Fruehauf JP
`
`Work Address
`
`CURRICULUM VITAE
`
`John Paul Fruehauf, M.D., Ph.D.
`
`Division of Hematology/Oncology
`UCI Medical Center, Building 56, Room 247
`101 The City Drive
`Orange, CA 92868
`714-456-5153
`714-456-2242 (FAX)
`email: jfruehau@uci.edu
`
`Home Address
`
`10855 Turnleaf Lane
`Tustin, CA 92782
`
`Education and Training
`
`1973–1977
`
`
`
`1978–1985
`
`1985–1987
`
`1987–1992
`
`Professional Positions
`
`1993–2000
`2003–2013
`
`July 2014-present
`
`2004-present
`
`February 2022
`
`University of California, Santa Barbara
`B.A.: Cellular and Organismal Biology
`B.A.: Psychology
`
`Rush University M.D., Ph.D.: Pharmacology
`
`University of California, Irvine
`Internal Medicine Residency
`
`National Cancer Institute, Bethesda, MD
`Clinical Oncology Program Medical Staff Fellow
`Research Officers Group, Commissioned Corps, PHS
`Biotechnology Fellow
`
`Assistant Clinical Professor, U.C. Irvine
`Associate Professor of Clinical Medicine,
`Biological Chemistry, Pharmaceutical Sciences
`and Biomedical Engineering
`
`
`Professor of Clinical Medicine,
`Biological Chemistry, Pharmaceutical Sciences
`and Biomedical Engineering
`
`Director, Clinical Pharmacology and Developmental Therapeutics
`Chao Family Comprehensive Cancer Research Center
`University of California, Irvine
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 1 of 28
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
` 1988–Present
` 1996–Present
` 1998–Present
`
`Vice President and Medical Director
`Senior Vice President and Medical Director
`Chief Scientific Officer
`
`
`Work Experience
`Oncotech, Inc.
`1992-1998
`
`1998-2002
`
`2002-2004
`
`
`
`Licensure
`
`1986
`California CA G58826
`Maryland D006157 1987
`
`Certifications
`
`American Board of Internal Medicine, Medical Oncology #124351, Recertified 2011
`
`Memberships and Societies
`
`American Association for Cancer Research
`American Society of Clinical Oncology
`SWOG, Melanoma Committee
`
`
`
`Awards and Honors
`
`Consumers Research Council of America Award for Top Oncologist
`2007
`OCMA Physician of Excellence
`
`
`
`
`
`2010, 2014, 2016
`U.S. News Top Doctor
`
`
`
`
`
`
`
`2011
`Teacher of the Year UCI Oncology Fellows
`
`
`
`
`2011
`
`Research Experience
`
`1993-present UC Irvine
`My group has focused on mechanisms of drug action and resistance with the goal of
`developing predictive tests that improve therapeutic outcomes for cancer patients. Active areas
`in my laboratory at UC Irvine include the role of glutathione and redox mechanisms in drug
`resistance, development of vascular endothelial cell models
`to predict response
`to
`antiangiogenesis agents, and the examination of differential gene expression that can distinguish
`between drug resistant and drug sensitive tumors. More recently we have focused on translating
`our bench work to the bedside through the development of clinical trials that include correlative
`laboratory studies.
`Discovery of agents that inhibit formation of tumor blood vessels continues to be an active
`area of therapeutic development. Insights into the immunomodulatory activity of antiangiogenesis
`agents has led to their effective combination with check point inhibitors (UCI 16-63). However,
`resistance to antiangiogenesis agents as a deterrent to the success of this approach has been
`overlooked. In order to define the role of angiogenesis in tumor progression, and to develop
`models that might predict treatment response, my group developed an angiogenesis index based
`on mutant p53, the angiogenesis suppressor thrombospondin-1 (TSP1), and intratumor
`
`Fruehauf JP
`
`
`
`
`
`Year
`
`February 2022
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 2 of 28
`
`

