The Cancer Moonshot ECCO2018 September 7, 2018

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1 The Cancer Moonshot ECCO2018 September 7, 2018 Dinah S. Singer, Ph.D. Deputy Director National Cancer Institute, NIH

2 Goals of the Cancer Moonshot Accelerate progress in cancer, including prevention & screening From cutting edge basic research to wider uptake of standard of care Encourage greater cooperation and collaboration Within and between academia, government, and private sector Enhance data sharing (Presidential Memo 2016) Blue Ribbon Panel 2016

3 Blue Ribbon Panel The Blue Ribbon Panel will provide expert advice on the vision, proposed scientific goals, and implementation of the National Cancer Moonshot...The panel may also recommend other cancer research activities to enhance this effort. The Panel will provide an intensive examination of the opportunities and impediments in cancer research Findings and recommendations of the Panel will be reported to the NCAB. The NCAB will use the Panel s findings and recommendations to provide final recommendations to the NCI Director. (Presidential Memo 2016) Blue Ribbon Panel 2016

4 Blue Ribbon Panel 28 Members Clinicians, researchers, advocates, representatives from pharma and IT Three face-to-face meetings to identify Moonshot recommendations 7 Working Groups Clinical trials, enhanced data sharing, cancer immunology, tumor evolution, implementation science, pediatric cancer, precision prevention and early detection Each group had members. In total, ~150 individuals were actively involved Met weekly for 6 weeks to generate 2-3 recommendations/working group of major scientific opportunities poised for acceleration Blue Ribbon Panel 2016

5 Scientific and Community Outreach Activities Goal: Provide opportunities for the public and experts ways to submit ideas Increase the public s participation in the Cancer Moonshot Approaches: Online public idea repository over 1600 ideas submitted One-on-one public input: BRP Listening sessions Professional conferences Response: Over 1600 ideas received Blue Ribbon Panel 2016

6 Overview of Blue Ribbon Panel Report The Report summarizes the recommendations of exceptional research opportunities that could lead to powerful advances in our understanding of cancer The online Report includes all recommendations in their entirety at Blue Ribbon Panel 2016

7 Blue Ribbon Panel Recommendations A. Network for direct patient engagement B. Cancer immunotherapy translational science network C. Therapeutic target identification to overcome drug resistance D. Creation of a national cancer data ecosystem E. Fusion oncoproteins in pediatric cancer F. Symptom management research G. Precision prevention and early detection H. Retrospective analysis of biospecimens from patients treated with standard of care I. Creation of human tumor atlas J. Development of new enabling technologies Cross Cutting Themes: Health disparities, prevention, data sharing, partnerships

8 Cancer Funding in 21 st Century Cures Act The cancer research portion is named the Beau Biden Cancer Moonshot Initiative $1.8 billion over 7 years $300 million for FY17 $300 million for FY18 To support cancer research, such as the development of cancer vaccines, the development of more sensitive diagnostic tests for cancer, immunotherapy and the development of combination therapies, research that has the potential to transform the scientific field that has inherently higher risk, and that seeks to address major challenges associated with cancer.

9 Cancer Moonshot Initiatives

10 Cancer Moonshot Potential International Collaborations Japan Korea Australia Ireland Serbia Sweden Germany Poland Taiwan Denmark United Kingdom Norway

11 Questions?

A Few of the 2018 Cancer Moonshot Initiatives Immuno-Oncology Translation Network Fusion Oncoproteins in Childhood Cancers Consortium Approaches to Identify and Care for

12 A Few of the 2018 Cancer Moonshot Initiatives Immuno-Oncology Translation Network Fusion Oncoproteins in Childhood Cancers Consortium Approaches to Identify and Care for Individuals with Inherited Cancer Syndromes Human Tumor Atlas Network Accelerating CRC Screening & Follow-up through Implementation Science (ACCSIS) Rare Tumor Patient Engagement Network

