myers Squibb
11:00 NEW: Tumor-Intrinsic Mechanisms of Resistance to Immunotherapy
Scott Ely, MD, MPH, Director, Pathology, Bristol-Myers Squibb
Mechanisms of resistance to immunotherapy may derive from factors in the tumor microenvironment or from the tumor cells themselves. Genetic mutations and copy number variants observed in the IFN-γ signaling pathway may affect antigen presentation
and T-cell infiltration. STK11 loss of function is associated with cold tumors that show diminished PD-L1 expression. This presentation will focus on the key role that genetic variants in tumor cells play in thwarting the anti-tumor immune response.
11:30 Immune Heterogeneity in Pancreatic Cancer: Implications for Effective Immune Therapy
Shannon
Liudahl, PhD, Postdoctoral Researcher, Cell, Developmental & Cancer Biology, Oregon Health & Science University
Multiplex immunohistochemistry (mIHC) enables unprecedented depth of in situ immune profiling of human tumors and is a promising tool for biomarker discovery. We have used mIHC to evaluate immune heterogeneity
of 120 pancreatic ductal adenocarcinoma (PDAC) surgical specimens and revealed associations between tumor immune subtype, mutational status and patient outcomes. Tumor immune signatures determined from these data have potential to inform patient
stratification and predict therapeutic response in immunotherapy trials in PDAC.
12:00 pm Reshaping Oncology Drug Development Landscape with ctDNA + ctRNA Liquid Biopsy Solutions
Shidong Jia, MD, PhD, CEO, Predicine
This talk will discuss the clinical applications of Predicine’s blood- and urine-based ctDNA+ctRNA liquid biopsy assays which detect a full range of genomic alterations including DNA copy number loss, RNA splicing, and RNA fusion.
Case studies of how a harmonized assay is utilized to accelerate global trials will be presented.
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:00 Cookie & Refreshment Break in the Exhibit Hall with Poster Viewing
1:30 Chairperson’s Remarks
Jaime Rodriguez-Canales, MD, FEBP, Senior Pathologist, Translational Pathology Laboratory, MedImmune
1:35 Highly Consistent Multiplex Immunofluorescence Automated Method for Clinical Trials
Jaime Rodriguez-Canales, MD, FEBP, Senior Pathologist, Translational Pathology Laboratory, MedImmune
1:50 Creating High-Quality Datasets for Biomarker Discovery Using Multiplex IF/IHC
Janis Taube, MD, MSc, Director, Division of Dermatopathology, Associate Professor of Dermatology, Johns Hopkins Medicine
We have developed a microscopic imaging pipeline, based upon an astronomy prototype, that allows us to generate high-quality maps of the tumor microenvironment. These maps will provide critical insights into mechanisms of cell-extrinsic immune
modulation (how cell A modulates the function of cell B via proximity or direct cell-cell contact, thus informing how cancer evades the immune system during development) and identify rational combinatorial therapeutic strategies and potential
new therapeutic targets.
2:15 Validation of Melanoma Immune Profile (MIP), a Prognostic Immune Gene Prediction Score for Stage II-III Melanoma
Yvonne
Saenger, MD, Department of Medicine, Division of Hematology/Oncology, Director, Melanoma Immunotherapy, Columbia University Irving Medical Center
Biomarkers are needed to stratify patients with stage II-III melanoma for clinical trials of adjuvant therapy because, while immunotherapy is protective, it also confers the risk of severe toxicity. We previously defined and validated a 53-immune
gene melanomaimmune profile (MIP) predictive both of distant metastatic recurrence and of disease-specific survival (DSS). Here, we test MIP on a third independent population.
2:40 Translational Advances of Multiplexed Immunofluorescence Methods
Clifford Hoyt, Vice
President, Translational and Scientific Affairs, Akoya Biosciences, Inc.
I will discuss advances in multiplexed immunofluorescence (mIF) analysis of FFPE tissue sections, including imaging capabilities, reagents for automation, panel design for accurate image analysis, and image storage infrastructure for sharing and
analysis of whole slide imagery. I will also discuss a multi-institutional demonstration of analytical performance and a meta-analysis of published studies suggesting expression and spatial information together correlate better with
response to immunotherapy than other biomarker approaches.