`

`Fruehauf JP
`
`microvessel counts (US Patent # 5,840,507). We applied this marker set to ovarian cancer
`patients receiving bevacizumab on a GOG clinical trial, finding that TSP1 expression was
`significantly associated with durability of response to Avastin (Gynecol Oncol 119:484-90, 2010).
`Our group has also explored the relationship between tumor class, drug response and
`differential gene and protein expression (Clinical Cancer Res 5 (Suppl), #476, 1999). One
`significant deficiency in current molecular approaches to cancer genomics is specimen purity. The
`complex mixture of cells within a tumor makes it difficult to delineate which mRNA species are
`cancer cell specific. We therefore developed flow-cytometry methods to selectively separate
`malignant cells and tumor derived vascular endothelial cells (VEC) from their stromal background
`tissue. Transcript levels were determined for the purified cancer cell and VEC cell populations
`using Affymetrix U133 A and B gene arrays containing 30,000 distinct genes and EST’s.
`Differential gene expression patterns that classify endothelial cells into drug resistance categories
`have been identified (Proc Am Assoc Cancer Res 43: #4502, 2002; Breast Cancer Res and Treat
`76: #562, 2002; Proc Am Assoc Cancer Res 2003, #3998 (Minisymposium Podium Presentation).
`My current position as Director of Clinical Pharmacology and Developmental Therapeutics
`in the Chao Family Comprehensive Cancer Center at UC Irvine allows me to take a translational
`approach to predictive oncology and to apply bioprofiling to patients on clinical trials. The
`tremendous complexity of aberrant pathways in cancer has been a major deterrent in the
`development of targeted therapeutics. With the advent of gene arrays and advanced mass
`spectrometry methods, this complexity may finally be captured. The capability to bioprofile the
`unique proteogenomic characteristics of an individual patient’s tumor is at hand. Co-development
`of proteogenomic “theragnostic” tests in conjunction with clinical trials of targeted agents are
`helping to define patient subsets most likely to benefit, while excluding patients with inappropriate
`biomarker profiles from potentially toxic treatment. The convergence of biotechnology, molecular
`biology and clinical pharmacology with bioinformatics should enable a rational approach to target
`cancer related pathways and improve outcomes for patients with cancer.
`
`
`Research Background
`
`1987-1993
`
`
`National Cancer Institute, NIH, Clin Pharm Branch
`
`Examined the mechanisms of cross resistance between chemotherapy
`and tumor necrosis factor in breast cancer and prostate cancer cell lines.
`
`
`
`Rush University, Department of Pharmacology
`Determined a novel mechanism of action of BCNU to inhibit DNA
`synthesis via glutathione depletion in conjunction with inhibition of
`glutathione recycling. (PhD Thesis)
`
`
`
`1978-1985
`
`
`1975-1977
`
`University of California, Santa Barbara, Dpt. Of Chemistry
`
`Worked on the isolation of the red blood cell glucose transporter using 3-
`deoxy-3-fluoro-glucose.
`
`Active Research Grant and Contract Support
`
`Current Peer Reviewed Awards
`
`
`
`
`
`
`
`
`
`
`
`
`February 2022
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 3 of 28
`
`

`

`Fruehauf JP
`
`
`NIH/NCI P30, CA-62203-14
`01/31/19–01/31/24
`UCI Cancer Center Support Grant. Center Grant to support UCI Cancer Center.
`Role: Chair, Data Safety Monitoring Board
`
`Company Sponsored Laboratory Research Awards
`1/18-12/14/21
`Astellas
`Topotecan Reversal of Enzalutamide Resistance in 22Rv1 Cells via Blockade of AR-V7
`Nuclear Translocation
`Role: PI
`$172,154.00
`
`Recently Completed Peer Reviewed Support
`
`01/01/11–12/31/16
`NIH/NCI R21, CA156032-02
`Novel biologic markers of treatment resistance in locally advanced cervical carcinoma.
`Role: C0-PI
`$150,000 (T)
`
`NIH/NCI RO1
`
`
`6/13-5/18
`PAK Kinases Regulate Melanoma Chemoresistance and Metastasis
`Role: Co-I (PI Anand Ganesan)
`$1,210,649 (T)
`
`NIH/NCI RO1
`
`
`6/13-5/18
`PAK Kinases Regulate Melanoma Chemoresistance and Metastasis
`Role: Co-I (PI Anand Ganesan)
`$1,210,649 (T)
`
`
`Current Clinical Trials Funding
`
`Industry Sponsored Trial/ UCI-18-64 : RPL-001-16 An Open-Label, Multicenter, Phase 1/2 Study
`of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors.
`PI 7/15/21-
`
`Industry Sponsored Trial/ UCI-20-57: A Phase 3, Randomized, Open-label Study to Compare
`Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab
`After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12).
`PI $593,944 (T) 11/01/2020 - 10/31/2023
`
`Industry Sponsored Trial/ UCI-19-140: A Randomized Phase II, Open-label, Active-controlled,
`Multicenter Study Investigating the Efficacy and Safety of UV1 Vaccination in Combination with
`Nivolumab and Ipilimumab as First-line Treatment of Patients with Unresectable or Metastatic
`Melanoma (UV1-202).
`PI $338,316 (T) 09/01/2020 - 08/31/2023
`
`Industry Sponsored Trial/ UCI-20-116: A RANDOMIZED, CONTROLLED, OPEN-LABEL, PHASE
`2 STUDY OF CEMIPLIMAB AS A SINGLE AGENT AND IN COMBINATION WITH RP1 IN
`PATIENTS WITH ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA.
`PI $493,338 (T) 11/01/2020 - 10/31/2023
`
`
`February 2022
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 4 of 28
`
`

