Spreading Hope, Pioneering Vaccines MANAGEMENT FINANCIAL COMMENTARY STATEMENTS

Total Page:16

File Type:pdf, Size:1020Kb

Spreading Hope, Pioneering Vaccines MANAGEMENT FINANCIAL COMMENTARY STATEMENTS ANNUAL REPORT 2020 Spreading hope, pioneering vaccines MANAGEMENT FINANCIAL COMMENTARY STATEMENTS Introduction Corporate information Consolidated financial statements 4 From research to real-life value 42 The Bavarian Nordic share 67 Consolidated Income Statements 6 Our vaccines 44 Sustainability 67 Consolidated Statements of Comprehensive Income 10 2020 achievements 46 Corporate governance 68 Consolidated Statements of Cash Flow 12 Letter to the stakeholders 48 Risk management 69 Consolidated Statements of Financial Position – Assets 14 Group Key Figures 2016–2020 52 Management of Bavarian Nordic 70 Consolidated Statements of Financial Position 15 Outlook for 2021 58 Financial review 2020 – Equity and Liabilities 18 Sales performance and market trends 71 Consolidated Statements of Changes in Equity 73 Notes Our strategy and business 22 Our strategy Financial statements of the parent company 24 Built on science, driven by people 120 Income Statements 28 Developing innovative life-saving 121 Statements of Financial Position – Assets vaccines 122 Statements of Financial Position – Equity and Liabilities 34 Driven by commercial excellence 123 Statements of Changes in Equity 38 Best in class vaccine manufacturing 124 Notes 139 Statement by Management on the Annual Report 141 Independent Auditor’s Reports CONTENTS 4 FROM RESEARCH Lowering the Annual Report 2020 Annual Report TO REAL-LIFE VALUE risk of infectious We are committed to developing and disease for the manufacturing life-saving vaccines greater good of our global community PIONEERING BEST IN DRIVEN BY RESEARCH AND CLASS VACCINE COMMERCIAL DEVELOPMENT MANUFACTURING EXCELLENCE We have a strong heritage in vaccine We are experts in live virus vaccine We have established a commercial development and with a proven technology, manufacturing and with the recent addition infrastructure with presence in key markets in we continue to make innovations to help of fill and finish capabilities we have enabled Europe and the USA to drive profitable growth fight existing and emerging diseases. end-to-end commercial-scale manufacturing. of our expanding portfolio of vaccines. 5 REVENUE 2020 Annual Report 2020 Annual Report 1, 852 mDKK EBITDA 2020 740 mDKK EMPLOYEES AT BAVARIAN NORDIC 700+ 40% employees by end of growth in employees 2020 0 100 200 300 400 500 600 700 since 2019 6 Annual Report 2020 Annual Report OUR VACCINES The ongoing COVID-19 pandemic is an unfortunate reminder of the vulnerability of our population, despite major scientific and medical advances over the past century. While new treatments have significantly improved our lives, the prevention of infectious diseases remains a complex matter in an ever more globalized society, particularly as the reservoir for these diseases are often animals, which we are poorly able to control, and mutations of the viruses present continuous challenges in our efforts to minimize the impact of emerging diseases. 7 Our vaccines are yet a small contribution to improving public health Annual Report 2020 Annual Report around the globe, but our commitment to saving and improving lives by unlocking the power of the immune system is strong, and our accomplishments in 2020 clearly demonstrate our ability to transform our knowledge, expertise and capabilities into life-saving vaccines. Rabies Tick-borne encephalitis Left untreated, rabies is almost invariably fatal and causes nearly Tick-borne encephalitis (TBE) is a viral infectious disease transmitted 60,000 deaths worldwide every year. While most of these incidents to humans by the bite of an infected tick. Although rare, TBE is a occur in developing countries, rabies remains a threat in the wildlife serious condition affecting the central nervous system that can lead in Western countries and may be transmitted to humans via bites or to death or long-term neurological sequelae after recovery from scratches mainly from bats, raccoons, skunks, and foxes. Rabies is infection. TBE is prevalent in central, eastern and northern Europe 100% preventable with post-exposure prophylaxis, i.e. wound care and the geographic range of the virus appears to have expanded and vaccination as soon as possible after being bitten and before the to new areas, likely due to a complex combination of changes in onset of symptoms. It is estimated that every 10 minutes, a person diagnosis and surveillance, human activities and socioeconomic in the US is vaccinated after potential exposure to rabies. Pre-ex- factors, and ecology and climate. TBE is a preventable disease and posure prophylaxis are often recommended for travelers visiting vaccination is recommended for people who live in TBE risk areas or countries and regions with high incidence of rabies and to animal who frequently visit forests and grasslands in TBE risk areas. handlers in some Western countries. 