Update: Planned Launch of ORIEN Avatar at City of Hope City of Hope and TGen Precision Medicine Symposium

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1 Update: Planned Launch of ORIEN Avatar at City of Hope City of Hope and TGen Precision Medicine Symposium Larry W. Kwak, M.D., Ph.D. Vice President and Deputy Director Comprehensive Cancer Center Director, Toni Stephenson Lymphoma Center Dr. Michael Friedman Professor for Translational Medicine & Xiaoyu Xia, Ph.D. Precision Medicine Project Manager June 13,

2 Larry W. Kwak, M.D., Ph.D. Disclosures I am a Consultant for PeproMene Bio, Xeme Biopharma, Sellas, Celltrion, Enzychem and Innolifes; and a Stock/Shareholder in Xeme Biopharma, PeproMene Bio and Innolifes. 2

3 Xiaoyu Xia, Ph.D. Disclosures I do not have anything to disclose. 3

4 Research trends favoring real world application of Precision Medicine As ongoing treatment efficacy is monitored in real time against multi-institutional data sets, treatment combinations can be increasingly tailored to individual tumor and host molecular profiles Newly developed models have the potential to determine ex vivo individual tumor sensitivity and resistance Prognostic, precision, low toxicity, and multidisciplinary combination therapies will all become standard of care 4

5 COH Precision Medicine Initiatives Vision COH will achieve for its patients greater health and wellness, by leveraging our strengths to rapidly exploit Omics discoveries into new standards of clinical care to prevent, predict, diagnose and treat disease. Guiding principles Our goal is not only to practice the standard of care (SOC), but also to invent the SOC (innovation) Every appropriate patient should have the opportunity to enroll in a data/specimen collection protocol Identify and leverage synergistic capabilities across both discovery research and clinical care Patient Entry Patient Data protocol Biospecimens Personalized Therapy Standard of Care Pathways Clinical trials (e.g NCI-MATCH) Real World Evidence Population Health Personalized Medicine/ Clinical Management Longitudinal Responder Profiles Bioinformatics/Data Warehouse (incl. integration with EMR, LIS, Oncore, LIMS) 5

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7 ORIEN Implementation A common protocol for consenting patients by all member institutions Meeting the challenges of drug discovery/development and clinical trials through a system that anticipates patient need Data from ORIEN Avatar will be made available to member institutions and pharma sponsors via M2Gen s informatics portals as well as through standard analytic tools 7

8 Benefits of ORIEN to City of Hope Longitudinal Follow-up Research Access Biomarker-driven Access Research Projects Financial Support Coordination Services of Patients granted by TCC Protocol to Large Multi-Centered Cohort Clinical Trial Enrollment by Avatar to Molecular and Clinical Data can be Proposed through ORIEN Network for Precision Medicine Needs ($1,500/Avatar Patient) via M2Gen 8

9 ORIEN Avatar Targeted Diseases Breast Cancer (Stage II/III and IV) o TNBC*, HER2+*, Malignant Phyllodes (All Stages) Cutaneous o Melanoma Cancer (State II/III and IV) o Other (Merkel, Squamous, Basal Cell Carcinoma) Thyroid Cancer Gastrointestinal o Esophageal o Gastric o Liver o Colorectal (State II/III and IV) * o Pancreatic* o Others (includes Appendix, small intestine) Genitourinary o Bladder (State II/III and IV) o Kidney (State III and IV) o Prostate (State III and IV) o Others (includes Upper Urinary Tract) Gynecologic o Ovarian* (Epithelial, Serous, Clear Cell, Endometrioid) o Others (includes Fallopian Tubes, Uterus, Cervix) Head and Neck Cancer Hematological* o Leukemia o Lymphoma o MDS/CMML o Multiple Myeloma o Others Neurological o Brain* (Astrocytoma, Glioblastoma, Oligodendroglioma) o Others Thoracic o Lung* (State II/III and IV) o Others Sarcoma Immuno-Oncology treated patients of all diseases * Special Interest of ORIEN pharmaceutical partners 9

10 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17 Jan-18 Feb-18 Mar-18 Apr-18 No. of Patients Consented ORIEN at City of Hope Joined in ,500+ Patients 3 rd member in the ORIEN consortium Enrolled in TCC Protocol 500 COH TCC Consent Progress by Month NPS 200 Clinics

