`
`Curriculum Vitae
`
`
`Date Prepared:
`Name:
`Office Address:
`
`Home Address:
`
`Molecular Biochemistry and Biophysics Yale University, New Haven, CT
`B.S.
`Molecular Biochemistry and Biophysics Yale University, New Haven, CT
`M.S.
`Medicine
`Washington University, St. Louis, MO
`M.D.
`M.M.Sc. Clinical Investigation
`Harvard University, Boston, MA
`
`January 1, 2018
`Daniel Chang Cho
`160 East 34th Street
`New York, New York 10016
`
`41-22 42nd Street, Apt 4K
`Sunnyside, NY
`
`Work Phone:
`212-731-5871
`Work Email:
`Daniel.Cho@nyumc.org
`Work FAX:
`212-731-5545
`Place of Birth: Washington, D.C.
`
`
`
`Education
`
`
`05/96
`
`
`05/96
`
`
`05/00
`06/07
`
`Postdoctoral Training
`
`
`06/00-07/01
`Internship
`
`
`07/01-07/03 Residency
`
`
`07/03-07/06
`Fellowship
`
`Faculty Academic Appointments
`
`
`06/00-06/06
`Clinical Teaching Fellow Medicine
`
`
`07/06-02/11
`Instructor
`Medicine
`
`
`03/11-09/13
`Assistant Professor
`Medicine
`12/13-2/17
`Assistant Professor
`Medicine
`
`
`
`Internal Medicine
`Internal Medicine
`Hematology and Oncology
`
`Beth Israel Deaconess Medical Center
`Beth Israel Deaconess Medical Center
`Beth Israel Deaconess Medical Center
`
`Harvard Medical School
`Harvard Medical School
`Harvard Medical School
`NYU School of Medicine
`
`1
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 001
`
`

`

`
`
`Appointments at Hospitals/Affiliated Institutions
`
`
`6/00-07/06
`Teaching Fellow
`Medicine
`
`
`07/06-09/13 Attending Oncologist Hematology and
`
`Oncology
`
`12/13-pres
`Attending Oncologist Hematology and
`Oncology
`
`Beth Israel Deaconess Medical Center
`Beth Israel Deaconess Medical Center
`
`Laura and Isaac Perlmutter Cancer
`Center at NYU Langone
`
`
`Other Professional Positions
`
`
`01/12-2016 Chairman, Proclivitiy Safety Committee
`
`
`
`
`Major Administrative Leadership Positions
`07/07-09/13 Course Director, Hematology and Oncology
`
`
`Grand Rounds
`
`
`03/10-09/13 Director, Experimental Therapeutics
`Program
`Director, Developmental Therapeutics
`Program
`Director, Translational Research Laboratory
`
`
`12/13-pres
`
`12/13-pres
`
`
`
`
`Committee Service
`07/06-09/13 DF/HCC Renal Cancer Program Clinical
`
`Trials Subcommittee
`
`
`07/06-09/13 Fellowship Selection Committee
`
`Division of Hematology and Oncology
`
`
`07/08-09/13 Scientific Review Committee 2
`07/08-09/13 GU Sub-Committee
`03/10-09/13 Translational Pharmacology and Early
`Therapeutic Trials Steering Committee
`Protocol Review and Monitoring
`Committee
`
`01/14-pres
`
`01/14-pres
`
`Co-Chair, Phase I/II Committee
`
`01/14-pres
`
`Data Safety Monitoring Committee
`
`Professional Societies
`
`Prometheus Pharmaceuticals
`
`Beth Israel Deaconess Medical Center
`
`Beth Israel Deaconess Medical Center
`
`Laura and Isaac Perlmutter Cancer Center at
`NYU Langone
`Laura and Isaac Perlmutter Cancer Center at
`NYU Langone
`
`Dana-Farber / Harvard Cancer Center
`
`Beth Israel Deaconess Medical Center
`
`Dana-Farber / Harvard Cancer Center
`Eastern Cooperative Oncology Group
`Dana-Farber /Harvard Cancer Center
`
`Laura and Isaac Perlmutter Cancer Center at
`NYU Langone
`
`Laura and Isaac Perlmutter Cancer Center at
`NYU Langone
`
`Laura and Isaac Perlmutter Cancer Center at
`NYU Langone
`
`2
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 002
`
`

