UPDATE 57: OCTOBER 1 TO OCTOBER 31, 2013
PDP FUNDERS GROUP
Items in blue or purple should be hyperlinked to the full text version; if I have made mistakes
many apologies. If you have any issues that you would like to include in the Update please
send them to Jane Rowley (jtfrowley@btinternet.com).
FUNDER ANNOUNCEMENTS (SINCE OCTOBER 1, 2013)
Bill & Melinda Gates Foundation
29 October 2013:
A New Partnership to Accelerate Vaccine Research and Development
Accelerating the development of affordable new vaccines for the developing world is one of the most
important factors in reducing child deaths and lifting the burden of disease that afflicts many poor
countries. Even as global child deaths have declined from 12.6 million to 6.6 million over the last two
decades, preventable diseases like pneumonia, diarrheal disease and malaria remain the world’s
leading causes of death among children under age 5. …
This new effort – known as the Vaccine Discovery Partnership – will be a way for our foundation to
work directly with pharmaceutical companies on promising new vaccines for global health.
GlaxoSmithKline (GSK) and Sanofi are the first two companies with whom we’ve signed agreements.
We’re optimistic that other pharmaceutical companies will also join the partnership. …
We will work with each company individually to identify a promising set of research projects that are
aligned with our foundation’s priorities. Projects funded through the Vaccine Discovery Partnership
will span the R&D lifecycle – from preclinical to experimental medicine Phase IIa trials.
One of the first projects we are working on – with GSK – focuses on increasing the thermostabilization
of new generation vaccines to facilitate delivery of such vaccines in special administration and
campaign settings in resource-limited countries. The goal would be to build thermostability into
vaccines as an integral part of new generation vaccine development.
By working together with pharmaceutical companies, these new partnerships will reduce the risks
associated with early-stage vaccine research, and increase the likelihood that the most promising new
vaccines are developed quickly, and at lower cost. This will be a win for everyone involved but most
importantly for the children around the world who will get the life-saving vaccines they need.
US - NIH
17 October 2013:
NIAID selects new director of the Vaccine Research Center
John R. Mascola, M.D., an internationally recognized expert on HIV vaccine development, has been
named the new director of the Vaccine Research Center (VRC) at the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of Health. In this role, he will lead a
comprehensive research program aimed at the design, development and testing of candidate
vaccines against HIV/AIDS, influenza and other globally important infectious diseases. He will also
serve as chief of the VRC virology laboratory.
18 October 2013:
NIH awards $17 million in grants to augment genomics research in Africa
The National Institutes of Health has awarded 10 new grants totaling up to $17 million over the next
four years to support genomics research in Africa, as part of the Human Heredity and Health in Africa
(H3Africa) program. This set of grants is the second disbursement of H3Africa awards and brings the
total amount of funding since the 2010 launch of the program to about $74 million. In addition to
genomics research, the new awards will support training of African genomic scientists and building
scientific infrastructure on the continent. H3Africa is funded by a partnership between NIH and the
United Kingdom's Wellcome Trust.
31 October 2013:
NIH scientists develop candidate vaccine against respiratory syncytial virus
An experimental vaccine to protect against respiratory syncytial virus (RSV), a leading cause of illness
and hospitalization among very young children, elicited high levels of RSV-specific antibodies when
UPDATE 57: OCTOBER 1 TO OCTOBER 31, 2013
tested in animals, according to a report in the journal Science.
Early-stage human clinical trials of the candidate vaccine are planned. Scientists from the Vaccine
Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health, built on their previous findings about the structure of a critical viral
protein to design the vaccine. The team was led by Peter D. Kwong, Ph.D., and Barney S. Graham,
M.D., Ph.D. …
WELLCOME TRUST
8 October 2013:
Candidate malaria vaccine moves towards regulatory approval application following
positive clinical trial results
An application for regulatory approval for the most clinically advanced malaria candidate, RTS,S, could
be submitted to the European Medicines Agency as early as next year following positive results from
a late-stage clinical trial in African children.