11 Proposed ORIEN Avatar Tissue and Data Workflow - Overview Step 1. Consent & Tissue Collection (Site: City of Hope) Step 2. Avatar Eligibility Determination (Site: City of Hope) Step 3. Biospecimen Workflow (Sites: City of Hope and TGen) Step 4. Generation & Return of Results (Sites: City of Hope and TGen) 11

12 Proposed ORIEN Avatar Tissue and Data Workflow Solid Tumors and Lymphoma Step 1. Consent & Tissue Collection Patient NPS and Pre-Anes Clinc Patient Consent to TCC, After Consented to General Research Consent (GRC, IRB 07047) Specimen collection Blood Surgical/Core Biopsy Blood Banked (Molecular Pathology) FFPE Biospecimen Banked 12

13 Proposed ORIEN Avatar Tissue and Data Workflow Solid Tumors and Lymphoma Step 2. Avatar Eligibility Determination Report Based on: Consent Status Inclusion Criteria Speci Coord Biospecimen Log Germline Sample Availability Review Path Report Manually to Confirm Stage and Diagnosis Matches Avatar Criteria Retrieve Inhouse FFPE Blocks Request to Retrieve Outside FFPE Pathologist Review to Ensure Specimen Meets Avatar Tissue Quality Standard Confirm Eligible Patient as Avatar Patient 13

14 Proposed ORIEN Avatar Tissue and Data Workflow Solid Tumors and Lymphoma Step 3. Biospecimen Workflow Generate Avatar Patient ID from M2Gen Speci Coord Request to Section FFPE Blocks in Path Core Lab Generate Avatar Biospecimen ID Speci Coord Gather Specimen & Matching Blood Samples (Molecular Pathology) Speci Coord Ship to TGen Avatar Clinical Data Abstraction Data Mgr 6-month Interval Follow-up Data Until Patient Expires 14

15 Proposed ORIEN Avatar Tissue and Data Workflow Solid Tumors and Lymphoma Step 4. Generation & Return of Results TGen Performs Sequencing (Research Grade) Whole Exome RNA Seq Access Qlik platform for Matched Annotated Sequencing Data Clinical Data Download and Store Raw Sequencing Data from DNA Nexus AWS Environment 15

16 Clinical Data Abstraction for Avatar Demographics o Gender, Ethnicity, Race o Date of First Contact o Date of Diagnosis o Primary Site of Diagnosis o Histology Clinical Staging o ct, cn, cm Stage Pathological Staging o pt, pn, pm Stage o Performance Status at Diagnosis o Most Recent Performance Status o Current Disease Status Comorbidities Drug-related Toxicities >Grade 2 Family History of Cancer Treatment o Surgery/Biopsy History o Current Status on a Clinical Trial Treatment Medications o Immunotherapy o Anti-neoplastic o Hormone o Radiation Imaging Tumor Markers Vital Status 16

17 Yearly COH ORIEN Avatar Patient Estimation * Assumptions made based on current consent data, and surgical resection cases screened for Avatar. Attrition rate varies largely on disease types and specimen types. TCC Consented Patients at COH (~4,000/year*) Fits Avatar Inclusion Criteria (4,000 x 80%* = 3,200) Available In house Specimen (3,200 x 60%* = 1,920) Pass Pathology QC (1,920 x 50%* = 960) Matching Germline Available (960 x 70%* = 672) Outside Specimen (3,200 x 40%* = 1,280) Retrievable Outside Specimen (1,280 x 50%* = 640) Pass Pathology QC (640 x 50%* = 320) Matching Germline Available (320 x 70%* = 224) Yearly Avatar Patients Estimation ~

18 Your Participation is Needed to Successfully Launch ORIEN Avatar at City of Hope Collaborate with ORIEN operational team on determining patient eligibility and specimen availability for Avatar Propose research projects utilizing ORIEN infrastructure and data generated from ORIEN Avatar Participate in collaborative research projects from ORIEN consortium (Ex. NOVA Award) Engage in ORIEN research community (Ex. joining a Disease Interest Group-DIG) 18