3:05 NeoGenomics Knowledgebase Provides Pathways for Patient Management
Forrest J. Holmes Blocker, PhD, Director, Scientific Affairs, NeoGenomics
NeoGenomics connects unique, patient-specific identifiers such as tumor type, DNA mutation, and molecular pathway, with targeted therapy. Which will continue to evolve and improve to incorporate new algorithms and decisions metrics to aid in specialized
research, improved diagnosis, as well as offering a more personalized approach to treatment of cancers.
3:35 Refreshment Break in the Exhibit Hall with Poster Viewing
4:25 Chairperson’s Remarks
Joseph Melenhorst, PhD, Adjunct Associate Professor, Pathology & Laboratory Medicine, University of Pennsylvania
4:30 The CAR T Cell Revolution
Joseph Melenhorst, PhD, Adjunct Associate Professor, Pathology & Laboratory Medicine, University of Pennsylvania
It has been almost a decade since we started treating leukemia patients with chimeric antigen receptor (CAR)-engineered T cells. General principles of efficacy and toxicities are starting to take shape. These principles have altered the way we
design trails, but also engineer CAR T cells. During my talk I will provide examples of such findings and novel, yet unpublished findings shaping this rapidly evolving field.
5:00 TCR Biomarkers in Cancer Immunotherapy Development
Elizabeth Maloney, Senior Research Associate, NGS & Molecular Biology, Gritstone Oncology
Gritstone Oncology is a cancer immunotherapy company working to help patients with the most difficult-to-treat tumors. Gritstone’s process leverages our EDGE AI platform to predict neoantigens that will be presented on a patient’s
tumor, creating a patient-specific immunotherapy that is designed to elicit a potent anti-tumor T cell response. Our team has developed a novel protocol for identifying these neoantigen-specific T cells to enable translational studies and
characterize immunotherapy response.
Independence H-I
5:30 NEW: Digital Counting of Target cfRNA and cfDNA with NanoString nCounter® Technology
Adam Abdool, Senior Product Manager, Life Sciences, NanoString
Liquid (versus tissue) biopsy offers advantages for early disease diagnosis, progression monitoring and evaluation of therapeutic interventions because sample collection is rapid, easy, minimally invasive, and repeatable. However,
detection has been difficult due to low abundance of target molecules, leading to complex workflows with highly variable signal detection. We’ll demonstrate utilizing nCounter technology for liquid biopsy applications (Research
Use Only), including mutation detection of ctDNA & RNA profiling, and fusion detection of cfRNA.
6:00 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing
7:00 Close of Day
WEDNESDAY, AUGUST 21
7:15 am Registration
Independence B-E and Foyer
7:30 Problem Solving Breakout Discussions with Continental Breakfast
Non-Genomic Biomarkers in Immuno-Oncology
Moderator: Ana I. Robles, PhD, Program Director, Office of Cancer Clinical Proteomics Research, Center for Strategic Scientific Initiatives, National Cancer Institute, National Institutes of Health
- What are the performance characteristics of currently available genomic and non-genomic biomarkers for Immuno-Oncology?
- What are the clinical needs that have not been (properly) addressed by existing biomarkers?
- Which non-genomic biomarkers are at early stages of development and how do we best prioritize and move them forward?
Novel Genomic Biomarkers in Oncology
Moderator: Matthew Marton, PhD, Director, Companion Diagnostics and Genomics, Merck & Co., Inc.
- What can Dx companies do to decrease the cost and increase the rate of NGS tumor testing?
- Will plasma-based cancer Dx testing supplant tumor-based Dx testing in oncology?
- What will be the dominant setting for future plasma-based Dx testing? Cancer detection or metastatic treatment decision-making?
- How broadly applicable will the tumor-agnostic Dx approach be?
- How do you think FDA is handling the regulation of novel genomic biomarker tests? What should they do differently?
NEW: Multiplexed IHC Advances in Immuno-Oncology
Moderator: Michael Surace, PhD, Scientist II, AstraZeneca
- Validation of Multiplex IHC methods for clinical specimens
- The role of multiplex IHC for biomarkers discovery and validation
- Potential application of Multiplex IHC in the clinical laboratory and for patient selection in clinical trials
8:25 Chairperson’s Remarks
Ana I. Robles, PhD, Program Director, Office of Cancer Clinical Proteomics Research, Center for Strategic Scientific Initiatives, National Cancer Institute, National Institutes of Health
8:30 Precision Medicine Targeting the Homologous Recombination Repair Pathway
Matthew Marton, PhD, Director, Companion Diagnostics and Genomics, Merck & Co., Inc.
