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WHO Drug Information Vol. 12, No. 3, 1998
WHO DRUG INFORMATION VOLUME 12 NUMBER 3 • 1998 RECOMMENDED INN LIST 40 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA Volume 12, Number 3, 1998 World Health Organization, Geneva WHO Drug Information Contents Seratrodast and hepatic dysfunction 146 Meloxicam safety similar to other NSAIDs 147 Proxibarbal withdrawn from the market 147 General Policy Issues Cholestin an unapproved drug 147 Vigabatrin and visual defects 147 Starting materials for pharmaceutical products: safety concerns 129 Glycerol contaminated with diethylene glycol 129 ATC/DDD Classification (final) 148 Pharmaceutical excipients: certificates of analysis and vendor qualification 130 ATC/DDD Classification Quality assurance and supply of starting (temporary) 150 materials 132 Implementation of vendor certification 134 Control and safe trade in starting materials Essential Drugs for pharmaceuticals: recommendations 134 WHO Model Formulary: Immunosuppressives, antineoplastics and drugs used in palliative care Reports on Individual Drugs Immunosuppresive drugs 153 Tamoxifen in the prevention and treatment Azathioprine 153 of breast cancer 136 Ciclosporin 154 Selective serotonin re-uptake inhibitors and Cytotoxic drugs 154 withdrawal reactions 136 Asparaginase 157 Triclabendazole and fascioliasis 138 Bleomycin 157 Calcium folinate 157 Chlormethine 158 Current Topics Cisplatin 158 Reverse transcriptase activity in vaccines 140 Cyclophosphamide 158 Consumer protection and herbal remedies 141 Cytarabine 159 Indiscriminate antibiotic -
Prior Approaches and Future Directions Marna Williams1, Anna Spreafico2, Kapil Vashisht3, Mary Jane Hinrichs4
Author Manuscript Published OnlineFirst on June 16, 2020; DOI: 10.1158/1535-7163.MCT-19-0993 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Patient Selection Strategies to Maximize Therapeutic Index of Antibody Drug Conjugates: Prior Approaches and Future Directions Marna Williams1, Anna Spreafico2, Kapil Vashisht3, Mary Jane Hinrichs4 1Translational Medicine, Oncology, AstraZeneca, Gaithersburg, USA 2Drug Development Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada 3AstraZeneca, Gaithersburg, USA. 4Early Development Oncology, Ipsen LLC, USA Corresponding author: Marna Williams Email: [email protected] Postal address: One MedImmune Way, Gaithersburg, MD, 20878 Phone: 301-398-1241 Fax: 240-306-1545 Running title Patient Selection Strategies for Antibody Drug Conjugates Keywords Antibody drug conjugates; therapeutic index; patient selection; biomarkers; cancer Conflicts of interest This study was funded by AstraZeneca. MW, KV and MJH are all current or former employees of AstraZeneca with stock/stock options in AstraZeneca. AS has been Advisory Board Consultant to Merck, Bristol-Myers Squibb, Novartis, Oncorus, Janssen, and has received Grant/Research support from Novartis, Bristol-Myers Squibb, Symphogen AstraZeneca/Medimmune, Merck, Bayer, Surface Oncology, Northern Biologics, Janssen Oncology/Johnson & Johnson, Roche, Regeneron, and Alkermes. Word count: Abstract: 197 Manuscript: 5,268 (excluding abstract) + 683 figure/table legends and footnotes Figures/tables: 5 (as agreed) 1 Downloaded from mct.aacrjournals.org on September 24, 2021. © 2020 American Association for Cancer Research. Author Manuscript Published OnlineFirst on June 16, 2020; DOI: 10.1158/1535-7163.MCT-19-0993 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. -
Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models. -
Advances and Limitations of Antibody Drug Conjugates for Cancer
