Filed on behalf of: Abraxis Biosciences, LLC
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`CIPLA LTD.
`Petitioner,
`
`v.
`
`ABRAXIS BIOSCIENCE, LLC
`Patent Owner.
`________________
`IPR2018-00162; IPR2018-00163; IPR2018-00164
`U.S. Patent Nos. 8,138,229; 7,820,788; and 7,923,536
`________________
`DECLARATION OF KATHERINE H.R. TKACZUK, M.D.
`
`
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`Abraxis EX2068
`Cipla Ltd. v. Abraxis Bioscience, LLC
`IPR2018-00162; IPR2018-00163; IPR2018-00164
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`Filed on behalf of: Abraxis Biosciences, LLC
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`I. BACKGROUND & QUALIFICATIONS .......................................................... 1
`II. SUMMARY OF OPINIONS ............................................................................... 3
`A. The clinical results observed with the 9:1 formulation were beneficial and
`unexpected .............................................................................................................. 3
`B. The 9:1 formulation shows unexpectedly improved benefits in comparison to
`solvent-based paclitaxel formulations .................................................................... 6
`C. Experience as a medical oncologist .................................................................. 7
`III. DECLARATION STATEMENT ..................................................................... 8
`
`
`
`i
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`Cipla Ltd. v. Abraxis Bioscience, LLC
`IPR2018-00162; IPR2018-00163; IPR2018-00164
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`Filed on behalf of: Abraxis Biosciences, LLC
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`I, Katherine H.R. Tkaczuk, M.D, submit the following declaration on behalf
`
`of Patent Owner Abraxis BioScience LLC (“Abraxis”), Patent Owner of U.S. Pat.
`
`Nos. 7,820,788 (“the ’788 patent”), 7,923,536 (“the ’536 patent”), and 8,138,229
`
`(“the ’229 patent”) (collectively, “the Abraxis Patents”) to provide my opinions on
`
`certain matters in connection with the petitions for inter partes reviews filed by
`
`Cipla Ltd. (“Cipla” or “Petitioner”) in case nos. IPR2018-00162, IPR2018-00163,
`
`and IPR2018-00164 (collectively, the “Cipla IPR Petitions”).
`
`I.
`
`BACKGROUND & QUALIFICATIONS
`Since 1991, I have been a board certified medical oncologist involved
`
`1.
`
`in the clinical management of cancer patients and in clinical drug development in
`
`phase 1-3 clinical trials.
`
`2.
`
`I am currently Professor of Medicine and Oncology at the University
`
`of Maryland Medical School and Director of the Breast Evaluation and Treatment
`
`Program at the Marlene and Stewart Greenebaum Cancer Center, also at the
`
`University of Maryland Medical Center.
`
`3.
`
`I received my undergraduate and M.D. degrees from Wroclaw
`
`Medical University Uniwersytet Medyczny im. Piastów Śląskich we Wrocławiu;
`
`Universitas Medicus Vratislaviensis in Wroclaw Poland in 1978-1984. I then
`
`conducted research in the Pathology Department at Hahnemann Hospital in
`
`
`
`1
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`IPR2018-00162; IPR2018-00163; IPR2018-00164
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`Philadelphia, Pennsylvania. I completed an internship and residency in Internal
`
`Medicine at St. Agnes Hospital in Baltimore, Maryland, and a fellowship in
`
`Hematology/Oncology from the University of Maryland Cancer Center in
`
`Baltimore, Maryland and the Veterans Administration Medical Center, also in
`
`Baltimore.
`
`4.
`
`I see approximately 35 stage 0-4 breast cancer patients every week. I
`
`regularly use paclitaxel products and other chemotherapeutic agents with these
`
`patients, and have prescribed Abraxane® in my practice since it was approved by
`
`FDA in 2005.
`
`5.
`
`In addition to seeing patients, I also conduct research focusing on
`
`clinical drug development in breast cancer and other solid tumor malignancies.