The therapeutic benefit of PARP inhibition in BRCA-mutated ovarian and breast cancer is well established. Recent data suggest this therapeutic benefit may extend to patients harboring other defects in the homologous recombination repair
pathway. Multiple predictive biomarkers are being studied in clinical trials. We will describe different predictive biomarker assays for response to PARP inhibition, as well as the potential routes and challenges to their development
into companion diagnostic tests.
9:00 Applications of Proteomics and Proteo-Genomics for Immuno-Oncology
Ana I. Robles,
PhD, Program Director, Office of Cancer Clinical Proteomics Research, Center for Strategic Scientific Initiatives, National Cancer Institute, National Institutes of Health
Successful use of immune checkpoint blockade for the treatment of patients with previously intractable advanced cancers has led to widespread enthusiasm for therapeutic approaches that are immunomodulatory, but challenges remain. Proteomics
can complement genomics for the development of biomarkers that predict which patients will most likely respond to immune-based therapy, and support informatic strategies that reveal which peptides translated from mutated sequences
are promising neoantigens for use in immunotherapy protocols.
9:30 A New Approach to Personalizing Cancer Therapies
Clifford
Reid, MBA, PhD, CEO, Travera
Travera has developed a multi-drug companion diagnostic that uses a phenotypic biomarker to match cancer drugs to cancer patients. It uses a breakthrough measurement tool invented at MIT that weighs single cells with sub-picogram accuracy.
We will enable oncologists to order a next-day test that predicts the most effective therapies for their relapsed patients. We are also exploring its use to characterize fitness of T cells used in immunotherapies.
10:00 Breakthrough DNA Methylation Technology Enables Epigenetic Diagnostic Biomarker Discovery and Clinical Applications
Adam Marsh, CSO, Genome Profiling LLC
GenPro’s novel DNA methylation quantification and predictive modeling provides efficient and direct utilization of these biomarkers (EpiMarkers) to assess underlying mechanisms and indications of disease phenotypes and drug responsiveness.
Our technology provides sensitive tools with unparalleled statistical power to identify epigenetic changes and translate those EpiMarkers into cost-effective clinical assays.
10:15 Leveraging Real-World Data for selection of biomarkers with high clinical utility for development of precision CDx
Sean Scott, VP, Business Development, QIAGEN
With so many considerations that go into translational medicine for precision oncology drugs, it is vital that the right biomarker targets and the right patient population are identified. Constructing the specific list of mutations to
be used in a Companion Diagnostic assay is complex, as the success of the project depends on maximizing the proportion of patients in the trial who are sensitive to the drug, while capturing as large a number of patients as possible
for the trial.
10:30 Coffee Break in the Exhibit Hall with Poster Viewing
Constitution A&B
11:30 Plenary Keynote Session
11:30 Chairperson’s Remarks
Charles Mathews, Principal, ClearView Healthcare Partners
11:40 NEW: Plenary Keynote Presentation: FDA Updates: Now and Looking to the Future
Katherine Donigan, PhD, Acting Director of Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Introduction and background of the new Office Director of OIR and updates on precision medicine and other initiatives at the FDA.
12:10 - 1:05 pm Plenary Keynote Discussion: Proposals and Solutions for Diagnostic Reform Including Oversight of Laboratory Developed Tests (LDTs)
Moderator:
Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition
- How are stakeholders influencing congressional activity on the Verifying Accurate Leading-edge IVCT Development (VALID) Act?
- How will the VALID Act change the current oversight landscape for diagnostics, including LDTs?
- How are policymakers addressing the role of CMS and CLIA in the VALID Act?
- How will increased regulatory and oversight activities at the FDA affect the diagnostics industry?
- What impact will changes in diagnostics regulation and oversight have on patient care?
Panelists:
Julie Khani, MPA, President, American Clinical Laboratory Association (ACLA)
Donald E. Horton, Jr., Senior Vice President, Global Government Relations & Public Policy, Laboratory Corporation of America Holdings
Susan Van Meter, Executive Director, AdvaMedDx
Tara Burke, PhD,
Senior Director, Public Policy & Advocacy, Association for Molecular Pathology (AMP)
Laura Lasiter, PhD, Science Policy Analyst, Friends of Cancer Research
1:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:35 End of Emerging Technologies & Biomarkers for Cancer Immunotherapy conference