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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. -
Consideration Toward Safety Guidance for Targeted Alpha Therapy in Japan
TAT-11, Ottawa Consideration toward Safety Guidance for Targeted Alpha Therapy in Japan Tsuneo YANO1), Koki HASEGAWA2), Tatsuhiko SATO3),1) Akiko HACHISUKA4), Koichi FUKASE5), Yoko HIRABAYASHI6) April 2nd, 2019 1) QiSS-Targeted Alpha Therapy Research, Research Center for Nuclear Physics, Osaka University 2) Center for Instrumental Analysis, Kyoto Pharmaceutical University 3) Nuclear Science and Engineering Center, Japan Atomic Energy Agency 4) Division of Biochemistry, National Institute of Health Sciences 5) Department of Chemistry, Graduate School of Science, Osaka University 6) Center for Biological Safety & Research, National Institute of Health Sciences TAT-11, Ottawa Preclinical Safety Evaluation 1) to identify an initial safe dose and subsequent dose escalation scheme in human 2) to identify potential target organs for toxicity and to examine whether such toxicity is reversible 3) to identify safety parameters for clinical monitoring We focused on both astatine 211At and actinium 225Ac as the alpha-emitters. We also discuss on initial human-dose and dose escalation, organ identification to suspect toxicity and evaluation items for monitoring upon considering physical half-lives, drug stabilities and accumulation into targeted cells. We also propose the selection method of TAT drug candidates which is satisfied with safety profile including delayed-type toxicities under our new evaluation system with histopathological examination. TAT-11, Ottawa Characteristics of Alpha Particle extremely High LET very Short Range Cell size: 10-100 mm α-particle Range: 40-90 mm Vessel β α LET: 100keV/mm Normal cells β-particle Range: 800-5000 mm LET: 0.8keV/mm Tumor cells TAT-11, Ottawa Strategy for Safety Evaluation at Preclinical Stage Problems to be solved 89Y-ibritumomab tiuxetan instead of 90Y- When stable isotope corresponding to alpha nuclide is existed, toxicity test is conducted by its labeled test compound. -
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 -
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 . -
(12) Patent Application Publication (10) Pub. No.: US 2015/0250896 A1 Zhao (43) Pub
US 20150250896A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0250896 A1 Zhao (43) Pub. Date: Sep. 10, 2015 (54) HYDROPHILIC LINKERS AND THEIR USES Publication Classification FOR CONUGATION OF DRUGS TO A CELL (51) Int. Cl BNDING MOLECULES A647/48 (2006.01) (71) Applicant: Yongxin R. ZHAO, Henan (CN) Ek E. 30.8 C07D 207/216 (2006.01) (72) Inventor: R. Yongxin Zhao, Lexington, MA (US) C07D 40/12 (2006.01) C07F 9/30 (2006.01) C07F 9/572 (2006.01) (73) Assignee: Hangzhou DAC Biotech Co., Ltd., (52) U.S. Cl. Hangzhou City, ZJ (CN) CPC ........... A61K47/48715 (2013.01); C07F 9/301 (2013.01); C07F 9/65583 (2013.01); C07F (21) Appl. No.: 14/432,073 9/5721 (2013.01); C07D 207/46 (2013.01); C07D 401/12 (2013.01); A61 K3I/454 (22) PCT Filed: Nov. 24, 2012 (2013.01) (86). PCT No.: PCT/B2O12/0567OO Cell(57) binding- agent-drugABSTRACT conjugates comprising hydrophilic- S371 (c)(1), linkers, and methods of using Such linkers and conjugates are (2) Date: Mar. 27, 2015 provided. Patent Application Publication Sep. 10, 2015 Sheet 1 of 23 US 2015/0250896 A1 O HMDS OSiMe 2n O Br H-B-H HPC 3 2 COOEt essiop-\5. E B to NH 120 °C, 2h OsiMe3 J 50 °C, 2h eSiO OEt 120 oC, sh 1 2 3. 42% from 1 Bra-11a1'oet - Brn 11-1 or a 1-1 or ÓH 140 °C ÓEt ÓEt 4 5 6 - --Messio. 8 B1a-Br aus 20 cc, hP-1}^-'ot Br1-Y. -
NSCLC Therapeutics in Asia-Pacific Markets to 2019 Personalized Therapies Focus on Untapped Segment of Squamous Cell Carcinoma to Expand Treatment Pool
NSCLC Therapeutics in Asia-Pacific Markets to 2019 Personalized Therapies Focus on Untapped Segment of Squamous Cell Carcinoma to Expand Treatment Pool GBI Research Report Guidance GBI Research Report Guidance Chapter two provides an overview of the disease, its symptoms, etiology, pathophysiology, diagnosis, classification, epidemiology, prognosis, staging and treatment options. Chapter three provides a detailed profiling and comparative heat map analysis in terms of safety and efficacy for currently marketed products in the NSCLC market. Chapter four presents a detailed pipeline analysis for the disease, including individual product profiles, a comparative efficacy and safety profile heat map analysis of the most promising pipeline products as well as analyses on the distribution of molecule types across the NSCLC developmental pipeline, the molecular targets of pipeline mAbs and the developmental program types. In addition, detailed analyses of the clinical trial failure rates, the clinical trial durations by phase and