biomedicines Review Advances and Limitations of Antibody Drug Conjugates for Cancer Candice Maria Mckertish and Veysel Kayser * Sydney School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW 2006, Australia; [email protected] * Correspondence: [email protected]; Tel.: +61-2-9351-3391 Abstract: The popularity of antibody drug conjugates (ADCs) has increased in recent years, mainly due to their unrivalled efficacy and specificity over chemotherapy agents. The success of the ADC is partly based on the stability and successful cleavage of selective linkers for the delivery of the payload. The current research focuses on overcoming intrinsic shortcomings that impact the successful devel- opment of ADCs. This review summarizes marketed and recently approved ADCs, compares the features of various linker designs and payloads commonly used for ADC conjugation, and outlines cancer specific ADCs that are currently in late-stage clinical trials for the treatment of cancer. In addition, it addresses the issues surrounding drug resistance and strategies to overcome resistance, the impact of a narrow therapeutic index on treatment outcomes, the impact of drug–antibody ratio (DAR) and hydrophobicity on ADC clearance and protein aggregation. Keywords: antibody drug conjugates; drug resistance; linkers; payloads; therapeutic index; target specific; ADC clearance; protein aggregation Citation: Mckertish, C.M.; Kayser, V. Advances and Limitations of Antibody Drug Conjugates for 1. Introduction Cancer. Biomedicines 2021, 9, 872. Conventional cancer therapy often entails a low therapeutic window and non-specificity https://doi.org/10.3390/ of chemotherapeutic agents that consequently affects normal cells with high mitotic rates biomedicines9080872 and provokes an array of adverse effects, and in some cases leads to drug resistance [1]. -
The Double Stranded RNA Analog Poly-IC Elicits Both Robust IFN-Λ Production and Oncolytic Activity in Human Gastrointestinal Cancer Cells
www.oncotarget.com Oncotarget, 2018, Vol. 9, (No. 77), pp: 34471-34484 Research Paper The double stranded RNA analog poly-IC elicits both robust IFN-λ production and oncolytic activity in human gastrointestinal cancer cells Chantal Bou-Hanna1,*, Anne Jarry1,2,*, Jean-François Mosnier1,3, Céline Bossard1,2,3 and Christian L. Laboisse1,3 1University of Nantes, EA4273 Biometadys, Nantes, France 2Current address: CRCINA, INSERM, Université d’Angers, Université de Nantes, Nantes, France 3Pathology Department, Nantes University Hospital, Nantes, France *Equal co-authors Correspondence to: Christian L. Laboisse, email: [email protected]; [email protected] Keywords: dsRNA/poly-IC; IFN-λ; immunoadjuvant; oncolysis; human gastrointestinal cancer Received: February 09, 2018 Accepted: September 06, 2018 Published: October 02, 2018 Copyright: Bou-Hanna et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License 3.0 (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. ABSTRACT Purpose: Type III IFN (IFN-λ) is the dominant frontline response over type I IFN in human normal intestinal epithelial cells upon viral infection, this response being mimicked by the dsRNA analog poly-IC. Poly-IC also induces cell death in murine intestinal crypts ex vivo. Here we examined whether these innate defense functions of normal intestinal epithelial cells are recapitulated in gastrointestinal carcinoma cells so that they could be harnessed to exert both immunoadjuvant and oncolytic functions, an unknown issue yet. Experimental design: Four human gastrointestinal carcinoma cell lines versus the Jurkat lymphoma cell line were used to assess the effects of intracellular poly-IC on i) IFN-λ secretion and cell proliferation and ii) role of NFκB signaling using the NFκB inhibitory peptide SN50 as a screening probe and a siRNA approach. -
IMGN779, a Novel CD33-Targeting Antibody-Drug Conjugate with DNA Alkylating Activity, Exhibits Potent Antitumor Activity in Models of AML
Author Manuscript Published OnlineFirst on March 27, 2018; DOI: 10.1158/1535-7163.MCT-17-1077 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. IMGN779, a Novel CD33-Targeting Antibody-Drug Conjugate with DNA Alkylating Activity, Exhibits Potent Antitumor Activity in Models of AML Yelena Kovtun1*, Paul Noordhuis2*, Kathleen R. Whiteman1, Krystal Watkins1, Gregory E. Jones1, Lauren Harvey1, Katharine C. Lai1, Scott Portwood3, Sharlene Adams1, Callum M. Sloss1, Gerrit Jan Schuurhuis2, Gert Ossenkoppele2, Eunice S. Wang3, and Jan Pinkas1 1ImmunoGen, Inc., Waltham, Massachusetts. 2Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands. 3Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York *These authors contributed equally to the work Running Title: Preclinical activity of IMGN779 in AML Corresponding author: Yelena Kovtun, ImmunoGen Inc., 830 Winter St, Waltham, MA 02451. Phone: (781) 895-0716; Fax: (781) 895-0611; Email: [email protected] Potential conflict of interests: E.S. Wang received financial support from, and has served on an advisory board for, Immunogen Inc. There are no other competing interests to declare. 1 Downloaded from mct.aacrjournals.org on September 24, 2021. © 2018 American Association for Cancer Research. Author Manuscript Published OnlineFirst on March 27, 2018; DOI: 10.1158/1535-7163.MCT-17-1077 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Abstract The myeloid differentiation antigen CD33 has long been exploited as a target for antibody-based therapeutic approaches in acute myeloid leukemia (AML). Validation of this strategy was provided with the approval of the CD33-targeting antibody-drug conjugate (ADC) gemtuzumab ozogamicin in 2000; the clinical utility of this agent has however been hampered by safety concerns. -
Tanibirumab (CUI C3490677) Add to Cart
5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor -
2017 Immuno-Oncology Medicines in Development
2017 Immuno-Oncology Medicines in Development Adoptive Cell Therapies Drug Name Organization Indication Development Phase ACTR087 + rituximab Unum Therapeutics B-cell lymphoma Phase I (antibody-coupled T-cell receptor Cambridge, MA www.unumrx.com immunotherapy + rituximab) AFP TCR Adaptimmune liver Phase I (T-cell receptor cell therapy) Philadelphia, PA www.adaptimmune.com anti-BCMA CAR-T cell therapy Juno Therapeutics multiple myeloma Phase I Seattle, WA www.junotherapeutics.com Memorial Sloan Kettering New York, NY anti-CD19 "armored" CAR-T Juno Therapeutics recurrent/relapsed chronic Phase I cell therapy Seattle, WA lymphocytic leukemia (CLL) www.junotherapeutics.com Memorial Sloan Kettering New York, NY anti-CD19 CAR-T cell therapy Intrexon B-cell malignancies Phase I Germantown, MD www.dna.com ZIOPHARM Oncology www.ziopharm.com Boston, MA anti-CD19 CAR-T cell therapy Kite Pharma hematological malignancies Phase I (second generation) Santa Monica, CA www.kitepharma.com National Cancer Institute Bethesda, MD Medicines in Development: Immuno-Oncology 1 Adoptive Cell Therapies Drug Name Organization Indication Development Phase anti-CEA CAR-T therapy Sorrento Therapeutics liver metastases Phase I San Diego, CA www.sorrentotherapeutics.com TNK Therapeutics San Diego, CA anti-PSMA CAR-T cell therapy TNK Therapeutics cancer Phase I San Diego, CA www.sorrentotherapeutics.com Sorrento Therapeutics San Diego, CA ATA520 Atara Biotherapeutics multiple myeloma, Phase I (WT1-specific T lymphocyte South San Francisco, CA plasma cell leukemia www.atarabio.com -
Antibody-Radionuclide Conjugates for Cancer Therapy: Historical Considerations and New Trends
CCR FOCUS Antibody-Radionuclide Conjugates for Cancer Therapy: Historical Considerations and New Trends Martina Steiner and Dario Neri Abstract When delivered at a sufficient dose and dose rate to a neoplastic mass, radiation can kill tumor cells. Because cancer frequently presents as a disseminated disease, it is imperative to deliver cytotoxic radiation not only to the primary tumor but also to distant metastases, while reducing exposure of healthy organs as much as possible. Monoclonal antibodies and their fragments, labeled with therapeutic radionuclides, have been used for many years in the development of anticancer strategies, with the aim of concentrating radioactivity at the tumor site and sparing normal tissues. This review surveys important milestones in the development and clinical implementation of radioimmunotherapy and critically examines new trends for the antibody-mediated targeted delivery of radionuclides to sites of cancer. Clin Cancer Res; 17(20); 6406–16. Ó2011 AACR. Introduction are immunogenic in humans and thus prevent repeated administration to patients [this limitation was subse- In 1975, the invention of hybridoma technology by quently overcome by the advent of chimeric, humanized, Kohler€ and Milstein (1) enabled for the first time the and fully human antibodies (7)]. Of more importance, production of rodent antibodies of single specificity most radioimmunotherapy approaches for the treatment (monoclonal antibodies). Antibodies recognize the cog- of solid tumors failed because the radiation dose deliv- nate -
