(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

PATIENT SELECTION BIOMARKERS AND COMPANION DIAGNOSTICS IN IMMUNO-ONCOLOGY
Waterfront 2

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

Ward_ChristineChristine 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

Anders_RobertRobert 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.

Quanterix 9:10 The Ultra-Sensitive Measurement of Proteins as Biomarkers of Immuno-Oncology Therapeutics using Simoa Platforms

Duffy_DavidDavid 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. 

Visiopharm_NEW9:25 Multiplex Image Analysis in The Tumor Microenvironment Using Artificial Intelligence

Lowe_AmandaAmanda 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

Destenaves_BenoitBenoit 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

Rimm_DavidDavid 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

BIOMARKERS FOR IMMUNO-ONCOLOGY CLINICAL TRIALS

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?

Daud_AdilAdil 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

Adam_StaceyStacey 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 

IO PLENARY SESSION: PARTNERING ECOSYSTEM
Amphitheater

3:10 PANEL DISCUSSION: Partnering, Preclinical Strategies and Tools, IO Clinical Trials; Capital Invested in IO Relative to Other Oncology Areas

Zawel_LeighModerator: Leigh Zawel, PhD, CSO, Cullinan Oncology; Executive Partner, MPM Capital


Panelists:

Woo_MichaelMichael Woo, PhD, Head, Search & Evaluation, Immuno-Oncology, Business Development & Licensing, Novartis Institutes for BioMedical Research, Inc.


Williams_SybilSybil Williams, PhD, Director, Biology Oncology Discovery, Merck


Young_PaulPaul Young, PhD, Executive Director, Business Development & Licensing, Merck


Adam_StaceyStacey 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

BIOMARKERS TO PREDICT RESPONSE TO IMMUNOTHERAPY
Waterfront 2

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

Weiss_GlenGlen 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

Hanash_SamirSamir 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

Wei_GeorgeGeorge 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

BIOMARKERS FOR COMBINATION IMMUNOTHERAPY

10:20 TMB/GEP Dual Biomarker Strategy for Personalized Checkpoint Blockade Combination Immunotherapy

Yuan_JiandaJianda 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

Kurtulus_SemaSema 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

Sougnez-Cibulskis_CarrieCarrie 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.

Concept_Life_Sciences 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

Stay on to attend Wednesday, June 19 - Thursday, June 20

Immuno-Oncology Biomarkers 2: Immune Profiling and Immune Monitoring