The latest results - which were announced this week at a conference in South Africa - show that over
18 months of follow-up, the vaccine candidate cut the number of malaria cases in young children by
almost half and reduced malaria cases in infants by around a quarter. …
9 October 2013:
New initiative supports research to strengthen health systems in low- and middleincome countries
The Wellcome Trust, the Department for International Development, the Medical Research Council
and the Economic and Social Research Council today announced a £15 million collaboration to
support research that will generate practical measures to improve health systems in low- and middleincome countries. …
15 October 2013:
Guy Thwaites begins as Director at Vietnam Research Programme
Dr Thwaites, who joins from King's College London, succeeds Dr Jeremy Farrar, who left the
Programme to become Director of the Wellcome Trust. As well as leading the Vietnam Research
Programme, Dr Thwaites is resuming his clinical research on tuberculosis and brain infections with an
academic appointment at Oxford University.
The Vietnam Research Programme is recognised internationally for its excellence in research into
infectious diseases. It is hosted by the Hospital for Tropical Diseases in Ho Chi Minh City and the
National Hospital for Tropical Diseases in Hanoi, and it is home to the Oxford University Clinical
Research Unit (OUCRU). The Programme has made seminal contributions to improving the care of
patients and understanding infections of the brain, dengue emerging infections, enteric fevers,
malaria, tuberculosis and zoonotic infections. …
PDP PRESS RELEASES (SINCE OCTOBER 1, 2013)
Aeras
14 October 2013:
EXPOSED Film Series Wins Best Cause-Related Video
Aeras has been awarded Best Cause-Related Video for its film series, EXPOSED: The Race Against
Tuberculosis by PR Daily. The PR Daily Digital PR award winners include some of the most recognized
names in public relations and communications from around the world. The EXPOSED series also won
an honorable mention under “Best Digital PR Campaign – Nonprofit Sector.” …
23 October 2013:
TB Report Underscores Need to Address R&D Gaps
A report published today by the World Health Organization (WHO) highlights that thousands of men,
women and children with drug-resistant tuberculosis fail to get the critical drug treatment they need.
According to the WHO, progress toward diagnosis and treatment of multi-drug resistant (MDR) TB is
“far off track,” and when coupled with the emergence of extensively drug-resistant (XDR) TB,
UPDATE 57: OCTOBER 1 TO OCTOBER 31, 2013
constitutes “a public health crisis.” The failure to detect and treat those with drug-resistant TB is
perpetuating a devastating cycle of transmission within families and communities, adding to the
urgency to develop and deliver new, effective prevention measures. …
DNDi
24 October 2013:
Deadly Gaps Persist in New Drug Development for Neglected Diseases
New study shows that, despite some progress, only 4% of new drugs and vaccines approved 20002011 were for neglected diseases, and a ‘fatal imbalance’ remains in R&D for many neglected patients
In a study published today in the open-access journal The Lancet Global Health, the Drugs for
Neglected Diseases initiative (DNDi) and other researchers report a persistent deficiency in truly new
therapeutics for neglected diseases, despite nominal progress and an acceleration in research and
development (R&D) efforts. This continued ‘fatal imbalance’ in medical R&D points to the urgent
need to develop and deliver groundbreaking new treatments for the world's poorest and most
neglected patients.
Researchers from DNDi, Médecins Sans Frontières/Doctors Without Borders (MSF), the Special
Programme for Research and Training in Tropical Diseases (WHO-TDR), and three universities
(University Hospital of Grenoble, France; Joseph Fourier University, France; University of Oxford, UK)
found that of the 850 new drugs and vaccines approved for all diseases, 4% (37) were for neglected
diseases, defined broadly as those prevalent primarily in poor countries: malaria, tuberculosis, 17
neglected tropical diseases (NTDs) as defined by the World Health Organization (WHO), 11 diarrheal
diseases, and 19 other diseases of poverty, excluding HIV/AIDS. Globally these neglected diseases
represent an 11% health burden, based on a recent assessment of 2010 disability-adjusted life-years
(DALYs).
Most newly developed therapeutic products were repurposed versions of existing drugs. Of the 336
brand-new drugs (new chemical entities, or NCEs) approved for all diseases in 2000-2011, only four,
or 1%, were for neglected diseases; three were for malaria, and one for diarrheal disease. None were
for any of the 17 WHO-listed NTDs. …
IAVI
11 October 2013:
Intermittent pre-exposure prophylaxis (PREP) for HIV may be feasible, study finds
New clinical trial findings in Uganda highlight the feasibility of intermittent treatment with preexposure prophylaxis (PrEP) for HIV prevention in HIV serodiscordant couples, where only one partner
is HIV-positive.