`
`From 1992 to the present, I have been involved in more than 100 phase 1-3 clinical
`
`trials, and have served as the institutional principal investigator on the majority of
`
`the University of Maryland Greenebaum Comprehensive Cancer Center
`
`(UMGCCC) breast cancer specific clinical trials. As the Director of UMGCCC
`
`Breast Evaluation and Treatment Program, a multidisciplinary program with
`
`commitment to comprehensive, multidisciplinary breast cancer care, I have
`
`overseen the clinical and research aspects of the program for several years. The
`
`UMGCCC clinical breast program continues to work in the area of clinical drug
`
`development with the focus on hormone resistance, role of microtentacles in breast
`
`
`
`2
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`Cipla Ltd. v. Abraxis Bioscience, LLC
`IPR2018-00162; IPR2018-00163; IPR2018-00164
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`cancer metastasis, the significance of brown adipose tissue in pathogenesis and
`
`progression of breast cancer, the GP-88 circulating marker and its significance in
`
`patients with breast cancer and in screening for breast cancer.
`
`6.
`
`I have authored 74 peer reviewed publications, as well as two book
`
`chapters.
`
`7.
`
`I have been recognized as one of America’s Top Doctors (2009-
`
`2014), one of American’s Top Doctors for Cancer (2005-2013) and have been
`
`awarded CMS Meaningful Use Stage 1 Certification. I have received the UMGCC
`
`Patient Choice Award, Favorite Physician.
`
`8.
`
`9.
`
`A copy of my CV is attached as Appendix A.
`
`Due to my background and experience, I am well-qualified to opine
`
`on the clinical effects of Abraxane® and to opine on clinical study data.
`
`10.
`
`I am being compensated for my time spent in connection with this
`
`matter at a rate of $ 650 per hour. My compensation does not depend on the
`
`outcome of the proceeding or the conclusions in my declaration.
`
`II.
`
`A.
`
`SUMMARY OF OPINIONS
`The clinical results observed with the 9:1 formulation were
`beneficial and unexpected
`I was asked by counsel to review the declaration of Dr. Desai, dated
`
`11.
`
`April 14, 2010. I understand that Dr. Desai’s declaration was submitted to the
`
`United States Patent and Trademark Office (“USPTO”) during prosecution of the
`
`
`
`3
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`Abraxis EX2068
`Cipla Ltd. v. Abraxis Bioscience, LLC
`IPR2018-00162; IPR2018-00163; IPR2018-00164
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`Filed on behalf of: Abraxis Biosciences, LLC
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`Abraxis Patents. I do not know if the data reported in Dr. Desai’s declaration was
`
`published, and my opinions are based upon my knowledge and experience and my
`
`review of Dr. Desai’s declaration, including the exhibits thereto.
`
`12. Dr. Desai’s declaration summarized comparative testing results
`
`between Abraxane® and a previous version of Abraxis’s albumin-paclitaxel
`
`nanoparticles. He compared the results seen with Abraxane®, which has an
`
`albumin-to-paclitaxel ratio of 9:1 to results observed with what he calls an “old
`
`formulation”, which has a higher albumin-to-paclitaxel ratio of 19:1. (EX1023 ¶¶
`
`23-30 and Exhibit 5.)
`
`13.
`
`In his declaration, Dr. Desai reported that Abraxane® (with a 9:1
`
`ratio) has a higher therapeutic efficacy and reduced toxicity in comparison to the
`
`“old formulation”. (EX1023 ¶¶ 23-30.)
`
`14. An experienced medical oncologist would be able to review Dr.
`
`Desai’s descriptions of the studies including the response rates and the side effect
`
`rates, and obtain clinically relevant information. In my opinion, they would be
`
`able to obtain enough clinically relevant information from Dr. Desai’s summaries
`
`of these clinical trials even if the patients did not necessarily receive identical
`
`dosing, infusion rates or have the same stages or types of cancer. In my
`
`experience, practicing medical oncologists often take this approach in clinical
`
`medicine as it is often impossible to repeat large randomized clinical trials due to
`
`
`
`4
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`Cipla Ltd. v. Abraxis Bioscience, LLC
`IPR2018-00162; IPR2018-00163; IPR2018-00164
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`limited patient resources and, as widely recognized in the oncology community,
`
`low rates of patient participation in clinical trials.
`
`15.
