(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

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

Spittle_CindyCindy Spittle, Vice President, Development and Scientific Affairs, 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 Dessert and Coffee Break in the Exhibit Hall with Poster Viewing


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

Rossi_JohnJohn M. Rossi, PhD, 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 Microenvironmental Links between Adipose Tissue and Cancer

Cipolletta_DanielaDaniela Cipolletta, PhD, Lab Head, Investigator III, Immuno-Oncology, Novartis Institutes for BioMedical Research

This presentation will cover: 1) excess adiposity in obesity has been associated with increased risk of cancer development as well as negative prognosis in several cancer types, 2) preclinical models of cancer and obesity, 3) contribution of cellular constituents of the adipose tissue to tumor development.

immunoSCAPE 4:40 Presentation to be Announced


Quanterix 4:55 The Ultra-Sensitive Measurement of Proteins as Biomarkers of Immuno-Oncology Therapeutics using Simoa Platforms

David Duffy, PhD, CTO, Quanterix Corporation

Immune-targeted therapies, e.g., checkpoint inhibitors, have emerged as the next generation approaches to treating cancer.  We will describe the use of two unique Simoa technologies to measure proteins that are emerging as important biomarkers for the effectiveness of immuno-oncology therapies, at low picogram or sub-picogram per milliliter concentrations. 

5:10 Networking Reception in the Exhibit Hall with Poster Viewing

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 View details 


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.

Visiopharm_NEW 9:15 Presentation to be Announced


ProImmune 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

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 A Simple Blood-Based Serologic Assay for Early Detection of Multiple Cancers

Katz_YisraelYisrael Katz, MD, CMO, Calviri; Center for Innovations in Medicine, Arizona Biodesign Institute

Our group has invented a 400K peptide array representing all potential immunogenic frameshift antigens produced by cancer cells. The assay is serologic, requiring <1mL of blood, no tissue or sequencing, and simultaneously interprets a diagnostic signature for multiple early-stage cancers with high accuracy; cost is substantially lower than DNA-based technologies, and results are obtained in a few hours. In multiple stage I and pre-stage I breast cancer and melanoma cohorts, accuracy of the test ranged from 85%-99%.

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 Sponsored Presentation (Opportunity Available)

1:00 Transition to Lunch

1:05 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

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


2:20 Chairperson’s Remarks

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

2:25 Development of a Panel of NGS-Based Immuno-Oncology Biomarkers in Support of Translational Research

Dougherty_BrianBrian Dougherty, PhD, Executive Director, Translational Science, Oncology IMED, AstraZeneca

2:55 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.

3:25 Immune Infiltrate as a Prognostic Biomarker in Merkel Cell Carcinoma

Tetzlaff_MichaelMichael T. Tetzlaff, MD, PhD, Associate Professor, Pathology, The University of Texas MD Anderson Cancer Center

Merkel cell carcinoma (MCC) is an aggressive cutaneous malignancy with unpredictable response to immune checkpoint blockade. To identify prognostic/predictive immune-related biomarkers for MCC, we quantified the density and composition of the tumor associated lymphoid infiltrate and confirmed associations with survival. Next, we performed T cell receptor sequencing to determine associations between the T cell repertoire and survival. Finally, we determined expression of immune checkpoint markers (beyond PD-L1) in MCC.

3:55 Panel Discussion: Emerging Trends in Immuno-Oncology Biomarkers

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

Panelists: Speakers of the day

Discussion topics include:

  • What are unmet needs for IO biomarkers?
  • What types of IO biomarkers show the most potential so far?
  • What is the progress in peripheral IO biomarkers?

4:25 Close of Conference

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

Immuno-Oncology Biomarkers 1: Predictive Biomarkers and Companion Diagnostics

Recommended Short Course

SC7: Fit-for-Purpose Biomarker Assay Development and Validation