`

`
`
`America Society of Clinical Oncology
`American Association for Cancer Research
`Eastern Cooperative Oncology Group
`Kidney Cancer Association
`
`07/04-
`07/05-
`07/05-
`07/06-
`
`Grant Review Activities
`07/11-
`New Agents Committee
`
`
`
`
`
`Cancer Research UK
`
`
`
`
`Editorial Activities
`
`
`Editorial Board Member, Journal of Kidney Cancer and VHL
`Ad Hoc Reviewer Cancer Research
`Ad Hoc Reviewer Clinical Cancer Research
`Ad Hoc Reviewer Cancer
`Ad Hoc Reviewer Clinical Genitourinary Cancer
`
`Honors and Prizes
`
`
`05/00
`Barnes Hospital Caring
`
`Spirit Award
`
`
`05/05
`Paul Carbone Award
`
`
`11/05
`
`06/06
`
`06/06
`
`AACR-Barletta Award for
`Translational Research
`Career Development
`Award
`ASCO Career
`Development Award
`
`Barnes Jewish Hospital
`
`Eastern Cooperative Oncology
`Group
`American Association for
`Cancer Research
`DF/HCC Renal Cancer
`SPORE
`American Society of Clinical
`Oncology
`
`Clinical Care
`
`Clinical Investigation
`
`Translational Research
`
`Bench Research
`
`Clinical Investigation
`
`
`
`Report of Funded and Unfunded Projects
`Funding Information
`Past
`
`
`05/05-04/06 A Phase I Trial of Denileukin Difitox in combination with HD IL-2 in Patients with
`
`Metastatic Melanoma.
`
`Paul Carbone Fellowship Award
`ECOG
`PI ($25,000)
`
`
`
`
`
`
`
`
`
`
`
`
`
`3
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 003
`
`

`

`
`
`The major goal of this project was to determine if Denileukin Difitox (Ontak) could
`suppress Regulatory T-Cell levels when given prior to HD IL-2.
`11/05-10/06 Predictive Biomarkers for Molecularly Targeted Agents in Renal Cell Carcinoma
`AACR-Barletta Foundation Fellows Grant for Translational Research
`AACR-Barletta Foundation
`
`
`PI ($35,000)
`The major goal of this project was to evaluate pre-treatment pathologic surrogates of
`targeted pathway activation to predict response to various molecularly targeted pathways
`in RCC. Through this study we were able to show that enhanced expression of phospho-S6
`and phospho-Akt in pre-treatment nephrectomy specimens may predict for response to the
`mTOR inhibitor temsirolimus.
`Identification of Novel Molecular Targets in Renal Cell Carcinoma
`Harvard/MIT Clinical Investigator Training Program
`Pfizer/Merck
`
`
`
`PI ($150,000)
`This project lead to the development of a phase II trial of the oral Akt inhibitor Perifosine
`in patients with advanced RCC. The training program also culminated in the awarding of a
`M.Sc. in Clinical Investigation from Harvard University.
`
`07/05-06/07
`
`06/07-05/09 Potential Synergy Between Triterpenoids and NADPH Oxidase Inhibitors in RCC
`DF/HCC Renal Cancer SPORE Developmental Project
`NIH/NCI P50CA101942
`
`
`
`Investigator
`
`
`The goal of this project was to evaluate the ability of the synthetic triterpenoid RTA 402 to
`downmodulate HIF activity. My role was to perform the in vitro assays.
`06/07-05/09 Enhancing the Efficacy of Sorafenib and Sunitinib in the Treatment of Advanced RCC by
`Concurrent Inhibition of Additional Kinases
`DF/HCC Renal Cancer SPORE Career Development Award
`NIH/NCI P50CA101942-05
`
`PI ($80,000)
`This main objective of this project was to determine if the anti-tumor efficacy of anti-
`angiogenic agents such as sorafenib and sunitinib could be enhanced through the inhibition
`of additional kinases. This work has lead to the identification of glycogen synthase kinase
`3β as a potential target in RCC therapy in combination with sorafenib.
`06/09-08/09 Targeting the PI3-K/Akt/mTOR in Renal Cell Carcinoma PI
`
`ASCO Career Development Award
`
`ASCO
`
`
`
`
`PI ($200,000)
`The major goal of this study was to identify predictive and pharmacodynamic biomarkers
`of response and/or resistance to inhibitors of PI3-K or mTOR in RCC through two
`prospective phase II clinical trials. A secondary objective was to explore potential
`pathways of resistance to PI3-K inhibitors in RCC so as to identify and direct potential
`combinational regimens with novel agents targeting these pathways. This award was
`relinquished with the funding of the K08 Award.
`08/09-09/09 Targeting the PI3-K/Akt Pathway for the Therapy of Renal Cell Carcinoma
`ACS Mentored Clinical Scientist Award
`4
`
`
`
`
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 004
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`American Cancer Society
`PI ($729,000)
`This major goal of this project was to investigate the mechanism of response and resistance
`of RCC to inhibitors of the PI3-K/Akt and develop rational combinational regimens using
`available molecularly targeted agents. This award was relinquished with the funding of the
`K08 Award.
`09/09-08/14 Targeting the PI3-Kinase/Akt Pathway for the Therapy of Advanced Renal Cell Carcinoma
`K08 Mentored Clinical Scientist Award
`NIH/NCI 1 K08CA142890-01
`
`PI ($785,000)
`The major goals of this project are to identify the mechanism of persistent production of
`VEGF and GSK3β activation as a result of PI3-K/mTOR inhibition and evaluate the
`therapeutic value of inhibiting either VEGF signaling or GSK3β activity in conjunction
`with PI3-K/mTOR inhibition.
`06/09-05/14 Targeting the PI3-Kinase/ Akt Pathway in RCC: Mechanism of Action and Opportunities
`for Rational Combination Therapy
`DF/HCC Renal Cancer SPORE Project 4
`NIH/NCI P50CA101942-05S1
`Co-Leader
`This major goal of this project is to investigate the mechanism of response and resistance
`of RCC to inhibitors of the PI3-K/Akt and develop rational combinational regimens using
`available molecularly targeted agents. My role is to perform all of the molecular assays
`and xenograft studies as well as write and conduct the phase II clinical trial proposed with
`NVP-BEZ235, a novel inhibitor of PI3-K/mTOR.
`03/10-02/14 Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis
`NIH/NCI 5U01CA062490-17
`Investigator
`The major role of this project to fund the infrastructure to facilitate the conduction of Phase
`I and early therapeutic clinical trials. My role is to participate in this DF/HCC
`collaboration as the Director of the BIDMC Phase I Program.
`
`
`
`
`
`
`
`
`Current
`
`None
`
`
`
`Report of Local Teaching and Training
`Teaching of Students in Courses
`07/05-09/13 HMS Patient Doctor II, Preceptor,
`
`1st Year Medical Students
`
`
`
`
`
`Formal Teaching of Residents, Clinical Fellows and Research Fellows (post-docs)
`
`5
`
`
`
`
`Harvard Medical School
`3 hour sessions for 6 weeks
`
`
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 005
`
`

