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Developing Pneumococcal, Meningococcal and Hib Vaccines

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Developing Pneumococcal, Meningococcal and Hib Vaccines George Siber MD CSO, ClearPath Vaccines Adjunct Professor, Johns Hopkins University Bloomberg School of Public Health Sabin Gold Medal Ceremony 2016 Inspiration To Be Practical “It’s good to learn the theory, but not enough. Make sure you do something useful with it.” …so Building Became a Passion For My Sister and Me Inspiration to Study Medicine Wilder Penfield 1891-1976 Canadian neurosurgeon Mapped regions of brain Founded the Montreal Neurological Institute “The Torch” by Wilder Penfield He beamed when I showed him my paperback copy of The Torch. “I had such fun writing it.” he said. “It’s the right way, really, the novelist approach. When you write imaginatively, you know what’s right. The historian can’t do that when he says such and such happened.” Alan Blum, A Bedside Conversation with Wilder Penfield CMAJ 2011 Inspiration to Work on Vaccines John F Enders - 1897-1985 Nobel Prize in Medicine - 1954 Shared with Tom Weller and Tony Robbins First grew viruses in tissue culture Enabled development of polio and many other viral vaccines Inspiration to Work on Hib, Pneumococcal and Meningococcal Vaccines Albert Lasker 1996 Clinical Medical Research Award Porter Anderson John Robbins for the Hib Conjugate Vaccine David Smith Rachel Schneerson Heroes and Mentors Maurice Hilleman Bob Austrian Stanley Plotkin Roger Glass Al Kapikian and Bob Chanock Rino Rappuoli Marc LaForce Why Hib, Pneumococcus and Meningococcus? Three most serious bacterial infections of mankind: H. influenzae b(Hib): most common cause of bacterial meningitis. Pneumococcus: single most common cause of serious bacterial infection of children and adults, including pneumonia, sepsis and meningitis. Meningococcus: though rare, causes overwhelming sepsis and meningitis. Can be fatal within 24 hours. Pneumococcal Disease Burden in US Children Invasive Number of cases/yr. in US 700 Meningitis Prevalence 13,000 ( ~X 10) Bacteremia 71,000 ( ~X 100) Disease severity Pneumonia 5 Million ( > 1000 X) Noninvasive Otitis media Adapted from: American Academy of Pediatrics. Pediatrics. 2000;106:367-376 & MMWR. 1997;46:1-24 Global Burden of Pneumococcal Disease in Children <5 Years (Deaths) O’Brien Lancet 2009 Hib, Pneumococcus and Meningococcus Are Surrounded By a Complex Sugar Coating The surface capsule defines the serotype. The capsule is a major virulence factor. Antibody to capsular polysaccharide is protective. Bar = 100 nm Early Work Important to make the Dx quickly to prevent serious complications: developed a simple Dx test that give results in minutes. But early Dx is not good enough: Children with cancer or lacking their spleen often die within 24h despite optimal antibiotic Rx. Pediatrics. 1982;69:466-71 Am J Dis Child. 1980;134:668-72 If Treatment was Not Good Enough, We Had to Prevent the Infections Who was at highest risk? Children who had both radiation and chemo had the lowest antibodies to polysaccharide antigens. But, immunizing them with investigational Ps vaccine did not work. The more treatment they had, the lower the antibody and the higher the risk. Found that the low polysaccharide antibody correlated with low levels of a subclass of antibodies called IgG2. NEJM. 1977;297:245-8 NEJM. 1978;299:442-8 NEJM. 1980;303:178-82 ..If They Can’t Respond to Vaccine, Then We’ll Find Somebody Who Can and Make Antibodies for Them Immunized blood and plasma donors with the available Ps vaccines to Hib, pneumococcus and meningococcus. Donna Ambrosino Enlisted Massachusetts Biologic Labs (MBL) for Help Had capability to purify human Ab by cold alcohol fractionation (Bacterial Polysaccharide Immune Globulin or BPIG) George Grady Infect Immun. 1984;45(1):248-54 Massachusetts Biologic Labs (MBL) Founded in 1894 by Massachusetts DPH to make diphtheria antitoxin Theobald Smith, the “father of American Microbiology” and discoverer of Salmonella was the first Director First of 6 state-run biologic labs in the US Evaluation of BPIG Showed BPIG worked in animals Showed good antibody levels in high-risk children Claudette Thompson Infect Immun. 