`
`In my opinion, the data presented in Dr. Desai’s declaration are
`
`indicative of a positive result with the 9:1 formulation of Abraxane® in
`
`comparison to the “old formulation”. These data demonstrate the unexpected
`
`benefits of the 9:1 formulation over the 19:1 formulation, and show that the lower
`
`9:1 albumin to paclitaxel ratio is associated with numerically fewer side-effects, in
`
`particular, for the following:
`
`• lymphopenia – 6% with Abraxane® vs. 36% with 19:1
`
`• anemia – 15% with Abraxane® vs. 77% with 19:1
`
`• anorexia – 18% with Abraxane® vs. 73% with 19:1
`
`• diarrhea – 15% with Abraxane® vs. 23% with 19:1
`
`• rash – 26% with Abraxane® vs. 41% with 19:1
`
`• fatigue – 15% with Abraxane® vs. 36% with 19:1.
`
`16.
`
`This improved side-effect profile seen with the 9:1 formulation is
`
`clinically meaningful and can positively impact patient quality of life while they
`
`are receiving treatment with this cytotoxic agent. For example, patients may be
`
`able to tolerate higher dosages of paclitaxel chemotherapy and/or continue with
`
`chemotherapeutic treatment. It is my opinion that this difference in the side effect
`
`
`
`5
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`Abraxis EX2068
`Cipla Ltd. v. Abraxis Bioscience, LLC
`IPR2018-00162; IPR2018-00163; IPR2018-00164
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`Filed on behalf of: Abraxis Biosciences, LLC
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`profile between the two formulations of albumin based Paclitaxel formulations
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`would not be expected.
`
`B.
`
`17.
`
`The 9:1 formulation shows unexpectedly improved benefits in
`comparison to solvent-based paclitaxel formulations
`Paclitaxel is available as a FDA-approved solvent-based formulation.
`
`The brand name for this formulation is “Taxol”. A solvent-based paclitaxel
`
`formulation was FDA approved and commercially available prior to 2002, when
`
`the patent applications leading to the Abraxane Patents were filed. The FDA-
`
`approved and available on the market 9:1 Abraxane® formulation showed
`
`unexpectedly improved clinical benefits in comparison to solvent-based paclitaxel
`
`formulations as evidenced by published clinical trial results in breast cancer, non-
`
`small cell lung cancer and pancreatic cancer.
`
`18. By 2002, medical oncologists were well aware of the problems
`
`presented by solvent-based paclitaxel formulations. Cremophor EL (CrEL) is a
`
`formulation vehicle used for various poorly-water soluble drugs, including the
`
`anticancer agent Taxol. The most recognized biological effect of paclitaxel
`
`formulated with CrEL is an acute hypersensitivity reaction, characterized by
`
`dyspnea, flushing, rash, chest pain, tachycardia, hypotension, angioedema, and
`
`generalized urticaria. Despite premedication, consisting of high-dose
`
`corticosteroids, H1 and H2 antagonists, minor reactions (flushing and rash) still
`
`occur in 41–44% of all patients and major, potentially life-threatening, reactions in
`
`
`
`6
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`Abraxis EX2068
`Cipla Ltd. v. Abraxis Bioscience, LLC
`IPR2018-00162; IPR2018-00163; IPR2018-00164
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`Filed on behalf of: Abraxis Biosciences, LLC
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`1.5–3%. (EX2090.) In 2002, having used solvent-based paclitaxel formulations,
`
`medical oncologists would have wanted an FDA-approved formulation of
`
`paclitaxel that was stable, could be administered in a smaller infusion volume,
`
`could be administered without pre-medication or without co-administration of
`
`steroids, and which did not have the adverse side effects caused by the solvent in
`
`such formulations. Abraxane®, with its 9:1 ratio of albumin-to-paclitaxel, and
`
`which does not contain Cremophor EL, satisfies these needs. In addition, further
`
`advantages are that Abraxane® is delivered at a higher dosage and over a shorter
`
`infusion period than solvent-based paclitaxel formulations. (EX2091.)