`

`
`
`07/06-09/13 Firm Conference Consultant, Medical
`Residents
`07/10-09/13 Fellows Basic Science Seminar,
`Hematology/Oncology Fellows, Lecturer
`
`01/14-pres
`
`Genitourinary Cancer Didactics
`Hematology/Oncology Fellows, Lecturer
`
`
`
`
`Clinical Supervisory and Training Responsibilities
`
`07/06-09/13 Biologics Therapy Clinic, Supervision of
`Fellows, Attending Physician
`
`
`Inpatient OMED Service, Supervision of
`07/07-09/09
`Medical Residents, Attending Physician
`03/10-09/13 Director, Phase I Program, Supervision of
`Fellows, Attending Physician
`Precept Fellows in Bellevue Hospital Clinic
`
`Beth Israel Deaconess Medical Center
`6 hours per year
`Beth Israel Deaconess Medical Center
`1-2 hours
`
`Laura and Isaac Perlmutter Cancer
`Center at NYU Langone
`
`Beth Israel Deaconess Medical Center
`
`Beth Israel Deaconess Medical Center
`
`Beth Israel Deaconess Medical Center
`
`
`
`
`
`
`
`NYU School of Medicine
`
`12/13-Pres
`
`
`Formally Supervised Trainees
`07/06-06/09 Ryan Sullivan M.D., Hematology and Oncology Fellow
`
`Supervised both laboratory and clinical research activities
`
`Awarded the ECOG Paul Carbone Award, Career Development Award from the DF/HCC
`
`Melanoma SPORE, and the ASCO Career Development Award. Assistant Professor,
`
`Harvard Medical School, Massachusetts General Hospital
`07/08-06/10 Elizabeth Buchbinder M.D., Hematology and Oncology Fellow
`Supervised laboratory activities which lead the awarding of the ASCO Young Investigator
`Award. Hired to a staff position at DFCI, Instructor, Harvard Medical School.
`07/08-07/10 Matthew Cohen B.S., Research Assistant
`Direct, one-on-one training on basic laboratory techniques including western blotting, RT-
`PCR, ELISA, cloning, cell culture technique, and animal work.
`Third-year Medical Student at Boston University and recently awarded the Betty Lea
`Stone Fellowship from the American Cancer Society to continue his work with us in the
`summer of 2010; Instructor, Harvard Medical School
`01/10-06/12 Shudong Zhu, PhD, Post-doctoral Research Fellow
`Direct supervision of laboratory research activities which include elucidation of the role of
`the unfolded protein response in the resistance of RCC to antiangiogenic therapies.
`Awarded a Developmental Project Award from DF/HCC Renal SPORE to support this
`work; Professor, Central South University, Changsha
`
`
`Formal Teaching of Peers (e.g., CME and other continuing education courses)
`06/06
`“Studies in TKI Refractory RCC Patients”
`
`Single Presentation
`
`Harvard Medical School
`
`
`
`
`6
`
`
`
`
`
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 006
`
`