8 Ebola Smallpox / Monkeypox Ebola virus disease causes severe hemorrhagic fever in humans, While smallpox was eradicated worldwide by 1980 as a result of Annual Report 2020 Annual Report often leading to death. In average, the mortality rate is around 50%, an unprecedented global immunization campaign, it remains one although mortality rates in historical outbreaks have ranged from of most dangerous infectious diseases in the history of mankind, 25% to 90%. The virus is transmitted to people from wild animals having killed an estimated 300 million people in the 20th centu- and then spreads in the human population through direct contact ry. Smallpox has been investigated as a biological weapon and in with the bodily fluids of infected people. Sporadic outbreaks have combination with fears over the risk of reoccurrence of the disease, occurred in West Africa since the virus was discovered in the 1970’s, either via synthesis or natural mutations, the US, as well as other but it was not until the large outbreak in 2014-2016, which killed countries have prioritized countermeasures against the virus and more than 11,000 people, that the development of an effective maintain a stockpile of smallpox vaccines. Our vaccine has been de- vaccine was expedited, leading to an unprecedented global effort veloped to mitigate the risks associated with the traditional, replicat- by governments and the pharmaceutical industry. Bavarian Nor- ing vaccines that were used during the eradication of smallpox, and dic’s MVA-BN-based Ebola vaccine candidate, which was originally which are not recommended for people with compromised immune developed in collaboration with the US government, was licensed by systems. Janssen in 2014 for use in a prime-boost vaccine regimen together with their adenovirus–based vaccine candidate. Following an exten- Monkeypox is a viral zoonosis (a virus transmitted to humans from sive development program, the vaccine regimen was approved by animals) occurring in Central and West Africa with symptoms similar the European Commission in 2020. to those seen in the past in smallpox patients, although it is clini- cally less severe. With the eradication of smallpox and subsequent cessation of smallpox vaccination, it has emerged as the most important orthopoxvirus and is considered the deadliest existing orthopoxvirus in humans with a mortality rate estimated at up to 10%. The FDA approval of our smallpox vaccine in 2019 also in- cluded approval for monkeypox and offers a new opportunity for the protection of those at high risk for exposure to this emerging infectious disease. 9 Annual Report 2020 Annual Report 10 Annual Report 2020 Annual Report 2020 marked year one in the commercial COMMERCIAL transformation of INTEGRATION Bavarian Nordic and the MOVING FORWARD accomplishment of several Following the acquisition of Rabipur/RabAvert and Encepur from GSK, a full global commercial organization has been established to support important milestones the integration of the products. during the year were Local core sales and marketing teams have been organized in Europe and the US, ensuring comprehensive commercial presence and infra- pivotal in the continued structure. The transfer of marketing and distribution of the acquired products were completed in several countries, including key markets journey to become one of such as Germany and the US. Building on these important advances in the commercial transformation of Bavarian Nordic, the remaining the world’s largest pure markets will be taken over during 2021. 2020 ACHIEVEMENTS play vaccine companies. 