Encouraging safety and adherence data from this Phase I/II study show that taking PrEP less than
once per day may be a potential alternative to daily treatment, which poses a long-term challenge as
ensuring daily adherence among healthy people may be difficult. PLOS ONE, the scientific journal of
the Public Library of Science, published findings from the study – which was conducted by researchers
at the Medical Research Council (MRC) / Uganda Virus Institute (UVRI) Uganda Research Unit on AIDS
in Entebbe, Uganda, and was sponsored by the International AIDS Vaccine Initiative (IAVI) – in
September 2013. The antiretroviral drug used in the study, Truvada – a combination of tenofovir and
emtricitabine – was provided by the manufacturer, Gilead Sciences. Truvada was approved by the
U.S. Food & Drug Administration (FDA) for daily use as PrEP after this study had ended. …
31 October 2013:
IAVI excited about progress that detailed picture of HIV envelope protein can bring
to fight against AIDS
The International AIDS Vaccine Initiative (IAVI) congratulates the researchers from The Scripps
Research Institute (TSRI) and Cornell University for their landmark findings published in Science,
describing the structure of the HIV trimer, the outer part of the tripartite HIV envelope protein.
IAVI is proud to have supported this research together with the National Institute of Health (NIH)*,
among others. “These findings have collectively achieved a major, decade-long goal of AIDS vaccine
research and are likely to advance and accelerate the design of vaccines to elicit broadly neutralizing
antibodies against HIV,” said IAVI Chief Scientific Officer Wayne Koff.
Broadly neutralizing antibodies (bNAbs), if elicited by a vaccine, could prevent infection by a broad
UPDATE 57: OCTOBER 1 TO OCTOBER 31, 2013
range of HIV’s many variants, and the envelope protein is the sole target available to these
antibodies. There are many challenges to the design and testing of such a vaccine, including the great
sequence diversity of the envelope protein and the instability of the trimer. Having in hand a stable
trimer and detailed information about its structure are major steps forward in vaccine design. …
IPM
21 October 2013:
IPM Receives Two Awards from USAID Through PEPFAR to Advance HIV Prevention
Technologies for Women
The International Partnership for Microbicides (IPM) announced today that it has received two
competitive five-year awards with a combined US$40 million ceiling from the US Agency for
International Development (USAID) provided through the US President's Emergency Plan for AIDS
Relief (PEPFAR). Both awards aim to advance new HIV prevention tools for women and to help ensure
their availability in developing countries where the epidemic has hit hardest. …
With this new award, USAID has committed up to US$25 million over five years toward the successful
completion of IPM’s Ring Study, and to obtain regulatory approval for the dapivirine ring in Africa and
other regions of the world with a high HIV burden. This critical support will help ensure that, pending
trial results in 2016, the ring will be distributed quickly at low cost to women who need it most.
This new award will also support a follow-on Phase IIIb study in 2016 that will give women who
volunteered for The Ring Study access to the product prior to regulatory approval. The USAID funding
will also support initial work to keep the cost of the ring for women as low as possible.
Bringing the global HIV epidemic to an end will require a diverse toolkit of products that women can
fit into their varying lifestyles. To that end, USAID is also providing up to an additional US$15 million
to support IPM’s pipeline to spur the development of other microbicides currently in earlier stage
research. …
MMV
3 October 2013:
First African patients treated with Eurartesim®
Last week, the first African patients were treated with Eurartesim® (dihydroartemisinin-piperaquine)
the EMA-approved antimalarial developed by MMV and partner Sigma-Tau, as part of the INESS
programme.1 INESS is a pan-African research organization funded by the Bill and Melinda Gates
Foundation that conducts Phase IV effectiveness and safety studies of antimalarial drugs. In the initial
stage of the programme, the medicine will be tested in four African countries – three sites in Ghana,
two sites in Burkina Faso and a site each in Tanzania and Mozambique.
