Victor M. Villalobos, M.D., Ph.D.

University of Colorado Anschutz Medical Campus

1665 Aurora Court

Anschutz Cancer Pavilion Room 5329, mail stop F704

Aurora, CO

PROFESSIONAL/ACADEMIC APPOINTMENTS

9/15/2014 – current Assistant Professor of Medicine

Division of Medical Oncology

University of Colorado Anschutz Medical Campus

9/15/2014 – current Director, Sarcoma Medical Oncology

University of Colorado Anschutz Medical Campus

5/1/2015 – current Director, T3 (Target-based Therapeutics Team), a multi-disease clinical research team dedicated to basket cohort, target based and supportive oncology trials.

University of Colorado Anschutz Medical Campus

7/1/2013 – 9/3/2014 Instructor of Medicine

Sarcoma, unknown primary cancers, and rare tumors clinic.

Division of Medical Oncology

Stanford University Medical Center

TRAINING

7/1/2008 – 6/30/2010 Internal Medicine Residency

Stanford University Medical Center

7/1/2010 – 6/30/2013 Fellowship in Medical Oncology

Stanford University Medical Center

EDUCATION

1995 – 1999 Baylor University; Waco, TX

Bachelor of Science, Biochemistry, Emphasis on Organic Synthesis

Research Advisor: Kevin Pinney, Ph.D.

1999 – 2008 Washington University School of Medicine; St. Louis, MO

Doctor of Medicine, May 2008

Doctor of Philosophy in Chemical Biology, February 2007

Research Advisor: David Piwnica-Worms, M.D., Ph.D.

Thesis: “Development and Characterization of Novel Optical Biosensors for Real-Time Interrogation of Signal Transduction Cascades in Live Cells.”

2012 Stanford University; Stanford, CA

Intensive Course in Clinical Research: Study Design and Performance

Stanford Center for Clinical and Translational Education and Research

BOARD CERTIFICATION AND LICENSING

5/2008 Physician and Surgeon License in California

Lic# CA-A109396

8/16/2012 Board certification in Internal Medicine (ABIM)

11/13/2013 Board certification in Medical Oncology (ABIM)

8/2014 Physician License in Colorado

Lic # DR.0054330

PROFESSIONAL SOCIETIES

2001 – 2010 Society for Molecular Imaging

2010 – present American Society of Clinical Oncology

2012 – present American College of Physicians

2012 – current Member Sarcoma Alliance through Research and Collaboration (SARC)

2013 – present Connective Tissue Oncology Society

2014 – present SWOG

2015 – present Rocky Mountain Oncology Society

PROFESSIONAL APPOINTMENTS & HONORS

2011 – 2014 ASCO University Committee

2011 – 2014 ASCO Professional Development Committee

2011 – 2014 ASCO Oncology Training Programs Subcommittee

2011 – 2014 ASCO Integrated Media and Technology Committee

2013 ASCO Excellence in Teaching Award Selection Committee

2012 – 2014 Planning Committee: Stanford Multidisciplinary Management of Cancers

2014 – current Associate Editor – ASCO University Editorial Board

2014 – current Steering Committee Member – University of Colorado Denver Molecular Tumor Board

2014 – current Member, SWOG Early Therapeutics and Rare Cancers Committee

2014 – 2015 Member, SWOG Sarcoma Survivorship Subcommittee

2015 – current NCCN Bone Cancer Guideline Panel Member

2015 – current Member, Intermountain Cancer Center Molecular Tumor Board

2015 – current Study Section and Grant Review - FDA Orphan Products Development

2016 – current Rocky Mountain Oncology Society Board Member

2016 – current Study Section and Grant Review - FDA Orphan Products Development - Orphan Products Natural History Grants program

JOURNAL PEER-REVIEWER

2014 – current ASCO University Editorial Board

2016 Journal of Oncology Practice

2016 Scientific Reports

2016 Case Reports in Oncological Medicine

2016 JCO Precision Medicine

2016 Oncology Board Review Manual

HONORS AND AWARDS

2002 – 2003 Nuclear Medicine Training Grant, Department of Energy

2013 – 2015 NIH Loan Repayment Program Award 2013-2015

2015 – 2017 Hope Foundation – SWOG Rare Tumors Fellow

CLINICAL EXPERTISE

2014 – current University of Colorado Hospital – Anschutz Medical Campus

-  Director, Sarcoma Medical Oncology

Mentor: Anthony Elias, MD

-  Early phase developmental therapeutics

Mentors: Gail Eckhardt, MD; Wells Messersmith, MD

2008 – 2014 Stanford University Hospitals and Clinics, Stanford, CA.

