DOCSLIB.ORG

Medimmune: Leading the Revolution in Respiratory Medicine with Biologics

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Medimmune: Leading the Revolution in Respiratory Medicine with Biologics SPONSOR FEATURE MedImmune: Leading the revolution in respiratory medicine with biologics he main culprit of many debilitating obstruction and susceptibility to exacerbations. smooth muscle contraction and hyperreactivity. respiratory, inflammatory and Activated eosinophils release several toxic MedImmune has developed a specific anti-IL-13 SPONSOR FEATURE T autoimmune diseases is an immune granule proteins that can damage lung tissue, monoclonal antibody, tralokinumab, (https:// system that is out of balance. Working to restore induce airway hyper-responsiveness and mucus www.youtube.com/watch?v=LB-wTJJmXFY), that balance are the scientists of MedImmune, secretion as well as trigger exacerbations. which has demonstrated clinical efficacy in a the global biologics research and development Benralizumab, (https://www.youtube.com/ subset of severe uncontrolled asthma patients. arm of AstraZeneca. By following the science watch?v=RPu6Vnp-WM8), is a humanized Tralokinumab significantly reduced the around immune-mediated inflammatory monoclonal antibody that binds with high frequency of acute exacerbations in patients diseases at the cellular and molecular level, affinity to interleukin (IL)- 5 receptor alpha with lung function reversibility and high serum MedImmune has built one of the richest, most and effectively depletes eosinophils and periostin concentrations, a biomarker for IL-13 diverse immunomodulatory portfolios in the basophils via antibody-dependent cell- pathway activation. In patients with high industry, targeting asthma, COPD, idiopathic mediated cytotoxicity1, through a different periostin levels, tralokinumab also markedly pulmonary fibrosis, lupus, multiple sclerosis, mechanism of action than that of the anti-IL-5 improved FEV1 and health-related quality of life, psoriasis and rheumatoid arthritis. ligand approaches. Benralizumab is a potent i.e. ACQ-6 score5. Tralokinumab is being further Asthma and COPD: Widespread use of eosinophil depleter inducing a complete investigated in ongoing Phase III clinical trials inhaled corticosteroids (ICS) as monotherapy or removal of these cells in the bone marrow and of patients with uncontrolled asthma, along in combination with long acting β2-agonists in peripheral blood of asthmatics, and an almost with the evaluation of the potential utility of asthma has resulted in a pronounced reduction complete depletion within the airway mucosa serum dipeptidyl peptidase-4 and periostin as in the burden of the disease and in asthma- and sputum2. Benralizumab has been well- biomarkers of IL-13 pathway activation. related mortality. In COPD, the appropriate tolerated and demonstrated clinical efficacy Modulating epithelial mediated diagnosis and treatment of patients is still a in a Phase IIb trial in patients with severe, inflammation: A growing body of evidence has fundamental challenge and long-term use of uncontrolled asthma3. Benralizumab reduced linked epithelial-derived cytokines with innate ICS is only recommended for some high risk the acute exacerbation rate in patients with high lymphoid cell (ILC) function and exacerbations patients who are not sufficiently controlled baseline blood eosinophils, (≥300 cells/μL), and of disease. Thymic stromal lymphopoietin (TSLP), with long-acting bronchodilators. However, the resulted in significant improvements in lung IL-25 and IL-33 are produced by epithelial cells response to ICS is poor in the majority of patients function, (FEV1), and health-related quality of life, in response to various pro-inflammatory stimuli, and adverse effects include increased risks of (i.e. ACQ-6 score), compared with placebo. including allergens and viral infection, and exert infection, diabetes, and fractures. Asthma and Moreover, we recently announced that potent effects on group 2 ILC function. TSLP is COPD control is, therefore, often suboptimal, benralizumab achieved the primary endpoints an upstream key initiator of allergic responses and many of the more severe patients continue in two pivotal Phase III trials in patients with having direct effects on ILCs and dendritic to experience frequent acute exacerbations of severe, uncontrolled asthma, demonstrating cells, which result in the subsequent initiation their disease. Thus, there remains a substantial significant reductions in annual asthma of Th2 pathway activation. In an allergen unmet need for treatments that achieve better exacerbation rates compared with placebo challenge study of patients with mild atopic symptom control and slow disease progression. (https://www.astrazeneca.com/media-centre/ asthma, tezepelumab, a humanized anti-TSLP Here, the use of specifically targeted and