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Cambridge Healthtech Institute’s 2nd Annual

Biomarkers for Immuno-Oncology

Predictive Biomarkers and Companion Diagnostics to Guide Cancer Immunotherapy
August 29-30, 2017 | Sheraton Boston | Boston, MA


As pharmaceutical and biotechnology companies increase their investment in immuno-oncology programs to facilitate rapid development of novel immunotherapies, there is increasing pressure to discover and validate relevant biomarkers. Cambridge Healthtech Institute’s Second Annual Biomarkers for Immuno-Oncology meeting will bring together biomarkers experts from industry and academia to address rapid development of predictive and prognostic IO biomarkers, utility of these biomarkers in clinical trials, and their potential as companion diagnostics.



Final Agenda


TUESDAY, AUGUST 29

12:00 pm Registration

PRECISION IMMUNO-ONCOLOGY: BIOMARKERS FOR PATIENT SELECTION

1:15 Chairperson’s Opening Remarks

Robert Anders, M.D., Ph.D., Associate Professor, Pathology, Johns Hopkins University


1:20 KEYNOTE PRESENTATION: Biomarker Strategies for Precision Immune-Oncology

David_KaufmanDavid Kaufman, M.D., Ph.D., Executive Director, Translational Immunology & Oncology, Merck Research Laboratories


1:50 Atezolizumab in Metastatic Triple-Negative Breast Cancer: Clinical and Biomarker Findings

Jakob_Dupont Jakob Dupont, M.D., MA, Vice President, Global Head Breast & Gyn Cancer Development, Genentech, A Member of the Roche Group


illumina NEW2:20 Leveraging RNA-Seq for a Robust, Accurate Measure of HLA Calling for Endpoints in Clinical Trials

Victor_WeigmanVictor Weigman, Ph.D., Director, Translational Genomics, Q2 Solutions, a Quintiles Quest Joint Venture

In this talk, EA Genomics will present information on new capabilities for Immune Oncology applications with RNA-Sequencing. Over the past year, EA has developed several applications for genomic testing across Immune Oncology Applications: infiltrating immune signatures, immune repertoire, mutational load, HLA identification and neoantigen discovery. We will also showcase HLAProfiler, a powerful algorithm which can make HLA calls from RNA-Seq data with high accuracy and discuss implications for doing so in FFPE specimens along with updates to substantially reducing input demands for RNA-Seq. Also discussed will be RNA-Seq as a confident measure for tumor immune response alongside routinely used clinical assays that is independent of application.

NeoGenomics2:50 Overlap Between Genomic and Immunohistological Immunotherapy Biomarkers

Maher Albitar, MD, SVP, Chief Medical Officer & Director, Research & Development, NeoGenomics Laboratories, Inc.

PD-L1 expression as detected by immunohistochemistry remains the most extensively studied and used biomarker in immunotherapy. However new molecular biomarkers are emerging as potential predictor of response in immunotherapy. This includes tumor mutation burden (TMB), microsatellite instability (MSI), abnormalities in DNA repair genes and others. In addition, combining immunotherapy with targeted therapy is being considered at this time and selecting biomarkers that can predict the efficacy of such combination is becoming a significant unmet need. Data correlating genomic biomarkers with PD-L1 expression as detected by IHC will be presented and discussed.

3:20 Refreshment Break in the Exhibit Hall with Poster Viewing


4:00 PLENARY KEYNOTE SESSION

4:00 Regulatory and Scientific Considerations for Cancer Vaccines and Adoptive Cellular Immunotherapy

Graeme E. Price, Ph.D., Research Microbiologist, Gene Transfer & Immunogenicity, FDA CBER

Cell and Gene therapy including therapeutic vaccines and cellular immunotherapy products are evaluated at FDA’s Center for Biologics Evaluation and Research in the Office of Tissues and Advanced Therapies (OTAT) previously known as Office of Cellular, Tissue and Gene Therapies. I will discuss current general regulatory and scientific considerations in the regulation of therapeutic cancer vaccines and cellular immunotherapy. In addition, research activities in OTAT will be summarized.

4:45 Market Access and Reimbursement for Immuno-Oncology Drugs in Today’s Healthcare System

Gergana Zlateva, Ph.D., Vice President, Payer Insights and Access, Oncology, Pfizer

Now that immunotherapies have hit the market, with the promise of more to come, the healthcare system will need to establish standards for cost and reimbursement of immuno-oncology agents. This talk will address how the healthcare marketplace can prepare for the adoption of novel pricing and reimbursement models to increase patient access to immunotherapies. Establishing the value of IO therapies to payers and HTAs will also be addressed in the context of pricing and evidence generation.