`
`19. As shown in the NCCN Guidelines, Abraxane® is considered to be
`
`one of the standard of care chemotherapeutic treatment options for patients with
`
`metastatic breast cancer and other cancers (such as lung and pancreatic cancers)
`
`demonstrating that this drug is widely accepted as an efficacious and safe treatment
`
`option for patients with these cancers. (See, e.g, EX2087; EX2088; EX2089;
`
`EX2092.)
`
`C.
`
`20.
`
`Experience as a medical oncologist
`I understand that Cipla’s IPR Petitions rely upon a Declaration from
`
`Cory Berkland, Ph.D, who provided opinions about the clinical trials discussed in
`
`the Desai Declaration. I understand that Dr. Berkland is not a physician and
`
`consequently does not treat cancer patients or conduct clinical trials in cancer
`
`
`
`7
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`IPR2018-00162; IPR2018-00163; IPR2018-00164
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`IPR2018-00162; IPR2018-00163; IPR2018-00164
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`APPENDIX A
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`
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`OMB No. 0925-0001 and 0925-0002 (Rev. 10/15 Approved Through 10/31/2018)
`
`BIOGRAPHICAL SKETCH
`Provide the following information for the Senior/key personnel and other significant contributors.
`Follow this format for each person. DO NOT EXCEED FIVE PAGES.
`NAME: Katherine H. R. Tkaczuk
`eRA COMMONS USER NAME (credential, e.g., agency login): ktkaczuk
`POSITION TITLE: Professor of Medicine and Oncology, Director, Breast Evaluation & Treatment Program
`EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing,
`include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)
`DEGREE
`Completion
`Date
`(if
`MM/YYYY
`applicable)
`
`FIELD OF STUDY
`
`
`
`
`
`1984
`1986
`1987
`1989
`1992
`
`INSTITUTION AND LOCATION
`
`
`
`M.D.
`Research
`Internship
`Residency
`Fellowship
`
`1989-1992
`
`Medicine
`Pathology
`Internal Medicine
`Internal Medicine
`Hematology/Oncology
`
`Wroclaw Medical University, Wroclaw, Poland
`Hahnemann Hospital, Philadelphia, PA
`St. Agnes Hospital
`St. Agnes Hospital
`University of MD Cancer Center
`
`A. Personal Statement
`
`My research interests are focused on clinical drug development in breast cancer (BC). From 1992 to present I
`have been involved in 100+ Phase 1-3 clinical trials and have served as the institutional principal investigator
`(PI) on the majority of the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC) BC-
`specific clinical trials. The UMGCCC “Hormonal Sensitive Program” (BREAST and PROSTATE) was
`instrumental in the UMGCCC receiving the P30 grant funding and the NCI Comprehensive Cancer Center
`designation in 2016. Our Clinical Breast Cancer Program contributes substantial numbers of patients to
`institutional and national/cooperative group clinical trials with rates of accrual much higher than the national
`average. In addition we also have excellent participation and accrual of minorities to our clinical trials (many of
`our trials have 40-50% AAF accruals). As the Director of UMGCCC Breast Evaluation and Treatment Program
`(BETP), a multidisciplinary program with commitment to comprehensive, multidisciplinary breast cancer care, I
`have been overseeing the clinical and research aspects of the program for several years. The UMGCCC
`clinical breast program continues to work in the area of clinical drug development with the focus on hormone
`resistance, novel drug combinations, breast cancer vaccines, role of microtentacles in breast cancer
`metastasis, the significance of brown adipose tissue in pathogenesis and progression of breast cancer, the
`GP-88 circulating marker and its significance in patients with breast cancer and in screening for breast cancer.
`In my role as the Director of the Breast Evaluation and Treatment Program at the University of Maryland
`Greenebaum Cancer Center I am wholeheartedly committed to the successful progress of our program.