And Poly-ICLC in Glioblastoma
De Waele et al. Journal of Experimental & Clinical Cancer Research (2021) 40:213 https://doi.org/10.1186/s13046-021-02017-2 REVIEW Open Access A systematic review on poly(I:C) and poly- ICLC in glioblastoma: adjuvants coordinating the unlocking of immunotherapy Jorrit De Waele1* , Tias Verhezen1, Sanne van der Heijden1, Zwi N. Berneman2,3,4, Marc Peeters1,5, Filip Lardon1, An Wouters1† and Evelien L. J. M. Smits1,4† Abstract Immunotherapy is currently under intensive investigation as a potential breakthrough treatment option for glioblastoma. Given the anatomical and immunological complexities surrounding glioblastoma, lymphocytes that infiltrate the brain to develop durable immunity with memory will be key. Polyinosinic:polycytidylic acid, or poly(I:C), and its derivative poly-ICLC could serve as a priming or boosting therapy to unleash lymphocytes and other factors in the (immuno)therapeutic armory against glioblastoma. Here, we present a systematic review on the effects and efficacy of poly(I:C)/poly-ICLC for glioblastoma treatment, ranging from preclinical work on cellular and murine glioblastoma models to reported and ongoing clinical studies. MEDLINE was searched until 15 May 2021 to identify preclinical (glioblastoma cells, murine models) and clinical studies that investigated poly(I:C) or poly-ICLC in glioblastoma. A systematic review approach was conducted according to PRISMA guidelines. ClinicalTrials.gov was queried for ongoing clinical studies. Direct pro-tumorigenic effects of poly(I:C) on glioblastoma cells have not been described. On the contrary, poly(I:C) changes the immunological profile of glioblastoma cells and can also kill them directly. In murine glioblastoma models, poly(I:C) has shown therapeutic relevance as an adjuvant therapy to several treatment modalities, including vaccination and immune checkpoint blockade. -
Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01 -
The Two Tontti Tudiul Lui Hi Ha Unit
THETWO TONTTI USTUDIUL 20170267753A1 LUI HI HA UNIT ( 19) United States (12 ) Patent Application Publication (10 ) Pub. No. : US 2017 /0267753 A1 Ehrenpreis (43 ) Pub . Date : Sep . 21 , 2017 ( 54 ) COMBINATION THERAPY FOR (52 ) U .S . CI. CO - ADMINISTRATION OF MONOCLONAL CPC .. .. CO7K 16 / 241 ( 2013 .01 ) ; A61K 39 / 3955 ANTIBODIES ( 2013 .01 ) ; A61K 31 /4706 ( 2013 .01 ) ; A61K 31 / 165 ( 2013 .01 ) ; CO7K 2317 /21 (2013 . 01 ) ; (71 ) Applicant: Eli D Ehrenpreis , Skokie , IL (US ) CO7K 2317/ 24 ( 2013. 01 ) ; A61K 2039/ 505 ( 2013 .01 ) (72 ) Inventor : Eli D Ehrenpreis, Skokie , IL (US ) (57 ) ABSTRACT Disclosed are methods for enhancing the efficacy of mono (21 ) Appl. No. : 15 /605 ,212 clonal antibody therapy , which entails co - administering a therapeutic monoclonal antibody , or a functional fragment (22 ) Filed : May 25 , 2017 thereof, and an effective amount of colchicine or hydroxy chloroquine , or a combination thereof, to a patient in need Related U . S . Application Data thereof . Also disclosed are methods of prolonging or increasing the time a monoclonal antibody remains in the (63 ) Continuation - in - part of application No . 14 / 947 , 193 , circulation of a patient, which entails co - administering a filed on Nov. 20 , 2015 . therapeutic monoclonal antibody , or a functional fragment ( 60 ) Provisional application No . 62/ 082, 682 , filed on Nov . of the monoclonal antibody , and an effective amount of 21 , 2014 . colchicine or hydroxychloroquine , or a combination thereof, to a patient in need thereof, wherein the time themonoclonal antibody remains in the circulation ( e . g . , blood serum ) of the Publication Classification patient is increased relative to the same regimen of admin (51 ) Int .