`

`Fruehauf JP
`
`Industry Sponsored Trial/ UCI-19-15 A Phase 2, Open-Label, Randomized, Multicenter Trial of
`Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With
`BRAFV600-Mutant Melanoma Brain Metastasis
`PI $299,658 (T) 11/5/19-10/21/22
`
`Industry Sponsored Trial/ UCI-17-73: A Sequential 2-arm, Open-label Phase 1 Study to
`Evaluate the Effects of Encorafenib in Combination with Binimetinib on the Pharmacokinetics of
`Losartan, Midazolam, Caffeine, Omeprazole, and Dextromethorphan Administered in a Cocktail
`Approach and on the Pharmacokinetics of Rosuvastatin in Patients with BRAF V600-mutant
`Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors.
`PI $171,895.00 (T) 1/24/18 – 10/21/22
`
`Industry Sponsored Trial/ UCI-16-102: A PHASE III, OPEN-LABEL, MULTICENTER, TWO-
`ARM, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF
`COBIMETINIB PLUS ATEZOLIZUMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH
`PREVIOUSLY UNTREATED ADVANCED BRAFV600 WILD-TYPE MELANOMA
`PI $378,399.00 (T). 11/15/17 - 11/14/20
`
`Industry Sponsored Trial/ UCI 17-09: A randomized, double-blind, placebo-controlled, phase III
`study comparing the combination of PDR001, dabrafenib and trametinib versus placebo,
`dabrafenib and trametinib in previously untreated patients with unresectable or metastatic BRAF
`V600 mutant melanoma
`PI $507,335.00 (T). 08/01/17 - 07/31/20
`
`Industry Sponsored Trial / UCI-16-92: A Phase III, Double-Blinded, Randomized, Placebo-
`Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib versus Placebo plus
`Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients
`with Unresectable Locally Advanced or Metastatic Melanoma
`PI $689,151.00 (T). 2/15/17 - 5/30/22
`
`Industry Sponsored Trial / UCI 16-63
`Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab
`(MK-3475) in Combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment
`for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)
`PI $292,747.00 (T). 1/17/17- 07/5/20
`
`Industry Sponsored Trial / UCI 15-12
`A Phase III, Open-Label, Randomized Study of MPDL3280A (Anti-PD-L1 Antibody) in
`Combination with Bevacizumab versus Sunitinib in Patients with Untreated Advanced Renal
`Cell Carcinoma
`PI $5,268,204 (T). 09/24/15 - 09/23/20
`
`Industry Sponsored Trial / UCI 14-82: PHASE III, RANDOMIZED, DOUBLE-BLIND,
`MULTICENTER TRIAL OF AUTOLOGOUS DENDRITIC CELLS LOADED WITH IRRADIATED
`AUTOLOGOUS TUMOR CELLS IN GM-CSF (DC-TC) VS. AUTOLOGOUS PERIPHERAL
`BLOOD MONONUCLEAR CELLS IN GM-CSF (MC) FOR THE TREATMENT OF PATIENTS
`WITH METASTATIC MELANOMA
`PI $216,091.00 (T). 06/25/15 - 06/24/20
`
`
`February 2022
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 5 of 28
`
`

`

`Fruehauf JP
`
`Industry Sponsored Trial / UCI 13-36: A Phase III randomized, 3-arm, open label, multicenter
`study of LGX818 plus MEK162 and LGX818 monotherapy compared with vemurafenib in
`patients with unresectable or metastatic BRAF V600 mutant melanoma
`PI $225,878.00 (T). 6/24/13 - 3/1/20
`
`UCI 14-48: A Phase 2, Multicenter, Randomized, Open-label Trial Assessing the Efficacy and
`Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery versus Surgery
`Alone for Resectable, Stage IIIB to IVM1a Melanoma
`PI: $133,069.00 (T). 08/21/15 - 08/20/20
`
`
`Investigator Initiated Research Contracts
`
`Novartis
`
`HDII Clinical Trial UCI 09-53
`A Phase II, Single-Arm Study of Pazopanib and Paclitaxel as First-Line Treatment for Subjects
`with Unresectable Stage III and Stage IV Melanoma.
`PI $560,730.00 (T) 6/24/10-12/31/20
`
`HDII Clinical Trial UCI 10-55 Pfizer
`Ph 2 Study of Anti-Angiogenesis Agent AG-013736 in Patients with Stage III Malignant
`Melanoma
`PI $469,970 12/15/11-5/11/20
`
`
`Prior Completed Research Grant Support
`
`1976
`
`
`1980, 1981, 1982
`
`
`National Science Foundation Summer Research Award
`UCSB, Department of Chemistry
`
`March of Dimes Summer Research Fellowship Award
`Rush University Department of Pharmacology
`
`
`1980
`
`
`1981–1982
`
`
`
`National Institutes of Health, COSTEP Program
`Laboratory of Immunodiagnosis, NCI, Dr. Ronald Herberman,
`
`Pharmaceutical Manufacturers Association Foundation Medical
`Student Research Fellowship: Pharmacology-Clinical
`Pharmacology, Rush University
`
`NCI, NIH SBIR Grant, R43 CA60219-01,
`Development of a Therapeutic TNF-Degradation Product
`($75,000) PI
`
`NCI, NIH SBIR Grant, R43 CA61372-01,
`Development of an MDR-1 Resistance Reversal Assay
`($75,000) PI
`
`
`
`
`
`
`
`California Cancer Research Program, CRC Cycle-II
`Angiogenesis as predictor of metastatic risk
` ($50,000) PI
`
`February 2022
`
`
`1994
`
`
`
`1994
`
`
`2000
`
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 6 of 28
`
`