11 Our longstanding partnership with the US government was again In July, the European Commission granted confirmed with the award of a new smallpox vaccine contract. The marketing authorization for MVABEA® for the USD 202 million contract not only covers the supply of up to 1.4 prevention of Ebola. The approval, which was Annual Report 2020 Annual Report million doses of the FDA-approved liquid-frozen JYNNEOS, which the second EU approval of a product based will ensure the availability of the vaccine in the U.S. Strategic on our MVA-BN platform technology, marks National Stockpile for potential use by first-line responders, but also a significant advance in the fight against the manufacturing of additional bulk vaccine for future supply of an Ebola and an important milestone in our improved, freeze-dried version of the vaccine. CONTINUED partnership with Janssen, who has licensed the commercial rights to the vaccine. In ADVANCES IN connection with the approval, Bavarian Nordic received a milestone payment of USD 10 VACCINE million from Janssen. MANUFACTURING EXPANSION After successful completion of the construction
Recommended publications
  • What You Need to Know About Rabies
    WHAT YOU NEED TO KNOW ABOUT RABIES ASSOCIATION OF IMMUNIZATION MANAGERS FEBRUARY 2021 Bavarian Nordic is a fully integrated, leading biotechnology company focused on the research, development, innovation, manufacturing and commercialization of vaccines for the prevention and treatment of life-threatening diseases 1 VIRAL DISEASE ALMOST ALWAYS FATAL IF UNTREATED Paralytic rabies Ascending spread of flaccid Classical (furious) rabies Onset of coma DEATH muscle weakness, bilateral Hyper-excitability, periods weakness of facial muscles, of confusion, hallucinations, sphincter involvement agitation and hydrophobia Coma (0–14 days) Acute neurological phase (2–7 days) Nonspecific symptoms Fever, malaise, chills, fatigue, First neurological signs insomnia, anorexia, headache, (>10 days) anxiety, irritability Prodromal phase (2–10 days) Exposure Bite or scratch from, or Incubation of virus mucosal contact with, (20–90 days) a rabid animal 1. Jackson et al. In Rabies (2nd edition). Chapter 7. 2007: 309–340; 2. WHO. Wkly Epidemiol Rec 2018; 93: 201–20; 3. Hemachudha et al. Lancet Neurol 2002;1:101–9; 4. WHO. Rabies: Fact Sheet. https://www.who.int/en/news-room/fact-sheets/Detail/rabies [accesseD July 2020]. PREVALENCE IN THE USA Rabies transmission in dogs has been virtually eliminated in the USA, in part due to widespread canine vaccination programs5 • As a result, wildlife has accounted for >90% of rabid animals reported in the USA since 19805-7 • Primary vectors in this region are skunks, foxes, raccoons, bats and mongooses (in Puerto Rico)5-7 • In the US, the primary rabies vector is the bat due to encounters with bats that may be less recognized e.g.
    [Show full text]
  • Study Protocol
    Protocol Number: VXA-G11-201.1 ________________________________________________________________________________ Clinical Study Protocol Protocol Title: Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model Protocol Number: VXA-G11-201.1 IND Sponsor: WCCT Global 3545 Howard Way, Costa Mesa, CA 92626 Maria Apkarian Vice President, Early Clinical Development Email: [email protected] Phone: 714-252-0700; ext: 1019 Funding Sponsor: Vaxart, Inc. Funding Sponsor POC: David N. Taylor, MD Chief Medical Officer Vaxart, Inc. 400 Oyster Point Blvd., Suite 222 South San Francisco, CA 94080 Email: [email protected] Mobile phone: 919-349-6109 Protocol Version Number: 1.1 Amendment 1 Date: 21 September 2018 Confidentiality Statement This document is confidential and is to be distributed for review only to investigators, potential investigators, consultants, study staff, and applicable independent ethics committees or institutional review boards. The contents of this document shall not be disclosed to others without written authorization from Vaxart (or others, as applicable), unless it is necessary to obtain informed consent from potential study subjects. SIGNATURE PAGE/STATEMENT OF COMPLIANCE Version 1.1 Confidential Page 1 of 50 Date: 21Sept 2018 Protocol Number: VXA-G11-201.1 ________________________________________________________________________________ Protocol Title: Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model Protocol Number: VXA-G11-201.1 Vaxart, Inc. ______________________________ ________________ David Taylor Date Chief Medical Officer The trial will be conducted in accordance with the International Conference on Harmonisation (ICH) E6 and the Code of Federal Regulations on the Protection of Human Subjects (45 CFR Part 46).