highly press-releases/2016/astrazeneca-announces- monoclonal antibody, attenuated the early potent therapeutic monoclonal antibodies has positive-results-from-benralizumab-phase-iii- allergen-induced bronchoconstriction and the the potential to modify disease and bring about programme-in-severe-asthma-17052016.html). late airway inflammatory response6. Treatment life changing improvements to patients. Eosinophilic inflammation is also associated with anti-TSLP antibody also decreased blood As with many other inflammatory diseases, with a sub-population of COPD patients. and sputum eosinophils and reduced the asthma and COPD encompass several distinct In a small Phase IIa study in patients with fraction of exhaled nitric oxide (levels of which patient phenotypes characterized by the shared moderate to very severe COPD, with a history correlate with eosinophilic inflammation). These presence of cellular and molecular biomarkers. of previous exacerbations and sputum data are consistent with a key role for TSLP in Linking biomarkers with clinical phenotypes eosinophilia, benralizumab treatment resulted allergen-induced airway responses and suggest has greatly advanced our understanding of in a significant improvement in FEV1. Although that blocking TSLP in asthma may modulate asthma pathophysiology and, importantly, the primary endpoint of significantly reducing multiple aspects of disease progression and facilitated the clinical development of our the exacerbation frequency was not met in this prevent exacerbations. MedImmune is currently innovative targeted biologics. MedImmune is study, a pre-specified subgroup analysis revealed investigating the effects of tezepelumab in committed to the discovery of novel biomarkers that benralizumab exhibited a trend towards a a Phase II asthma development program in and complementary or companion diagnostics reduction in exacerbation rate for these patients collaboration with Amgen. to identify the patients who are most likely with elevated blood eosinophils4. Patients with Emerging science: MedImmune has a key to respond to, and benefit from, a specific increased blood eosinophils also exhibited a interest in understanding epithelial biology and treatment. We have developed therapeutic significant improvement in COPD symptom identifying ways to modulate epithelial function. monoclonal antibodies with significant potential scores4. Two phase III studies are currently Indeed, we have reported a number of critical for the treatment of patients with asthma underway examining the effects of eosinophil observations regarding the crosstalk between and COPD. These “treatable traits” include depletion in patients with COPD. epithelial cytokines and ILC function. Specifically, eosinophilic disease, TH2 high disease and TH2 high associated asthma: IL-13 is a IL-33 has been implicated through genetic and epithelial-mediated pathologies (see Figure 1). cytokine that plays a significant role in mediating functional studies to play a role in inflammatory Eosinophilic disease: Increased eosinophils the key features of chronic severe asthma, diseases, including asthma. Multiple mechanisms in the airways of patients with asthma correlate including mucus metaplasia and hypersecretion, have evolved to regulate the activity of IL-33 and with increased disease severity, airway as well as having direct effects on airway its receptor, ST2, including proteolytic processing SPONSOR RETAINS SOLE RESPONSIBILITY FOR CONTENT SPONSOR FEATURE and neutralization of soluble ST2. We have smoke exposure and/or infection can trigger AUTHORS shown that in vivo regulation of this cytokine ILC1 conversion and, importantly, the increased Alison A Humbles1, Roland Kolbeck1 and is also tightly controlled by oxidation, which is frequency of ILC1s in patients with COPD Tomas Mustelin1 associated with a conformational change rapidly correlate with disease severity and susceptibility 1 Department of Respiratory, Inflammation and Autoimmunity, eliminating ST2-dependent activity7. IL-33 to exacerbations10. Thus, functional plasticity MedImmune LLC, One MedImmune Way, Gaithersburg, Maryland 20878, United States of America activation is predominantly associated with TH2 in ILC2s exacerbates anti-viral immunity and immunity via the induction of IL-13 from ILC2s may have adverse consequences in respiratory REFERENCES and TH2 cells. However, we have demonstrated diseases like COPD. Additional research is 1. Kolbeck, R. et al. MEDI-563, a humanized SPONSOR FEATURE a novel role for this cytokine in COPD, whereby ongoing to characterize the extent of ILC anti-IL-5 receptor alpha mAb with enhanced cigarette smoke exposure is associated with a plasticity and whether manipulating these antibody-dependent cell-mediated striking redistribution of ST2 expression, the pathways may offer therapeutic approaches cytotoxicity function. J. Allergy.