clinical trial sizes, by participant numbers. Chapter five provides market forecasts for countries across the globe, with special attention given to the APAC countries: India, Australia, China and Japan. The multiple scenario forecasts take into account a range of factors that are likely to vary and provide a clear perspective on the level of the potential degree of variance in the market sizes. Chapter six covers the major deals that have taken place in the disease market in recent years. Coverage includes co-development deals and licensing agreements, which are segmented on the basis of geography and total value. A concomitant analysis of the licensing deal values for products by molecule types and molecular targets is also provided. -
(INN) for Biological and Biotechnological Substances
INN Working Document 05.179 Update 2013 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) INN Working Document 05.179 Distr.: GENERAL ENGLISH ONLY 2013 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) International Nonproprietary Names (INN) Programme Technologies Standards and Norms (TSN) Regulation of Medicines and other Health Technologies (RHT) Essential Medicines and Health Products (EMP) International Nonproprietary Names (INN) for biological and biotechnological substances (a review) © World Health Organization 2013 All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int ) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected] ). Requests for permission to reproduce or translate WHO publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press through the WHO web site (http://www.who.int/about/licensing/copyright_form/en/index.html ). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. -
Ep 3321281 A1
(19) TZZ¥¥ _ __T (11) EP 3 321 281 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 16.05.2018 Bulletin 2018/20 C07K 14/79 (2006.01) A61K 38/40 (2006.01) A61K 38/00 (2006.01) A61K 38/17 (2006.01) (2006.01) (2006.01) (21) Application number: 17192980.5 A61K 39/395 A61K 39/44 C07K 16/18 (2006.01) (22) Date of filing: 03.08.2012 (84) Designated Contracting States: • TIAN, Mei Mei AL AT BE BG CH CY CZ DE DK EE ES FI FR GB Coquitlam, BC V3J 7E6 (CA) GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO • VITALIS, Timothy PL PT RO RS SE SI SK SM TR Vancouver, BC V6Z 2N1 (CA) (30) Priority: 05.08.2011 US 201161515792 P (74) Representative: Gowshall, Jonathan Vallance Forresters IP LLP (62) Document number(s) of the earlier application(s) in Skygarden accordance with Art. 76 EPC: Erika-Mann-Strasse 11 12746240.6 / 2 739 649 80636 München (DE) (71) Applicant: biOasis Technologies Inc Remarks: Richmond BC V6X 2W8 (CA) •This application was filed on 25.09.2017 as a divisional application to the application mentioned (72) Inventors: under INID code 62. • JEFFERIES, Wilfred •Claims filed after the date of receipt of the divisional South Surrey, BC V4A 2V5 (CA) application (Rule 68(4) EPC). (54) P97 FRAGMENTS WITH TRANSFER ACTIVITY (57) The present invention is related to fragments of duction of the melanotransferrin fragment conjugated to human melanotransferrin (p97). In particular, this inven- a therapeutic or diagnostic agent to a subject. -
PANI: a Novel Algorithm for Fast Discovery of Putative Target Nodes in Signaling Networks
PANI: A Novel Algorithm for Fast Discovery of Putative Target Nodes in Signaling Networks Huey-Eng Chua§ Sourav S Bhowmick§ Lisa Tucker-Kellogg‡ Qing Zhao§ C F Dewey, Jr† Hanry Yu¶ §School of Computer Engineering, Nanyang Technological University, Singapore ‡Mechanobiology Institute, National University of Singapore, Singapore ¶Department of Physiology, National University of Singapore, Singapore †Division of Biological Engineering, Massachusetts Institute of Technology, USA chua0530|assourav|[email protected], LisaTK|[email protected], [email protected] ABSTRACT of disease [26]. Observation-based approaches screen drug Biological network analysis often aims at the target identifi- compounds in vitro, ex vivo, or in vivo; and measure em- cation problem, which is to predict which molecule to inhibit pirical outcome for determining which drugs are “active” (or activate) for a disease treatment to achieve optimum ef- against the disease. In contrast, target-based approaches ficacy and safety. A related goal, arising from the increasing identify a particular molecule (e.g., enzyme, receptor) that availability of semi-automated assays and moderately par- functions prominently in a validated mechanism of the dis- allel experiments, is to suggest many molecules as potential ease, and then synthesize a drug compound to interact specif- targets. The target prioritization problem is to predict a sub- ically with that target molecule. One key expectation in set of molecules in a given disease-associated network which target-based drug development is that specificity for one contains successful drug targets with highest probability. disease-causing molecule and lack of binding to other Sensitivity analysis prioritizes targets in a dynamic network molecules will minimize toxicity. -
