(Shared Conference with Biomarker World Congress and IO Pharma Congress)

Cambridge Healthtech Institute’s 3rd Annual

Immuno-Oncology Biomarkers 2: Immune Profiling and Immune Monitoring

June 19-20, 2019

Advances in immuno-oncology promise to revolutionize cancer treatment. However, many patients do not respond to immunotherapy. Immune profiling promises to identify biomarkers that predict response to immunotherapy and to help monitor its progress. Cambridge Healthtech Institute’s 3rd Annual Immuno-Oncology Biomarkers 2: Immune Profiling and Immune Monitoring meeting will cover approaches to assess the state of the immune system, profile the tumor microenvironment and peripheral blood, determine tumor mutational burden and profile neoepitopes, and develop predictive and response biomarkers.

Final Agenda

Wednesday, June 19

12:00 pm NEW: BRIDGING LUNCHEON PRESENTATION: Strategically Leveraging Biomarkers to Reduce the Risk Profile and to Provide a Line of Sight to NDA Submission

Fritz Eibel, Senior Vice President, MolecularMD

Leveraging the use of a biomarker can greatly increase the likelihood of attaining regulatory approval for a therapeutic. In IO, novel biomarkers are emerging, and with ongoing efforts, clinical utility continues to amass. However, are these biomarkers capable of broad clinical deployment and achieving optimal market access? Effective planning and establishing the right co-development strategy is critical to the success of the drug program. Case studies and valuable insights will be shared and discussed.

12:30 Transition to Plenary


2:20 Booth Crawl and Dessert Break in the Exhibit Hall with Poster Viewing

2:25 Meet the Plenary Keynotes

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3:05 Chairperson’s Remarks

Andrey Loboda, PhD, Director, Genetics and Pharmacogenomics, Merck

3:10 KEYNOTE PRESENTATION: Molecular Biomarkers of Response to Keytruda

Loboda_AndreyAndrey Loboda, PhD, Director, Genetics and Pharmacogenomics, Merck

The talk will address molecular biomarkers of response to Pembrolizumab, including the role of tumor antigenicity, as measured by mutational load (ML), and key gene expression signatures in predicting the response to Pembrolizumab. Data will be presented that prospectively validates the utility of both biomarkers as tumor type agnostic and orthogonal measures of response. These findings provide a biomarker framework for development of Pembrolizumab as a monotherapy and for characterizing responses to novel immunotherapy regimens.

3:40 Determinants of Clinical Response to Engineered T Cell Therapy

Milletti_FrancescaFrancesca Milletti, PhD, Associate Director, Translational Medicine, Kite, a Gilead Company

Limited data has been published describing mechanisms of resistance to CAR T cell therapy. The well-annotated ZUMA-1 clinical trial serves as a benchmark to address outstanding questions. Translational research focusing on the association between CAR T cell product attributes, tumor immune microenvironment and resistance will be presented.

4:10 Melanoma-Associated Lymphatics and the Cargo They Carry: Roles in Immunomodulation and Metastasis

Broggi_MariaMaria A.S. Broggi, PhD, Investigator II, Exploratory Immuno-Oncology, Novartis Institutes for BioMedical Research

This presentation will cover the role of tumor-associated lymphatics in potentiating response to immuno-therapy and the recent findings showing that lymph isolated from metastatic melanoma patients is highly enriched in tumor-associated factors and is therefore a promising source for biomarker discovery.

immunoSCAPE 4:40 Leveraging Multi-Parametric Profiling by Mass Cytometry to Identify and Deeply Characterize Tumor-Reactive T Cells

Roumanes_DavidDavid Roumanes, Business Development Scientist, immunoSCAPE

immunoSCAPE is a biotechnology start-up providing high-dimensional immune profiling for target and biomarker discovery and validation. In this talk, we will demonstrate how hundreds of antigen-specific T cells can be detected by mass cytometry using tetramer barcoding and immuno-phenotyping, and how this technology can be applied to detect potential biomarkers.