`

`
`
`
`
`
`
`Regional Renal Cancer Symposium, Boston MA
`
`
`
`07/06
`
`01/09
`
`02/09
`
`06/09
`
`
`Local Invited Presentations
`06/06
`“Renal Cancer: Staging and Prognosis”, BIDMC RCC Preceptorship / Lecturer,
`
`Beth Israel Deaconess Medical Center
`
`06/06
`“Novel Therapies in Renal Cancer”, BIDMC RCC Preceptorship / Lecturer,
`
`
`Beth Israel Deaconess Medical Center
`“Studies in TKI Refractory RCC Patients”, DF/HCC Renal SPORE Monthly Lecture
`Series / Invited Speaker, Dana-Farber/Harvard Cancer Center
`“Targeting PI3-K/Akt in RCC”, DF/HCC Renal SPORE Monthly Lecture Series / Invited
`Speaker, Dana-Farber/Harvard Cancer Center
`“Targeting PI3-K/Akt in RCC”, Cancer Biology Seminar / Invited Speaker,
`Beth Israel Deaconess Medical Center
`“PI3-K/mTOR”, DF/HCC Renal SPORE Scientific Retreat / Invited Speaker,
`Commonwealth Hotel, Boston, MA
`”Endoplasmic Reticular Stress in HCC”, HCC Research Symposium / Invited Speaker,
`Massachusetts General Hospital
`“Targeting PI3K-Akt in Renal Cancer”, Dana Farber Genitourinary Seminar Series /
`Invited Speaker, Dana Farber Cancer Institute
`“Phase I Clinical Trials”, Cancer Biology Faculty Seminar / Invited Speaker,
`Beth Israel Deaconess Medical Center
`“PD-1 and PD-L1 Antibodies for the Treatment of Advanced Solid Malignancies”, NYU
`Department of Medicine Grand Rounds / Invited Speaker, NYU Langone Medical Center
`
`09/09
`
`01/10
`
`03/11
`
`03/14
`
`
`
`Report of Regional, National and International Invited Teaching and
`Presentations
`Invited Presentations and Courses
`
`National
`02/10
`
`
`
`06/10
`
`
`“PI3-K/Akt Inhibitors in RCC”, 2010 Genitourinary ASCO Meeting / Invited Speaker,
`San Francisco, CA
`“Targeting the PI3-Kinase in RCC”, 2010 Innovations and Challenges in Kidney Cancer:
`3rd Cambridge Conference, Boston, MA
`“PD-1 and PD-L1 Antibodies in Renal Cell Carcinoma”, 2013 Chemotherapy Foundation
`Symposium / Invited Speaker, New York, NY
`“Developments in Immunotherapy”, 2016 Korean-American Medical Association National
`Meeting / Invited Speaker, Pallisades Park, NJ
`
`7
`
`
`
`11/13
`
`08/16
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 007
`
`

`

`
`
`
`
`International
`10/07
`
`
`
`10/07
`
`
`10/09
`
`03/10
`
`09/10
`
`09/11
`
`09/12
`
`06/13
`
`“Novel Therapies in RCC: Perifosine”, 6th International Kidney Cancer Symposium /
`Invited Speaker, Chicago, IL
`“Biomarkers for mTOR inhibitors”, 6th International Kidney Cancer Symposium / Invited
`Speaker, Chicago, IL
`“PI3-K/Akt Inhibitors in RCC”, 8th International Kidney Cancer Symposium / Invited
`Speaker, Chicago, IL
`“New Pathways in RCC”, 5th Annual European Kidney Cancer Symposium / Invited
`Speaker, London, England
`Chair, Oral Abstract Session
`9th International Kidney Cancer Symposium / Session Chair
`“Novel Inhibitors of the PI3-K/Akt/mTOR Pathway”, 10th International Kidney Cancer
`Symposium/ Invited Speaker, Chicago, IL
`“Novel Inhibitors of PI3-K”, 11th International Kidney Cancer Symposium, Invited
`Speaker, Chicago, IL
`”Clinical activity, safety, and biomarkers of MPDL3208A, an enginerred PD-L1 antibody
`in patients with metastatic renal cell carcinoma”, 2013 ASCO Annual Meeting, Oral
`Abstract Presentation, Chicago, IL
`
`
`
`
`
`Report of Clinical Activities and Innovations
`Current Licensure and Certification
`
` 07/02-2015 Full License, Massachusetts (214680)
`
`
`11/03-2013 Board Certification, Internal Medicine
`11/06-
`Board Certification, Medical Oncology (re-certified 2016)
`11/13-
`Full License, New York (272990)
`
`Practice Activities
`
`12/13-Pres
`
`Ambulatory Care
`
`12/13-Pres
`
`Ambulatory Care
`
`12/13-Pres
`
`Inpatient Care
`
`12/13-Pres
`
`Inpatient Care
`
`Genitourinary Oncology Clinic
`(Prostate, Bladder, Renal Cancer)
`Phase I Clinic (solid tumors
`including more than 20% lung
`cancer, GI malignancies, ovarian
`CA, etc)
`Inpatient Oncology Service,
`Tisch Hospital
`Inpatient Oncology Consult
`Service, Bellevue Hospital
`
`4 sessions per week
`
` 2 sessions per week
`
`Two weeks per year
`
`Two weeks per year
`
`8
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 008
`
`