`
`B. Positions and Honors
`
`Positions and Employment
`1985-1986 Research Associate, Pathology Department, Hahnemann Hospital, Philadelphia, PA
`1986-1987
`Internship (Medical), St. Agnes Hospital, Caton and Wilkens Avenue, Baltimore, MD
`1987-1989 Residency (Medical), St. Agnes Hospital, Caton and Wilkens Avenue, Baltimore, MD
`1989-1992
`Fellowship (Hematology/Oncology), University of Maryland Cancer Center, 22 South Greene
`Street, Baltimore, MD
`Assistant Instructor, University of Maryland School of Medicine, Department of Medicine,
`University of Maryland Cancer Center
`1990-1992 Recipient of the American Cancer Society Clinical Oncology Fellowship
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`1992-2001
`
`1992-1996 Member, University of Maryland Breast Evaluation Program, University of Maryland Medical
`System
`Assistant Professor of Medicine and Oncology, University of Maryland School of Medicine,
`Department of Medicine, University of Maryland Cancer Center
`1992-Present Protocol Chairperson for all Breast Protocols, University of Maryland Cancer Center
`1992-Present Protocol Chairperson for Investigator initiated Breast Cancer Clinical Trials University of
`Maryland Cancer Center
`Acting Director, University of Maryland Breast Evaluation Program, University of Maryland
`Medical System
`1998-Present Director, University of Maryland Cancer Center Breast Evaluation & Treatment Program.
`2001-2009
`Associate Professor of Medicine and Oncology, University of Maryland School of Medicine,
`Department of Medicine, University of Maryland Cancer Center
`2009-Present Professor of Medicine and Oncology, University of Maryland School of Medicine, Department of
`Medicine, University of Maryland Cancer Center
`
`1996-1998
`
`
`Professional Memberships
`1992 American Medical Association
`1992 American Society of Clinical Oncology
`1992 American College of Physicians
`1995 European Society for Medical Oncology
`2011 AACR
`
`Research Committees Memberships
`
`1996-present
`2012-present
`2012-present
`
`Honors
`1990-1992
`1991
`2007
`
`University of Maryland IRB
`Chesapeake IRB
`University of Maryland Greenebaum CCC Data Safety Monitoring Committee
`
`
`
`Recipient of American Cancer Society Clinical Oncology Fellowship
`Recipient of ASCO Fellow Support Award
`Recipient of University of Maryland Marlene and Stewart Greenebaum Cancer Center 2007
`Patient Appreciation Award
`
`C. Contribution to Science
`1. Early studies conducted here at UMGCCC in breast cancer patients helped us to understand the
`significance of clinical and laboratory collaborations which eventually may lead to breakthrough discoveries
`to help to guide our anticancer therapy recommendations. Since then, molecular, multigene tests have
`been developed and help the clinicians to risk stratify early stage BC patients and guide specific treatment
`approaches. Breast tumor circulating cells are of significant interest to us here at UMGCCC. I have also
`been involved in a study focused on imaging of Her2+ breast tumors. Our current collaborations include
`studies with the Stuart Martin laboratory (UMGCCC), which discovered cellular extensions on BC cells
`called microtentacles, with the plan to develop a clinical trial in metastatic BC patients looking at the clinical
`significance of the these microtentacles in the setting of treatment with chemotherapy with a Vinca Alkaloid.
`
`a. Tkaczuk KH, Goloubeva O, Tait NS, Feldman F, Tan M, Lum ZP, Lesko SA, Van Echo DA and
`Ts’o PO. (2008). The significance of circulating epithelial cells in breast cancer patients by a novel
`negative selection method. Breast Cancer Research and Treatment 111, 355-364.
`
`b. Tkaczuk KH, Tait NS Ioffe O, Tan M, Goloubeva OG, Lesko SA, Deamond SF, Zhou D, Lum ZP,
`Sutula MJ, Van Echo D and Ts’o PO. (2011). Computer assisted quantitative immunofluorescence of
`tumor tissue marker expression and clinical outcome to chemotherapy in advanced breast cancer
`patients. Discovery Medicine 12, 33-40.
