Draft:Dale T Umetsu

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Dale T Umetsu is an American physician, scientist, educator, professor, clinical investigator and pharmaceutical executive.

Umetsu has devoted his career to understanding the cellular and molecular basis of allergic diseases and asthma, to the development of more effective therapies for the treatment of, and to caring for, patients with allergic and immunological diseases.

He was a successful researcher, and received continuous grant funding from the NIH for more than 25 years. He and his research team published more that 200 peer-reviewed articles, describing the importance of different types of immune cells in allergic inflammatory disorders (e.g., Type 2 inflammatory cells including Th2 cells, ILC2s, as well as regulatory T cells and iNKT cells), and discovered the TIM gene family (1), members of which are currently the target of multiple industry sponsored clinical trials (2).

He taught scores of students, physicians and researchers at Stanford and Harvard Universities, many of whom became leaders in academics and in industry.

He was also a highly esteemed clinician, board certified in pediatrics and allergy/immunology, and was consistently listed amoung the best physicians in the San Francisco, San Jose, and Boston areas. Umetsu was a leader in his subspecialty field, allergy and immunology, and was elected to the Board of Directors of the American Board of Allergy and Immunology.    

Late in his career, he left academic medicine and was a clinical investigator and pharmaceutical executive at Genentech/Roche, where he developed FDA approved pharmaceuticals for patients with allergy and in particular, developed innovative treatments for patients with food allergy.

He has also served as a member of the FDA Allergenic Products Advisory Committee, and as a member of multiple scientific advisory boards in the US and abroad.

Education

After graduating from Columbia University with a degree in biochemistry, Umetsu completed MD and PhD degrees at New York University, funded by the Medical Scientist Training Program grant (NIH). His doctoral advisor was Jennette Thorbecke. He then completed internship and residency training in pediatrics at Boston Children’s Hospital, Harvard Medical School. This was followed by a fellowship and postdoctoral training in immunology and allergy at Harvard Medical School, supported by an NIH National Research Service Award and a Charles H Hood Foundation grant award. He is board-certified in pediatrics and allergy immunology.  

Career and research

In 1986, Umetsu was appointed as assistant professor of pediatrics at Stanford University; he was promoted to associate professor with tenure in 1993, and to full professor in 1999. He was appointed chief of the division of Allergy and Immunology at Stanford in 1995, Director of the Center for Asthma and Allergic Diseases, head of the fellowship training program in Allergy and Immunology, and on the faculty for the Immunology Program and Cancer Biology Program. In 2005, he was appointed as The Prince Turki Bin Abdul Azis al Saud Professor of Pediatrics, an endowed chair position, at Harvard Medical School and Director of the Asthma Center at Boston Children’s Hospital.

His research at Stanford and at Harvard Universities focused on understanding the immunological basis of allergic diseases and asthma, and on developing immune-based therapies for allergic diseases. He and his team were among the first investigators to describe subsets of CD4 T helper cells (Th2 cells) (3), to describe the role of type 2 innate lymphoid cells (ILC2s) in allergic diseases (4), the role of iNKT cells in asthma (5), and to discover the TIM gene family (1). One member of the family, TIM-1 (HAVCR1), is the receptor for the hepatitis A, Ebola and Dengue viruses (6, 7, 8) and regulates allergic responses, asthma and transplant tolerance. Another member of the family, TIM-3, functions as an inhibitory molecule on T cells (9) and is a target in several ongoing clinical trials (2). In addition, his clinical translational work was the first to show that omalizumab (anti-IgE mAb) was extraordinarily effective in reducing allergic symptoms occurring during oral immunotherapy (10, 11). These studies showed the unique benefits of omalizumab in allergy and ultimately led to the FDA approval of omalizumab in food allergy in 2024.

