A. Personal Statement

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1 OMB No and (Rev. 09/17 Approved Through 03/31/2020) BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Ravandi-Kashani, Farhad era COMMONS USER NAME (credential, e.g., agency login): fravandi POSITION TITLE: Professor EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) INSTITUTION AND LOCATION DEGREE (if applicable) END DATE MM/YYYY FIELD OF STUDY University of London, Imperial College MD 01/1988 University of London, London Resident 08/1993 Emergency Medicine, Internal Medicine, Hematology The University of Texas, Houston, Texas Resident 07/1996 Internal Medicine Baylor College of Medicine, Houston, Texas Resident 07/1997 Hematology The University of Texas MD Anderson Cancer Fellow 07/1999 Hematology/Oncology Center, Houston, Texas The University of Texas MD Anderson Cancer Center, Houston, Texas Fellow 07/2000 Hematology/Stem Cell Transplantation A. Personal Statement I am a Professor of Medicine and Chief, Section of Developmental Therapeutics within the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. I am actively involved in clinical and translational research for treatment of patients with various hematological malignancies, in particular Leukemias. I have extensively published my clinical research results in field of Adult Leukemias, with a focus on Acute Leukemias. 1. Ravandi F, Jorgensen JL, O'Brien SM, Jabbour E, Thomas DA, Borthakur G, Garris R, Huang X, Garcia-Manero G, Burger JA, Ferrajoli A, Wierda W, Kadia T, Jain N, Wang SA, Konoplev S, Kebriaei P, Champlin RE, McCue D, Estrov Z, Cortes JE, Kantarjian HM. Minimal residual disease assessed by multi-parameter flow cytometry is highly prognostic in adult patients with acute lymphoblastic leukaemia. Br J Haematol Feb;172(3): PubMed PMID: ; PubMed Central PMCID: PMC Ravandi F, Pigneux A, DeAngelo DJ, Raffoux E, Delaunay J, Thomas X, Kadia T, Kantarjian H, Scheuenpflug J, Zhao C, Guo W, Smith BD. Clinical, pharmacokinetic and pharmacodynamic data for the MEK1/2 inhibitor pimasertib in patients with advanced hematologic malignancies. Blood Cancer J Dec 11;5:e375. PubMed PMID: ; PubMed Central PMCID: PMC Ravandi F, O'Brien SM, Cortes JE, Thomas DM, Garris R, Faderl S, Burger JA, Rytting ME, Ferrajoli A, Wierda WG, Verstovsek S, Champlin R, Kebriaei P, McCue DA, Huang X, Jabbour E, Garcia-Manero G, Estrov Z, Kantarjian HM. Long-term follow-up of a phase 2 study of chemotherapy plus dasatinib for the initial treatment of patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. Cancer Dec 1;121(23): PubMed PMID: ; PubMed Central PMCID: PMC Ravandi F, Ritchie EK, Sayar H, Lancet JE, Craig MD, Vey N, Strickland SA, Schiller GJ, Jabbour E, Erba HP, Pigneux A, Horst HA, Recher C, Klimek VM, Cortes J, Roboz GJ, Odenike O, Thomas X, Havelange V, Maertens J, Derigs HG, Heuser M, Damon L, Powell BL, Gaidano G, Carella AM, Wei A, Hogge D, Craig AR, Fox JA, Ward R, Smith JA, Acton G, Mehta C, Stuart RK, Kantarjian HM. Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3