`
`c. Burks SR, Macedo LF, Barth ED, Tkaczuk KH, Martin SS, Rosen GM, Halpern HJ, Brodie AM and
`Kao JP. (2010). Anti-HER2 immunoliposomes for selective delivery of electron paramagnetic
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`resonance imaging probes to HER2-overexpressing breast tumor cells. Breast Cancer Research &
`Treatment 124, 121-31. (PMCID: 4041539)
`
`2. We have conducted studies with Dr Ginette Serrero and her company to assess the prognostic value of
`glycoprotein 88 (GP-88) as a tumor tissue marker. We found that GP-88 is a negative prognostic marker in
`BC patients with hormone sensitive cancer, which may be
`independent of Her2; additionally,
`overexpression of GP-88 may render BC tumors resistant to anti Her2 therapy with trastuzumab. Studies
`conducted in the UMGCCC also established that GP-88 can be detected in sera of patients with BC and
`this level is increased in BC patients as compared to healthy volunteers. We then conducted a study of GP-
`88 as a screening test for breast cancer in healthy volunteers at average risk for developing breast cancer.
`In addition, we are planning a Phase 1 study of GP88 monoclonal antibody in patients with advanced solid
`tumor malignancies and breast cancer patients with triple negative and hormone resistant breast cancer.
`
`
`a. Tkaczuk, KR. Yue B, Zhan M, Tait N, Yarlagadda L, Dai H and Serrero G. (2011). Increased
`circulating level of the survival factor GP88 (progranulin) in the serum of breast cancer patients. Breast
`Cancer (Auckl.) 5, 155-162. (PMCID: 3140268)
`
`b. Serrero, G Hawkins DM, Yue B, Ioffe, O, Bejarano P, Phillips JT, Head JF, Elliott RL, Tkaczuk KR,
`Godwin AK, Weaver J and Kim WE. (2012). Progranulin (GP88) tumor tissue expression is associated
`with increased risk of recurrence in breast cancer patients diagnosed with estrogen receptor positive
`invasive ductal carcinoma. Breast Cancer Research 14, R26. (PMCID: 3496144)
`
`c. Serrero G, Hawkins DM, Bejarano PA, Ioffe O, Tkaczuk KR, Elliott RE, Head JF, Phillips J, Godwin
`AK, Weaver J, Hicks D and Yue B. (2016). Determination of GP88 (progranulin) expression in breast
`tumor biopsies improves the risk predictive value of the Nottingham Prognostic Index. Diagnosis
`Pathology 11, 71.
`
`3. A clinical translational protocol with Dr. Tonya Webb (UMGCCC) has led to a recent publication by Dr.
`Webb showing invariant natural killer T (iNKT) cells constitute an important subset of T cells that can both
`directly and indirectly mediate anti-tumor immunity. Cancer patients have a reduction in both iNKT cell
`number and function, and these deficits limit the potential clinical application of iNKT cells for cancer
`therapy. Our data demonstrate that co-culture of HSPC with OP9-DL1 stromal cells results in a functional
`CD3(+) T cell population. These T cells can be further differentiated into iNKT cells by secondary culture
`with CD1d-Ig-based artificial antigen-presenting cells (aAPC). Importantly, these in vitro-generated iNKT
`cells are functional, as demonstrated by their ability to proliferate and secrete IFN-γ and GM-CSF following
`stimulation.
`
`a. Reese AS, Feigenberg SJ, Husain A, Webb TJ, Hausner PF, Edelman MJ, Feliciano J, Tkaczuk KH
`and Sharma NK. (2013). Stereotactic Ablative Radiotherapy (SABR): Impact on the immune system and
`potential for future therapeutic modulation. Molecular & Cellular Pharmacolology 5, 19-25. (PMCID:
`4128167).
`
`b. Sohn S, Tiper I, Japp E, Sun W, Tkaczuk K and Webb TJ. (2014). Development of a qPCR
`method to rapidly assess the function of NKT cells. Journal of Immunological Methods 407, 82-89.
`(PMCID: 4073584).
`
`c. Sun W, Wang Y, East JE, Kimball AS, Tkaczuk K, Kesmodel S, Strome SE and Webb TJ.
`(2015). Invariant natural killer T cells generated from human adult hematopoietic stem-progenitor
`cells are poly-functional. Cytokine 72, 48-57. (PMCID: 4329102).
`
`Complete List of Published Work in My Bibliography (74 peer-reviewed publications):
`https://www.ncbi.nlm.nih.gov/pubmed/?term=Tkaczuk+K
`
`D. Research Support
`
`
`
`
`
`
`
`
`
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`Ongoing
`1016GCC: The role of NKT cells in Breast Cancer Patients and Healthy Volunteers
`
`1167GCC: Aims and Audiologic Abnormalities after Aromatase Inhibitor Use.