IONpath 4:55 Multiplexed Ion Bean Imaging: High Multiplex IHC Unveils a Structured Tumor-Immune Microenvironment in Breast Cancer

Lowe_JohnJohn Lowe, MD, Principal, Lowe Consulting

Multiplexed Ion Beam Imaging (MIBI), a mass spectrometry-based highly multiplex IHC technology, affords the ability to detect and quantify upwards of 40 distinct proteins markers simultaneously, at single cell resolution, on a single tissue slide, and to then display and quantify spatial relationships between the cells types within a tumor. An overview of the technology will be presented, together with examples of its application in breast cancer and in neuroscience.

5:25 4th of July Celebration in the Exhibit Hall with Poster Viewing

5:30-5:45 Speed Networking: Oncology

6:05 Close of Day

5:45 Dinner Short Course Registration

6:15 Dinner Short Course*

*Separate registration required.

Thursday, June 20

7:15 am Registration Open

7:15 Breakout Discussion Groups with Continental Breakfast

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8:10 Chairperson’s Remarks

Wei Guo, PhD, Professor, Biology, University of Pennsylvania


8:15 KEYNOTE PRESENTATION: The Role of Plasma-Derived Exosomes in Monitoring of Immunotherapy Trials

Whiteside_TheresaTheresa Whiteside, PhD, Professor, Pathology, Immunology & Otolaryngology, Hillman Cancer Center, University of Pittsburgh School of Medicine

Exosomes have recently emerged as a potential biomarker of response to therapy in cancer. Preliminary evidence suggests that plasma-derived exosomes can serve as a new monitoring platform for cancer patients enrolled in therapeutic clinical trials.

8:45 Exosomal PD-L1 Contributes to Immunosuppression and Is Associated with Melanoma Patient Response to Anti-PD-1 Therapy

Guo_WeiWei Guo, PhD, Professor, Biology, University of Pennsylvania

Tumor cells secrete exosomes enriched with PD-L1, which suppress antitumor immunity. In a cohort of patients with metastatic melanoma, the baseline level of plasma exosomal PD-L1 stratifies responders from non-responders to anti-PD-1 therapy. Furthermore, the early on-treatment change of exosomal PD-L1 correlates with T cell reinvigoration and is associated with patient response. Exosomal PD-L1 can potentially be developed as a liquid-based biomarker to predict patient response to anti-PD-1 therapy.

Metabolon 9:15 Precision Metabolomics™ as a Leading Technology in Biomarker Discovery

DeBalsi_KarenKaren DeBalsi, PhD, Senior Study Director, Metabolon, Inc.

The metabolome is highly responsive to homeostatic changes induced by genetics, external factors and treatment, which provides an ideal measure to track the connection of these influences to phenotype.  We will discuss how Metabolon’s Precision MetabolomicsTM technology is a powerful tool for biomarker discovery to predict disease and patient response.


9:45 Immunogenicity Assessment for Immuno-Oncology Programs

El-Khouri_MargotMargot El-Khouri, PhD, Immunology Sales Specialist, ProImmune

Immunogenicity is at the forefront of immuno-oncology studies. In addition to effective tumour cell killing, minimal side effects and protection from recurrence, the ideal anti-cancer candidate should achieve high tumour specificity. ProImmune provides innovative solutions to characterise epitopes presented by tumour cells, which could potentially be the targets of the next anti-cancer agent. Whether this immunogenicity is desired as for cancer epitopes or unwanted in the context of drug development safety, immunogenicity assessment is critical.

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

10:45 Poster Winner Announced

11:00 Monitoring T Cell Responses in Peripheral Blood During PD-1 Blockade Therapies

Kamphorst_AliceAlice O. Kamphorst, PhD, Assistant Professor, Oncological Sciences, Precision Immunology Institute, Icahn School of Medicine at Mount Sinai

11:30 Genomic Biomarkers for Oncology Rx: Challenges to LDTs and CDx Commercialization in the Era of NGS

Garlick_RussellRussell Garlick, PhD, CSO, SeraCare Life Sciences

Next-generation sequencing is the dominant platform for nucleic acid-based biomarker development for solid tumor and liquid biopsies. However, recent studies have shown assay discordance especially in liquid biopsy confounding the use of technology. This presentation will discuss different approaches to assess LDT performance and support CDx adoption for improved cancer genotyping in global markets.