`

`
`
`
`Current Clinical Trials
`A Phase 1b study of ONT 10 and Varlilumab in Patients with Advanced Ovarian Cancer or Breast Cancer
`(PI: Cho) – Closed to Accrual
`
` A
`
` Phase 1 Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Tremelimumab (Anti-
`CTLA-4 Antibody) in Subjects with Advanced Solid Tumors (PI: Cho)
`
`Phase 1B Open Label, Dose Finding Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics
`Of Axitinib (AG-013736) In Combination With MK-3475 In Patients With Advanced Renal Cell Cancer
`(PI: Cho)
`
` A
`
` Phase 1 Trial of REGN2810 alone or in combination with radiation therapy, cytoxan, or both in patients
`with advanced malignancies (PI: Cho)
`
` A
`
` Phase II, Open-label, Study in Subjects with BRAF V600E Mutated Rare Cancers Combination
`Therapy of Dabrafenib and Trametinib (PI: Cho)
`
`Phase 2 Randomized Double-Blind Study Of Dalantercept In Combination With Axitinib Compared To
`Axitinib Alone In Patients With Advanced Renal Cell Carcinoma (PI: Cho)
`
` A
`
` Phase I, Open-Label, Dose Finding Study of GSK2636771 Administered in Combination with
`Enzalutamide (Xtandi) in Male Subjects with Metastatic Castration-Resistant Prostate Cancer (PI: Cho)
`
`Phase IB, Open-Label Trial of Avelumab with Axitinib in Patients with Untreated Advanced Renal Cell
`Cancer (PI: Cho)
`
` A
`
` Phase 3, Multinational, Randomized, Open-Label, Parallel-Arm Study Of Avelumab (MSB0010718C)
`In Combination With Axitinib (Inlyta(Registered)) Versus Sunitinib (Sutent(Registered)) Monotherapy In
`The First-Line Treatment Of Patients With Advanced Renal Cell Carcinoma (PI: Cho)
`
` A
`
` Platform Study Exploring the Safety, Tolerability, Effects on the Tumor Microenvironment, and
`Efficacy of Pembrolizumab (MK-3475) + INCB Combinations in Advanced Solid Tumors (PI: Cho)
`
` A
`
` Phase I, Open-Label Study of GSK3174998 Administered Alone and in Combination with Anticancer
`Agents including Pembrolizumab in Subjects with Selected Advanced Solid Tumors (PI: Cho)
`
` A
`
` A
`
` Phase 1 Study of ALKS 4230 in Subjects with Advanced Solid Tumors (PI: Cho)
`
` Phase 1 Open-Label Study of the Safety, Tolerability and Efficacy of KPT-9274, a Dual Inhibitor of
`PAK4 and NAMPT, in Patients with Advanced Solid Malignancies or Non-Hodgkin’s Lymphoma (PI:
`Cho)
`
` A
`
` Phase 2, Multicenter, Single-arm Study to Assess the Safety, Feasibility, and Efficacy of Cell Transfer
`Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-144) Followed by IL-2 for Treatment of
`Metastatic Melanoma (PI: Cho)
`
`
`9
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 009
`
`

`

`
`
`A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR 214 in
`Subjects with Locally Advanced or Metastatic Solid Tumor Malignancies (PI: Cho)
`
` A
`
` Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects
`With Advanced or Metastatic Solid Tumors (PI: Cho)
`
` A
`
` Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-214 and
`Nivolumab in Subjects with Locally Advanced or Metastatic Solid Tumor Malignancies (PI: Cho)
`
`An open-label, dose-finding and proof of concept study for Probody Therapeutics (Probody Tx) in
`subjects with metastatic or locally advanced unrespectable solid tumors and/or lymphoma (PI: Cho)
`
` A
`
` multinational, open-label, dose escalation Phase I/II study to assess the safety and clinical activity of
`multiple administrations of NKR-2 in patients with different metastatic tumor types (PI: Cho)
`
` A
`
` Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, and Immunogenicity of
`mRNA-4157 Alone in Subjects with Resected Solid Tumors and in Combination with Pembrolizumab in
`Subjects with Unresectable Solid Tumors (PI: Cho)
`
` A
`
` Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x
`CD3 Dual-Affinity Re-Targeting (DART®) Protein in Patients with Unresectable or Metastatic B7-H3-
`Expressing Neoplasms and Neoplasms whose Vasculature Expresses B7-H3 (PI: Cho)
`
` A
`
` Phase II Single-arm, Open-label Monotherapy Clinical Trial of Pembrolizumab (MK-3475) in
`Advanced Renal Cell Carcinoma (RCC) (KEYNOTE-427) (PI: Cho)
`
` A
`
` Phase I/II Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of
`Anti-CD27 Antibody (Varlilumab) Administered in Combination with Anti-PD-1 (Nivolumab) in
`Advanced Refractory Solid Tumors (PI: Cho)
`
` A
`
` Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety,
`Tolerability, Activity and Pharmacokinetics of REGN3767 (anti-LAG-3 mAb) Administered Alone or in
`Combination with REGN2810 (anti-PD-1 mAb) in Patients with Advanced Malignancies (PI: Cho)
`
` A
`
` Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab in Advanced
`Malignant Tumor (PI: Cho)
`
` A
`
` Phase I Open Label Study of GSK3359609 Administered Alone and in Combination with Anticancer
`Agents in Subjects with Selected Advanced Solid Tumors (PI: Cho)
`
`Report of Education of Patients and Service to the Community
`Activities
`06/07
`
`
`
`09/07
`
`BIDMC Celebration of Life Conference / Speaker, New Therapies in RCC, Boston,
`MA
`Kidney Cancer Association Regional Patients Conference / Speaker, Novel Therapies
`
`10
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 0010
`
`