    [Show full text]
  • Valneva and Bavarian Nordic Announce Marketing and Distribution Partnership
    VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva and Bavarian Nordic Announce Marketing and Distribution Partnership Saint-Herblain, France, June 18, 2020 – Valneva SE, (“Valneva”), a specialty vaccine company, and Bavarian Nordic A/S (OMX: BAVA) today announced that they have signed a binding term sheet to establish a partnership for the marketing and distribution of their commercial products. The partnership will provide both companies with additional critical mass, significant commercial synergies and a market leadership position in the specialty vaccine industry. Under the agreed terms, Valneva will commercialize Bavarian Nordic’s marketed vaccines leveraging its commercial infrastructure in Canada, UK, France and Austria. Valneva will also take responsibility for Belgium and the Netherlands where it will set up new commercial operations. Bavarian Nordic will commercialize Valneva’s marketed products in Germany and Switzerland. The partnership includes vaccines that protect against rabies, Japanese Encephalitis, tick-borne encephalitis and cholera. The agreement follows Bavarian Nordic’s recent acquisition of two commercial vaccines from GlaxoSmithKline. The transition from current arrangements will commence later this year and through 2021 in line with existing distribution agreements. Valneva expects limited additional revenues in 2020 with more material impact from 2021 onwards. Thomas Lingelbach, CEO of Valneva, commented, “We are excited to join forces with Bavarian Nordic to continue to build our commercial business and to enhance our product offering to our customers. This partnership provides excellent synergy for both companies as well as greater breadth in our commercial portfolios.” Paul Chaplin, President & CEO of Bavarian Nordic, added, “We are pleased to collaborate with Valneva in the ongoing commercialization of our business.
    [Show full text]
  • Placebos, Randomization and Financial Incentives
    1 Placebos, randomization, and financial incentives – oh my! Balancing ethical considerations in clinical research Stephanie Kraft, JD and Kathryn Porter, JD, MPH ITHS Bioethics Core Treuman Katz Center for Pediatric Bioethics Seattle Children’s Research Institute Learning Objectives 1• Describe eight benchmarks for ethical clinical research 2 Discuss how empirical data illustrates limitations of ethics regulations of randomization 3 Identify elements of a proposed research study that warrant ethical deliberation Outline 1 Introduction to a framework for ethical clinical research 2 Case studies: what to do when benchmarks conflict 3 Group discussion and practice applying the framework Why research ethics? Please vote: Do you consider yourself an ethically responsible researcher? Why research ethics? “Isn’t ethics for people who have bad motivations?” • Not just about preventing egregious violations - no such thing as the “ethics police” • Also offers guidance, identifies potential challenges Why research ethics? Please vote: Have you ever faced an ethical challenge in your research that was outside the scope of the IRB? Why research ethics? “Aren’t there regulations for that?” • Research ethics analysis helps flesh out responsibilities above the regulatory floor Why research ethics? Please vote: Have you ever raised an ethics issue to a colleague or PI? Why research ethics? “Is it really my job to worry about ethics?” • Yes! • Ethics analysis is important for all research team members • Framework can empower researchers to identify and
    [Show full text]
  • Written Statement for Dr. Anthony Fauci, Director, NIAID
    DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH The Role of the National Institute of Allergy and Infectious Diseases Research in Addressing Ebola Virus Disease Testimony before the House Foreign Affairs Committee Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations Anthony S. Fauci, M.D. Director National Institute of Allergy and Infectious Diseases September 17, 2014 Mr. Chairman and Members of the Committee: Thank you for the opportunity to discuss the National Institutes of Health (NIH) response to the global health emergency of Ebola virus disease. I direct the National Institute of Allergy and Infectious Diseases (NIAID), the lead institute of the NIH for conducting and supporting research on infectious diseases, including viral hemorrhagic fevers such as those caused by Ebola virus infection. For over six decades, NIAID has made important contributions to advancing the understanding of infectious, immunologic, and allergic diseases, from basic research on mechanisms of disease to applied research to develop diagnostics, therapeutics, and vaccines. NIAID has a dual mandate that balances research addressing current biomedical challenges with the capacity to respond quickly to newly emerging and re-emerging infectious diseases, including bioterror threats. Critical to these efforts are NIAID’s partnerships with academia and pharmaceutical companies, and collaborations with other federal entities, particularly the Centers for Disease Control and Prevention, the Food and Drug Administration (FDA), the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense. OVERVIEW OF EBOLA VIRUS DISEASE Viral hemorrhagic fevers are severe illnesses that can be fatal and are caused by a diverse group of viruses including Marburg virus, Lassa virus, and Ebola virus.