Load more

Recommended publications
  • The Scientific Organizing Committee Gratefully Acknowledges the Pharmaceutical and Biotechnology Industry for Their Generous Support of WCBP 2019
    The Scientific Organizing Committee gratefully acknowledges the pharmaceutical and biotechnology industry for their generous support of WCBP 2019: Strategic Diamond Program Partners F. Hoffmann-La Roche Ltd. Genentech, a Member of the Roche Group Strategic Platinum Program Partners Amgen Inc. Biogen MedImmune, A member of the AstraZeneca Group Strategic Gold Program Partners Eli Lilly and Company Merck & Co., Inc. Novo Nordisk A/S Pfizer, Inc. Strategic Silver Program Partner Sanofi 1 Gold Program Partner Bill and Melinda Gates Foundation Silver Program Partners BioMarin Pharmaceutical Inc. Bristol-Myers Squibb Company GlaxoSmithKline Jazz Pharmaceuticals Bronze Program Partner Seattle Genetics, Inc. Friend of CASSS Janssen R&D, LLC 2 The Scientific Organizing Committee gratefully acknowledges the Program Partners and Exhibitors for their generous support of WCBP 2019: Diamond Program Partners Agilent Technologies Catalent Pharma Solutions Eurofins Pharma Discovery Services ProteinSimple, a Bio-Techne brand Thermo Fisher Scientific Waters Corporation Platinum Program Partners BioAnalytix SCIEX Bronze Program Partner Bruker Corporation 3 The Scientific Organizing Committee gratefully acknowledges the Exhibitors for their generous support of WCBP 2019: Exhibitor Partners 908 Devices Inc. NanoImaging Services Agilent Technologies New England Biolabs Associates of Cape Cod, Inc. Postnova Analytics Inc. BioAnalytix Inc. Pressure BioSciences Inc. Bruker Corporation Protein Metrics, Inc. Catalent Pharma Solutions ProteinSimple, a Bio-Techne brand Charles River Laboratories ProZyme, A part of Agilent Covance, Inc. RedShift BioAnalytics, Inc. Cygnus Technologies Rockland Immunochemicals, Inc. Envigo SCIEX Eurofins BioPharma Product Testing SGS Life Science Services Eurofins Pharma Discovery Services Shimadzu Scientific Instruments, Inc. FortéBio - Biologics by Molecular Devices Thermo Fisher Scientific GE Healthcare Life Sciences U.S.
    [Show full text]
  • 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.
    [Show full text]
  • Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
    CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products.
    [Show full text]
  • Atopic Dermatitis (AD)
    This activity is provided by PRIME Education. There is no fee to participate. This activity is supported by education grants from AbbVie, Inc., Sanofi Genzyme and Regeneron Pharmaceuticals. © 2019 PRIME® Education, LLC. All Rights Reserved.. Overview This downloadable fact‐sheet provides an easy‐to‐follow collection of the latest evidence shaping the treatment and management of psoriasis (PsO) and atopic dermatitis (AD). Learn about validated tools, evidence‐based strategies, and new and emerging targeted therapies that can be incorporated in daily practice to improve outcomes for patients with these conditions. © 2019 PRIME® Education, LLC. All Rights Reserved.. 2 1 Learning Objectives • Identify major barriers to evidence‐based treatment and management in federal and public sectors • Implement appropriate methods for diagnosis and assessment of disease activity • Assess current evidence on targeted biologic and small‐molecule therapies to guide treatment decisions for patients with moderate to severe disease • Monitor treatment responses according to treat‐to‐target principles and methods • Apply current evidence and guidelines to inform treatment decisions for patients with inadequate responses to initial therapies • Incorporate patient‐reported outcomes and shared decision‐making into clinical practice • Apply effective strategies for multidisciplinary care coordination and shared patient management © 2019 PRIME® Education, LLC. All Rights Reserved.. 3 Accreditation In support of improving patient care, PRIME® is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team, and learners will receive 2.25 Interprofessional Continuing Education (IPCE) credits for learning and change.