`

`NCI, NIH R43 CA83551
`A New High Throughput Assay for Human MDR1 Substrates
`($75,000) PI
`
`NCI, NIH R21
`Investigation of Angiogenic Function by MRI.
`Co-Investigator
`
`NCI, NIH P20 CA-86182 Pre-Center Dvpmnt Grant,
`In Vivo Cellular and Molecular Imaging Centers
`Co-investigator
`
`CA Breast Cancer Research Program 6JB-0029
`Selective Thrombosis of Vessels for Anti-Angiogenic Therapy of
`Breast Cancer
`Co-Investigator
`
`NCI, NIH R43 HL70490-01
`Genomics Screening for Antiangiogenesis Drugs
`($75,000) PI
`
`DOD DAMD 17-01-0178 Breast Cancer Research Program
`Anti-angiogenic Therapeutic Indicators in Breast Cancer
`Co-Investigator
`
`
`
`
`
`NCI, NIH RO1
`Prediction of Metastatic Disease in Early Breast Cancer
`PI, Sub-Contract
`
`
`
`
`
`
`
`NCI. NIH R21
`Lycopene & Docetaxel in Prostate Cancer: An IGF-I Receptor
`Targeting Approach
`Co-Investigator
`
`
`
`Fruehauf JP
`
`2001-2002
`
`
`2000–2001
`
`
`2000-2003
`
`
`
`
`2001-2003
`
`
`2002–2003
`
`
`
`2001-2003
`
`
`
`2001–2007
`
`
`2008–2010
`
`
`
`
`
`
`
`
`
`
`
`
`Completed Clinical Translational Research Activities
`
`
`
`Clinical Trial UCI 09-34 (GSK)
`2010–2013
`A Double-Blind Randomized Placebo-Controlled Ph III Study to Assess Efficacy of recMAGE-
`A3+AS15 ASCI as Adjuvant Therapy in Patients with MAGE-A3 Positive Resected Stage III
`Melanoma
`PI
`
`
`Clinical Trial UC 09-28 (GSK)
`2009–2013
`Open, Single-Arm Study to Assess the Clinical Activity of recMAGE-A3 + AS15 in Patients With
`Unresectable, MAGE-A3 Positive Metastatic Cutaneous Melanoma
`PI
`
`Translational Study (GSK)
`
`
`2008-2011
`Oral Topotecan, Utilization of a Metronomic Dosing Schedule to Treat Recurrent Ovarian
`Cancer
`
`February 2022
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 7 of 28
`
`

`

`Fruehauf JP
`
`($24,000) PI
`
`
`
`
`
`Clinical Trial UCI 07-55 (Wyeth)
`2008–2012
`Randomized Trial of Temsirolimus and Sorafenib as Second-Line Therapy in Advanced Renal
`Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy.
`($169,460) PI
`
`
`Clinical Trial UCI 07-11 (Genentech)
`2007-2009
`Ph II Bevacizumab with Carboplatin & Pacilitaxel in Metastatic Melanoma
`($414,655) PI
`
`Preclinical correlates ATN39758 and ATN224 (Attenuon)
`2006-2008
`Redox related antimelanoma activity of ATN224
`($22,875) PI
`
`Clinical Trial UCI 06-39 (Attenuon)
`2006-2009
`UCI 06-39: A randomized phase II trial of ATN-224 in combination with temozolomide or
`temozolomide followed by ATN-224 in systemic-treatment naive patients with advanced
`melanoma.
`($107,467) PI
`
`
`
`
`Clinical Trial UCI 04-48 (Cell Genesys)
`2006-2007
`A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and
`Prednisone in Patients with Metastatic Hormone-Refractory prostate Cancer who are
`Chemotherapy-Naive
`($145,850) PI
`
`Clinical Trial UCI 05-47 (GSK)
`2006-2008
`UCI 05-47 A Phase II Study of GW786034 Using a Randomized Discontinuation Design in
`Subjects with Locally Recurrent or Metastatic Clear-Cell Renal Cell Carcinoma
`($69,335) PI
`
`HDII Clinical Trial UCI 04-35 (Sanofi-Aventis)
`2006-2009
`Phase II Oxaliplatin with Gemcitabine for Stage IV Bladder Cancer
`($227,925) PI
`
`Preclinical Study OX-06-005 (Sanofi)
`2006-2008
`OX-06-005: “Defects in DNA adduct repair predict bladder cancer response to oxaliplatin”
`($86,330) PI
`
`HDII Clinical Trial UCI 02-23 (Berlex/Bayer)
`2005–2010
`Docetaxel plus Vinorelbine with Sargramostim for Stage IV Melanoma
`($209,258) PI
`
`
`
`
`Clinical Trial UCI 05-19 (Attenuon)
`2005-2007
`A Dose Ranging Phase II Open Label Study of ATN161 in Advanced Renal Cell Cancer
`($246,491) PI
`
`
`Clinical Trial UCI 04-34 (Pfizer)
`2004-2007
`Phase II Antiangiogenesis Study of AG 013736 for Stage IV Melanoma
`($136,209) PI
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`February 2022
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 8 of 28
`
`