12:00 pm Peripheral Blood Immuno-Biological Biomarkers to Predict Responses to Immunotherapy

Dronca_RoxanaRoxana S. Dronca, MD, Associate Professor, Oncology, Mayo Clinic Cancer Center, Mayo Clinic College of Medicine and Science

Despite unprecedented successes with immune checkpoint blockade in advanced cancers, these agents provide durable clinical benefit in only a subset of patients. In addition, the clinical management of patients receiving immune checkpoint blockade remains quite challenging due to the unpredictable and kinetically heterogeneous responses which can manifest as late responses, pseudoprogression, or hyperprogression in subsets of patients. During this presentation, I will discuss the need for identification of biomarkers able to predict clinical responses and inform selection of immunotherapy agents and combinatorial strategies in patients with advanced cancers. I will review our data regarding the use of blood-based biomarkers such as Bim (BH3-only protein) and soluble PD-L1 (sPD-L1), as well as other reported markers in the literature.

12:30 Association of Mutational Profiles with Cytogenetic Risk Groups and Mutational Shift after Treatment in Acute Myeloid Leukemia

Morrissette_JenniferJennifer J.D. Morrissette, PhD, Scientific Director, Clinical Cancer Cytogenetics, Clinical Director, Center for Personalized Diagnostics, University of Pennsylvania

Genetic analysis of patients with acute myeloid leukemia (AML) is considered standard of care at diagnosis, for decision making, and throughout the course of disease, for monitoring. These studies generally include cytogenetics (chromosome and FISH) and molecular analysis, which has been moving from single gene testing toward panel testing of critical genes. There are several large studies that have categorized AML patients into risk groups based on cytogenetic findings at diagnosis

1:00 Transition to Lunch

1:05 Enjoy Lunch on Your Own

1:35 Dessert and Coffee Break in the Exhibit Hall with Poster Viewing

1:45-2:00 Speed Networking: Last Chance to Meet with Potential Partners and Collaborators!

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2:20 Chairperson’s Remarks

Carrie Northcott, PhD, Research Project Lead, Digital Medicine and Translational Imaging (DMTI), Early Clinical Development, Pfizer, Inc.

2:25 Presentation to be Announced

2:55 The Verification and Use of Digital Wearable Technology to Evaluate Scratching and Sleep in Atopic Dermatitis

Carrie Northcott, PhD, Research Project Lead, Digital Medicine and Translational Imaging (DMTI), Early Clinical Development, Pfizer, Inc.

Atopic Dermatitis is often accompanied by unrelenting nighttime pruritus resulting in reduced sleep. Quantitatively evaluating nighttime scratch and sleep via accelerometry using digital wearables to continuously monitor patients in their “home environment” would provide insight into the disease and effectiveness of treatments. A key aspect to provide value in these assessments is that the methods and devices are vetted and verified to detect clinically meaningful changes.

3:25 Shaping the Future of Digital Health Technologies in Parkinson's Research

Julia Keefe, Associate Director, Research Programs, Michael J. Fox Foundation

The Michael J. Fox Foundation for Parkinson’s Research collaborates with leading researchers, industry partners, and the data science community to generate and analyze robust sensor-based datasets. In this talk, Lauren will report on results and best practices that are bringing us closer than ever to developing clinically meaningful endpoints and using them to support Parkinson’s disease clinical development.

3:55 Close of Conference

Arrive early to attend Tuesday, June 18 - Wednesday, June 19

Immuno-Oncology Biomarkers 1: Predictive Biomarkers and Companion Diagnostics