`

`
`
`09/07
`
`09/08
`
`09/10
`
`in RCC, Cambridge, MA
`VHL Family Alliance Conference / Invited Speaker, Recent Advances in RCC
`Therapy, Boston, MA
`Kidney Cancer Association Regional Patients Conference / Speaker, Immune
`Therapies in RCC, Cambridge, MA
`Kidney Cancer Association Regional Patients Conference / Speaker, Novel Therapies
`in RCC, Newton, MA
`
`
`
`Report of Scholarship
`Publications
`
`
`
`Peer reviewed publications in print or other media
`
`
`
`
`
`1. Cho DC, Scharl EC, Steitz JA. Decreasing the distance between the two conserved sequence
`elements of histone pre-messenger RNA interferes with 3' processing in vitro. RNA 1995. 1(9):
`905-14.
`2. Abendschein DR, Yang LY, Chun J, Cho D, Scherrer D, St Pierre J. Prolonged procoagulant
`activity on overstretch-injured coronary arteries in pigs. J Thromb Haemost 2003. 1(4): 836-42.
`3. Chan B, Sinha S, Cho D, Ramachandran R, Sukhatme V. Critical roles of CD146 in zebrafish
`vascular development. Dev Dyn 2005. 232(1): 232-44.
`4. Cho D, Kocher O, Pasi JA, Halmos B. Mutation of the epidermal growth factor receptor in an
`elderly male with advanced, gefitinib-responsive non-small cell lung cancer. J Clin Oncol 2005.
`1; 23(1), 235-.
`5. Cho D, McDermott D, Atkins MB. Designing clinical trials for kidney cancer based on newly
`developed prognostic and predictive tools. Curr Urol Rep 2006; 7(1): 2309-2313.
`6. Cho D, Signoretti S, Regan M, Mier JW, Atkins MB. The role of mammalian target of
`rapamycin inhibitors the treatment of advanced renal cancer. Clin Cancer Res 2007; 13(2): 758s-
`63s.
`7. Cho D, Signoretti S, Dabora S, Regan M, Seeley A, Mariotti M, Youmans A, Polivy A, Mandato
`L, McDermott D, Stanbridge E, Atkins M. Potential histologic and molecular predictors of
`response to temsirolimus in patients with advanced renal cell carcinoma. Clin Genitourin Cancer
`2007; (6):379-85.
`8. Panka DJ, Cho DC, Atkins MB, Mier JW. GSK-3β inhibition enhances sorafenib-induced
`apoptosis in melanoma cell lines. J Biol Chem 2007. 283(2):726-32.
`9. Atkins MB, Choueiri T, Cho DC, Regan M, Signoretti S. Treatment selection for patients with
`metastatic renal cancer. Cancer 2009; 115(S10): 2327-2333.
`10. Cho DC, Puzanov I, Regan MM, Schwarzberg T, Seery V, Lee MY, Liu V, Rhatt R, Koon H,
`Mier JW, Sosman JA, Atkins MD, McDermott DF. A Retrospective Analysis of the Safety and
`Efficacy of Interleukin-2 Following Prior VEGF-Targeted Therapy in Patients with Advanced
`Renal Cell Carcinoma. J Immunother 2009; 32(2):181-5.
`11. Medioni J, Choueiri T, Zinzindouhe F, Cho D, Casser-Queudeville A, Fournier L, Oudard S.
`Response of renal cell carcinoma pancreatic metastases to sunitinib treatment: a retrospective
`
`11
`
`West-Ward Exhibit 1113
`Cho CV
`Page 0011
`
`