13 Immuno-Oncology Translational Network (IOTN) Recommendation: Accelerate translation of basic discoveries to clinical applications to improve immunotherapy outcomes for both hot and cold cancers Implementation: Leverage the expertise and resources of a collaborative network of investigators focused on improving immunotherapy approaches The IOTN collaborates with other NCI Programs: o PREVENT, Early Clinical Trials, and ETCTN Cancer Immunotherapy Consortium Partnerships * Immunoprevention Pancreatic Data Management and Steering Resource Committee Center Steering Committee Lung Ovarian Immunogenomics Resource Centers o o o Cancer Immunotherapy Trials Network CIMACs and Data Commons Network Canine Immunotherapy Trials Prostate # TNBC ^MSI hi *GBM, Head & Neck, etc. Sync d with Tumor Atlas Group Colorectal^ Breast # Cell Therapy Data Registry & Biorepository o Pediatric Immunotherapy Discovery and Development Network

14 Drug targets? Fusion Oncoproteins in Childhood Cancers (FusOnC2) Consortium Recommendation: Improve our understanding of fusion oncoproteins in pediatric cancer. Implementation: Creation of a multi-disciplinary consortium of research teams taking a comprehensive approach to understanding the biology of fusion oncoproteins and developing therapeutics. EWSR1 FLI1 TAD TAD X EWSR FLI DBD DBD Fusion Oncoproteins o 3 Centers: Research Projects, Administrative Core, and Shared Resource Cores Focus on high risk fusion-driven cancers without existing effective targeted agents. Altered transcription complexes Aberrant activation of developmentally regulated genes Tumor initiation and progression

Approaches to Identify and Care for Individuals with Inherited Cancer Syndromes Recommendation: Improve prevention and early detection for individuals with an inherited predisposition and high risk

15 Approaches to Identify and Care for Individuals with Inherited Cancer Syndromes Recommendation: Improve prevention and early detection for individuals with an inherited predisposition and high risk for cancer. Implementation: Support collaborative, multidisciplinary research projects investigating the detection of hereditary cancers and delivery of care for high-risk individuals o o o Evidence-based services Behavioral and psychosocial effects of genetic testing Best practices for diagnostic and follow-up care Involves the development of sustainable approaches in diverse care settings and populations

from premalignancy to metastasis Implementation: Create a collaborative network to build high-priority human tumor atlases to

16 Human Tumor Atlas Network Experimental Measurements (HTAN) Recommendation: Generate 3D and 4D atlases of tumors over time Human Tumor Atlases o Describe molecular, cellular, and physiological events across multiple scales o Enable predictive modeling o Span from premalignancy to metastasis Implementation: Create a collaborative network to build high-priority human tumor atlases to understand transitions in cancer o HTA and Pre-Cancer Research Centers o Coordinating Center o NCI CCR Project Figure from A. Regev and HTAPP Team

Accelerating Colorectal Cancer Screening and follow-up through Implementation Science (ACCSIS)

detection ACCSIS Signature Trial Implementation: Signature Trial to determine effective implementation

Center Emphasis on addressing disparities in CRC screening and follow-up, including: o o o Underserved

(UG3) Phase 2 (UH3) Pilot Test Feasibility and pilot testing of multilevel intervention among a target

17 Accelerating Colorectal Cancer Screening and follow-up through Implementation Science (ACCSIS) Recommendation: Generate effective implementation strategies that substantially improve early cancer detection ACCSIS Signature Trial Implementation: Signature Trial to determine effective implementation approaches to increase colorectal cancer (CRC) screening o 3 Research Projects and a Coordinating Center Emphasis on addressing disparities in CRC screening and follow-up, including: o o o Underserved racial and ethnic minority populations Rural and hard-to-reach populations High-risk subgroups Phase 1 (UG3) Phase 2 (UH3) Pilot Test Feasibility and pilot testing of multilevel intervention among a target population Comparative effectiveness trial of implementation strategies to increase CRC screening and follow-up

Rare Tumor Patient Engagement Network Funded by the Cancer Moonshot. Build a national network to study selected rare pediatric and adult tumors and develop a network of clinical trials.