2 study. Lancet Oncol Sep;16(9): PubMed PMID: ; PubMed Central PMCID: PMC B. Positions and Honors Positions and Employment Director, Leukemia/Hematologic Malignancies Program, University of Illinois, Chicago, IL Assistant Professor, University of Illinois, Chicago, IL Associate Professor, The University of Houston MD Anderson Cancer Center, Houston, TX Professor, The University of Texas MD Anderson Cancer Center, Houston, TX Other Experience and Professional Memberships Section Chief of Developmental Therapeutics, The University of Texas MD Anderson Cancer Center Janiece and Stephen A. Lasher, The University of Texas MD Anderson Cancer Center Honors 1999 Travel Award, Joint ASCO/AACR 1999 Upjohn Achievement in Research Award, MD Anderson/Pharmacia 1999 Travel Award, US National Medical Oncology Fellows Forum 1999 Travel Award, Ninth Annual Hematology/Oncology Reviews, Mayo 2000 Travel Award, US National Medical Oncology Fellows Forum C. Contribution to Science 1. Minimal Residual Disease (MRD) monitoring in leukemia. Dr Ravandi has led pioneering research in the role of MRD assessment as a predictor of outcome in a number of leukemias and is leading the field in demonstrating the importance of its eradication in the management of a number of hematological malignancies. Starting with pioneering papers in hairy cell leukemia where he demonstrated the feasibility of MRD monitoring and eradication in this disease, followed by studies showing the importance of MRD assessment in Philadelphia Chromosome positive acute lymphoblastic leukemia (ALL)and in ALL patients in general he has been at the forefront of the field that is gathering increasing importance in leukemia therapy with the availability of novel, effective, and non-toxic agents that can be used in maintenance therapy of acute leukemias. His original study in maintenance therapy and MRD detection in adult acute myeloid leukemia is being emulated in large, randomized trial examining the efficacy of hypomethylating agents in the maintenance treatment of patients with acute myeloid leukemia (AML) with ongoing further work in MRD detection and eradication in AML. a. Ravandi F, Jorgensen JL, O'Brien SM, Verstovsek S, Koller CA, Faderl S, Giles FJ, Ferrajoli A, Wierda WG, Odinga S, Huang X, Thomas DA, Freireich EJ, Jones D, Keating MJ, Kantarjian HM. Eradication of minimal residual disease in hairy cell leukemia. Blood Jun 15;107(12): PubMed PMID: b. Ravandi F, O'Brien S, Jorgensen J, Pierce S, Faderl S, Ferrajoli A, Koller C, Challagundla P, York S, Brandt M, Luthra R, Burger J, Thomas D, Keating M, Kantarjian H. Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia. Blood Oct 6;118(14): PubMed PMID: ; PubMed Central PMCID: PMC c. Boumber Y, Kantarjian H, Jorgensen J, Wen S, Faderl S, Castoro R, Autry J, Garcia-Manero G, Borthakur G, Jabbour E, Estrov Z, Cortes J, Issa JP, Ravandi F. A randomized study of decitabine versus conventional care for maintenance therapy in patients with acute myeloid leukemia in complete remission. Leukemia Nov;26(11): PubMed PMID: ; PubMed Central PMCID: PMC d. Ravandi F, Jorgensen JL, Thomas DA, O'Brien S, Garris R, Faderl S, Huang X, Wen S, Burger JA, Ferrajoli A, Kebriaei P, Champlin RE, Estrov Z, Challagundla P, Wang SA, Luthra R, Cortes JE, Kantarjian HM. Detection of MRD may predict the outcome of patients with Philadelphia chromosome-

3 positive ALL treated with tyrosine kinase inhibitors plus chemotherapy. Blood Aug 15;122(7): PubMed PMID: ; PubMed Central PMCID: PMC Effective treatment of patients with Philadelphia-chromsome positive ALL (Ph+ ALL) Ph+ ALL has historically been considered a very poor prognosis leukemia with historical long term survival rates of less than 20%. Dr. Ravandi has led the field by conducting studies demonstrating the feasibility and high efficacy of combining traditional chemotherapeutic agents with tyrosine kinase inhibitors directed against oncogenic BCR-ABL1 fusion product of the Philadelphia chromosome. He has led the first ever intergroup trial in patients with Ph+ ALL which has completed showing 80% survival in patients receiving the combination followed by allogeneic stem cell transplant; the data will be presented in the upcoming American Society of Hematology meeting. a. Ravandi F, O'Brien S, Thomas D, Faderl S, Jones D, Garris R, Dara S, Jorgensen J, Kebriaei P, Champlin R, Borthakur G, Burger J, Ferrajoli A, Garcia-Manero G, Wierda W, Cortes J, Kantarjian H. First report of phase 2 study of dasatinib with hyper-cvad for the frontline treatment of patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia. Blood Sep 23;116(12): PubMed PMID: ; PubMed Central PMCID: PMC Treatment of relapsed AML. Dr. Ravandi led the largest ever conducted clinical trial in patients with AML in first relapse. This multi-national randomized trial accrued over 710 patients and demonstrated the superiority of the combination of cytarabine and the novel agent, voseroxin, to cytarabine alone and may lead to the approval of this drug for use in this setting. a. Ravandi F, Ritchie EK, Sayar H, Lancet JE, Craig MD, Vey N, Strickland SA, Schiller GJ, Jabbour E, Erba HP, Pigneux A, Horst HA, Recher C, Klimek VM, Cortes J, Roboz GJ, Odenike O, Thomas X, Havelange V, Maertens J, Derigs HG, Heuser M, Damon L, Powell BL, Gaidano G, Carella AM, Wei A, Hogge D, Craig AR, Fox JA, Ward R, Smith JA, Acton G, Mehta C, Stuart RK, Kantarjian HM. Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study. Lancet Oncol Sep;16(9): PubMed PMID: ; PubMed Central PMCID: PMC Treatment of FLT3 mutated AML Dr. Ravandi s pioneering work in combining FLT3 kinase inhibitors with traditional cytotoxic agents has clearly demonstrated the feasibility and efficacy of such strategies in treating patients with FLT3 mutated AML (accounting for about a third of patients with AML. Through largely to his efforts sorafenib has become established as an effective agent in this disease and has been included in the NCCN guidelines for AML. a. Ravandi F, Cortes JE, Jones D, Faderl S, Garcia-Manero G, Konopleva MY, O'Brien S, Estrov Z, Borthakur G, Thomas D, Pierce SR, Brandt M, Byrd A, Bekele BN, Pratz K, Luthra R, Levis M, Andreeff M, Kantarjian HM. Phase I/II study of combination therapy with sorafenib, idarubicin, and cytarabine in younger patients with acute myeloid leukemia. J Clin Oncol Apr 10;28(11): PubMed PMID: ; PubMed Central PMCID: PMC b. Ravandi F, Alattar ML, Grunwald MR, Rudek MA, Rajkhowa T, Richie MA, Pierce S, Daver N, Garcia- Manero G, Faderl S, Nazha A, Konopleva M, Borthakur G, Burger J, Kadia T, Dellasala S, Andreeff M, Cortes J, Kantarjian H, Levis M. Phase 2 study of azacytidine plus sorafenib in patients with acute myeloid leukemia and FLT-3 internal tandem duplication mutation. Blood Jun 6;121(23): PubMed PMID: ; PubMed Central PMCID: PMC Treatment of acute promyelocytic leukemia (APL) without chemotherapy. Pioneering work published by Dr. Ravandi has led the way in treating patients with APL with all-trans-retinoic acid and arsenic trioxide without chemotherapy. The pioneering regimen initially reported by him and his colleagues has been emulated in two large European randomized trials and have demonstrated the significant superiority of this chemotherapy-free regimen using targeted agents; more importantly this is likely to lead the path towards developing other similar strategies in other leukemias and other cancers in the future.