`

`
`
`analysis. J Urol 2009; 181(6):2470-5.
`12. Choueiri TK, Regan MM, Rosenberg JE, Oh WK, Clement J, Amato AM, McDermott D, Cho
`DC, Atkins MB, Signoretti S. Carbonic anhydrase IX and pathological features as predictors of
`outcome in patients with metastatic clear-cell renal cell carcinoma receiving vascular endothelial
`growth factor-targeted therapy. BJUI 2010; 106(6): 772-8.
`13. Cho DC, Atkins MB. Everolimus: Emerging evidence of its therapeutic impact in patients with
`advanced renal cell carcinoma. Clinical Medicine Reviews in Oncology 2010; In press.
`14. Cho DC, Cohen MB, Panka DJ, Collins M, Ghebremichael M, Atkins MB, Signoretti S, Mier
`JW. Efficacy of the novel dual PI3-Kinase/mTOR inhibitor NVP-BEZ235 compared to
`rapamycin in renal cell carcinoma. Clinical Cancer Res 2010; 16(14): 3628-38.
`15. Elfiky AA, Cho DC, McDermott DF, Rosenberg JE, Fortner B, Antràs L, Chen K, Sheng Duh
`M, Jayawant SS, Oh WK, Atkins MB, Choueiri TK. Predictors of response to sequential
`sunitinib and the impact of prior VEGF-targeted drug washout in patients with metastatic clear-
`cell renal cell carcinoma. Urol Oncol. 2011; 29(6):756-63.
`16. Cho DC, Atkins MD. Future Directions in renal cell carcinoma: 2011 and Beyond. Hematol
`Oncol Clin N Am 2011; 25(4): 917-35.
`17. Pandya S, Mier JW, McDermott D, Cho DC. The role of adding gemcitabine at time of sunitinib
`resistance in patients with metastatic renal cell carcinoma. BJUI 2011; 108(8 pt 2): E245-9.
`18. Battelli C, Cho DC. mTOR inhibitors in renal cell carcinoma. Therapy 2011; 8(4): 359-367.
`19. Tannir NM, Wong YN, Kollmannsberger CK, Ernstoff MS, Perry DJ, Appleman LJ, Posadas EM,
`Cho D, Choueiri TK, Coates A, Gupta N, Pradhan R, Qian J, Chen J, Scappaticci FA, Ricker JL,
`Carlson DM, Michaelson MD. Phase 2 Trial of Linifanib (ABT-869) in Patients with Advanced
`Renal Cell Cancer (RCC) after Sunitinib Failure. Eur J Cancer 2011; 47(18):2706-14.
`20. Dabydeen DA, Jagannathan JP, Ramaiya N, Krajewski K, Schutz FA, Cho DC, Pedrosa
`Choueiri TK. Pneumonitis Associated with mTOR Therapy in Patients with Metastatic Renal
`Cell Carcinoma: Incidence, Radiographic Findings, and Correlation with Clinical Outcome. Eur
`J Cancer 2012; 48(10):1519-24.
`21. Cho DC, Hudson TE, Samlowski W, Sportelli P, Somer B, Richards P, Sosman JA, Puzanov I,
`Michaelson MD, Flaherty KT, Figlin RA, Vogelzang NJ. Two phase II trials of the novel Akt
`inhibitor perifosine in patients with advanced renal cell carcinoma following failure to VEGF-
`targeted therapy. Cancer 2012; 118(24):6055-62.
`22. Cho DC, Atkins MB. Serum cholesterol and mTOR inhibitors: surrogate biomarker or
`epiphenomenon? Clin Cancer Res 2012; 18(11):2999-3001.
`23. Zhu S, Cohen MB, Bjorge JD, Mier JW, Cho DC. PI3K inhibition potentiates Bcl-2-dependent
`apoptosis in renal carcinoma cells. J Cell Mol Med 2013; 17(3):377-85.
`24. Cho DC. Therapeutic challenges in renal cell carcinoma. Clin Pract (Lond) 2013; 10(1):39-46.
`25. Tabernero J, Shapiro GI, LoRusso PM, Cervantes A, Schwartz GK, Weiss GJ, Paz-Ares L, Cho
`DC, Infante JR, Alsina M, Gounder MM, Falzone R, Harrop J, White AC, Toudjarska I, Bumcrot
`D, Meyers RE, Hinkle G, Svrzikapa N, Hutabarat RM, Clausen VA, Cehelsky J, Nochur SV,
`Gamba-Vitalo C, Vaishnaw AK, Sah DW, Gollob JA, Burris HA 3rd. First-in-humans trial of an
`RNA interference therapeutic targeting VEGF and KSP in cancer patients with liver
`involvement. Cancer Discov 2013; 3(4):406-17.
`26. Srivastava N, Cho DC. Perifosine in renal cell carcinoma. Expert Opin Investig Drugs 2013;
`22(2):285-91.
`27. Cho DC. Sequential therapy in renal cell carcinoma. Personalized Medicine in Oncology 2013;
`2(3): 147-150.
`28. Cho D. Novel targeting of phosphatidylinositol 3-kinase and mammalian target of rapamycin in
`renal cell carcinoma. Cancer J. 2013; 19(4):311-5.
`12
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 0012
`
`

