(Shared Conference with Biomarker World Congress and IO Pharma Congress)
Cambridge Healthtech Institute’s 4th Annual
Immuno-Oncology Biomarkers 1: Predictive Biomarkers and Companion Diagnostics
June 18-19, 2019
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 4th Annual Immuno-Oncology Biomarkers 1: Predictive Biomarkers and Companion Diagnostics 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, June 18
7:00 am Registration Open and Morning Coffee
8:00 Chairperson’s Remarks
Christine Ward, PhD, Executive Director, Late Stage Oncology Translational Medicine Program Lead, Bristol-Myers Squibb
8:10 KEYNOTE PRESENTATION: The Role of Pharmacodiagnostics in the Evolving Field of IO Translational Medicine
Christine Ward,
PhD, Executive Director, Late Stage Oncology Translational Medicine Program Lead, Bristol-Myers Squibb
Translational medicine plays a critical role in transforming cancer patient care by bringing novel biomarker and diagnostic discoveries from the bench to the bedside. The development of novel pharmacodiagnostic tools is helping to guide treatment decisions
and improve outcomes for patients. In Immuno-Oncology, testing for established biomarkers, such as PD-L1 and microsatellite instability, as well as emerging biomarkers, such as tumor mutational burden, can select patients more likely to respond to
therapy, when assessed individually or in combination. We will discuss how advances in pharmacodiagnostics are contributing to the effectiveness of precision medicine in Immuno-Oncology.
8:40 Turning Low Frequency Immuno-Oncology Responses into FDA Approved Therapies: Case Study in Colorectal Cancer
Robert Anders, MD,
PhD, Associate Professor, Pathology, Johns Hopkins University
Anti-PD-1 therapy for mismatch repair deficient colorectal cancers (CRC) developed out of the low (~5%) frequency of response in anti-PD-1 treated CRC patients. The apparent failure of anti-PD-1 therapy to benefit CRC patients was the key to moving forward.
By focusing on those patients that do respond to immune therapy, it is possible to carefully select patients who are more likely to have a high frequency of response.
9:10 The Ultra-Sensitive Measurement of Proteins as Biomarkers of Immuno-Oncology Therapeutics using Simoa Platforms
David Duffy, PhD, Chief Technology Officer, 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.
9:25
Multiplex Image Analysis in The Tumor Microenvironment Using Artificial Intelligence
Amanda Lowe, Managing Director, Visiopharm Corporation
The tumor microenvironment (TME) plays critical roles in cancer progression, impacting diagnosis, prognosis, and treatment decisions. TME phenotyping requires multiplex assays and software capable of unbiased cell identification and classification. Artificial
Intelligence applied to tissue image analysis accurately defines TME phenotypes to understand cancer progression and develop safe, effective treatments.
9:40 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing
10:25 Opportunities and Challenges of Liquid Biopsy IVDs for Cancer Immunotherapy
Benoit
Destenaves, PharmD, Director, Diagnostics Lead, Precision Medicine and Genomics, Innovative Medicines and Early Development (IMED) Biotech Unit, AstraZeneca
Next generation sequencing and liquid biopsies offer exciting novel opportunities to bring innovative drugs to patients. But these opportunities do not come without challenges and will need to be resolved particularly when looking at genomic signatures
such as Tumor Mutational Burden (TMB).
10:55 KEYNOTE PRESENTATION: Predictive Markers for Immunotherapy
David L. Rimm, MD, PhD, Professor,
Pathology, Yale University
Immune checkpoint inhibitor (ICI) therapy has shown dramatic improvements in outcome, but only for a percentage of the patients, and sometimes with severe side effects that can even be fatal in 1 in 200 cases. These facts suggest companion diagnostics
should probably accompany every therapy. While PD-L1 assessment has shown promise, and is still the only FDA approved test, it is neither sensitive nor specific. In this session we will show new promising technologies for predicting response to ICI
therapy.