1983;39:709-14 J Infect Dis. 1986;153(1):1-7 How Do We Show That BPIG Works? Need hundreds of children at high risk. Difficult to do with cancer patients or patients post-splenectomy… Saved by a call from Mathu Santosham …moi talking to Mathu Mathu Santosham Richard Moxon BPIG Study Group – Apache Reservation David Klein Pamela McInnes Left to Right: Ray Reid, George Siber, Mathu Santosham, Front Row: Claudette Thompson, Janne Croll and Mark Wolff Richard Moxon, Donna Ambrosino Many Wonderful Site Visits Later We Got Great Results… Efficacy of BPIG vs. Hib and Pneumococcal Disease NEJM. 1987;317(15):923-9 BPIG was Introduced into Alaska Native Population Ros Singleton Jim Berner Singleton et al. Decline of Haemophilus influenzae type b disease in a region of high risk: impact of passive and active immunization. Pediatr Infect Dis J. 1994;13:362-7 BPIG: Opportunity for Scientific Discoveries Genetic factors affecting ability to make Ab to polysaccharide antigens in adult donors. Found impaired Ab responses of Apache children to Hib Ps vaccine. Development of standardized antibody assays and antibody standards still used in vaccine evaluations today. Defined protective antibody levels to Hib and pneumococcus that were associated with protection: used as basis to license future vaccines. Hib Antibody Levels in BPIG Recipients NEJM. 1987;317(15):923-9 BPIG: Opportunity to Lead MBL 1982-1996 FDA licensed, public sector vaccine facility State budget was ~ $1M/year Survival depended on developing new products MBL Staff - circa 1984 Products Developed at MBL 1982-1996 1. Varicella Zoster Immune Globulin (VZIG) 2. BPIG 3. CMVIG-IV (Cytogam) 4. RSVIG-IV (Respigam) Synagis (MedImmune) 5. Pertussis toxoid vaccine 6. Pertussis Immune Globulin (PIG) 7. Botulism IG for infant botulism (Baby-BIG) 8. Hib-TT conjugate (as component of Quinvaxem) RSV Immune Globulin (Respigam) Collaboration with USUHS and MedImmune (1989) Trial funded by NIAID Efficacy vs severe RSV demonstrated (Groothuis et al.) Market approval (1996) – follow-on product: Synagis Wayne Hockmeier, George Siber, Jeanne Leszczynski Jim McIver Frank Top and Val Hemming Donna Ambrosino – MBL CEO 1998-2011 Established new facilities with MAb development and manufacturing capacity. Developed MAbs to Rabies, C. difficile toxins and Hepatitis C. George Siber, Donna Ambrosino Donna Ambrosino and Jeanne Leszczynski Mass Biologics Manufacturing Building Dedication – May 12, 2006 Licensed Conjugate Vaccines • Hib conjugate (US - 1990) • Meningococcal C (UK – 1999) • Pneumococcal 7-valent (PCV7: US – 2000) • [Meningococcal 4-valent (US - 2005)] • [Pneumococcal 10-valent (EU – 2009)] • Pneumococcal 13-valent (PCV13: US – 2010) Polysaccharide Vaccines Stimulate Only B Cells * * Polysaccharide specific antibody B • Do not recruit T cell help • No immunologic memory, no boosting • Do not induce protective Ab response in children <2 y • Repeat doses in adults may induce tolerance Conjugate Vaccines Were Developed to Solve Shortcomings of PS Vaccines PS are covalently linked to proteins to convert a T-independent antigen into a T-dependent antigen: + Protein Polysaccharide Conjugate • Conjugates induce protective antibodies in infants • Boost the antibody response Decline of Haemophilus influenzae Meningitis in U.S. Children Under Five Years Following Introduction of Haemophilus B Conjugate Vaccines Impact of Meningococcal C Conjugate Vaccine in the UK All Laboratory Confirmed Cases of Meningococcal Disease (by quarter) England & Wales. 