NCI-CONNECT Comprehensive Oncology Network Evaluating Rare CNS Tumors Leade

18 Rare Tumor Patient Engagement Network Funded by the Cancer Moonshot. Build a national network to study selected rare pediatric and adult tumors and develop a network of clinical trials. Partnering with patient advocacy networks. Partnering with centers of excellence to broaden the reach and impact. NCI-CONNECT Comprehensive Oncology Network Evaluating Rare CNS Tumors Leaders: Mark Gilbert, M.D., and Terri Arm strong, P h.d. Aims to advance our understanding of adult rare central nervous system cancers by establishing and fostering patient-advocacy-provider partnerships and networks to improve approaches to care and treatment. MyPART Moonshot Pediatric, Adolescent, and Adult Rare Tumors Netw ork Leaders: Karlyn e R e i l l y, Ph.D., and Brigitte W i d e mann, M.D. To increase patient and patient family involvement in rare tumor research and develop new therapies for rare pediatric and adult solid tumors through increased understanding of tumor biology and natural history

19 Summary of the Recommendations A. Network for direct patient engagement: Enlist patients in federated network where patients can pre-register for clinical trials and contribute their tumor profile data to expand knowledge about what therapies work and in whom. B. Cancer immunotherapy translation network. Organize a network to discover and evaluate novel immune-based approaches for adult and pediatric cancers, and eventually develop vaccines. C. Therapeutic target identification to overcome drug resistance. Launch interdisciplinary studies to delineate mechanisms that lead cancer cells to become resistant to previously effective treatments. D. Creation of a national cancer data ecosystem. Create an ecosystem to collect, share, and interconnect datasets. Blue Ribbon Panel 2016

20 Summary of the Recommendations (continued) E. Fusion oncoproteins in pediatric cancer. Improve understanding of the abnormal fusion proteins that result from chromosomal translocations and drive many pediatric cancers. F. Symptom management research. Support research to accelerate development of guidelines for management of patient-reported symptoms to improve quality of life and adherence to treatment regimens. G. Precision prevention and early detection: Implementation of evidence-based approaches. Conduct implementation science research to encourage broader adoption of HPV vaccination, colorectal cancer screening, and tobacco cessation. Blue Ribbon Panel 2016

21 Summary of the Recommendations (continued) H. Retrospective analysis of biospecimens from patients treated with standard of care. Analyze biopsies to learn which features predict outcome to better plan treatment for future patients. I. Creation of human tumor atlas. Catalog the evolution of genetic lesions and cellular interactions in tumor/immune/other cells in tumor microenvironment from the earliest detected lesions to metastasis and develop predictive models J. Development of new enabling technologies. Support development of technologies to accelerate testing of therapies and tumor characterization. Blue Ribbon Panel 2016

22 Process for Implementation of BRP Recommendations NCI Leadership Implementation Coordinating Committee Implementation Partnership Committee Cancer Moonshot Implementation Teams (CMIT) Aligned with BRP Recommendations

23 Cancer Moonshot Update: Status of FY17 Initiatives RFAs: Cancer Immune Monitoring and Analysis Centers Cancer Immunologic Data Commons Canine Immunotherapy Trials Coordinating Center for Canine Immunotherapy Consortium for Pancreatic Ductal Adenocarcinoma Translational Studies PDAC Resource Center Drug Resistance and Sensitivity New Enabling Technologies Administrative Supplements: Gene Fusions in Pediatric Sarcomas Smoking Cessation Program Tobacco Control in Cancer Patients Symptom Management Autoimmune Sequelae with NIAID New Technologies PDX Development and Trial Centers PDX Data Commons Center

24 Cancer Moonshot Update: Status of FY17 Initiatives FY 17 Moonshot Contracts Category Fusion Oncoproteins in Childhood Cancers Generation of Human Tumor Atlases National Cancer Data Ecosystem Network for Direct Patient Engagement New Enabling Technologies Retrospective Analysis of Biospecimens from Patients Treated with Standard of Care Therapeutic Target Identification to Overcome Drug Resistance Cancer Immunotherapy Translational Science (Pediatric and Adult) Prevention and Early Detection: Implementation Science Contract Pediatric Core BioBank Tumor Atlas Pilot Program Cancer Data Ecosystem Pilots FNLCR Contract Expand Data Commons and Data Sharing - FNLCR contract NCI Office of Data Coordination BioBank DOE-NCI Collaborations: Predictive models for preclinical screening; RAS-complex interaction modeling; Integration, analysis, and modeling of population information DOE-NCI Collaborations: Predictive models for preclinical screening; RAS-complex interaction modeling; Integration, analysis, and modeling of population information (DCCPS) Retrospective tumor characterization analysis for patients on trials Human Cancer Models Initiative (HCMI) - FLNCR Human Cancer Models Initiative (HCMI) - OA Contracts Clinical Center Lab Infrastructure for New Immunotherapy Cell-related Research (National Center for Cell-based Therapy) (Intramural) Costa Rica HPV Vaccine Trial Contract (Intramural)