His research was continuously funded by NIH (NIAID and NHLBI) grant awards for over 25 years during his academic career. His research was also was supported by a Hyde Watson Developing Investigator Grant Award from the Asthma and Allergy Foundation, a Basil O'Connor Research Grant from the National Foundation for the March of Dimes, Thrasher Research Foundation and grants from the American Lung Association and the Food Allergy Research and Education Foundation. He received an NIAID Immunologic and Allergic Diseases Academic Award. Later in his career, he focused on translational clinically oriented studies that could lead to novel therapies for patients with allergic diseases, in particular, therapies for patients with food allergy. Umetsu has published more than 230 peer reviewed articles in the field of immunology and allergy.

In 2013, Umetsu left academic medicine to serve as an executive (Principal Medical Director) at Genentech/Roche (F. Hoffmann-La Roche AG), where he was Global Development Team Leader. His move to industry was driven in part by a desire to push for the development of improved treatments for allergic diseases and in particular, for food allergy. Within Genentech, a large pharmaceutical corporation, he worked primarily on the drug omalizumab (Xolair), an anti-IgE monoclonal antibody, which he had previously shown while at Harvard to be surprisingly effective in patients with food allergy. At Genentech, he actively spearheaded projects that led to FDA approval of omalizumab for chronic idiopathic urticaria, for pediatric asthma, chronic rhinosinusitis with nasal polyps, and FDA approval of omalizumab supplied in prefilled syringes for home use. Moreover, he strongly urged Genentech to pursue the use of omalizumab in food allergy. These efforts led to the granting of Breakthrough Therapy Designation by the FDA to Genentech for omalizumab in food allergy, and to the establishment of a collaboration between Genentech/Roche, Novartis Pharmaceuticals and the NIH Consortium for Food Allergy Research (CoFAR,), and the organization of a Phase 3 clinical trial of omalizumab in food allergy (12). This Phase 3 study, called OUtMATCH, led by Drs. Robert Wood and Sharon Chinthrajah (NIH sponsored clinical investigators based at Johns Hopkins and Stanford respectively), was successfully completed meeting its endpoints, resulting in FDA Priority Review approval of omalizumab for food allergy in early 2024. Omalizumab is the second FDA approved drug for food allergy, but it is the first for the treatment of food allergies beyond peanut (e.g., milk, egg and cashew and others, as well as peanut), the first treatment for patients who have multiple concomitant food allergies, the first for children 1 to 4 years of age with any food allergy and the first for adults with any food allergy. As such, omalizumab has the potential to greatly improve and transform the treatment paradigm for food allergy, which Umetsu had projected earlier while at Genentech. Food allergy is a major health burden affecting up to 17 million children and adults in the US; therefore omalizumab could benefit a large number of patients. In 2017, Umetsu received a Genentech Product Development Breakthrough Innovation Award for his work with omalizumab. In 2018, Umetsu retired from Genentech, although he later served as VP for Clinical Development at Dermira, Inc (later acquired by Eli Lilly) and later as consultant and acting chief medical officer for several small biotech companies.  

While in academics, Umetsu was elected to the Board of Directors for the American Board of Allergy and Immunology, to the Collegium Internationale Allergologicum and the American Society for Clinical Investigation.

He served as Chairperson of the NIH Immunological Sciences Study Section (grant review body for the NIH),and on the scientific advisory board of RIKEN (National Science and Technology Institutes, Japan). As a clinician, he received a Northern California Association for the Care of Children’s Health Outstanding Physician Award, was selected as Top Docs (San Jose Magazine, San Francisco Magazine, Boston Magazine) and as one of Best Doctors in America, America’sTop Docs from 2001 to 2024. In 2020, he served as a volunteer physician for the California Medical Assistance Team, California Health Corps, and was deployed to a Field Hospital in Imperial Valley California to treat COVID patients; in 2020-21 he served as a volunteer medical lead for COVID contract tracers with the San Francisco Department of Public Health, and in 2022 he served as a volunteer physician with the Medical Volunteers International deployed to Ukraine to care for Ukrainian refugees.  

Teaching and mentoring.