    [Show full text]
  • Human Challenge Trials for Vaccine Development: Regulatory Considerations
    POST ECBS Version ENGLISH ONLY EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION Geneva, 17 to 21 October 2016 Human Challenge Trials for Vaccine Development: regulatory considerations © World Health Organization 2016 All rights reserved. Publications of the World Health Organization can be obtained 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 noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: [email protected]). 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. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader.
    [Show full text]
  • A Toddler PCV Booster Dose Following 3 Infancy Priming Doses Increases
    Vaccine 36 (2018) 2774–2782 Contents lists available at ScienceDirect Vaccine journal homepage: www.elsevier.com/locate/vaccine A toddler PCV booster dose following 3 infancy priming doses increases circulating serotype-specific IGG levels but does not increase protection against carriage ⇑ Ron Dagan a, , Shalom Ben-Shimol a,b, Birgit Simell c, David Greenberg a,b, Nurith Porat a,b, Helena Käyhty d, Noga Givon-Lavi a,b a The Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel b The Pediatric Infectious Disease Unit, Soroka University Medical Center, Beer-Sheva, Israel c Institute for Molecular Medicine Finland (FIMM), University of Helsinki, Helsinki, Finland d Department of Vaccination and Immune Protection, National Institute for Health and Welfare (THL), Helsinki, Finland article info abstract Article history: Background: We compared PCV7 serological response and protection against carriage in infants receiving Received 7 January 2018 3 doses (2, 4, 6 months; 3+0 schedule) to those receiving a booster (12 months; 3+1). Received in revised form 30 March 2018 Methods: A prospective, randomized controlled study, conducted between 2005 and 2008, before PCVs Accepted 3 April 2018 were implemented in Israel. Healthy infants were randomized 1:1:1 to receive 3+1, 3+0 and 0+2 (control Available online 11 April 2018 group; 12, 18 months doses). Nasopharyngeal/oropharyngeal swabs were obtained at all visits. Serum serotype-specific IgG concentrations and opsonic activities (OPA) were measured at 2, 7, 13 and 19 Keywords: months. This study was registered with Current Controlled Trials, Ltd. ISRCTN28445844. Pneumococcal conjugate vaccines Results: Overall, 544 infants were enrolled: 3+1 (n = 178), 3+0 (n = 178) and 0+2 (n = 188).