800 Serogroup C Immunisation with MCC began David Salisbury Serogroup B 700 600 500 400 no of cases 300 200 100 0 1997 1998 1999 2000 2001 2002 Courtesy of Dr Ray Borrow, PHLS Invasive Pneumococcal Disease Serotypes in North American Young Children 30 100 Vaccine types 90 25 80 20 70 60 15 50 40 Cumulative (%) 10 30 Cross-reactive types 20 5 Noncross-reactive types Total invasive disease (%) invasive Total 10 0 0 14 6B 19F18C23F 4 9V 19A 6A 9N 18B18F 7F 3 1 22F15C12F11A33F10A 38 13 Serotype Hausdorff WP et al. Clin Infect Dis. 2000;30:100-121. Hausdorff WP et al. Unpublished data, 1999. ™ MANUFACTURING PROCESS FOR PREVENAR 4 6B 9V 14 18C 19F 23F Large scale fermentation and purification of saccharide QC Each type of saccharide is separately activated and conjugated to CRM protein carrier QC Conjugates are mixed to formulate vaccine Prevnar QC Kaiser Permanente Vaccine Trial: Invasive Pneumococcal Disease Efficacy (Vaccine Serotypes) Control Subjects PCV7 (Mening C) Efficacy (95%CI) (n=38,000) Per protocol 1 39 97.4% (84.8, 99.9) Intent-to-treat 3* 49 93.9% (81.0, 98.8) * 1 fully vaccinated after 4 doses 1 partially vaccinated with 1 dose 1 immuno-compromised Steve Black Henry Shinefield Black et al. Pediatr Infect Dis J. 2000;19:187-95 Pneumococcal Conjugate Vaccine Efficacy Trials in Infants 97.4% #1 2000 Invasive Disease Kaiser Permanente, CA #2 2001 Otitis Media 57% Finland #3 2003 Invasive Disease 76.8% Navajo Indians #4 83% 20% 2004 Invasive Disease/Pneumonia (CXR +ve) Soweto, S. Afr. #5 2005 Invasive Disease/Pneumonia/Death The Gambia 77%/37%/16% Courtesy of David Goldblatt Rates of IPD Among Children Aged <5 years, 1998-2009 – USA, ABC Network 2009 vs. Average 1998-99 Percent change Rate Types (95% CI) difference All -76 (-79,-73) -75 PCV7 -100 (-100,-99) -81 19A +284 (+160,+466) +8 PCV7 intro- duction Rates of IPD Caused by PCV7 Serotypes Among Adults >18 Years Old - ABCs 1998-2009 PCV7 2009 vs. baseline Intro- 65+: -97% (-96,-98) duction 50-64: -92% (-89,-94) 18-49: -96% (-94,-97) What is Herd Immunity? Partially Vaccinated Population Prevents the Spread of Infection x x x Courtesy of Matt Moore, CDC Vaccine-Type Invasive Pneumococcal Disease Prevented by Direct and Indirect Effects of PCV7 - ABCs 2003 25,000 20,460 20,000 15,000 9,140 10,000 5,000 0 Estimated no. cases prevented Direct effects Indirect effects CDC.
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  • ASTELLAS to FORM STRATEGIC PARTNERSHIP with CLEARPATH to BUILD VACCINE PORTFOLIO In‐License Vaccine Technology for Respiratory Syncytial Virus (RSV) from Mymetics

    ASTELLAS to FORM STRATEGIC PARTNERSHIP with CLEARPATH to BUILD VACCINE PORTFOLIO In‐License Vaccine Technology for Respiratory Syncytial Virus (RSV) from Mymetics

    ASTELLAS TO FORM STRATEGIC PARTNERSHIP WITH CLEARPATH TO BUILD VACCINE PORTFOLIO In‐license Vaccine Technology for Respiratory Syncytial Virus (RSV) from Mymetics Tokyo, Japan; Rockville, MD; and Epalinges, Switzerland – January 6, 2014 – Astellas Pharma Inc. (Astellas) and ClearPath Development Company (ClearPath) announced today a strategic partnership to form a portfolio of development companies focused on vaccines targeting infectious diseases. The partnership was established to support Astellas’ goal of building a global vaccine franchise and launched its first company, RSV Corporation (RSVC), in December 2013. Astellas will fund RSVC’s development of a virosome vaccine technology, licensed from Mymetics Corporation (Mymetics ‐ OTC BB: MYMX), for respiratory syncytial virus (RSV) through completion of a Phase 2b human proof‐of‐concept study. Based on the strategic partnership, Astellas received exclusive rights to acquire RSVC as well as further develop and commercialize the vaccine product. “This partnership highlights our commitment to build a global vaccine business and represents a highly efficient model for bringing innovative vaccines to market. It is also a unique opportunity for Astellas to utilize external cutting edge science and technology to enhance our ability to generate innovative drugs, as part of the “Reshaping Research Framework” program announced in May, 2013,” said Kenji Yasukawa, Senior Vice President and Chief Strategy Officer, Astellas. RSV is a respiratory pathogen which infects patients of all ages. The infection can be especially severe in infants and older adults with chronic pulmonary or cardiovascular disease. Each year the virus infects 64 million people and is responsible for 160,000 deaths worldwide. Currently, there is no vaccine available for this virus.