R&D for TB: Updates & Opportunities for the Private Sector
Christian LienhardtSenior Scientific Advisor,Stop TB PartnershipWHO, Geneva
GBC Conference on TB, TB/HIV co-infection &
Global Fund Partnership-
Johannesburg, October 11-13, 2010
Contents
• Context/Scene-Setting• Brief “pipeline update”• Role of PDPs in R&D• Advocacy for TB R&D: what can the private sector do?
Estimated number of
cases
Estimated number of
deaths
1.9 million
(range 1.6–2.3 million)
9.4 million(range 8.9–9.9 million)
440,000 (0.39-0.51 million)
All forms of TB
Multidrug-resistant TB (MDR-TB)
HIV-associated TB 1.4 million (15%)(1.3–1.6 million)
520,000(0.45–0.62 million)
The global burden of TB in 2008
150,000(0.05–0.27 million)
Estimated TB Incidence rates, 2008
Africa 31%
West Pacific 20%
SE Asia 34%
Europe 5%
East Mediterranean 7%
Americas 3%
TB Control Global Targets
2015: 50% reduction in TB prevalence and deaths relative to 1990 levels2050: elimination (<1 case per million population)
2015: Goal 6: Combat HIV/AIDS, malaria and other diseases Target 8: to have halted by 2015 and begun to reverse the
incidence… Indicator 23: incidence, prevalence and deaths associated with TB
Indicator 24: proportion of TB cases detected and cured under DOTS
The Global Plan 2006-2015
defines direction and costs
A new strategy requires a new plan…
11 billion US$ to
develop new tools
The Global Plan 2011-2015
strengthens the fight
9.8 billion US$ to
develop new tools
7
Sputum smear microscopyDiscovered 1882
DIAGNOSTIC
1st-line TB drugs Discovered 1943-1970
TREATMENTVACCINE
BCGDeveloped 1920s
Today's tools for TB control are old tools – a struggle to cut deaths by half by 2015 and eliminate TB by 2050
TB care and control
Development
Research
Health systemsAnd policies
Traditionalarea of core TB control
not enough
Traditionalarea of core TB control
not enough
Need to focus on research
Need to focus on research
Innovative action needed in 4 spheres
"Moving beyond the TB box"
TB Drug Pipeline WGND, July 2010
•Gatifloxacin•Moxifloxacin
•TMC-207•OPC-67683•PA-824•Rifapentine•Linezolid•LL3858
•AZD5847•SQ-109•Oxazolidinone
•CPZEN-45•SQ641•SQ609•DC-159a•Benzothiozinones
Preclinical DevelopmentDiscovery Clinical Development
•Nitroimidazoles•Mycobacterial Gyrase Inhibitors•Riminophenazines•Diarylquinoline•TL1 Inhibitor•MTopo
•InhA Inhibitor•Tryptanthrins•LeuRS Inhibitor•Protein Kinase Inhibitors•ActinomyceteMetabolites•Fungal Metabolites•DNA metabolism•Novel compound evaluations
•Phenotypic screens
TB Vaccine Pipeline
VPM 1002
rBCG30*
AdAg85A
Hybrid-I+CAF01
Hyvac 4/ AERAS-404
RUTI
M smegmatis*
Hybrid-I+IC31
M72
MVA85A/AERAS-485
AERAS-402/ Crucell Ad35
M vaccae*
Preclinical Phase II Phase IIIPhase IIbPhase I
*indicates candidates that have been in clinical trials in the past, but are not currently being tested in clinical trials
Source: Tuberculosis Vaccine Candidates – 2009; Stop TB Partnership Working Group on New TB Vaccines
Working Group on New vaccines - July 2010
AERAS-rBCG
Mtb [∆lysA ∆panCD ∆secA2]
MTBVAC01 [∆phoP, ∆fad D26]
HBHA
Hybrid 56
HG85 A/B
Prime
Boost
Post-infection
Immunotherapy
Preclinical vaccine candidates are not yet in clinical trials, but have been manufactured under Good Manufacturing Practice (GMP) for clinical use and have undergone some preclinical testing that meets regulatory standards.
Advocacy for TB R&D: what can the private sector do?
• direct investment in R&D• patronage/sponsoring university research• support innovative starts-ups (venture capital funding)• Advocate for tax breaks for R&D• offer incentives• "champions" for promotion of innovation in R&D• promote debates and discussions (roundtables)
Conclusion – the TB Research Movement
• TB Research Movement promotes the need for harmonized and complementary funding of TB research to target revolutionary discoveries that will foster better care and control for the elimination of TB.
• Development of a consensus-driven Roadmap for International Research to eliminate TB
www.stoptb.org/researchmovement/