    [Show full text]
  • Bavarian Nordic Annual Report 2018 Management Commentary | Financial Statements
    Unlocking the power of the ANNUAL immune system REPORT 2018 199425 2019 YEARS OF GREAT ACHIEVEMENTS IN THE VACCINE SPACE STIMULATING THE IMMUNE SYSTEM GIVING HOPE TO MILLIONS Management commentary | Financial statements CONTENTS MANAGEMENT FINANCIAL COMMENTARY STATEMENTS INTRODUCTION BUSINESS AND PIPELINE CONSOLIDATED FINANCIAL STATEMENTS Letter from the CEO & chairman .................... 4 Product pipeline.................................. 20 Consolidated income statements .................. 68 At a glance ....................................... 6 Infectious disease ................................ 22 Consolidated statements of comprehensive 25 years of great achievements .................... 8 Our partnership with Janssen ...................... 28 income .......................................... 68 Key developments................................ 10 Cancer immunotherapy ........................... 36 Consolidated statements of cash flow.............. 69 A word from the new CFO......................... 12 Chordoma........................................ 38 Consolidated statements of financial position Strategy track ................................... .16 – assets ......................................... 70 Financial results for 2018 ......................... .18 CORPORATE INFORMATION Consolidated statements of financial position The Bavarian Nordic share ........................ .46 – equity/liabilities ............................... 71 Corporate social responsibility .................... .48 Consolidated statements of changes in
    [Show full text]
  • Harnessing the Immune System to Prevent Cancer: Basic Immunologic Mechanisms & Their Application to Clinical Trials of Vaccines Part 2: the Vaccines Barbara K
    Harnessing the Immune System to Prevent Cancer: Basic Immunologic Mechanisms & Their Application to Clinical Trials of Vaccines Part 2: The Vaccines Barbara K. Dunn NCI/Division of Cancer Prevention August 3, 2020 Harnessing the Immune System to Prevent Cancer: Basic Immunologic Mechanisms and Therapeutic Approaches that are Relevant to Cancer Prevention I. Basic immunologic mechanisms II. Application to prevention & treatment of cancer 1. Antibodies: as drugs 2. Vaccines: general principles & your vaccine trials & more… I) Vaccines to prevent cancers caused by infectious agents II) Vaccines to prevent non-infection associated cancer (directed toward tumor associated antigens) Harnessing the Immune System to Prevent Cancer: Basic Immunologic Mechanisms and Therapeutic Approaches that are Relevant to Cancer Prevention I. Basic immunologic mechanisms II. Application to prevention & treatment of cancer 1. Antibodies: as drugs “passive immunity” 2. Vaccines: general principles & your vaccine trials & more… I) Vaccines to prevent cancers caused by infectious agents “active II) Vaccines to prevent immunity” non-infection associated cancer (directed toward tumor associated antigens) Harnessing the Immune System to Prevent Cancer: Basic Immunologic Mechanisms and Therapeutic Approaches that are Relevant to Cancer Prevention I. Basic immunologic mechanisms II. Application to prevention & treatment of cancer 1. Antibodies:Focus as on drugs the Antigen “passive !immunity” 2. Vaccines: general principles & your vaccine trials & more… I) Vaccines
    [Show full text]
  • The Tangible Effects of COVID-19 in Latin American Countries Boletín Del Colegio Mexicano De UROLOGIA´
    Care and management in Urology oncology: The tangible effects of COVID-19 in Latin American countries Boletín del Colegio Mexicano de UROLOGIA´ BOLETÍN DEL COLEGIO MEXICANO DE UROLOGÍA, Vol. 36, año 2021, es una revista de publicación continua editada por el Colegio Mexicano de Urología Nacional, A.C., Montecito No. 38, Piso 33, Oficina 32, Col. Nápoles, C.P. 03810 CDMX, México. Tel. directo: (01-55) 9000-8053. http://www.cmu.org.mx Director: Dr. Héctor Berea Domínguez, Editor responsable: Dr. Erick Sierra Díaz, Co-Editores: Dr. Israel Presteguín Rosas, Dr. Rafael Sandoval Gómez, Asistente editorial: Lic. Angélica M. Arévalo Zacarías. Reservas de Derechos al Uso Exclusivo del título (04-2011-12081034400-106). ISNN: (0187-4829). Licitud de Título Núm. 016. Licitud de Contenido Núm. 008, de fecha 15 de agosto de 1979, ambos otorgados por la Comisión Clasifica- dora de Publicaciones y Revistas Ilustradas de la Secretaría de Gobernación. Los conceptos vertidos en los artículos publicados en este Bletín son responsabilidad exclusiva de los autores, y no reflejan necesariamente el criterio de el Colegio Mexicano de Urología Nacional, A.C. Este número se terminó de imprimir en abril de 2021. Publicación realizada, comercializada y distribuida por Edición y Farmacia SA de CV (Nieto Editores®). Cerrada de Antonio Maceo 68, colonia Escandón, 11800 Ciudad de México. Teléfono: 5678-2811. Queda estrictamente prohibida la reproducción total o parcial de los contenidos e imágenes de la publicación sin pevia auto- rización del Colegio Mexicano de Urología Nacional, A.C. Mesa Directiva 2019-2021 Dr. Ignacio López Caballero Presidente Dr. Héctor Raúl Vargas Zamora Vicepresidente Dr.