`

`Fruehauf JP
`
`
`
`
`
`
`HDII Clinical Trial, UCI 99-25R (GSK)
`1999–2007
`Topotecan plus cisplatin followed by paclitaxel consolidation for the treatment of stage III and IV
`epithelial ovarian cancer and primary peritoneal cancer with in vitro correlates of response
`($72,813) PI
`
`Editorial Activities
`World Journal of Clinical Oncology Editorial Board Member
`
`Ad Hoc Reviewer
`Gynecologic Oncology
`Breast Cancer Research and Treatment
`Clinical Cancer Research
`Anti-Cancer Drugs
`The Cancer Journal
`European Journal of Cancer
`Pharmacological Research
`Cancer
`
`Study Sections
`
`
`6/94 NCI, NIH: Ad Hoc Contracts Technical Review Group for Phase I Studies
`3/03 NCI, NIH: ZES RAM-C-C3, Special Emphasis Panel for the Review of Development
`Of Microarray Profiles for Microbial Toxicity
`
`
`
`
`
`4/03 NCI, NIH: ZRG SSS-1 12B, Diagnosis and Treatment of Cancer
`
`
`
`6/07 NCI, NIH Cancer Center Renewal Site Visit Team, NYU
`
`
`
`
`6/99 HHS Medicare Negotiated Rulemaking Taskforce: Author of Medicare Tumor Marker
`Coverage Policy for CA125
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`University Service
`1996–2010 Member, UC Irvine Translational Seed Grants Committee
`1999–2002 UC Irvine Institutional Biosafety Committee
`1999–2004 Chair, Clinical Trials Protocol Review and Monitoring Committee
`2003 Chair, Search Committee, UCI Department of Radiology
`2005–2008 Member, UC Irvine Allied Health Committee
`
`2006–2007 UC Wide Scientific Advisory Committee for Pharmacology
`2008–2022 Vice Chair, UC Irvine Institutional Review Board B
`2020 -Present Chair, UC Irvine Institutional Review Board WB
`2010–Present Chair, Cancer Center Data Safety and Monitoring Board
`2017-Present Chair, UC Irvine Institutional Review Board WB
`
`Supervision of Graduate Students
`Co-Chair, PhD Defense Committee: John Sinek, Biomedical Engineering 2005
`Co-Chair, PhD Committee: Hermann Frieboes, Biomedical Engineering 2005
`
`Primary PhD Advisor:
`
`2004-2009 Valerie Trapp, PhD awarded Biomedical Engineering,
`
`2007-2012 Basmina Parmakhtiar, PhD awarded Biological Chemistry
`
`2010-2012 Maliheh Movassat, Biological Chemistry
`
`Post Doctoral Trainees/Fellows Mentoring
`
`2005-2007 Ernest Han, Fellow Gyn/Onc
`
`February 2022
`
`
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 9 of 28
`
`