-  Soft Tissue and Bone Sarcoma

Mentors: Kristen Ganjoo, MD; Sant Chawla, MD, FRACP

-  Carcinoma of unknown primary, ovarian, and other rare cancers

-  Early phase Developmental therapeutics

Mentors: Branimir Sikic, MD; Dmitri Colevas MD

CLINICAL AND TRANSLATIONAL SCIENCE RESEARCH

2016 – current A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma

Role: Principal investigator

Sponsor: Eli Lilly

2016 – current M15-394 A Multicenter, Phase I, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects with Advanced Solid Tumors (COMIRB 16-0263) (PRMS 16-33)

Role: Principal investigator

Sponsor: Abbvie

2015 – current Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma

Role: Principal investigator

Sponsor: Epizyme

2015 – current NCI - EAY131 - Molecular Analysis for Therapy Choice (MATCH)

Role: SWOG Study Co-Chair/Champion

Sponsor: ECOG-ACRIN

2015 – current Medimmune – A Phase 1 Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Tremelimumab (Anti-CTLA-4 Antibody) in Subjects with Advanced Solid Tumors who Have Received, Progressed, or are Intolerant to Standard Therapy and Have Received No More Than 3 Prior Therapies for Metastatic or Recurrent Disease.

Role: Principal Investigator

Sponsor: Medimmune

2015 – 2016 A091401: Phase II Study of Nivolumab with or Without Ipilimumab in Patients with Metastatic or Unresectable Sarcoma

Role: Principal Investigator

Sponsor: ALLIANCE

2015 – current A091202 - A Phase II Randomized, Double Blinded Study Of The Peroxisome Proliferator-Activated Receptor Gamma Agonist, Efatutazone Vs. Placebo In Patients With Previously Treated, Unresectable Myxoid Liposarcoma

Role: Principal Investigator

Sponsor: ALLIANCE

2015 – current ARST1321 - Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib

Role: Principal Investigator/SWOG Co-Chair/Champion

Sponsor: NRG

2015 – current A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Role: Principal Investigator

Sponsor: Pharmamar

2015 – current A Phase 3, Randomized (1:1), Double-Blind, Placebo-Controlled, Trial of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients with Advanced or Metastatic Soft Tissue Sarcoma (excluding Kaposi’s and GIST) which is not amenable to treatment with surgery or radiotherapy with curative intent (may have had any number of prior systemic cytotoxic therapies for advanced/metastatic disease except prior treatment with anthracyclines).

Role: Principal investigator

Sponsor: Eli Lilly

2014 – current An Open-Label Study to Evaluate the Pharmacokinetics of Doxorubicin following the Concomitant Intravenous Administration of Olaratumab (IMC-3G3) to Patients with Advanced Soft Tissue Sarcoma

Role: Principal Investigator

Sponsor: Eli Lilly and Co.

2014 – current A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Solid Tumors, Including Glioma, with an IDH1 Mutation (Chondrosarcoma)

Role: Co-Investigator

Sponsor: Agios Pharmaceuticals

2014 – current A Multi-Center, Open Label, First In Human, Phase I Dose Escalation Study To Investigate Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of RO6839921, An MDM2 Antagonist Following Intravenous Administration In Patients With Advanced Malignancies, Including Acute Myeloid Leukemia (AML)

Role: Co-Investigator

Sponsor: Roche

2014 – current A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator’s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy

Role: Co-Investigator

Sponsor: CytRx Corporation

2014 – current A Multicenter, Open-Label Single-Arm Study of YONDELIS (trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Excluding Leiomyosarcoma and Liposarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment

Role: Co-Investigator

Sponsor: Janssen Research & Development, LLC

2014 – current A Randomized, Open-label, Phase II, Multi-center Trial of Gemcitabine (G) with Pazopanib (P) or Gemcitabine (G) with Docetaxel (T) in Previously Treated Subjects with Advanced Soft Tissue Sarcoma.