`

`
`
`29. Mahoney KM, Ackerman A, Cho DC, McDermott DF, Peters T, Atkins MB. Vemurafenib
`induced cardiac tamponade, a rare but potentially life threatening complication.J Clin Oncol
`2013; 31(21):e364-6.
`30. Cho DC. Prognostic biomarkers for patients with advanced renal cell carcinoma treated with
`VEGF-targeted therapy. Onco Targets Ther 2013; 6: 679-84.
`31. Cho DC, Mier JM. PI3-K/mTOR inhibitors in renal cell carcinoma. Curr Cancer Drug Targets
`2013; 13(2):126-42.
`32. Ghamande S, Lin CC, Cho DC, Shapiro GI, Kwak EL, Silverman MH, Tseng Y, Kuo MW,
`Mach WB, Hsu SC, Coleman T, Yang JC, Cheng AL, Ghalib MH, Chuadhary I, Goel S. A
`phase 1 open-label, sequential dose-escalation study investigating the safety, tolerability, and
`pharmacokinetics of intravenous TLC388 administered to patients with advanced solid tumors.
`Invest New Drugs. 2014; 32(3):445-51.
`33. Cho DC. Targeting the PI3K/Akt/mTOR pathway in malignancy: rationale and clinical outlook.
`Biodrugs. 2014; 28(4):373-81.
`34. Cho DC. A practical guide to sequencing of VEGFR and mTOR targeted therapy in advanced
`renal cell carcinoma. Contemporary Oncology 2015; 7(1): 8-13.
`35. Abramson VG, Supko JG, Ballinger T, Cleary JM, Hilton JF, Tolaney S, Chau NG, Cho DC,
`Lager JJ, Pearlberg J, Shapiro GI, Arteaga CL. Phase Ib study of safety and pharmacokinetics of
`the PI3K inhibitor SAR245408 with the HER3 neutralizing human antibody SAR256212 in
`patients with solid tumors. Clin Cancer Res, 2016. In press
`36. Atkins MB, Plimack ER, Puzanov I, Fishman M, McDermott DF, MD, Cho DC, Vaishampayan
`U, George S, Olencki TE, Tarazi JC, Rosbrook J, Fernandez KC, Lechuga M, Choueiri TC.
`Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: Results
`from a non-randomised, open-label, dose-finding and dose expansion phase 1b trial. Lancet
`Oncology, In press
`
`
`
`
`Non-peer reviewed scientific or medical publications/materials in print or other media
`
`
`
`
`1. Cho D and Aktins MB. Molecular aberrations in kidney cancer: vertical and horizontal
`inhibition of signaling pathways. Monographs in Renal Cell Carcinoma 2005; 1(1): 5-8.
`2. Cho D, Mier J, Atkins M. Renal Cell Carcinoma: Molecular Targets and Clinical Applications.
`2nd Edition. New Jersey: Humana Press; 2007. Chapter 12, PI3K/Akt/mTOR pathway: A
`growth and proliferation pathway.
`3. Cho D. Encyclopedia of Cancer. 2nd Edition. Springer Press; 2009 On-Line Version.
`Everolimus.
`4. Cho DC, Atkins MB. Comprehensive Textbook of Genitourinary Oncology. 4th edition. New
`York: Lippincott Williams & Wilkins; 2010 in press. mTOR Pathways and mTOR Inhibition in
`Renal Cell Carcinoma.
`5. Cho DC. Anti-Angiogenic and Targeted Therapy in Renal Cancer: Targeting the mTOR
`Pathway in Renal Cell Carcinoma. Webinar on the 3rd Cambridge Conference on Innovations
`and Challenges in Renal Cancer 2010.
`6. Courtney K, Cho DC, Choueiri TK. Emerging Cancer Therapeutics: Renal Cancer. New York:
`Demos Medical Publishing 2010 in press. Chapter 22, Novel and emerging therapeutic targets.\
`7. Cho DC, Mier JM. Renal Cell Carcinoma: Molecular Targets and Clinical Applications. 3rd
`Edition. Springer Press; in press. Chapter 12: PI3-Kinase, Akt, and mTOR in Renal Cell
`Carcinoma.
`
`13
`
`
`
`West-Ward Exhibit 1113
`Cho CV
`Page 0013
`
`

`

`
`
`
`
`
`Clinical Guidelines and Reports
`
`
`
`
`1. Cho D, Kocher O, Parker JA, Halmos B. Multiple Positron-emission Tomography False
`Positives in a Patient with Malignant Melanoma. Clin Oncol 2006. 18(1): 87-88.
`
`
`
`
`
`
`
`
`Abstracts, Poster Presentations and Exhibits Presented at Professional Meetings
`
`
`
`
`1. Cho D, Panka D, Panka P, Atkins M, Mier J. The sensitivity of renal cell carcinoma cell lines is
`dependent upon Akt and glycogen synthase kinase-3β activity. AACR Annual Meeting
`Proceedings 2006; 4515.
`2. Cho D, Atkins MB, Mier JW. Inhibition of glycogen synthase kinase 3β (GSK3β) enhances the in
`vitro activity of the Akt inhibitor perifosine in renal cell carcinoma (RCC) cell lines. AACR
`Annual Meeting Proceedings 2007; 1823.
`3. Cho D, Panka DJ, Cohen MB, Atkins MB, Mier JW. Enhancement of endoplasmic reticular
`stress in renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) through the combination
`of sorafenib and inhibition of glycogen synthase kinase-3β. AACR Annual Meeting 2009.
`4. Cho D, Cohen MB, Panka DJ, Bhatt R, Signoretti S, Atkins MB, Mier JW. In vitro and In vivo
`eff