WAVA Update to LSDF Board December 7, 2010 Larry Corey WAVA Science Director Incoming President of the Fred Hutchinson Cancer Center Harlan Patterson WAVA Executive Director 1
Washington Vaccine Alliance (WAVA) A nonprofit consortium formed to accelerate the research and development pathway for vaccines. WAVA s purpose is to establish a shared translational research infrastructure - providing access to interdisciplinary expertise, linking facilities, and building collaborations across public and private institutions. 2
Washington Vaccine Alliance 3
WAVA Executive Committee Comprised of leaders from each member organization. Its members are responsible for the overall direction and approval of WAVA projects. Larry Corey, Fred Hutchinson Cancer Research Center King Holmes, University of Washington - Dept of Global Health Hugh Chang, PATH Terry Johnson, Battelle Sheila Lukehart, University of Washington Terry McElwain, Washington State University Samuel Miller, University of Washington Eileen Murphy, Seattle BioMed Guy Palmer, Washington State University Steven Reed, Infectious Disease Research Institute Steve Self, Fred Hutchinson Cancer Research Center Ken Stuart, Seattle BioMed 4
WAVA Science Advisory Board Responsible for reviewing all project proposals for which WAVA funding and infrastructure support will be provided. Larry Corey, Fred Hutchinson Cancer Research Center Mark Alderson, PATH Malcolm Gardner, Seattle BioMed Julie McElrath, Fred Hutchinson Cancer Research Center Guy Palmer, Washington State University Steven Reed, Infectious Disease Research Institute Karin Rodland, Pacific Northwest National Laboratories Wes Van Voorhis, University of Washington Anna Wald, University of Washington 5
WAVA Project Review Since its inception, WAVA has conducted 6 half-day scientific reviews on both progress of funded programs and pilot funding: In 2010, of four pilot grant proposals submitted, two were awarded; one additional idea has led to collaboration between research laboratory and major pharmaceutical company (Novartis Vaccines Institute for Global Health). Active surveillance of potential projects through meeting with faculty involved in vaccines as identified by Executive Committee. E.coli project has created formal collaborations discussions with industry organization that would be interested in potential vaccine. 6
WAVA Project Review Scientific Review: Ongoing Projects Review of first experiment results for the E.coli and Syphilis projects, including proposed adjustments to development plans and recommendations to the WAVA Executive Committee. Review of options to move forward with two different candidates for HSV-2 clinical trial. Final recommendation is Immune Design Corp, a new venturefunded for-profit corporation. Executive Committee Review: New and Ongoing Projects Review of all project proposals. Approval of WAVA support for three primary projects and two pilot projects to date. Review of project progress for all projects quarterly. Review and approval for continuation of projects at each major milestone. 7
WAVA External Advisory Board Members Rip Ballou GlaxoSmithKline John Boslego PATH Walter Orenstein - Bill & Melinda Gates Foundation Rino Rappuoli Novartis Review all approved WAVA projects for market perspective on proposed product profiles and targeted populations. Provide input on industry partnerships and collaborations. 8
Fostering Innovation The WAVA Model Creating project teams: WAVA identifies and connects experts to plan and execute work from early development to commercialization through planning, project management, and partnerships. Resources and tools: WAVA provides development resources and pathways to increase the effectiveness and reduce the time of the vaccine development process at a competitive cost. 9
WAVA Funded Projects E. coli O157:H7 (WSU/University of Idaho) HSV-2 Vaccine (UW/Immune Design Corp) T. Pallidum Vaccine (UW/University of Victoria) Pilot Awards Non-typhoidal salmonella vaccines (WSU) Inactivated typhoid vaccine (UW/Novartis ) 10
E. coli O157:H7 Vaccine: Why? Disease is episodic but severe High case fatality in children and elderly $US 405$US 30M in medical costs M total costs per annum No effective treatment Prevention is key Cattle are the major reservoir for human transmission 21 separate E. coli O157:H7 recalls in 2007 $US 3B total financial cost to the industry 11
E. coli O157:H7 Vaccine Project Trials 1 3 Complete Trials examined efficacy of adjuvant and route of administration in developing an immune response Two groups per trial, subcutaneous or mucosal application administration All animals prescreened and selected for the 1201 MHC class II allele Antigens used were intimin and ovalbumin Intimin is an strain specific protein that plays a key role in attachment to the rectal mucosa Ovalbumin is used as a second antigen that would not be affected if there were concurrent infection with E. coli O157 12
E. coli O157:H7 Vaccine Project Trial 4 Optimization of adjuvant formulation with IDRI Two immunization protocols Both groups, initial subcutaneous administration of vaccine First group: subcutaneous boost Second group: Mucosal application boost Challenge study: design based on Trial 4 results 13
Syphilis Vaccine: Why? Infectious syphilis cases have doubled in US since 2000 Nearly $1B in public health dollars spent directly for syphilis control programs 12 M new infectious cases per year globally (1998 est.) China 70-fold in past 15 yrs 50% of stillbirths, miscarriages in sub-saharan Africa Recognized risk factor for HIV acquisition and transmission 14
Syphilis Vaccine Project Status First series of experiments with candidate antigens were disappointing; little protection seen and studies in small animals did not confirm the preliminary results on which the project was based. However, there were data to suggest that one particular type of antibody was associated with protection, hence providing an important pre-clinical predictor of what candidate antigens and adjuvants need to elicit in order to be effective; an important insight for the field. Studies to test the above concept as well as effectiveness of additional vaccine formulations are being initiated. 15
HSV-2 Vaccine: Why? In Washington State 1 in 5 adults infected Most frequent infectious disease of neonates 1 in 3,500 infants with neonatal HSV Over $2B/yr in US alone on treatment of genital herpes 40 50% of adults in developing world affected Increases risk of HIV-1 acquisition 2-4 fold Increases risk of HIV-1 transmission 6-8 fold 16
HSV-2 Vaccine Project Goal of this project is to develop a successful vaccine candidate to treat chronic HSV-2 infections. 2 different vaccine approaches presented to SAB and Executive Committee: Both groups voted that approach being led by Immune Design Corp. in Seattle was scientifically better and more fitting for WAVA funding. IDC providing support for manufacturing of the vaccine. Status Finalizing collaboration agreements Preparing milestones and budget Clinical trial estimated to begin summer 2011 17
Vaccine Pilot Projects Salmonella for Poultry Vaccine FDA increased emphasis on food safety Improved Typhoid Vaccine Reduce toxicity of killed vaccine target populations of immune compromised individuals and children below 6 years of age. 18
Zoonotic vaccines: Campylobacter Early clinical stage: Vaccine Pipeline TB, Flu, HIV, Malaria Preclinical stage: Chlamydia, West Nile, CMV, Hepatitis C, Helicobacter Immunosenescence Program 19