Dr. Umetsu has taught and mentored scores of students and postdoctoral fellows. His students have included undergraduates at Stanford and Harvard, medical students, graduate students, postdocs, interns, residents and clinical fellows at Stanford and Harvard.  He has also been a member of many PhD thesis committees.  Many of his former students are now faculty members, some department chairpersons and leaders at institutions around the world:    

Luiz Rizzo, MD, PhD, postdoc 1989-92.  Current:  Executive Director, Albert Einstein Institute for Education and Research, Brazil;

Heather Secrist, PhD, postdoc 1991-95.  Current:  CEO Genetic ID NA;

Tae Sung Kim, PhD, postdoc 1995-97.  Current:  Professor, School of Life Sciences and Biotechnology, Korea University, Seoul, Korea;

Gesine Hansen, MD, PhD, postdoc 1998-2000.  Current:  Professor, Chair, Department of Pulmonology, allergology and immunology, Hannover School of Medicine, Germany;

Daphne Tsitoura, MD, PhD, postdoc, 1998-2000.  Current: head of clinical science, Allergy Therapeutics, Munich;

Dianne Campbell, MD, PhD, postdoc 98-00.  Current:  Professor, University of Sydney, Chief, Pediatric Allergy and Immunology, Sub-Dean, NSW, Australia;

Omid Akbari, PhD, postdoc 2000-2006.  Current:  Professor, Department of Molecular Microbiology and Immunology, University of Southern California:

Kari Nadeau, MD, PhD, fellow in allergy immunology 2003-5.  Current:  John Rock Professor of Climate and Population Studies, Chair, Department of Environmental Health, Harvard School of Public Health;

Wen Wei Tu, MD, PhD, postdoc 2000 2001.  Current: Professor of Paediatrics, University of Hong Kong;  

Jae Won Oh, MD, PhD.  Postdoc, 2000-2002.  Current:  Professor of Pediatrics, Department Head; Hanyang University, Seoul, Korea.  

Hyun-Hee Lee, PhD, postdoc, 2009-11.  Current:  VP of Biology at Lynk Pharmaceuticals, Boston.  

Denis Bedoret, PhD, postdoc, 2010-11.  Current:  Chief Executive Officer, Imcyse SA, Belgium;

Hye-Young Kim, PhD, Postdoc 2007-13, Instructor, 2009-13.  Current:  Professor, Institute of Allergy and Clinical Immunology, Seoul National University, South Korea.

Jennifer Clare Jones, MD, PhD, Graduate student, Stanford Immunology Program, 1997-2003, Stanford University.  Current: NIH Stadtman Investigator, head of translational nanobiology section at the National Cancer Institute, NIH

Everett Meyer, MD, PhD, Graduate student, Stanford Immunology Program, 2002-06.  Current:  Associate Professor of Medicine and Pediatrics, Stanford University

Ponpan Matangkasombut, MD, SD, Graduate student, Harvard School of Public Health, 2006-2009.  Current:  Associate Professor, Department of Microbiology, Faculty of Science, Mahidol University, Bangkok, Thailand

Lee Albacker, PhD.  Graduate student, Harvard Immunology Program, 2006-11.  Current:  head immunotherapy biomarker research, Foundation Medicine. Cambridge, MA.  

Matthew Kan, MD, PhD, undergraduate student, Harvard College, 2005-07. Current Assistant Professor of Pediatrics, University of California, San Francisco.

References

doi10.1038/ni739PMID11725301S2CID7243788

2. Zeidan AM, Giagounidis A, Sekeres MA, Xiao Z, Guillermo FS, Van Hoef M, Ma F, Hertle S, Santini V (March 2023). “STIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453) + azacitidine in higher risk MDS and CMML-2”. Future Oncol. 19(9):631-642. doi: 10.2217/fon-2022-1237. Epub 2023 Apr 21.  

3. Umetsu DT, Jabara HH, DeKruyff RH, Abbas AK, Abrams JS, Geha RS (June 1988). “Functional heterogeneity among human inducer T cell clones”. J Immunol. 140(12):4211-6. PMID: 2967331.

4. Chang YJ, Kim HY, Albacker LA, Baumgarth N, McKenzie AN, Smith DE, Dekruyff RH, Umetsu DT (May 2011). “Innate lymphoid cells mediate influenza-induced airway hyper-reactivity independently of adaptive immunity”. Nat Immunol. 12(7)631-8. doi: 10.1038/ni.2045. PMID: 21623379.  