Role: Co-Investigator

Sponsor: Medical University of South Carolina/GlaxoSmithKline

2012 – 2014 A First-in-Human Phase I Dose Escalation Trial of the Humanized Anti-CD47 Monoclonal Antibody Hu5F9-G4 in Patients with Advanced Solid Malignancies.

Role: Co-investigator; Protocol co-developer; Coauthor

Sponsor: Stanford University

2013 – 2014 A Phase 1, Open-label, Dose-escalation, Safety and Pharmacokinetic Study of CDX-1127 in Patients with Selected Refractory or Relapsed Hematologic Malignancies or Solid Tumors

Role: Co-investigator

Sponsor: Celldex Therapeutics

NCT01460134

2011 – 2012 HGS1029-C1078: Phase 1 Dose Ranging Study in Patients with Advanced Solid Malignancies.

Role: Co-investigator

Sponsor: Human Genome Sciences

NCT00708006

2011- 2012 OMP-21M18: A Phase 1 Dose Escalation Study of OMP-21M18 in Subjects with Solid Tumors.

Role: Co-investigator

Sponsor: Oncomed Pharmaceuticals

NCT00744562

2011 – 2012 XL-184: A Randomized Discontinuation Study of XL184 in Subjects with Advanced Solid Tumors: Non-Randomized Extension.

Role: Co-investigator

Sponsor: Exelixis

NCT00940225

2011 - 2013 A Phase II Study of Pazopanib in Patients with Imatinib and Sunitinib Refractory or Intolerant Gastrointestinal Stroma Tumors (GIST)

Role: Co-investigator; Coauthor

Sponsor: Glaxo-Smith-Kline/Investigator initiated

NCT 01391611

2011 – 2014 A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, and Vincristine alternating with Irinotecan and Temozolomide in Patients with Newly Diagnosed Metastatic Ewing's Sarcoma

Role: Co-investigator

Type of Study: Investigator initiated multi-institutional study

Sponsor: Amgen

NCT 01313884

2010 - 2013 A Multi-center Single Agent Phase II Study of the Efficacy of Nilotinib in Patients with Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/diffuse-type Giant Cell Tumor

Role: Co-investigator

Type of Study: Multi-center Study

Sponsor: Dana Farber Cancer Institute

NCT 01207492

2011 – 2014 A Randomized Controlled Study of Yondelis (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma previously Treated with an Anthracycline and Ifosfamide

Role: Co-investigator

Type of Study: Multi-center Study

Sponsor: Johnson & Johnson

NCT 01343277

2012 – 2014 A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

Role: Co-investigator

Type of Study: Multi-center Study

Sponsor: Threshold Pharmaceuticals

NCT 01440088

BASIC SCIENCE RESEARCH

2011 – 2013 Stanford University, Stanford, CA

Elucidation of predictive biomarkers in ovarian cancer using the TCGA cancer database.

I performed a fundamental reannotation of the TCGA clinical dataset in ovarian cancer. We worked closely with several bioinformaticians to include the more robust chemotherapy data to identify several novel predictive biomarkers for platinum sensitivity.

Mentor: Branimir Sikic, M.D.

2001 – 2007 Washington University School of Medicine, St. Louis, MO

I developed novel BRET (bioluminescence resonance energy transfer) systems for imaging protease activity in living cells using new donor proteins.

Mentor: David Piwnica-Worms, M.D., Ph.D.

2003 – 2008 Washington University School of Medicine, St. Louis, MO.

Developed novel non-destructive multicolored protein-protein interaction sensors for use in vitro and in vivo, with the ability to monitor two discreet protein interactions simultaneously in the same cells in real-time.

Mentor: David Piwnica-Worms, M.D., Ph.D.

1996 – 1999 Baylor University, Waco, TX.

Synthesized novel antitumor therapeutics for optimized bioavailability and function. Among these were drugs based on combretastatin A-4, a colchicine analogue, with primary mechanism of tubulin binding and inhibition of tubulin polymerization.

Mentor: Kevin Pinney, Ph.D.

PUBLICATIONS

1)  Villalobos VM, Hoffner B, Elias AD. We CAN study ultrarare tumors effectively in this day and age, it just takes a cooperative approach: The role of dasatinib in assorted indolent sarcomas. Cancer. 2016 Oct 3. doi: 10.1002/cncr.30377.

