Miguel Villalona-Calero, M.D.
- 1995-present, ABIM/Subspecialty Board of Medical Oncology
1985, Medical School, Universidad Nacional Pedro Henríquez Ureña, Santo Domingo, Dominican Republic
1980, Premedical School, Universidad Nacional Pedro Henríquez Ureña, Santo Domingo, Dominican Republic
2001-2002, NHMA Health Policy Leadership, New York University, Robert Wagner Graduate School of Public Service, New York, NY
1994-1995, Drug Development, Institute for Drug Development, University of Texas Health Sciences Center, San Antonio, TX
1990-1992, Medical Oncology, Roswell Park Cancer Institute, Buffalo, NY
1989-1990, Medical Oncology, University of Minnesota Hospital & Clinics, Minneapolis, MN
1986-1989, Internal Medicine, Kings County Hospital Center, State University of New York Health Sciences Center, Brooklyn, NY
2021-present, Co-Program Leader, Developmental Cancer Therapeutics Program, City of Hope, Duarte, CA
2020-present, Director, Early Phase Therapeutics Program, City of Hope, Duarte, CA
2020-present, Professor, Department of Medical Oncology & Therapeutics Research, City of Hope, Duarte, CA
2015-2019, Deputy Director and Chief Scientific Officer, Miami Cancer Institute, Miami, FL
2015-2019, Attending Physician, Miami Cancer Institute, Baptist Health South Florida, Miami-Dade County, FL
2015, Associate Director, Translational Research, The Ohio State University Comprehensive Cancer Center, Columbus, OH
2010-2015, Director, Division Medical Oncology, Department of Internal Medicine, The Ohio State University College of Medicine and Public Health, Columbus, OH
2010-2015, Section Chief, Arthur James Cancer Hospital, The Ohio State University, Columbus, OH
2007-2015, Professor of Medicine, Arthur G. James Comprehensive Cancer Center and Richard J. Solove Research Institute, Department of Internal Medicine, The Ohio State University College of Medicine and Public Health, Columbus, OH
2007-2015, Professor of Pharmacology, Department of Pharmacology, The Ohio State University College of Medicine and Public Health, Columbus, OH
2004-2015, Co-Medical Director of Clinical Research Unit, Arthur G. James Cancer Hospital, Columbus, OH
2002-2007, Associate Professor of Medicine and Lung Cancer Physician, Arthur G. James Cancer Hospital and Department of Internal Medicine, The Ohio State University College of Medicine and Public Health, Columbus, OH
1999-2002, Assistant Professor of Medicine and Lung Cancer Physician, Arthur G. James Cancer Hospital and Department of Internal Medicine, The Ohio State University of Medicine and Public Health, Columbus, OH
1995-1999, Research Physician, Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX
1992-1995, Physician and Director Chemotherapy Service, Pickens County Hospital, Carrolton, AL
2022, Finalist, Premio Oscar de la Renta al Emigrante Dominicano
2019, Honorary Professor, Universidad Nacional Pedro Henríquez Ureña, Santo Domingo, Dominican Republic
2018, Honorary Professor, Universidad Autónoma de Santo Domingo, Santo Domingo, Dominican Republic
2018, Dedication of the Summer Congress of The Dominican Society of Hematology and Oncology, “Personalized Therapy in Oncology”
2018, Top Scholar for Research and Creative Activities, Florida International University, Miami, FL
2017, National Cancer Institute Continuing Umbrella of Research Experiences (CURE) Lifetime Achievement Award
2013, Fellow, American Association for the Advancement of Science
2005, The V Foundation, American Association for Cancer Research Translational Cancer Research Award for Scientific Excellence in the Fight Against Cancer
2003, The Fray Anton de Montesinos Award to the Dominican Professional of the Year in The United States, Alumni Association Universidad Autónoma de Santo Domingo, Inc., Queens, NY
1999, Fellow, American College of Physicians, American Society of Internal Medicine, Philadelphia, PA
American College of Physicians/American Society of Internal Medicine
American Society of Clinical Oncology
American Association for Cancer Research
American Association for the Advancement of Science
International Association for the Study of Lung Cancer
National Hispanic Medical Association
Sociedad Dominicana de Hematología y Oncología
Florida Society of Clinical Oncology
SWOG Cancer Research Network
Focus/Project 1: The identification of subgroups of patients who are exquisitely responsive to treatment with DNA breaking and molecularly targeted agents has led to the identification of pathways that are critical for DNA repair and of mutations that drive the malignancies. Dr Villalona’s laboratory developed an all-inclusive method assessing the functionality of the Fanconi Anemia/BRCA pathway: An immunofluorescence-based test (FATSI) in paraffin embedded tissues, which could potentially lead to the identification of patients most likely to respond to DNA breaking agents or to agents inhibiting compensatory mechanisms of repair. A human trial using selection by this strategy to treat cancer patients was supported through a grant by the NCI/CTEP ACTNOW program. An NCI R01 to further explore this concept was awarded. 600 + pts were screened, 61 pts were treated. An R21 to study this concept in lung cancer was subsequently funded (Dr. Duan PI). This project was extended with two subsequent investigator-initiated clinical trials to evaluate if this test can also identify patients susceptible to immune check point inhibitors.
Focus Project 2: The laboratories of Drs Yu and Caligiuri have demonstrated that cancer cells upregulate PD-L1 on NK cells, resulting in enhanced NK-cell function. Furthermore, the PD-L1 inhibitor atezolizumab (AZ) resulted in enhanced leukemic cell killing against myeloid leukemia lacking PD-L1 expression. Furthermore, mice treated with selective cytokines (IL12, IL15, and IL18) in combination with AZ showed a significant improvement in survival including NK cells from patients with non-small cell lung cancer (NSCLC), even in the absence of PD-L1 expression in their tumor tissue.