`
`1378GCC: PUMA-NER-1301: A Study of Neratinib plus Capecitabine Versus Lapatinib Plus Capecitabine
`
`GCC 1403 An Umbrella Protocol for tissue collection from PTS with Breast Cancer, or suspected DX of BC or
`Normal Subjects
`
`1430GCC: A Randomized Study of CDX-011 in Patients with Metastatic, GPNMB Over-Expressing, Triple-
`Negative Breast Cancer
`
`1540GCC: Background parenchymal enhancement on contrast enhanced breast MRI and its association with
`known breast cancer risk factors.
`
`1594GCC: An Open-Label, Single-Arm, Phase II Study of Pertuzumab with High-Dose Trastuzumab for the
`Treatment of Central Nervous System Progression Post-Radiotherapy in Patients with HER2-Positive
`Metastatic Breast Cancer (Patricia)
`
`1601GCC: A Study Looking the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast
`Cancer Treated With Neratinib and Loperamide
`
`
`1604GCC: Folate Receptor Alpha Peptide Vaccine with GM-CSF in Patients With Triple Negative Breast
`Cancer
`
`1645GCC: A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic
`Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
`
`1681GCC: RU011301I, ATOP TRIAL: Adjuvant Ado-Trastuzumab Emtansine (T-DM1) For Older Patients with
`Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
`
`Recently Completed
`
`
`0107GCC Determination of the level of Circulating PC-Cell Derived Growth Factor (PCDGF) in Breast Cancer
`Patients
`
`0777 GCC: Antiemetic Efficacy of Tens unit At P6 Acupoint in the Treatment of chemotherapy Induced
`Nausea and vomiting In Stage 1-3 Breast Cancer Patients Receiving Adjuvant/Neoadjuvant Chemotherapy.
`
`0927GCC: Neoadjuvant Entinostat and Anastrozole in Triple Negative Breast Cancer.
`
`0967GCC: Relationship between Vitamin D deficiency and breast cancer histology
`
`
`1051GCC Patient-reported adherence to AI adjuvant therapy for stage (1-3) breast cancer: An evaluation of
`baseline predictors
`
`1019GCC: Retrospective Study of MRI imaging in young breast cancer survivors
`
`1303GCC: Trastuzmab & Pertuzumab alone or combo w/HT or chemo w/Eribulin in women aged >=60 with
`HER2/neu overexpression local advanced/MBC
`
`1380GCC: GP-88 as Screening Test for Breast Cancer.
`
`1486GCC: A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients with Recurrent
`Brain Metastases [ANG1005-CLN-04
`
`Abraxis EX2068
`Cipla Ltd. v. Abraxis Bioscience, LLC
`IPR2018-00162; IPR2018-00163; IPR2018-00164
`Page 15 of 16
`
`

`

`
`1432GCC: Phase 2 Study of Ruxolitinib/Placebo in Combination with Capecitabine in Subjects with Previously
`Treated Advanced Breast Cancer
`
`Most Recent Completed Research Support
`Maryland Industry Partnerships
`3/2014-3/2015
`GP-88 as a Screening Test for Breast Cancer
`Role: Principal Investigator
`
`2/2008-3/2010
`Maryland Industrial Partnerships
`Clinical Studies of Drug Response Indicator Test
`Role: Principal Investigator
`
`5/2005-6/2007
`Maryland Industrial Partnerships
`Serum PCDGF/GP88 in Breast Cancer Patients
`Role: Principal Investigator
`
`5/2007-6/2009
`Maryland Industrial Partnerships
`Serum PCDGF/GP88 in Breast Cancer Patients
`Role: Principal Investigator
`
`Multiple other completed research clinical trials by CALGB, Intergroup and various other sponsors
`between 1992-2017.
`
`
`Abraxis EX2068
`Cipla Ltd. v. Abraxis Bioscience, LLC
`IPR2018-00162; IPR2018-00163; IPR2018-00164
`Page 16 of 16
`
`