`

`Fruehauf JP
`
`2007-2008 Leslie Randall-Whitis, Fellow Gyn/Onc
`2008-2009 Dana Chase, Fellow Gyn/Onc
`2012-2013 Shlomid Ein-Gal, Fellow, Heme/Onc
`2013-2014 GK Ford, Fellow, Gyn/Onc
`2014-2016 Teresa Longoria, Fellow Gyn/Onc
`2015-2016 Sarmen Sarkissian, Fellow Heme/Onc
`2016-2017 Monica El-Masry, Fellow Heme/Onc
`
`
`Masters Students Mentoring:
`
`2005–2006: Miranda King, Biotechnology
`
`2006–2007: Peter Foss, Biotechnology
`
`Undergraduate Research Supervision
`Bio 199 Instructor:
`4-5 students per quarter 2004–Present
`
`
`Teaching Experience
`2007 to Present: Pharmaceutical Sciences M172 Course Director, Fall Quarter
`
`
`Patents (Citations)
`Treatment of Tumor Cells with TNF Degradation Products.
`US Patent No 5,543,139, Aug 6, 1996
`Methods for Cancer Prognosis and Diagnosis: Angiogenesis Index.
`US Patent No 5,840,507. April 11, 1997
`Radiation Resistance Assays for Predicting Treatment Response and Clinical Outcome.
`US Patent No 6,008,007. Dec 28, 1999 (44)
`(Co-Inventor: Dr. R. Parker)
`Methods for Cancer Prognosis and Diagnosis
`US Patent No 6,303,324. Nov 24, 1998 (19)
`Radiation Resistance Assays for Predicting Treatment Response and Clinical Outcome.
`US Patent No 6,261,795. July 17, 2001 (20)
`(Co-Inventor: Dr. R. Parker)
`Methods and Reagents for Preparing and Using Immunological Agents Specific for
`P-glycoprotein.
`US Patent No 6,365,357. April 2, 2002
`(Co-inventor: Dr. E. Mechetner)
`Methods for In Vitro Genotyping of Drug-Sensitive and Drug-Resistant Subsets of Primary
`Tumors.
`US Patent No 6,511,806. January 28, 2003 (19)
`Methods for cancer prognosis and diagnosis relating to tumor vascular endothelial cells.
`US patent No 6,998,234. February 14, 2006 (7)
`
`
`Google Scholar: Citations 6325: h-Index 43
`Peer Reviewed Publications (# Citations)
`1. Fruehauf JP, Bonnard GD, Herberman RB. The effect of lentinan on production of
`interleukin-1 by human monocytes. Immunopharmacology 5:65-74, 1982. (118)
`2. Fruehauf JP, Myers CE, Sinha BK. Synergistic activity of suramin with tumor necrosis
`factor and doxorubicin on prostate cancer cell lines. J Natl Cancer Inst 82:1206-1209, 1990.
`(70)
`
`February 2022
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 10 of 28
`
`

`

`Fruehauf JP
`
`3. Fruehauf JP, Mimnaugh E, Sinha BK. Doxorubicin-induced cross-resistance to tumor
`necrosis factor (TNF) related to differential TNF processing. J Immunotherapy 10:165-173,
`1991. (15)
`4. Mimnaugh EG, Fairchild CR, Fruehauf JP, Sinha BK. Biochemical and pharmacological
`characterization of MCF-7 drug-sensitive and AdrR multidrug-resistant human breast tumor
`xenografts in athymic nude mice. Biochemical Pharm 42:391-402, 1991. (48)
`5. Fruehauf JP, Sinha BKS. Selective formation of tumor necrosis factor alpha (TNF)
`degradation products contributes to TNF mediated cytotoxicity. Oncology Res 4:91-101,
`1992. (11)
`6. Santin AD, Hiserodt JC, Fruehauf J, DiSaia PJ, Pecorelli S, Granger G. Effects of irradiation
`on the expression of surface antigens in human ovarian cancer. Gynecol Oncol 60:468-474,
`1996. (37)
`7. Santin AD, Rose GS, Hiserodt JC, Fruehauf J, Eck LM, Garcia RI, Schranz V, DiSaia PJ,
`Pecorelli S, Granger GA. Effects of tumor necrosis factor-alfa plus interferon-gamma
`combined with high dose gamma irradiation on the expression of major histocompatibility
`complex molecules and intercellular adhesion molecule-1 in human ovarian cancers. Intl J
`Cancer 65:688-694, 1996. (4)
`8. Santin AD, Hermonat PL, Hiserodt JC, Fruehauf J, et al. Differential Transforming Growth
`Factor-β secretion in adenocarcinoma and squamous cell carcinoma of the uterine cervix.
`Gyn Onc 64:476-480, 1997. (29)
`9. Fruehauf JP, Zonis S, Al-Bassam M, Kyshtoobayeva A, Dasgupta C, Milovanovic T, Parker
`RJ, Buzaid AC. Selective and synergistic activity of L-S,R-buthionine sulfoximine on
`malignant melanoma is accompanied by decreased expression of glutathione-S-transferase.
`Pigment Cell Res 10:236-249, 1997. (21)
`10. Mechetner E, Kyshtoobayeva A, Zonis S, Kim H, Stroup R, Garcia R, Parker RJ, Fruehauf
`JP. Levels of multidrug resistance (MDR1) P-glycoprotein expression by human breast
`cancer correlates with in vitro resistance to taxol and doxorubicin. Clinical Cancer Res
`4:389-398, 1998. (340)
`11. Grant SW, Kyshtoobayeva AS, Jakowatz J, Fruehauf JP. Mutant p53 correlates with
`reduced expression of thrombospondin-1, increased angiogenesis, and metastatic
`progression in melanoma. Cancer Det Prev 22(3): 185-195, 1998. (96)
`12. Coppola D, Lu L, Fruehauf JP, Kyshtoobayeva A, Karl RC, Nicosia SV, Yeatman TJ.
`Analysis of p53, p21 WAF1, and TGF-beta 1 in human ductal adenocarcinoma of the
`pancreas: TGF-beta1 protein expression predicts longer survival. Am J Clin Pathol 110:16-
`23, 1998. (73)
`13. Fruehauf JP, Zonis, S., Al-Bassam, M., Kyshtoobayeva, A., Dasgupta, G., Milovanovic, T.,
`Parker, R., Buzaid, A.C. Melanin content and down regulation of glutathione-S-transferase
`contribute to the action of L-buthionine-S-sulfoximine on human melanoma. Chemico-
`Biological Interactions. 111-112: 277-305, 1998. (31)
`14. Haber M, Bordow SB, Gilbert J, Madafiglio J, Kavallaris M, , Marshall GM, Mechetner EB,
`Fruehauf JP, Tee L, Cohn SL, Salwen H, Schmidt ML, Norris MD. Altered expression of
`the MYCN oncogene modulates MRP gene expression and response to cytotoxic drugs in
`neuroblastoma cells. Oncogene, 18:2777-2782, 1999. (83)
`
`February 2022
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 11 of 28
`
`