8 October 2013:
First-ever drug compound developed on African soil, an antimalarial, to move to
human trials
A promising next-generation drug is expected to move to Phase I human trials in 2014, pending
approval from Safety, Ethics and Regulatory committees. The development was announced by
researchers today at a major conference on malaria that also presented efforts to stop growing
resistance by malaria parasites to artemisinin in Southeast Asia and to keep artemisinin combination
therapies effective for as long as possible. Other researchers in West Africa reported on work to test
the safety of multiple administration of a new ACT, Pyramax (pyranoridine-artesunate), which was
recently approved by the European Medicines Agency. …
23 October 2013:
MMV partner receives PLOS Accelerating Science Award
This week in Washington DC, an MMV-funded project team, led by Dr Mat Todd at the University of
Sydney, received a Public Library of Science (PLOS) Accelerating Science Award Program
(ASAP)1 award of USD 30,000. The ‘Open Source Malaria’ project was selected from more than 200
nominations from 30 countries for turning publicly available data into a global effort to identify new
medicines for malaria. …
The Open Source Malaria project was the first collaboration within MMV’s Open Source Drug
Discovery (OSDD) programme, established in 2011 to help identify new compounds active against
malaria. Since 2011, in addition to financial support from MMV and the Australian Research Council,
UPDATE 57: OCTOBER 1 TO OCTOBER 31, 2013
MMV has provided the project with chemical starting points, screening tools and drug discovery
expertise to help accelerate its progress to produce a viable drug candidate.
As the team conducts research, details are posted online in an 'electronic lab book' that is freely
available on the internet. Alerts then go out via social media whenever new data are added and the
team holds regular open web conferences to ensure everyone is up to speed. Scientists from around
the world can thereby contribute in real-time to help advance compounds. The project has clearly
demonstrated the willingness of scientists to share expertise and data. …
PATH
7 October 2013:
Malaria vaccine candidate reduces disease over 18 months of follow-up in late-stage
study of more than 15,000 infants and young children
Results from a large-scale Phase III trial, presented today in Durban, show that the most clinically
advanced malaria vaccine candidate, RTS,S, continued to protect young children and infants from
clinical malaria up to 18 months after vaccination. Based on these data, GlaxoSmithKline (GSK) now
intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA). The
World Health Organization (WHO) has indicated that a policy recommendation for the RTS,S malaria
vaccine candidate is possible as early as 2015 if it is granted a positive scientific opinion by EMA.
These latest results demonstrated that over 18 months of follow-up, RTS,S was shown to almost halve
the number of malaria cases in young children (aged 5-17 months at first vaccination) and to reduce
by around a quarter the malaria cases in infants (aged 6-12 weeks at first vaccination).
Vaccine efficacy was also assessed separately at each of the trial sites, which represent a wide range
of malaria transmission settings; efficacy was found to be statistically significant at all sites in young
children and at four sites in infants.
Eleven African research centres in seven African countries1 are conducting this trial, together with
GSK and the PATH Malaria Vaccine Initiative (MVI), with grant funding from the Bill & Melinda Gates
Foundation to MVI. …
9 October 2013:
Japanese encephalitis vaccine achieves WHO prequalification, a key step in
expanding access and protecting more children
An affordable vaccine to protect children against deadly Japanese encephalitis (JE) has been
prequalified by the World Health Organization (WHO), paving the way to reach millions more children
across Asia at risk for the disease. The announcement was made today by PATH, a global health
nonprofit organization, and China National Biotec Group Co., Ltd. (CNBG), the leading vaccine
manufacturer in China.
The SA 14-14-2 live, attenuated JE vaccine is the first JE vaccine to be prequalified for use in children
by WHO. This milestone also marks the first time a Chinese vaccine manufacturer has achieved WHO
prequalification. The vaccine is manufactured by Chengdu Institute of Biological Products Co., Ltd.
(CDIBP), a subsidiary of CNBG.
With funding from the Bill & Melinda Gates Foundation, PATH led a series of pivotal clinical trials to
establish the immunogenicity and safety of the vaccine in at-risk children and provided technical and
financial support to help CDIBP meet the international manufacturing standards required for WHO
prequalification. …
22 October 2013:
PATH Malaria Vaccine Initiative names new director
PATH announced today the appointment of Ashley Birkett, PhD, as director of its Malaria Vaccine
Initiative (MVI), which drives the development of safe and effective vaccines for the fight against
malaria. The malaria parasite still kills an estimated 660,000 people each year, most of them children
in sub-Saharan Africa, and half the world’s population remains at risk of contracting malaria. The
announcement was made this morning at Harvard University’s Harvard Malaria Forum, entitled
“Rethinking R&D in the New Era of Malaria Eradication.”
