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*

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.

SC8: 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

UTILIZING CUTTING EDGE TECHNOLOGIES IN IO

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

Paulovich_AmandaAmanda 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

Pomerantz_AndreaAndrea Pomerantz, investigator III, Microscopy and Biophotonics (MiBs), Analytical Sciences and Imaging, Novartis Institutes for Biomedical Research, Inc.


Liu_TingyuTingyu 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

DECIPHERING MECHANISMS OF RESISTANCE

10:55 Chairperson’s Remarks

Robin Edwards, MD, Group Director, Pathology, Bristol-Myers Squibb

11:00 Tumor-Intrinsic Mechanisms of Resistance to Immunotherapy

Edwards_RobinRobin Edwards, MD, Group 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

Luidahl_ShannonShannon 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 Sponsored Presentation (Opportunity Available)

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

MULTIPLEXED IHC

1:30 Chairperson’s Remarks

Jaime Rodriguez-Canales, MD, FEBP, Senior Pathologist, Translational Pathology Laboratory, MedImmune

1:35 Creating High-Quality Datasets for Biomarker Discovery Using Multiplex IF/IHC

Taube_JanisJanis 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.

2:05 Validation of Melanoma Immune Profile (MIP), a Prognostic Immune Gene Prediction Score for Stage II-III Melanoma

Saenger_YvonneYvonne 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.

2:35 Translational Advances of Multiplexed Immunofluorescence Methods

Hoyt_CliffClifford 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 Presentation to be Announced

 

3:20 Presentation to be Announced

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing

CAR T CELL BIOMARKERS UPDATE

4:25 Chairperson’s Remarks

Joseph Melenhorst, PhD, Adjunct Associate Professor, Pathology & Laboratory Medicine, University of Pennsylvania

4:30 The CAR T Cell Revolution

Melenhorst_J_JosephJoseph 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 T Cell Receptor Sequencing as a Means to Monitor Response to Immunotherapy

McNeel_DouglasDouglas G. McNeel, MD, PhD, Professor of Medicine, Director, Solid Tumor Immunology Research, Carbone Cancer Center, University of Wisconsin-Madison

T cell receptor sequencing permits one to evaluate the specificity of individual T cells. T cell receptor sequencing has been used to monitor for changes in T cell clonality or diversity following different immunotherapy treatments. These approaches and future applications of this methodology will be discussed.

5:30 Sponsored Presentation (Opportunity Available)


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


7:30 Problem Solving Breakout Discussions with Continental Breakfast

NOVEL APPROACHES

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

Robles_AnaAna 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

Reid_CliffordClifford 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 Sponsored Presentation (Opportunity Available)

10:30 Coffee Break in the Exhibit Hall with Poster Viewing


11:30 Plenary Keynote Session

11:30 Chairperson’s Remarks

Charles Mathews, Principal, ClearView Healthcare Partners

 

 

 

 

 

11:40 Plenary Keynote Presentation: FDA Updates: Now and Looking to the Future

Tim Stenzel, MD, PhD, Director, 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

 

 

 

 

 

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