    [Show full text]
  • Smoldering Inflammation in Cardio-Immune-Metabolic Disorders
    EDITORIAL published: 19 March 2021 doi: 10.3389/fphys.2021.651946 Editorial: Smoldering Inflammation in Cardio-Immune-Metabolic Disorders Gilda Varricchi 1,2,3*, Nazareno Paolocci 4,5, Felice Rivellese 6 and Giuseppe Rengo 1,7 1 Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy, 2 Center for Basic and Clinical Immunology Research (CISI), University of Naples Federico II, Naples, Italy, 3 Institute of Experimental Endocrinology and Oncology (IEOS), National Research Council, Naples, Italy, 4 Division of Cardiology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States, 5 Department of Biomedical Sciences, University of Padova, Padova, Italy, 6 Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom, 7 Istituti Clinici Scientifici Maugeri SpA Società Benefit, Telese Terme, Italy Keywords: allergic disorders, diabetes, obesity, low grade inflammation, sinovitis, IL-5, mast cells, Alzheimer’s disease Editorial on the Research Topic Smoldering Inflammation in Cardio-Immune-Metabolic Disorders “If many remedies are prescribed for an illness, you may be certain that the illness has no cure.” Anton Chekhov - The Cherry Orchard - Smoldering or low-grade inflammation plays a pivotal role in both physiological and pathological conditions (Calder et al., 2017; Zelechowska et al., 2018; Ronnback and Hansson, 2019). Aging is accompanied by
    [Show full text]
  • The Impact of Secondary Innovation on Firm Market Value in the Pharmaceutical Industry
    The Impact of Secondary Innovation on Firm Market Value in the Pharmaceutical Industry By: Maitri Punjabi Honors Thesis Economics Department The University of North Carolina at Chapel Hill March 2016 Approved: ______________________________ Dr. Jonathan Williams Punjabi 2 Abstract This paper analyzes the effect of the changing nature of innovation on pharmaceutical firm market value from the years 1987 to 2010 by using U.S. patent and claim data. Over the years, firms have started shifting focus from primary innovation to secondary innovation as new ideas and new compounds become more difficult to generate. In this study, we analyze the impact of this patent portfolio shift on the market capitalization of pharmaceutical firms. After using firm fixed effects and the instrumental variable approach, we find that there exists a strong positive relationship between secondary innovations and the market value of the firm– in fact, we find a stronger relationship than is observed between primary innovation and market value. When focusing on the different levels of innovation within the industry, we find that this relationship is stronger for less-innovative firms (those that have produced fewer patents) than it is for highly- innovative firms. We also find that this relationship is stronger for firms that spend less on research and development, complementing earlier findings that research productivity is declining over time. Punjabi 3 Acknowledgements I would primarily like to thank my adviser, Dr. Jonathan Williams, for his patience and constant support. Without his kind and helpful attitude, this project would have been a much more frustrating process. Through his knowledge of the industry, I have gained valuable insight and have learned a great deal about a unique and growing field.
    [Show full text]
  • Looking for Therapeutic Antibodies in Next Generation Sequencing Repositories
    bioRxiv preprint doi: https://doi.org/10.1101/572958; this version posted March 10, 2019. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. Title: Looking for Therapeutic Antibodies in Next Generation Sequencing Repositories. Authors: Konrad Krawczyk1*, Matthew Raybould2, Aleksandr Kovaltsuk2, Charlotte M. Deane2 1 NaturalAntibody, Hamburg, Germany 2 Oxford University Department of Statistics, Oxford, UK *Correspondence to [email protected] Abstract: Recently it has become possible to query the great diversity of natural antibody repertoires using Next Generation Sequencing (NGS). These methods are capable of producing millions of sequences in a single experiment. Here we compare Clinical Stage Therapeutic antibodies to the ~1b sequences from 60 independent sequencing studies in the Observed Antibody Space Database. Of the 242 post Phase I antibodies, we find 16 with sequence identity matches of 95% or better for both heavy and light chains. There are also 54 perfect matches to therapeutic CDR-H3 regions in the NGS outputs, suggesting a nontrivial amount of convergence between naturally observed sequences and those developed artificially. This has potential implications for both the discovery of antibody therapeutics and the legal protection of commercial antibodies. Introduction Antibodies are proteins in jawed vertebrates that recognize noxious molecules (antigens) for elimination. An organism expresses millions of diverse antibodies to increase the chances that some of them will be able to bind the foreign antigen, initiating the adaptive immune response.
    [Show full text]
  • United States Securities and Exchange Commission Form 10-K Shire Pharmaceuticals Group
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ፤ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 1999 អ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 0-29630 SHIRE PHARMACEUTICALS GROUP PLC (Exact name of registrant as specified in its charter) England and Wales (State or other jurisdiction (I.R.S. Employer of incorporation or organization) Identification No.) N.A. East Anton, Andover, Hampshire SP10 5RG England (Address of principal executive offices) (Zip Code) 44 1264 333455 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of exchange on which registered American Depository Shares, each representing Nasdaq National Market 3 Ordinary Shares, 5 pence nominal value per share Securities registered pursuant to Section 12(g) of the Act: None (Title of class) Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ፤ No អ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant's knowledge, in definitive proxy or information statements incorporated by reference to Part III of this Form 10-K or any amendment to this Form 10-K.
    [Show full text]
  • 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 .