Click here for keynote biographies

5:30 Welcome Reception in the Exhibit Hall with Poster Viewing

5:30 Dinner Short Course Registration*

SC1: Bioinformatics for Immuno-Oncology and Translational Research

SC2: Microbiome in Immuno-Oncology

*Separate registration required, please click here for more information.

WEDNESDAY, AUGUST 30

7:00 am Registration

7:25 Breakout Discussion Groups with Continental Breakfast

PREDICTIVE BIOMARKERS IN IMMUNO-ONCOLOGY

8:25 Chairperson’s Remarks

Zhen Su, M.D., MBA, Vice President & Head of Global Medical Affairs – Oncology, EMD Serono

8:30 Are Biomarkers Still Necessary for the Era of Immuno-Oncology?

Zhen_SuZhen Su, M.D., MBA, Vice President & Head of Global Medical Affairs – Oncology, EMD Serono

The recent breakthroughs in cancer immunotherapy have reshaped our understanding of tumor biology, especially its microenvironment. Despite the new promises from the first wave of immune checkpoint blockage therapies, only a minority of cancer patients can truly benefit from its long-term anti-tumor effect. As the result of the speedy approval and broad biological impacts of immunotherapy, there is a significant knowledge gap for the real-world adaptation of these new treatments and reliable biomarkers to guide safe and effective use of this new class of therapy in addition to the SOC.

9:00 Molecular Biomarkers of Response to Keytruda

Andrey Loboda, Ph.D., 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 T-cell inflamed microenvironment 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.

9:30 Building a Better Biomarker for Immune Therapy: Lessons Learned from Colon Cancer

Robert_AndersRobert Anders, M.D., Ph.D., Associate Professor, Pathology, Johns Hopkins University

Cancer samples are predictive biomarkers that have long been used to select a patient’s therapy. Predictive biomarkers such as the expression of specific proteins or presence of DNA mutations in an oncogenic pathway have been used to select patients for targeted therapies. It is unlikely a single biomarker will be specific for selecting patients for immunotherapy. These concepts will be discussed in the setting of colorectal cancer.

Isoplexis10:00 Novel Biomarker Discovery Data Predicts Patient Outcomes

Sean Mackay, CEO, IsoPlexis

This presentation will explore the first high parameter, single-cell technology capable of defining subsets of powerful multi-functional, protein secreting cells that can determine and help predict patient response. The Precision Profiling platform captures the end function of thousands of single cells in a patient sample using to discover new information in immunotherapy and predictive biomarkers in CAR-T and TCR-T therapies.

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


11:15 KEYNOTE PRESENTATION: Strategy for Development of Predictive Biomarkers for Immunotherapy

Ignacio_WistubaIgnacio I. Wistuba, M.D., Department Chair, Department of Translational Molecular Pathology, Division of Pathology & Lab Medicine, The University of Texas MD Anderson Cancer Center

As new immunotherapy strategies are being developed, particularly inhibition of immune checkpoints, there is an urgent need to develop predictive biomarkers for these therapies. We are increasing our ability to characterize the immune, molecular and genomic events associated with response or resistance to these treatments in tumor tissue, blood and other specimens of patients treated with these novel therapies. This approach will help to identify mechanisms of resistance to immunotherapy.

11:45 Predictive and Prognostic IO Biomarkers and Their Utility in Clinical Trials

Jaclyn_NeelyJaclyn Neely, Ph.D., Senior Research Investigator II, Translational Medicine, IO Biomarker Lead, Bristol-Myers Squibb

The clinical benefit of immunotherapies is only demonstrated in a subset of patients. Single biomarkers are often not sufficient to predict response to immunotherapies. This presentation will review the importance of collecting predictive biomarker data, the associated challenges and opportunities, and how this data may inform the appropriate treatment of patients.

12:15 pm Multi-Omics Artificial Intelligence-Based Approaches for Identifying Immunotherapy Responders

Olivier Elemento, Ph.D., Cancer Systems Biology and Precision Medicine, Weill Cornell Medicine

In this talk I will present my group’s work on the (CLIA) whole-exome sequencing-based genomic test for precision cancer medicine and immunotherapy. A novel analytical pipeline that analyzes genomic profiles to unravel the immune landscape of tumors and integrates multi-omics features using machine learning to predict immunotherapy response will be described. Finally, high-throughput single cell genomics approaches to dissect the tumor microenvironment and unravel immune repertoires at the single cell resolution will be presented.