2)  Willis S, Villalobos VM, Gevaert O, Abramovitz M, Williams C, Sikic BI, Leyland-Jones B. Single Gene Prognostic Biomarkers in Ovarian Cancer: A Meta-Analysis. PLoS One. 2016 Feb 17;11(2):e0149183.

3)  Ganjoo KN, Villalobos VM, Kamaya A, Fisher GA, Butrynski JE, Morgan JA, Wagner AJ, D’Adamo D, McMillan A, Demetri GD, and George S. A Multicenter Phase II Study of Pazopanib in Patients with Metastatic Gastrointestinal Stromal Tumors (GIST) Following Failure of at Least Imatinib and Sunitinib. Ann Oncol 2014 25 (1): 236-240.

4)  Gevaert O, Villalobos V, Sikic BI, Plevritis S. Identification of ovarian cancer driver genes by using module network integration of multi-omics data. Interface Focus 2013 3(4): 201130013.

5)  Henry E, Villalobos V, Million L, Jensen KC, West R, Ganjoo K, Lebensohn A, Ford JM, Telli ML. Chest wall leiomyosarcoma after breast-conservative therapy for early-stage breast cancer in a young woman with li-fraumeni syndrome. J Natl Compr Canc Netw. 2012 Aug 1;10(8):939-42.

6)  Villalobos VM, Naik S, Bruinsma M, Dothager RS, Pan MH, Samrakandi M, Moss B, Elhammali A, Piwnica-Worms D. Dual-color Click Beetle Luciferase heteroprotein fragment complementation assays. Chem Biol. 2010 Sep 24;17(9): 1018-29.

7)  Gammon ST*, Villalobos VM*, Roshal M, Samrakandi M, Piwnica-Worms D. Rational design of novel red-shifted BRET pairs: Platforms for real-time single-chain protease biosensors Biotechnol Prog. 2009 Mar-Apr;25(2):559-69. *Co-first authors

8)  Villalobos VM, Naik, S, Piwnica-Worms, D. Detection of protein-protein interactions in live cells and animals with split firefly luciferase protein fragment complementation Methods Mol Biol. 2008; 439:339-52.

9)  Villalobos VM, Naik, S, Piwnica-Worms, D. Current state of imaging protein-protein interactions in vivo with genetically encoded reporters. Annu Rev Biomed Eng. 2007; 9:321-49

10)  Bullok KE, Gammon ST, Violini S, Prantner AM, Villalobos VM, Sharma V, Piwnica-Worms D. Permeation peptide conjugates for in vivo molecular imaging applications. Molecular Imaging. 2006; 5: 1-15.

11)  Piwnica-Worms, David; Luker, Kathryn E.; Villalobos, Victor M. (2005) Molecular imaging of protein-protein interactions in living animals. In: Schuster DP, Blackwell TS (Eds.), Lung Biology in Health and Disease: Molecular Imaging of the Lungs, Boca Raton, FL: Taylor & Francis Group, pp. 313-326.

12)  Gammon ST, Villalobos VM, Prior JL, Sharma V, Piwnica-Worms D. Quantitative analysis of permeation peptide complexes labeled with Technetium-99m: Chiral and sequence-specific effects on net cell uptake. Bioconjugate Chemistry. 2003; 14: 368-76.

13)  Ferdani, Ricardo; Hu, Jiaxin; Leevy, W. Matthew; Pajewska, Jolanta; Pajewski, Robert; Villalobos, Victor; Barbour, Leonard J.; Gokel, George W. Solid-state evidence for alkali metal to arene Pi-complexation. Journal of Inclusion Phenomena and Macrocyclic Chemistry. 2001, 41: 7-12.

14)  Pinney, K. G.; Mejia, M. P.; Villalobos, V. M.; Rosenquist, B. E.; Pettit, G. R.; Verdier-Pinard, P.; Hamel, E. Synthesis and biological evaluation of aryl azide derivatives of combretastatin A-4 as molecular probes for tubulin. Bioorganic & Medicinal Chemistry. 2000, 8, 2417-2425.

ORAL PRESENTATIONS (Bolded represents national or international presentations)