Prescrire's Response
World Health Organization Raffaella Balocco INN Programme Manager Quality Assurance & Safety : Medecines CH 1211 GENEVA 27 Switzerland Prescrire’s contribution to the WHO consultation on List 100 of Proposed INNs Prescrire is an independent continuing education journal for healthcare professionals. It is wholly funded by its subscribers, it carries no advertising and receives no other financial support whatsoever. As an active member of the Medicines in Europe Forum and the International Society of Drug Bulletins (ISDB), Prescrire has long been advocating the routine use, by both healthcare professionals and patients, of international nonproprietary names (INNs), which are clearer and therefore safer than brand names (1-4). Making INNs safer. The principles underlying the creation of INNs are the same that apply to the prevention of medication errors, namely standardization, differentiation, redundancy, and built-in logical controls. INNs make pharmaceutical substances easier to identify and are less frequently confused than brand names (5). However, even with the INN system there is a residual risk of confusion, partly owing to the sheer number of INNs now in circulation. A report from the Council of Europe, which recommends the use of INN, calls for active participation in public consultations on proposed INNs, within a 4-month period of the date of final adoption, in order to review proposed INNs from the perspective of in-use safety (6). Prescrire is participating in this phase of the survey and has now examined the List 100 of proposed INNs, published on 16 February 2009 (7). Our analysis of List 100 of Proposed INNs was based on the 2006 list of common stems and its updates, the INN database, and on a database of drugs marketed in France, which provides both brand names and corresponding INNs (8-10). -
WO 2014/197854 Al 11 December 2014 (11.12.2014) P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2014/197854 Al 11 December 2014 (11.12.2014) P O P C T (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, A61K 47/48 (2006.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, PCT/US2014/041399 KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, (22) International Filing Date: MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 6 June 2014 (06.06.2014) OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (25) Filing Language: English TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (26) Publication Language: English ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/832,130 6 June 2013 (06.06.2013) US kind of regional protection available): ARIPO (BW, GH, PCT/US20 13/064 147 GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, 9 October 201 3 (09. 10.2013) US UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, 61/891,390 15 October 2013 (15. -
Antibody–Drug Conjugates for Cancer Therapy
molecules Review Antibody–Drug Conjugates for Cancer Therapy Umbreen Hafeez 1,2,3, Sagun Parakh 1,2,3 , Hui K. Gan 1,2,3,4 and Andrew M. Scott 1,3,4,5,* 1 Tumour Targeting Laboratory, Olivia Newton-John Cancer Research Institute, Melbourne, VIC 3084, Australia; [email protected] (U.H.); [email protected] (S.P.); [email protected] (H.K.G.) 2 Department of Medical Oncology, Olivia Newton-John Cancer and Wellness Centre, Austin Health, Melbourne, VIC 3084, Australia 3 School of Cancer Medicine, La Trobe University, Melbourne, VIC 3084, Australia 4 Department of Medicine, University of Melbourne, Melbourne, VIC 3084, Australia 5 Department of Molecular Imaging and Therapy, Austin Health, Melbourne, VIC 3084, Australia * Correspondence: [email protected]; Tel.: +61-39496-5000 Academic Editor: João Paulo C. Tomé Received: 14 August 2020; Accepted: 13 October 2020; Published: 16 October 2020 Abstract: Antibody–drug conjugates (ADCs) are novel drugs that exploit the specificity of a monoclonal antibody (mAb) to reach target antigens expressed on cancer cells for the delivery of a potent cytotoxic payload. ADCs provide a unique opportunity to deliver drugs to tumor cells while minimizing toxicity to normal tissue, achieving wider therapeutic windows and enhanced pharmacokinetic/pharmacodynamic properties. To date, nine ADCs have been approved by the FDA and more than 80 ADCs are under clinical development worldwide. In this paper, we provide an overview of the biology and chemistry of each component of ADC design. We briefly discuss the clinical experience with approved ADCs and the various pathways involved in ADC resistance.