4 a. Ravandi F, Estey E, Jones D, Faderl S, O'Brien S, Fiorentino J, Pierce S, Blamble D, Estrov Z, Wierda W, Ferrajoli A, Verstovsek S, Garcia-Manero G, Cortes J, Kantarjian H. Effective treatment of acute promyelocytic leukemia with all-trans-retinoic acid, arsenic trioxide, and gemtuzumab ozogamicin. J Clin Oncol Feb 1;27(4): PubMed PMID: ; PubMed Central PMCID: PMC b. Ravandi F, Kantarjian H. Time to abandon traditional chemotherapy for acute promyelocytic leukaemia?. Lancet Oncol Oct;16(13): PubMed PMID: D. Additional Information: Research Support and/or Scholastic Performance Ongoing Research Support 5 P50 CA , NIH/NCI 09/13/13-08/31/18 SPORE SPORE in Leukemia Project 1: Epigenetics and Epigenetic Therapy in AML, Role: Co-Investigator CS , AMGEN 08/06/15-01/01/20 AMG 330 Phase I first-in-human study Evaluating the Safety, Tolerability Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects with Relapsed/Refractory Acute Myeloid Leukemia Completed Research Support Celgene, /21/12-12/20/ A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care versus Best Supportive Care as Maintenance in AML in complete remission. Compare efficacy and safety of oral azacitidine plus best supportive care vs best supportive care as maintenance in AML in complete remission Incyte, Incyte 12/10/14-12/09/ Study of Ruxolitib Plus Decitabine in Patients with Post Myeloproliferative Neoplasm - Acute Myeloid Leukemia Seattle Genetics, Seattle Genetics 11/04/14-11/03/

5 A Phase 1 Trial of SGn-CD33A in patients with CD33-positivie acute myeloid leukemia CS , Merck 03/20/12-03/19/ A Phase 1 Study to Evaluate the Safety and Tolerability and Pharmacokinetic/Pharmacodynamics of MK-8242 Administered Alone and in Combination with Chemotherapy in Subjects with Recurrent Acute Myelogenous Leukemia Evaluate the safety, tolerability and pharmacokinetic/pharmacodynamics of MK-8242 administered alone and in combination with chemotherapy in AML. A Phase 1 Study to Evaluate the Safety and Tolerability and Pharmacokinetic/Pharmacodynamics of MK-8242 Administered Alone and in Combination with Chemotherapy in Subjects with Recurrent Acute Myelogenous Leukemia Evaluate the safety, tolerability and pharmacokinetic/pharmacodynamics of MK-8242 administered alone and in combination with chemotherapy in AML MedImmune, MedImmune 10/04/13-10/03/ Phase I/II Study of of Moxetumomab in Patients with relapsed and/or refractory Acute Lymphoblastic Leukemia (ALL) CS , Bayer 08/18/10-05/16/ Phase II Study of Sorafenib and 5-Azacitidine for the Treatment of Patients with Refractory or Relapsed Acute Leukemia and Myelodysplastic Syndrome (MDS) - (VZ-MDS-PI-0227) Study of safety and efficacy of sorafenib and 5-Azacitidine in refractory or relapsed acute leukemia and MDS. 5 U10 CA , NIH/NCI 07/26/04-12/31/15 SWOG0805 The institution-wide participation in and design of trials (phase I, II, III) of promising cancer therapy, prevention, and control regimens and participation in and design of translational therapy and prevention studies within the setting of the NCI cooperative Southwest Oncology Group (SWOG), thus advancing the overall practice and science of cancer therapy, prevention and control Seattle Genetics, Seattle Genetics 01/20/15-01/19/

6 A Phase 1b dose-escalation study of SGN-CD33A in combination with standard-of-care for patients with newly diagnosed acute myeloid leukemia (AML),

Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, Texas; 2 Sunesis Pharmaceuticals, Inc, South San Francisco

Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, Texas; 2 Sunesis Pharmaceuticals, Inc, South San Francisco Phase I/II Study of Vosaroxin and Decitabine in Newly Diagnosed Older Patients with Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) Naval Daver 1, Hagop Kantarjian 1, Guillermo