`

`Fruehauf JP
`
`15. Moore MM, Tewari KT, Rose S, Fruehauf JP, DiSaia PJ. Long-term consequences
`following conservative management of epithelial ovarian cancer in an infertile patient.
`Gynecol Oncol 73: 452-454, 1999. (19)
`16. Tewari K, Kyshtoobayeva AS, Mehta RS, Yu I-R, Burger RA, DiSaia PJ, Fruehauf JP.
`Biomarker conservation in primary and metastatic epithelial ovarian carcinoma. Gynecol.
`Oncol. 78:130-136, 2000. (56)
`17. Mehta R, Kyshtoobayeva A, Kurosaki T, Small EJ, Kim H, Stroup R, McClaren C, Li K-T,
`Fruehauf JP. Independent association of angiogenesis index with outcome in prostate
`cancer. Clinical Cancer Res 7:81-88, 2001. (121)
`18. Mehta RS, Bornstein R, Yu IR, Parker RJ, McLaren CE, Nguyen KP, Li K-T, Fruehauf JP.
`Breast cancer survival and in vitro tumor response in the Extreme Drug Resistance Assay.
`Breast Cancer Research and Treatment 66:225-237, 2001. (65)
`19. Reavy-Cantwell JF, Haroun RI, Zahurak M, Clatterbuck RE, Parker RJ, Mehta R, Fruehauf
`JP, Brem H. The prognostic value of tumor markers in patients with glioblastomas
`multiforme: analysis of 32 patients and review of the literature. J Neuro-Onc 55:195-204,
`2001. (101)
`20. Ellis RJ, Fabian CJ, Kimler BF, Tawfik O, Mayo MS, Decelis CR, Jewell WR, Connor C,
`Modrell C, Praeger M, McGinness M, Mehta R, Fruehauf JP. Factors associated with
`success of the extreme drug resistance assay in primary breast cancer specimens. Breast
`Cancer Res Treat 71:95-102, 2002. (11)
`21. Haroun RI, Clatterbuck RE, Gibbons MC, Burger PC, Parker R, Fruehauf JP, Brem H.
`Extreme drug resistance in primary brain tumors: in vitro analysis of 64 resection specimens.
`J Neuro-Onc 58:115-123, 2002. (23)
`22. Holloway RW, Mehta RS, Finkler NJ, Li K-T, McLaren CE, Parker RJ, Fruehauf JP.
`Association between in vitro platinum resistance in the EDR assay and clinical outcomes for
`ovarian cancer patients. Gynecol Oncol 87:8-16, 2002. (107)
`23. Monk BJ, Burger RA, Parker R, Radney EH, Redpath L, Fruehauf JP. Development of an
`in vitro chemo-radiation response assay for cervical carcinoma. Gynecol Oncol 87:193-199,
`2002. (13)
`24. Su M-Y, Yu H, Chiou J-Y, Wang J, Fruehauf JP, Nalcioglu O, Mehta RS, Baick CH.
`Measurement of volumetric and vascular changes with dynamic contrast enhanced MRI for
`cancer therapy monitoring. Technology in Cancer Research and Treatment, 1(6): 479-488,
`2002. (15)
`25. Park SW, Lomri N, Simeoni LA, Fruehauf JP, Mechetner E. Analysis of p-glycoprotein-
`mediated membrane transport in human peripheral blood lymphocytes using the UIC2 shift
`assay. Cytometry 53A:67-78, 2003. (58)
`26. Sommers KR, Kong KM, Bui DT, Fruehauf JP, Holcombe RF. Stevens-Johnson
`syndrome/toxic epidermal necrolysis in a patient receiving concurrent radiation and
`gemcitabine. Anti-Cancer Drugs 14:659-662, 2003. (34)
`27. Su M-Y, Cheung Y-C, Fruehauf JP, Yu H, Mechetner E, Kyshtoobayeva A, Chen S-C,
`Hsueh S, McLaren CE, Nalcioglu O, Wan Y-L. Correlation of dynamic contrast enhancement
`MRI parameters with microvessel density and VEGF for assessment of angiogenesis in
`breast cancer. JMRI 18:467-477, 2003. (200)
`28. del Carmen MG, Smith Sehdev AE, Nickles Fader A, Zahurak ML, Richardson M, Fruehauf
`JP, Montz FJ, Bristow RE. Endometriosis-associated ovarian carcinoma: Differential
`
`February 2022
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 12 of 28
`
`

