MEDICAL and SCIENTIFIC ADVISORY BOARD

Dean Lee, M.D., Ph.D.Dean Lee, M.D., Ph.D. Vice President, Medical Director, Cofounder, and Chair of SAB

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Dean Lee, M.D., Ph.D. is the cofounder, vice president, and medical director of CytoSen Therapeutics. Dr. Lee’s ground-breaking methods for natural killer (NK) cell stimulation with feeder cells expressing membrane-bound IL-21 are vital for the expansion of NK cell therapeutics. He developed this method with the aim of improving and expanding highly active clinical-grade NK cells, enabling repeated delivery of large cell doses for improved efficacy.

His method has been implemented in at least seven first-in-human clinical trials of NK cell adoptive immunotherapy under FDA Investigational New Drug applications. Dr. Lee brings his vast knowledge of immunology, NK cell biology, GMP cell manufacturing, and clinical trials of adoptive cell therapy to CytoSen. As medical director, he leads clinical development of the company’s NK cell therapies toward approval.

Dr. Lee has also developed genetic and non-genetic methods for improving tumor targeting and tissue homing of NK cells, leading to over a dozen invention disclosures, patents, and commercial licensing agreements.

In 2016, Dr. Lee joined Nationwide Children’s Hospital and The Ohio State University School of Medicine as professor of Pediatrics and director of the new joint Cellular Therapy and Cancer Immunotherapy Program. He serves as co-chair of the Cellular Therapy Working Group for the Pediatric Blood and Marrow Transplant Consortium, and is a member of the Cellular Therapy Steering Committee of the Children’s Oncology Group, the NIH Recombinant DNA Advisory Committee, and the NIH Gene Transfer Safety Assessment Board. Dr. Lee achieved his B.A. in Natural Sciences at Fresno Pacific College, his M.D. at Loma Linda University, and his Ph.D. in immunology at Loma Linda University.

[–][+] Relevant publications

Haploidentical Natural Killer Cells Infused before Allogeneic Stem Cell Transplantation for Myeloid Malignancies: A Phase I Trial. Biology of Blood and Marrow Transplantation 2016. Lee DA, Denman CJ, Rondon G, Woodworth G, Chen J, Fisher T, Kaur I, Fernandez-Vina M, Cao K, Ciurea S, Shpall EJ, Champlin RE. Membrane-bound IL-21 promotes sustained ex vivo proliferation of human natural killer cells. PLOS ONE 2012. Denman CJ, Senyukov VV, Somanchi SS, Phatarpekar PV, Kopp LM, Johnson JL, Singh H, Hurton L, Maiti SN, Huls MH, Champlin RE, Cooper LJ, Lee DA.

Stefan O. Ciurea, M.D.
Co-Founder and Medical Advisory Board Member

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Dr. Ciurea’s research focuses on clinical-experimental and translational hematopoietic stem cell transplantation in the area of alternative donors. He has developed a program in haploidentical transplantation at the University of Texas MD Anderson Cancer Center starting from the premise that this is a cost effective form of transplant that can be applied to almost every patient in need regardless of race and donor availability. Developed treatment methods that have doubled survival rates, and haploidentical transplants have now changed from a morbid, highly lethal procedure to a feasible type of transplant, with GVHD incidence and outcomes comparable with HLA matched transplantation. His main focus now is on prevention of disease relapse post-transplant. He is principal investigator for a number of clinical trials. A unique approach is the use of cellular therapy post-transplant to enhance the graft-versus-tumor effect. Two approaches, infusion of mbIL-21 ex vivo expanded NK cells for myeloid malignancies and CAR T cells for B lymphoid malignancies, have shown very promising results in early phase clinical trials.

Dr. Ciurea received his MD degree from University of Medicine, Iasi, Romania, completed clinical training in Internal Medicine at Harrisburg Hospital/Penn State University where he was Chief Resident, Hematology/Oncology fellowship at University of Illinois at Chicago, and Hematopoietic Stem Cell Transplantation fellowship at MD Anderson Cancer. He became a faculty member in the Department of Stem Cell Transplantation and Cellular Therapy and was promoted to Associate Professor in 2014. He is the leader of the Haploidentical Stem cell Transplant Program at this institution.

[–][+] Relevant publications

Predictive model for survival in patients with AML/MDS receiving haploidentical stem cell transplantation. Blood 2017. Bachegowda LS, Saliba RM, Ramlal R, Kongtim P, Chen J, Rondon G, Wallis W, Alousi A, Ahmed S, Hosing CM, Parmar S, Qazilbash M, Khouri IF, Bashir Q, Oran B, Popat U, Shpall EJ, Marin D, Rezvani K, Kebriaei P, Champlin RE, Ciurea SO.

Haploidentical Transplantation with Post-Transplantation Cyclophosphamide for High-Risk Acute Lymphoblastic Leukemia. Biol Blood Marrow Transplant 2017. Srour SA, Milton DR, Bashey A, Karduss-Urueta A, Al Malki MM, Romee R, Solomon S, Nademanee A, Brown S, Slade M, Perez R, Rondon G, Forman SJ, Champlin RE, Kebriaei P, Ciurea SO.

Results of a 2-arm, phase 2 clinical trial using post-transplantation cyclophosphamide for the prevention of graft-versus-host disease in haploidentical donor and mismatched unrelated donor hematopoietic stem cell transplantation. Cancer 2016. Gaballa S, Ge I, El Fakih R, Brammer JE, Kongtim P, Tomuleasa C, Wang SA, Lee D, Petropoulos D, Cao K, Rondon G, Chen J, Hammerstrom A, Lombardi L, Alatrash G, Korbling M, Oran B, Kebriaei P, Ahmed S, Shah N, Rezvani K, Marin D, Bashir Q, Alousi A, Nieto Y, Qazilbash M, Hosing C, Popat U, Shpall EJ, Khouri I, Champlin RE, Ciurea SO.