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Session Break

COMPLEMENTARY AND COMPANION DIAGNOSTICS: PD-L1 AND BEYOND

1:55 Chairperson’s Remarks

Deepti Aurora-Garg, Ph.D., Director, Companion Diagnostics, Merck

2:00 Development of a Complementary Diagnostic for Tecentriq

Zachary Boyd, Ph.D., Companion Diagnostic Program Leader - Tecentriq (Atezolizumab), Genentech

Tecentriq (Atezolizumab) is the first anti-PD-L1 cancer immunotherapy to approved for the treatment of advanced non-small cell lung cancer (NSCLC) and urothelial carcinoma (UC). To assess the association of PD-L1 expression with therapeutic benefit, we partnered with Ventana Medical Systems to develop an immunohistochemistry assay to detect PD-L1 expression on specific cell types within the tumor microenvironment. The Ventana SP142 PD-L1 IHC was co-labeled with Tecentriq as a complementary diagnostic in NSCLC and UC. In this talk, I will review the underlying biomarker hypotheses that informed development of the SP142 assay and ultimate approval as a complementary diagnostic.

2:30 Evaluation of Multiple Biomarkers in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) in Response to Keytuda®

Deepti_Aurora-GargDeepti Aurora-Garg, Ph.D., Director, Companion Diagnostics, Merck

HNSCC is generally associated with deficiencies of the immune system. Tumor-infiltrating lymphocytes activate interferon-mediated signaling that in turn induces expression of immune suppressive molecules (eg, PD-L1, PD-L2, IDO1) on cells in the tumor environment. Upregulation of immune suppressive molecules enables tumors to evade immune surveillance and progress. Keytruda, an anti-PD-1 antibody, blocks the interaction between PD-1 and its ligands. Hence in the Keytruda trials PD-L1, PD-L2 and gene expression signatures were evaluated to understand their utility in predicting response to Keytruda.

Personal Genome Diagnostics3:00 NGS Solutions Across the Oncology Drug Development Continuum: From Biomarker Discovery to IVD

Simmons_JohnJohn K. Simmons, Ph.D., Director, Translational Science & Diagnostics, Personal Genome Diagnostics, Inc.

At PGDx, we use NGS techniques in plasma and tissue to identify potential biomarkers of response and resistance mechanisms that are critical to making informed treatment decisions. We offer CLIA-validated and custom assays for immuno-oncology and targeted panels in both tissue and plasma. Our panels can be used in clinical trials for both prospective enrollment and retrospective analysis. Ultimately, these panels can be clinically and analytically validated for FDA submission as in vitro diagnostics (IVDs).

 

3:30 Refreshment Break in the Exhibit Hall with Poster Viewing

BIOMARKERS OF RESPONSE AND RESISTANCE TO IMMUNOTHERAPY

4:15 Pathologic Response Patterns in Neoadjuvant Trials with Immunotherapy

Janis_TaubeJanis Taube, M.D., Associate Professor, Dermatology & Pathology, Johns Hopkins University

Neoadjuvant therapeutic response is graded by surgical pathology upon receipt of the resection specimen. Histopathologic features of response to immunotherapy in the neoadjuvant setting differ from features seen in response to neoadjuvant chemotherapy and targeted therapies. Those histopathologic features will be highlighted in the context of early clinical trials of immunotherapeutics in the neoadjuvant setting. These specimens also provide opportunity to study mechanisms of response and resistance to immunotherapy.

4:45 Understanding the Heterogeneity and Dynamics of Responses to Checkpoint Blockade in Melanoma

Alexandre_ReubenAlexandre Reuben, Ph.D., Postdoctoral Fellow, Surgical Oncology, The University of Texas MD Anderson Cancer Center

The success of immune checkpoint blockade has led to major efforts to identify biomarkers and mechanisms of response and resistance, specifically in melanoma. Here, we performed molecular (whole exome sequencing, gene expression profiling) and immune (immunohistochemistry, T cell receptor sequencing) profiling of longitudinal samples from patients treated with sequential CTLA-4 and PD-1 blockade. These studies shed light on biomarkers of response and mechanisms of resistance to immune checkpoint blockade.

5:15 Close of Biomarkers for Immuno-Oncology


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