`

`Fruehauf JP
`
`expression of vascular endothelial growth factor and estrogen/progesterone receptors.
`Cancer 98:1658-1663, 2003. (51)
`29. Cloven N, Kyshtoobayeva A, Burger RA, Yu I-R, Fruehauf JP. In vitro chemoresistance and
`biomarker profiles are unique for histologic subtypes of epithelial ovarian cancer. Gyn Oncol
`92: 160-166, 2004. (84)
`30. Parker RJ, Fruehauf JP, Mehta R, Filka E, Cloughesy T. A prospective blinded study of the
`predictive value of extreme drug resistance assays in patients receiving CPT-11 for
`recurrent glioma. J Neuro-Oncology, 66:365-375, 2004. (19)
`31. Gossett DR, Alo P, Bristow RE, Galati M, Kyshtoobayeva A, Fruehauf J, Montz FJ. Inability
`of immunohistochemistry to predict clinical outcomes of endometrial cancer patients. Int J
`Gynecol Cancer 14:145-151, 2004. (6)
`32. Fabian CJ, Kimler BF, Anderson J, Tawfik OW, Mayo MS, Burak Jr WE, O’Shaughnessy
`JA, Albain KS, Hyams DM, Budd GT, Ganz PA, Sauter ER, Beenken SW, Grizzle WE,
`Fruehauf JP, Arneson DW, Bacus JW, Lagios MD, Johnson KA, Browne D. Breast cancer
`chemoprevention phase I evaluation of biomarker modulation by arzoxifene, a third
`generation selective estrogen receptor modulator. Clin Cancer Res 10:5403-5417, 2004.
`(66)
`33. Fruehauf JP, Kong K, Jakowatz JG. Phase II clinical trial evaluating docetaxel and
`vinorelbine plus GM-CSF in malignant melanoma. Oncology 19 (suppl 2):19-22, 2005. (14)
`34. Goodhart MJ, Ritchie JM, Rose SL, Fruehauf JP, De Young BR, Buller RE. The relationship
`of molecular markers of P53 function and angiogenesis to prognosis of stage I epithelial
`ovarian cancer. Clin Cancer Res 11:3733-3742, 2005. (87)
`35. Tewari KS, Mehta RS, Burger RA, Yu I-R, Kyshtoobayeva AS, Monk BJ, Manetta A,
`Berman ML, DiSaia PJ, Fruehauf JP. Conservation of in vitro drug resistance patterns in
`epithelial ovarian carcinoma. Gynecol Oncol 98:360-368, 2005. (29)
`36. Tewari D, Monk BJ, Al-Ghazi MS, Parker R, Heck JD, Burger RA, Fruehauf JP. Gene
`expression profiling of in vitro radiation resistance in cervical carcinoma: a feasibility study.
`Gynecol Oncol 99:84-91, 2005. (31)
`37. Fruehauf JP, Brem H, Brem S, Sloan A, Barger G, Huang W, Parker R. In vitro drug
`response and molecular markers associated with drug resistance in malignant gliomas. Clin
`Can Res 12:4523-32, 2006. (86)
`38. Prabhu S, Saadat D, Zhang M, Halbur L, Fruehauf JP, Ong ST. A novel mechanism for
`Bcr-Abl action: Bcr-Abl-mediated induction of the eIF4F translation initiation complex and
`mRNA translation. Oncogene 26:1188-200, 2007. (58)
`39. Nishimoto KP, Newkirk D, Hou S, Fruehauf J, Nelson EL. Fluorescence activated cell
`sorting (FACS) using RNAlater to minimize RNA degradation and perturbation of mRNA
`expression from cells involved in initial host microbe interactions. J Microbiol Methods.
`70(1):205-8, 2007. (16)
`40. Einspahr JG, Thomas TL, Saboda K, Nickolof BJ, Wameke J, Curiel-Lewandrowski C,
`Ranger-Moore J, Duckett L, Bangert J, Fruehauf JP, Alberts DS. Expression of Vascular
`Endothelial Growth Factor in early cutaneous melanocytic lesion progression. Cancer:
`110:2519-27, 2007. (64)
`41. Mathews MS, Linskey ME, Hasso AN, Fruehauf JP. The effect of bevacizumab (Avastin)
`on neuroimaging of brain metastases. Surg Neurol. 70(6):649-53, 2008. (41)
`
`February 2022
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1094, p. 13 of 28
`
`

`

`Fruehauf JP
`
`42. Zhang M, Fu W, Prabhu S, Moore JC, Ko J, Kim JW, Druker BJ, Trapp V, Fruehauf J,
`Gram H, Fan HY, Ong ST. Inhibition of polysome assembly enhances imatinib act