    [Show full text]
  • Putting Into Perspective the Future of Cancer Vaccines: Targeted Immunotherapy
    Putting into Perspective the Future of Cancer Vaccines: Targeted Immunotherapy Authors: Issam Makhoul,1,2 *Thomas Kieber-Emmons2,3 1. Department of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA 2. Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA 3. Department of Pathology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA *Correspondence to [email protected] Disclosure: The authors have declared no conflicts of interest. Received: 11.11.19 Accepted: 12.02.20 Keywords: Cancer, cancer vaccine, checkpoint inhibitors. Citation: EMJ. 2020;5[3]:102-113. Abstract Pre-clinical models and human clinical trials have confirmed the ability of cancer vaccines to induce immune responses that are tumour-specific and, in some cases, associated with clinical response. However, cancer vaccines as a targeted immunotherapy strategy have not yet come of age. So, why the discordance after so much research has been invested in cancer vaccines? There are several reasons for this that include: limited tumour immunogenicity (limited targeted antigen expression, antigen tolerance); antigenic heterogeneity in tumours; heterogeneity of individual immune responses; multiple mechanisms associated with suppressed functional activity of immune effector cells, the underlying rationale for the use of immune checkpoint inhibitors; and immune system exhaustion. The success of checkpoint therapy has refocussed investigations into defining relationships between tumours and host immune systems, appreciating the mechanisms by which tumour cells escape immune surveillance and reinforcing recognition of the potential of vaccines in the treatment and prevention of cancer. Recent developments in cancer immunotherapies, together with associated technologies, for instance, the unparalleled achievements by immune checkpoint inhibitors and neo- antigen identification tools, may foster potential improvements in cancer vaccines for the treatment of malignancies.
    [Show full text]
  • ISSN: 2320-5407 Int. J. Adv. Res. 6(3), 1363-1370
    ISSN: 2320-5407 Int. J. Adv. Res. 6(3), 1363-1370 Journal Homepage: -www.journalijar.com Article DOI:10.21474/IJAR01/6806 DOI URL: http://dx.doi.org/10.21474/IJAR01/6806 RESEARCH ARTICLE A CRITIQUE ON CANCER VACCINE. Sambathkumar R1, Amala Baby2, Sudha M3 and Venkateswaramurthy N2. 1. Department of Pharmaceutics. 2. Department of Pharmacy Practice. 3. Department of Pharmacology J.K.K. Nattraja College of Pharmacy, Kumarapalayam, Tamilnadu - 638183, India. …………………………………………………………………………………………………….... Manuscript Info Abstract ……………………. ……………………………………………………………… Manuscript History The goal of a successful vaccine is to prepare the immune system for invasion of a foreign pathogen and teach them to recognize antigens as Received: 21 January 2018 well as reduce the risk of transmission. In the field of cancer, vaccines Final Accepted: 23 February 2018 are found to be the latest discovery. Provenge® (Sipuleucel-T) is the Published: March 2018 only vaccine approved by Food and Drug Administration for the Keywords:- treatment of cancer. Vaccines are an appealing therapeutic strategy Cancer vaccine, Cells, Treatment. because they are specific. In addition they stimulate the adaptive immune system, thereby producing a memory response allowing for sustained effect without repeated therapy. Revelation of a potential anticancer treatment is as yet a test to the researchers. Thus, the development of effective cancer vaccines require, thoughtful clinical trials, and scientific progress which might induce long-term specific anticancer response and could contribute to effective and lasting elimination of malignant cells. Copy Right, IJAR, 2018,. All rights reserved. …………………………………………………………………………………………………….... Introduction:- Worldwide 6.7 million deaths were reported due to cancer in 2000. But the WHO has predicted this figure to be 15 million by 2020.[1, 2] Despite great efforts to develop better therapy, in 1997 more than 6 million people worldwide died from cancer.
    [Show full text]