25 Generation of Human Tumor Atlases Status of FY18 RFAs RFA Receipt Date Number of Apps CMIT RFA Title RFA Number Pediatric Immunotherapy Pediatric Immunotherapy Discovery and Development Network (PI-DDN)(U54) RFA-CA /19/17 3 Network Pediatric Immunotherapy Discovery and Development Network (PI-DDN)(U01) RFA-CA /19/17 25 Immuno-Oncology Translation Network (IOTN): Cancer Immunotherapy Research Projects (U01) RFA-CA /16/18 72 (56 NCI) Adult Immunotherapy Immuno-Oncology Translation Network (IOTN): Cancer Immunoprevention Research Projects (U01) RFA-CA /16/18 12 (9 NCI) Network Immuno-Oncology Translation Network (IOTN): Data Management and Resource-Sharing Center (DMRC) (U24) RFA-CA /16/18 3 Immuno-Oncology Translation Network (IOTN): Cellular Immunotherapy Data Resource (CIDR) (U24) RFA-CA /16/18 1 Target ID to Overcome Mechanisms of Cancer Drug Resistance and Sensitivity: Drug Resistance Coordinating Center (U24) RFA-CA /5/18 0 Fusion Oncoproteins Fusion Oncoproteins in Childhood Cancers (FusOnC2) Consortium (U54) RFA-CA /15/17 11 Analyzing and Interpreting Clinician and Patient Adverse Event Data to Better Understand Tolerability (U01) RFA-CA /18/18 7 Symptom Management Research Centers for Improving Management of Symptoms During and Following Cancer Treatment (UM1) RFA-CA /17/18 10 Coordinating Center for Research Centers for Improving Management of Symptoms During and Following Cancer RFA-CA /17/18 6 Treatment (U24) High Risk Cancers Approaches to Identify and Care for Individuals with Inherited Cancer Syndromes (U01) RFA-CA /9/18 23 Accelerating Colorectal Cancer Screening and follow-up through Implementation Science (ACCSIS)(UG3/UH3) RFA-CA /18/18 16 Prevention and Screening Accelerating Colorectal Cancer Screening and follow-up through Implementation Science (ACCSIS): Coordinating RFA-CA /18/18 7 Center (U24) Human Tumor Atlas Research Centers (U2C) RFA-CA /18/18 18 Pre-Cancer Atlas (PCA) Research Centers (U2C) RFA-CA /18/18 20 Human Tumor Atlas Network: Data Coordinating Center (U24) RFA-CA /18/18 6

26 Ongoing Partnership Discussions NCI Council of Research Advocates (NCRA) Rare Tumor Patient Engagement Network VA Connected Health Direct Patient Engagement Coalition Against Childhood Cancer (CAC2) Fusion Oncoproteins St. Baldrick s Foundation Pediatric Immunotherapy AACR Immunotherapy workshops OnPar All moonshot areas Chan-Zuckerberg Initiative Human Tumor Atlas Partnerships_CancerMoonshot@nih.gov

27 Status of FY17 Initiatives (Cont.) Partnerships Partnership for Accelerating Cancer Therapies APPOLLO Intramural National Center for Cell-based Therapy (CCR) Rare Tumor Patient Engagement Network PSMA-PET Imaging of High Risk Prostate Cancer Divide and Conquer with Combinations (DiCoCo): A Master Trial in Lymphoma Understanding, Measuring and Preventing Chronic GVHD across the lifespan

NCI Cancer Moonshot. Christine Siemon National Cancer Institute, NIH. November 30, 2017

NCI Cancer Moonshot. Christine Siemon National Cancer Institute, NIH. November 30, 2017 NCI Cancer Moonshot Christine Siemon National Cancer Institute, NIH November 30, 2017 Presidential Memo 2016 Overall Goals of the Cancer Moonshot Accelerate progress in cancer, including prevention & screening