5. Akbari O, Stock P, Meyer E, Kronenberg M, Sidobre S, Nakayama T, Taniguchi M, Grusby MJ, DeKruyff RH, Umetsu DT (May 2003). “Essential role of NKT cells producing IL-4 and IL-13 in the development of allergen-induced airway hyperreactivity”. Nat Med. 9(5):582-8. doi: 10.1038/nm851. Epub 2003 Mar 31. PMID: 12669034

6. Costafreda, Maria Isabel; Abbasi, Abdolrahim; Lu, Hsinyi; Kaplan, Gerardo (September 2020). "Exosome mimicry by a HAVCR1-NPC1 pathway of endosomal fusion mediates hepatitis A virus infection". Nature Microbiology. 5 (9): 1096–1106. doi:10.1038/s41564-020-0740-y. ISSN 2058-5276. PMC 7483988. PMID 32541946.

7. Kondratowicz AS, Lennemann NJ, Sinn PL, Davey RA, Hunt CL, Moller-Tank S, Meyerholz DK, Rennert P, Mullins RF, Brindley M, Sandersfeld LM, Quinn K, Weller M, McCray PB, Chiorini J, Maury W (May 2011). "T-cell immunoglobulin and mucin domain 1 (TIM-1) is a receptor for Zaire Ebolavirus and Lake Victoria Marburgvirus". Proceedings of the National Academy of Sciences, USA. 108 (20): 8426–8431. Bibcode:2011PNAS..108.8426K. doi:10.1073/pnas.1019030108. PMC 3100998. PMID 21536871.

8. Meertens L, Carnec X, Lecoin MP, Ramdasi R, Guivel-Benhassine F, Lew E, Lemke G, Schwartz O, Amara A (October 2012). "The TIM and TAM families of phosphatidylserine receptors mediate dengue virus entry". Cell Host Microbe. 12 (4): 544–557. doi:10.1016/j.chom.2012.08.009. PMC 3572209. PMID 23084921.

9. Zhu C, Anderson AC, Schubart A, Xiong H, Imitola J, Khoury SJ, Zheng XX, Strom TB, Kuchroo VK (December 2005). "The Tim-3 ligand galectin-9 negatively regulates T helper type 1 immunity". Nature Immunology. 6 (12): 1245–1252. doi:10.1038/ni1271. PMID 16286920. S2CID 24886582.

10. Nadeau KC, Schneider LC, Hoyte L, Borras I, Umetsu DT (June 2011). “Rapid oral desensitization in combination with omalizumab therapy in patients with cow's milk allergy”.

J Allergy Clin Immunol. 127(6):1622-4. doi: 10.1016/j.jaci.2011.04.009. Epub 2011 May 4. PMID: 21546071  

11. Schneider LC, Rachid R, LeBovidge J, Blood E, Mittal M, Umetsu DT (Dec 2013) “A pilot study of omalizumab to facilitate rapid oral desensitization in high-risk peanut-allergic patients”.  J Allergy Clin Immunol. 132(6):1368-74. doi: 10.1016/j.jaci.2013.09.046. Epub 2013 Oct 28. PMID: 24176117.

12. Wood RA, Chinthrajah RS, Rudman Spergel AK, Babineau DC, Sicherer SH, Kim EH, Shreffler WG, Jones SM, Leung DYM, Vickery BP, Bird JA, Spergel JM, Kulis M, Iqbal A, Kaufman D, Umetsu DT, Ligueros-Saylan M, Uddin A, Fogel RB, Lussier S, Mudd K, Poyser J, MacPhee M, Veri M, Davidson W, Hamrah S, Long A, Togias A (July 2022) “Protocol design and synopsis: Omalizumab as Monotherapy and as Adjunct Therapy to Multiallergen OIT in Children and Adults with Food Allergy (OUtMATCH)”. J Allergy Clin Immunol Glob. 1(4):225-232. doi: 10.1016/j.jacig.2022.05.006. eCollection 2022 Nov. PMID: 37779534.