    [Show full text]
  • Antibodies to Watch in 2021 Hélène Kaplona and Janice M
    MABS 2021, VOL. 13, NO. 1, e1860476 (34 pages) https://doi.org/10.1080/19420862.2020.1860476 PERSPECTIVE Antibodies to watch in 2021 Hélène Kaplona and Janice M. Reichert b aInstitut De Recherches Internationales Servier, Translational Medicine Department, Suresnes, France; bThe Antibody Society, Inc., Framingham, MA, USA ABSTRACT ARTICLE HISTORY In this 12th annual installment of the Antibodies to Watch article series, we discuss key events in antibody Received 1 December 2020 therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The Accepted 1 December 2020 coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the KEYWORDS healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two Antibody therapeutics; anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were cancer; COVID-19; Food and authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed Drug Administration; antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 European Medicines Agency; in Russia and India, respectively. Despite the pandemic, 10 antibody therapeutics had been granted the immune-mediated disorders; first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may Sars-CoV-2 be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan. The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency.
    [Show full text]
  • Dyax Corp. 300 Technology Square Cambridge, MA 02139 617 225-2500
    Dyax Corp. 300 Technology Square Cambridge, MA 02139 617 225-2500 www.dyax.com Other Offices Dyax SA, Liege, Belgium ADVANCING NOVEL THERAPEUTIC PRODUCTS Dyax Corp. Annual Report 2003 Corporate Information Dyax Achievements 2003 Dyax Goals 2004 Directors Executive Officers and Stock Listing Henry E. Blair Key Employees Common stock has been traded on the Nasdaq Stock Market Advances in Clinical Development Clinical Development Chairman, President and Henry E. Blair* under the symbol DYAX since our initial public offering in Milestones Chief Executive Officer, Chairman, President and August 14, 2000. DX-88/Hereditary Angioedema Dyax Corp. Chief Executive Officer DX-88/Hereditary Constantine E. Stephen S. Galliker, CPA* The following table gives the quarterly high and low sales G Completed 9-patient Phase II trial, met primary endpoints Angioedema Anagnostopoulos, Ph.D. EVP Finance and prices of our common stock for the last three years. G Genzyme Corporation joined Dyax as joint venture partner Managing General Partner, Administration and G Complete Phase II 2001 2002 2003 G Gateway Associates, LP Chief Financial Officer Completed 3 of 4 dose cohorts in 48-patient Phase II EDEMA1 trial EDEMA1 study High Low High Low High Low G Susan B. Bayh, J.D. Lynn G. Baird, Ph.D.* Initiated Phase II EDEMA2 trial G Periodically observe James W. Fordyce SVP Development First Quarter $20.94 $6.56 $11.38 $3.10 $2.25 $1.52 G Orphan Drug designation granted in U.S. and Europe effects of repeat dosing in Phase II EDEMA2 Managing Partner, Robert C. Ladner, Ph.D. Second Quarter $19.99 $6.81 $ 4.68 $3.20 $4.90 $1.67 Fordyce & Gabrielson, LLC SVP and Chief DX-88/On-Pump Open Heart Surgery (CABG) study Third Quarter $21.24 $6.05 $ 4.20 $1.65 $7.50 $2.58 Mary Ann Gray, Ph.D.
    [Show full text]
  • 2016 Medicines in Development for Rare Diseases a LIST of ORPHAN DRUGS in the PIPELINE
    2016 Medicines in Development for Rare Diseases A LIST OF ORPHAN DRUGS IN THE PIPELINE Autoimmune Diseases Product Name Sponsor Official FDA Designation* Development Status Actemra® Genentech treatment of systemic sclerosis Phase III tocilizumab South San Francisco, CA www.gene.com Adempas® Bayer HealthCare Pharmaceuticals treatment of systemic sclerosis Phase II riociguat Whippany, NJ www.pharma.bayer.com ARA 290 Araim Pharmaceuticals treatment of neuropathic pain in patients Phase II Tarrytown, NY with sarcoidosis www.ariampharma.com ARG201 arGentis Pharmaceuticals treatment of diffuse systemic sclerosis Phase II (type 1 native bovine skin Collierville, TN www.argentisrx.com collagen) BYM338 Novartis Pharmaceuticals treatment of inclusion body myositis Phase III (bimagrumab) East Hanover, NJ www.novartis.com CCX168 ChemoCentryx treatment of anti-neutrophil cytoplasmic Phase II (5a receptor antagonist) Mountain View, CA auto-antibodies associated vasculitides www.chemocentryx.com (granulomatosis with polyangitis or Wegener's granulomatosis), microscopic polyangitis, and Churg-Strauss syndrome * This designation is issued by the FDA's Office of Orphan Products Development while the drug is still in development. The designation makes the sponsor of the drug eligible for entitlements under the Orphan Drug Act of 1983. The entitlements include seven years of marketing exclusivity following FDA approval of the drug for the designated use. Medicines in Development: Rare Diseases | 2016 1 Autoimmune Diseases Product Name Sponsor Official FDA
    [Show full text]