11:25 Streamlined CDx™ – A Proven Strategy to Accelerate Drug Approvals
Michael Vishnevetsky, PhD,
Head, Global Business Development, Invivoscribe
Companion Diagnostics have revolutionized precision medicine as they play a pivotal role in defining the efficacy of targeted therapies. Invivoscribe’s Streamlined CDx™ program has been shown to collapse development timelines, improve and
accelerate selection of patient cohorts, leading to earlier submissions and accelerated FDA, EMA and PMDA approvals of new targeted therapies. Streamlined CDx™ partnership model has proven successful in approval of the first ever AML companion
diagnostic – The LeukoStrat® CDx FLT3 Mutation Assay.
11:55 Transition to Lunch
12:00 pm Luncheon Presentation: Protein Profiling of Liquid Biopsies Reveal Predictive Biomarkers of Immunotherapy Responses
Keith Flaherty, Director, Clinical Research, Massachusetts General Hospital Cancer Center
The response of metastatic melanoma to immune checkpoint blockade is highly heterogeneous. There are no non-invasive predictors of response and toxicity that could guide treatment decisions. We performed whole plasma proteomic profiling in 150 metastatic
melanoma patients receiving anti-PD1 at MGH using Olink Proteomics innovative multiplex proximity extension assay. Whole plasma proteomic profiling of anti-PD1 treated patients revealed differentially expressed proteins between responders and non-responders
that may enable a liquid biopsy to predict anti-PD1 response.
12:30 Session Break
1:05 Chairperson’s Remarks
Adil Daud, MD, Professor, Hematology/Oncology, University of California, San Francisco: Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center
1:10 Turning Cold Tumors Hot - What Do We Know Today in Melanoma?
Adil Daud, MD, Professor, Hematology/Oncology,
University of California, San Francisco; Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center
1:40 Public-Private Partnerships Generating Critical Resources and Novel Methods for Developing Immuno-Oncology Biomarkers
Stacey J. Adam, PhD, Director, Cancer Research Partnerships, Foundation for the National Institutes of Health
The Foundation for the NIH (FNIH) is a 501(c)(3) organization that supports the NIH by forming and facilitating public-private partnerships (PPPs) for biomedical research. The Partnership for Accelerating Cancer Therapies (PACT), a PPP involving the NCI,
U.S. FDA, multiple pharmaceutical companies, non-profits, and patient advocates seeks to provide a systematic approach to immuno-oncology biomarker investigation by supporting development of standardized/harmonized biomarkers and assays and their
implementation in clinical trials.
2:10 How Biospecimen Sourcing Can Impact Your R&D Results
Vanessa Tumilasci, PhD, Commercial Director, Trans-Hit Biomarkers
Biospecimen sourcing is becoming a challenge for many scientists who need to respect timelines for R&D plans as well as regulatory and ethical constraints. Are the scientists working with the samples aware of all the imperatives to obtain them; quality,
respect of laws, ethics and regulations?
2:25 Refreshment Break in the Exhibit Hall with Poster Viewing
2:30-2:45 Speed Networking: Young Professionals
3:10 PANEL DISCUSSION: Partnering, Preclinical Strategies and Tools, IO Clinical Trials; Capital Invested in IO Relative to Other Oncology Areas
Moderator: Leigh Zawel, PhD, CSO, Cullinan Oncology; Executive Partner, MPM Capital
Panelists:
Michael Woo, PhD, Head, Search & Evaluation, Immuno-Oncology, Business Development & Licensing, Novartis Institutes for BioMedical Research, Inc.
Sybil Williams, PhD, Director, Biology Oncology Discovery, Merck
Paul Young, PhD, Executive Director, Business Development & Licensing, Merck
Stacey J. Adam, PhD, Director, Cancer Research Partnerships, Foundation for the National Institutes of Health
- Has the IO bubble popped? Why have no other IO drugs emerged with PD1/PDL1-like efficacy?
- What combination strategies are being explored to convert poorly PD1 responsive tumors to more responsive ones?
- Are there new IO monotherapies or combos that appear promising?
- Is patient stratification practical with IO therapies?
- What partnering strategies are most effective?
- What is a recent deal your firm signed that you’re excited about?
