(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 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

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

Immuno-Oncology Biomarkers 2: Immune Profiling and Immune Monitoring

Recommended Short Course

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

Tuesday, June 18

7:00 am Registration Open and Morning Coffee

PATIENT SELECTION BIOMARKERS AND COMPANION DIAGNOSTICS IN IMMUNO-ONCOLOGY

8:00 Chairperson’s Remarks

George A. Green IV, PhD, Executive Director, Precision Medicine, Head, Pharmacodiagnostics, Translational Medicine, Bristol-Myers Squibb


8:10 KEYNOTE PRESENTATION: The Role of Pharmacodiagnostics in the Evolving Field of IO Translational Medicine

George A. Green IV, PhD, Executive Director, Precision Medicine, Head, Pharmacodiagnostics, Translational Medicine, Bristol-Myers Squibb

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 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).

9:40 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

10:25 PD-L1 as a Companion Diagnostic for Tumors Beyond Non-Small Cell Lung Cancer: It’s the Same Thing, Only Different

Kenneth Emancipator, MD, Executive Medical Director and Head of Companion Diagnostics, Merck & Co.

The PD-L1 companion diagnostic had a huge impact on the clinical development of pembrolizumab, making it the first immunotherapy approved as a first-line agent for non-small cell lung cancer. However, this is just the beginning of the story, not the end. Adapting the PD-L1 diagnostic to incorporate immune cell expression facilitated approval of pembrolizumab for several additional indications and may shed light on the mechanism of action of checkpoint inhibitors.

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 CDxtm – A Proven Strategy to Accelerate Drug Approvals

Jeffery Miller, Founder, CSO & CEO, Invivoscribe

Our Streamlined CDxtm approach has proven successful in approval of the first ever AML companion diagnostic – The LeukoStrat® CDx FLT3 Mutation Assay, helping accelerate FDA and PMDA approvals of new targeted therapies for the most deadly form of leukemia.

11:55 Transition to Lunch

12:00 pm Luncheon Presentation to be Announced

12:30 Session Break

BIOMARKERS FOR IMMUNO-ONCOLOGY CLINICAL TRIALS

1:05 Chairperson’s Remarks

David L. Rimm, MD, PhD, Professor, Pathology, Yale University

1:10 Outcomes by Line of Therapy and Programmed Death Ligand 1 Expression in Patients with Advanced Melanoma Treated with Pembrolizumab or Ipilimumab in KEYNOTE-006: A Randomised Clinical Trial

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

IO PLENARY SESSION: PARTNERING ECOSYSTEM

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


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


Godec_JernejJernej Godec, PhD, Associate, Apple Tree Partners


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 Welcome Reception in the Exhibit Hall with Poster Viewing

6:35 Find Your Table, Meet Your Moderator

6:40 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

8:00 Chairperson’s Remarks

Elizabeth Trehu, MD, CMO, Jounce Therapeutics

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 Presentation to be Announced

9:35 Coffee Break in the Exhibit Hall with Poster Viewing

BIOMARKERS FOR COMBINATION IMMUNOTHERAPY

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 Presentation to be Announced

Concept_Life_Sciences 11:35 Advanced Techniques for Interrogation of Biomarkers to Indicate Therapeutic Response

Nikola Hunter, Principal Scientist, Concept Life Sciences

11:50 Transition to Lunch

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

Cindy 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


12:50 PLENARY KEYNOTE SESSION

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

3:05 Close of Conference

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

Immuno-Oncology Biomarkers 2: Immune Profiling and Immune Monitoring

Recommended Short Course

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