Haploidentical Donors: Can Faster Transplantation Be Life-Saving for Patients with Advanced Disease? Acta Haematol 2016. Tanase A, Tomuleasa C, Marculescu A, Bardas A, Colita A, Orban C, Ciurea SO.

Post-transplantation cyclophosphamide versus conventional graft-versus-host disease prophylaxis in mismatched unrelated donor haematopoietic cell transplantation. Br J Haematol 2016. Mehta RS, Saliba RM, Chen J, Rondon G, Hammerstrom AE, Alousi A, Qazilbash M, Bashir Q, Ahmed S, Popat U, Hosing C, Khouri I, Shpall EJ, Champlin RE, Ciurea SO.

Haploidentical Natural Killer Cells Infused before Allogeneic Stem Cell Transplantation for Myeloid Malignancies: A Phase I Trial. Biology of Blood and Marrow Transplantation 2016. Lee DA, Denman CJ, Rondon G, Woodworth G, Chen J, Fisher T, Kaur I, Fernandez-Vina M, Cao K, Ciurea S, Shpall EJ, Champlin RE.

Michael A. Caligiuri, M.D.

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Michael A. Caligiuri, M.D. is the director of The Ohio State University Comprehensive Cancer Center, chief executive officer of Ohio State’s James Cancer Hospital and Solove Research Institute, and holder of the John L. Marakas Nationwide Insurance Enterprise Foundation Chair in Cancer Research. He also is a professor in the Department of Internal Medicine and in the Department of Molecular Virology, Immunology and Medical Genetics in Ohio State’s College of Medicine. One of the research areas of Dr. Caligiuri’s laboratory is the development and normal role of the body’s large granular lymphocytes called natural killer cells so as to exploit their properties to develop effective therapies against cancer and immune deficiency. Dr. Caligiuri has designed and conducted many clinical studies for leukemia and lymphoma patients and has more than 400 original publications, abstracts and review articles on immunology or leukemia. He also is an elected member of the American Association for Clinical Investigation and the American Association of Physicians, and he is an elected Fellow in the American Association for the Advancement of Science. He recently served as the president of the Association for American Cancer Institutes (AACI). He also sits on the boards of the American Society of Hematology and the American Association of Cancer Research, and he chairs the Institute of Medicine’s National Cancer Policy Forum.

Zhijian “James” Chen, Ph.D.

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Zhijian “James” Chen, Ph.D. is the George L. MacGregor Distinguished Chair in Biomedical Science, director of the Inflammation Research Center, a professor of molecular biology at the University of Texas Southwestern Medical Center, and an HHMI Investigator.  Dr. Chen’s research into complex cellular biochemistry has led to the discovery of pathways and proteins that trigger immune and stress responses.  He has received numerous awards including the Norman Hackerman Award in Chemical Research from the Welch Foundation, the Edith and Peter O’Donnell Award in Science, Academy of Medicine, Engineering, and Science of Texas, and the National Academy of Sciences Award in Molecular Biology. Dr. Chen is a fellow of the American Association for the Advancement of Science and a member of the National Academy of Sciences.

Todd A. Fehniger, M.D., Ph.D.,

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Todd A. Fehniger, M.D, Ph.D., associate professor of Medicine at Washington University School of Medicine, is a physician-scientist with interests that span basic, translational, and clinical aspects of immunology and oncology.  With more than 20 years of experience in the field, his research program focuses on understanding basic mechanisms of natural killer (NK) cell development and function, translational approaches to elucidate new ways to enhance NK cell anti-tumor activity, and clinical studies applying advances in NK cell biology as novel immunotherapy strategies for patients with cancer, especially hematologic malignancies.

Helen Heslop, MD

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Helen Heslop, M.D. is professor of Medicine and Pediatrics at Baylor College of Medicine, and the director of the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston Methodist Hospital and Texas Children’s Hospital. She is also associate director for Clinical Research at the Dan L Duncan Cancer Center. Dr. Heslop is a physician scientist engaged in translational research focusing on adoptive immunotherapy with gene-modified effector cells, to improve hemopoietic stem cell transplantation and cancer therapy. An additional focus in reconstituting antiviral immunity post transplant and she has led an NHLBI-funded multicenter trial of allogeneic multivirus specific T cells. She therefore has extensive experience in developing and conducting transplant studies and cell and gene therapy studies.

Jeffrey S. Miller, M.D.

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Jeffrey S. Miller, M.D., is a professor of Medicine at the University of Minnesota and the deputy director of the University of Minnesota Masonic Comprehensive Cancer Center. He has more than 20 years of experience studying the biology of NK cells and other immune effector cells and their use in clinical immunotherapy. After completing a post-doctoral fellowship in Hematology, Oncology and Transplantation at the University of Minnesota, he joined the faculty in 1991. He completed an internship and residency in internal medicine at the University of Iowa in Iowa City. Dr. Miller is a member of numerous societies such as the American Society of Hematology, the American Association of Immunologists, a member of the American Society of Clinical Investigation since 1999. He has more than 200 peer-reviewed publication, serves on the editorial board for Blood, and is a reviewer for a number of journals and NIH grants. Dr. Miller received a B.S. degree from Northwestern University in Evanston, Illinois and received his M.D. from Northwestern University School of Medicine. In 2015 he was awarded an Outstanding Investigator Award by the National Cancer Institute.