4:10 Transition to Keynote
4:20 PLENARY KEYNOTE SESSION
5:20 Taste of New England Welcome Reception in the Exhibit Hall with Poster Viewing
5:25 Meet the Plenary Keynotes
6:25 Find Your Table, Meet Your Moderator
6:30 Breakout Discussion Groups
7:30 Close of Day
Wednesday, June 19
7:00 am Registration Open and Morning Coffee
8:00 Chairperson’s Remarks
Samir Hanash, MD, PhD, Director, McCombs Institute for Early Detection and Treatment, MD Anderson Cancer Center
8:05 Theranostic Biomarkers for Cancer Immunotherapy
Glen J. Weiss, MD, MBA, Director,
Phase I Clinical Research, Beth Israel Deaconess Medical Center/Harvard Medical School
A small percentage of cancer patients experience an impressive durable response to immunotherapy treatment. How are these therapies selected and how is efficacy monitored? The lecture will highlight current data on theranostic biomarkers for treatment
selection and monitoring.
8:35 Metabolic Signatures Predictive of Tumor Immune Phenotypes
Samir Hanash MD, PhD,
Director, McCombs Institute for Cancer Early Detection and Treatment, MD Anderson Cancer Center
The tumor microenvironment is a key modulator of the immune response to tumor development. Metabolomics has identified tumor metabolic profiles that correlate with immune cell infiltration and that are predictive of outcome as illustrated in studies of
breast cancer.
9:05 Profiling Tumor and Neighboring Microenvironment for Immunotherapy Response Prediction
George Wei, PhD, Vice President, Research & Development, ACT Genomics
Several biomarkers have recently emerged as clinically beneficial in predicting the outcome to immune checkpoint inhibitors. Tumor mutational burden is one that shows a good correlation with objective response rate across various type of cancers. Additionally,
extrinsic factors such as catalytic activities, checkpoint molecule profiles, and immune cell compositions, all play important roles in evaluating a patient for immunotherapy. In this presentation, a sample-conserving product duo designed to accommodate
FFPE tissue samples will be discussed.
9:35 Coffee Break in the Exhibit Hall with Poster Viewing
10:05 Poster Winner Announced
10:20 TMB/GEP Dual Biomarker Strategy for Personalized Checkpoint Blockade Combination Immunotherapy
Jianda Yuan, MD, PhD,
Senior Director, Translational Oncology, Merck
Immune checkpoint blockade therapies are revolutionizing the standard cancer treatment. Despite the current success of these therapies, not all patients respond to immunotherapy. Combination approaches are the keys to improving clinical response. Tumor
mutational burden (TMB) and gene expression profile (GEP) are emerging biomarkers predicting patient response. Dual TMB/GEP biomarkers allow us to understand novel translational biomarkers to stratify patients effectively for personalized cancer immunotherapy.
10:50 Combination Immunotherapy and Biomarkers of Response
Sema Kurtulus,
PhD, Investigator II, Translational Immuno-Oncology, Novartis Institutes for Biomedical Research
Although immunotherapies have been tremendously successful in the clinic, there is still a need to improve the response rate in patients. To meet this need, many novel immunotherapies are entering into the clinics in combination with the current checkpoint
blockade immunotherapies. It is critical to assess biomarkers and their correlation with response to decide the right combination regimen for each patient.
11:20 TMB Harmonization Project: Update on Efforts to Standardize TMB Measurements by High Content NGS Panels
Carrie Sougnez Cibulskis, PhD, Director, Somatic Portfolio, The Broad Institute
Accurate measurement of TMB is essential before establishing clinical utility as an I-O biomarker. NGS-based assays are designed to detect genomic aberrations in specific target regions. These approaches need further testing. We’ll review results
from multiple NGS TMB panels compared to WES using reference materials designed to harmonize TMB testing.
11:35 Cutting-Edge Immunology Expertise and Innovative Experimental Design for Clinical Biomarker Analysis
Nikola Hunter, Principal Scientist, Translational Biology, Concept Life Sciences
We will discuss how our cutting-edge immunology expertise enables us to devise innovative techniques to evaluate accessible biomarkers which reduce the need for invasive procedures, while enhancing the study data set. Designing a bespoke and adaptable
clinical biomarker study, allows quick turnaround of patient data.
11:50 Transition to Lunch
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
12:50 PLENARY KEYNOTE SESSION
2:20 Booth Crawl and Dessert Break in the Exhibit Hall with Poster Viewing
2:25 Meet the Plenary Keynotes
3:05 Close of Conference