19 Thank you 19

20 ORIEN Ecosystem Benefiting all Stakeholders in the Healthcare Ecosystem Cancer Centers 20

21 ORIEN Progress ORIEN Member Institutions 18 Pharmaceutical Sponsors 5 TCC Enrolled Patients 200,000 + Avatar Patient Sequence Inter-member Research Projects 40 + Disease Interest Groups

22 Total Cancer Care Protocol (TCC) - A Common Protocol for Patient Enrollment Collect from enrolled patient: Tissue Specimens A Common Protocol Molecular Data Longitudinal Clinical Data Follow the patient throughout his/her lifetime permitting sharing of data and information Study the patient s tumor using molecular technology Maintain ongoing contact with each patient 22

23 ORIEN Avatar Anticipating Need for Biomarker-Driven Clinical Trials TCC consented patients donate tissue and data for partners to use to actively track patients for enrollment to biomarker driven clinical trials Patients are genotypically and clinically profiled at time of TCC consent actively tracked for recurrence/disease progression and are matched to Trials in real time as they become eligible 23

24 ORIEN Informatics Data collected under TCC Protocol and Avatar Data To be Shared with M2Gen and Pharma Sponsors Clinical Tissue Avatar Molecular Longitudinal Diagnosis & Stage Consent File Cancer Registry Non-reportable/- analytical Pathological Quality Collection and Shipping Details Disease Status Treatment Info Radiology Comorbidities Tumor Markers Sequencing Results DNA RNA 6-month Follow-up Vital Status Family History Progress Through ORIEN Avatar 24

ORIEN Informatics Providing Raw and Analyzed Data

Vendors Sequencing vendors will perform sequencing

Molecular Data Hosting DNAnexus platform allows users

environment Data Warehouse Cloudticity manages and

and ORIEN members Data Visualization Vendor Qlik

25 ORIEN Informatics Providing Raw and Analyzed Data Through Secured Cloud Platform Molecular Sequencing Vendors Sequencing vendors will perform sequencing tests on samples from M2Gen and ORIEN members Molecular Data Hosting DNAnexus platform allows users to share and manage genomic data in a secured environment Data Warehouse Cloudticity manages and hosts HIPAAcompliant data warehouse on AWS for M2Gen and ORIEN members Data Visualization Vendor Qlik allows interrogation, visualization and analysis of clinical and molecular data 25

26 ORIEN 17 Members Click to edit Master title style 26

27 ORIEN 5 Pharma Sponsors Click to edit Master title style 27

28 COH ORIEN Organizational Chart Steven Rosen, MD Co- chairs Larry Kwak, MD PhD Sorena Nadaf, MS MMI Operations Xiaoyu Xia, PhD Proj Mgr Omar Khalid, PhD Informatics Dir Yvette Estrada CRC Carlos Luna-Gomez Biospec Coord Vincent La Data Mgr Scientific Informatics Data and Specimen Committees Bus & Ops Contract PR & Marketing Patient Advisory TCC Protocol Disease Teams Sorena Nadaf, MS MMI Omar Khalid, PhD Xiaoyu Xia, PhD Xiaoyu Xia, PhD Omar Khalid, PhD Yvette Estrada Carlos Luna- Gomez Ashley Baker Lee Xiaoyu Xia, PhD Benjamin Diamond, Esq Chantal Roshetar Matthew Loscalzo Vincent Chung, MD Yvette Estrada Xiaoyu Xia, PhD Leslie Popplewell, MD Karen Miller Leticia Najera 28

29 2 Avatar Pilots Piloting with: o 1 solid tumor cancer: Colorectal Cancer Stage 3, surgical resection o 1 Hematological Malignancy: CLL Rationale: o Line-up specimen, ready to ship when COH Avatar Agreement is signed TGen Lab is ready for sequencing for ORIEN o Refined proposed workflow o Establish point of contact for each step of the workflow Goal: o 10 patients each a) Confirmed Avatar Patients with both tumor and normal specimen available b) Avatar clinical data abstracted 29

The Cancer Genome Atlas

The Cancer Genome Atlas July 14, 2011 Kenna M. Shaw, Ph.D. Deputy Director The Cancer Genome Atlas Program TCGA: Core Objectives Launched in 2006 as a pilot and expanded in 2009, the goals of TCGA are