Umbilical cord NK cells transduced to express soluble IL15 (sIL15) tagged with a truncated epithelial growth factor receptor demonstrated cytotoxicity against A549 NSCLC cells and substantial reductions in tumor volume in an orthotopic mouse model of human NSCLC. These data suggest that anti-PD-L1 mAb therapy has a unique therapeutic role in treating PD-L1 negative cancer, acting through PD-L1(+) NK cells. This activity is achieved independent of PD-1 activity and in the presence of NK-activating cytokines. We hypothesize that cytokine “enhanced” NK cells will provide clinical benefit in NSCLC patients and that the antitumor activity of this approach will be further enhanced by co-administration of AZ. In order to test this hypothesis and document the safety of this strategy, I am working with Drs Caligiuri and Yu in in vivo safety and efficacy studies followed by a phase 1 study in which CB NK cells, genetically modified to express soluble IL15, followed by ex-vivo expansion in the presence of IL-2, IL-18 and IL-12 will be administered following lymphocyte depletion to NSCLC cancer patients whose tumor has previously progressed on or after treatment with PD-1/PD-L1 inhibitors. The clinical study has been initiated. This project has received NCI R01 funding. Villalona/Yu Multi-PI.
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Bekaii-Saab T, Phelps M, Li X, Saji M, Goff L, Kauh J, O'Neil B, Balsom S, Balint C, Liersemann R, Vasko V, Marsh W, Doyle LA, Ellison G, Grever G, Ringel M, Villalona Calero M.A. Multi-Institutional Phase II Study of Selumetinib (AZD6244, ARRY142886) in Patients with Metastatic Biliary Cancers. J Clin Oncol. 2011; 29 (17): 2357-2363 PMCID: 3107751.
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Villalona-Calero M, Lam E, Otterson G, Zhao W, Timmons M, Subramaniam D, Hade E, Gill GM, Coffey M, Selvaggi G, Bertino E, Chao B, Knopp M. Oncolytic Reovirus in Combination with Chemotherapy in Metastatic or Recurrent Non-Small Cell Lung Cancer Patients with Kras Activated Tumors. Cancer. 2016; Mar 15;122(6):875-83. PMC ID 5068485
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Villalona-Calero M, Atkins I, Thurman A, Rodriguez G, Drengler R, Reigner B, McCune D, Burris H, Weiss G, Moczygemba J, Griffin T, Osterwalder B, Von Hoff D, Rowinsky E. Phase I and pharmacokinetic study of capecitabine and paclitaxel in patients with advanced solid tumors. J Clin Oncol. 1999;17:1915-1925. PMID10561233.
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Nadella P, Shapiro C, Otterson G, Hauger M, Erdal S, Kraut E, Clinton S, Shah M, Stanek M, Monk P, Villalona-Calero M. Pharmaco-biologically based scheduling of capecitabine and docetaxel results in antitumor activity in resistant human malignancies. J Clin Oncol. 2002; 20:2616-2623. PMID: 12039922.
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Villalona-Calero M, Ritch P, Figueroa J, Otterson G, Belt R, Dow E, George S, Leonardo J, McCachren S, Miller GL, Modiano M, Valdivieso M, Geary R, Oliver J, Holmlund J. A Phase I/II Study of LY900003 (AffinitakTM, ISIS 3521), an Antisense Inhibitor of Protein Kinase C Alpha, in Combination with Cisplatin and Gemcitabine in Pts with Advanced NSC Lung Cancer. Clin Canc Res. 2004; 10(8):6086-93. PMID: 15447994.
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Kendra K, Plummer R, Salgia R, O'Brien M, Paul E, Suttle A, Compton N, Xu C, Ottesen L, Villalona-Calero M. A Multicenter Phase I Study of Pazopanib in Combination with Paclitaxel in First-Line Treatment of Patients with Advanced Solid Tumors. Molecular Cancer Therapeutics 2015; 14(2):461-9. PMID:25504632.
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Duan W, Gao L, Wu X, Hade E, Gao J, Ding H, Barsky S, Otterson G, and Villalona-Calero M. Expression of a mutant p53 results in an age-related demographic shift in spontaneous lung tumor formation in transgenic mice. PLoS One 2009;4(5):e5563. PMCID: 2680060.
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Duan W, Gao L, Kalvala A, Aguila B, Brooks C, Mo X, Ding H, Shilo K, Otterson G, and Villalona-Calero M. Type of P53 mutation influences oncogenic potential and spectrum of associated K-ras mutations in lung specific transgenic mice. International Journal of Cancer. 2019; 145(9):2418-2426. PMID: 30873587.
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Duan W, Gao L, Zhao W, Leon M, Sadee W, Webb A, Resnick K, Wu X, Ramaswamy B, Cohn D, Shapiro C, Andreassen P, Otterson G, and Villalona-Calero M. Assesment of FANCD2 nuclear foci formation in paraffin embedded tumors: a potential patient enrichment strategy for treatment with DNA interstrand crosslink agents. Translational Research. 2013;161(3):156-64. PMCID: 3755957.
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Villalona-Calero M, Duan W, Zhao W, Shilo K, Schaaf L, Thurmond J, Westman J, Marshall J, Xiaobai L, Ji J, Rose J, Lustberg M, Bekaii-Saab T, Chen A, Timmers C. Veliparib Alone or in Combination with Mitomycin C in Patients with Solid Tumors with Functional Deficiency in Homologous Recombination Repair. Journal of The National Cancer Institute. 2016 Feb 4;108 (7). PMCID: PMC4948564.
(Selected publications from a total of 129. To view all publications, please click here.)