A five-year veteran of MVI, Birkett was most recently the program’s deputy director, serving
simultaneously as director of research and development (R&D)—the latter a position he has held
since joining PATH in 2008. Birkett’s appointment as director became effective earlier this month. …
UPDATE 57: OCTOBER 1 TO OCTOBER 31, 2013
Sabin Vaccine Institute
21 October 2013:
Michael Posner Joins Sabin Vaccine Institute’s Board of Trustees
The Sabin Vaccine Institute today announced the election to its Board of Trustees of Michael H.
Posner, Professor of Business and Society at New York University’s Stern School of Business. For more
than three decades, Mr. Posner has advanced the causes of inclusive global human rights, dignity,
freedom and justice. …
TB Alliance
30 October 2013:
New Collaboration Will Develop, Deliver Needed Childhood TB Medicines. Svizera
Europe and TB Alliance commit to fulfill urgent need
In an effort to develop and deliver treatments for children with tuberculosis (TB)—answering a critical
need in public health today—TB Alliance, a not-for-profit organization with the mission to develop
better, faster-acting, and affordable drugs for TB, has entered into a collaboration with Svizera
Europe, one of the leading global supply and distribution companies for TB treatments. The
partnership aims to create and enable access to new medicines for childhood TB. Tuberculosis is
among the top 10 killers of children and an estimated 500,000 children have TB, but many suspect the
burden could be much higher.
Today, there are no quality-assured medicines available in the formulations recommended by the
World Health Organization (WHO) to treat children with TB. TB Alliance has spearheaded an initiative,
in partnership with WHO and primarily funded by the global health initiative UNITAID, to facilitate the
development and delivery of appropriately dosed, child-friendly formulations of the “first-line” TB
treatment to increase child survival and decrease the emergence of drug resistance. The partnership
between TB Alliance and Svizera should advance these goals. …
RECENTLY RELEASED PDP REPORTS/ BRIEFING PAPERS/ ARTICLES
Articles in Peer Reviewed Journals
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Selection and optimization of hits from a high-throughput phenotypic screen against
Trypanosoma cruzi. Keenan M et al. Future Med Chem, October 2013, Vol. 5, No. 15, Pages
1733-1752
The drug and vaccine landscape for neglected diseases (2000—11): a systematic assessment.
Pedrique B et al. The Lancet Global Health, Early Online Publication, 24 October 2013
Diagnostic accuracy of Loopamp Trypanosoma brucei Detection Kit for diagnosis of human
African trypanosomiasis in clinical samples. Mitashi P et al. PLoS Negl Trop Dis 7(10): e2504.
Other PDP Publications/ Briefing papers
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EVI Annual Report 2012. October 2013.
IAVI Annual Progress Report 2012. October 2013.
Seasonal Malaria Chemoprevention can save children’s lives today. MMV Issues in Focus.
October 2013
Injectable artesunate: A safer, more effective treatment. MMV Issues in Focus. October 2013
RECENTLY RELEASED PDP RELATED REPORTS/ BRIEFING PAPERS/ ARTICLES
Reports/ briefing papers/ books
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Roadmap for childhood TB: towards zero deaths. WHO. October 2013
WHO Global Tuberculosis Report 2013. October 2013
Why Invest in Vaccines. GAVI Website. October 2013
2013 Report on Tuberculosis Research Funding Trends, 2005–2012. TAG. October 2013.
UPDATE 57: OCTOBER 1 TO OCTOBER 31, 2013
PDP RELATED NEWS/ ARTICLES (SINCE OCTOBER 1, 2013)
HIV/AIDS
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TB
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Vaccines
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Clinical
Trials
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Other
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1 October: MA company debuts Dx device that could dramatically speed up HIV,
other tests
3 October: Researchers launch phase II clinical trial of rectal microbicide to
prevent HIV infections
8 October: HIV vaccines elicit immune response in infants
9 October: South Africa: SA offers HIV vaccine research hope
10 October: GeoVax Labs receives notice of allowance for HIV vaccine
16 October: HIV Vaccine trials - where next?
17 October: HIV vaccine raised infection risk
17 October: Microbicide adherence biomarkers, patient uptake challenges focus
of symposium
18 October: Promising HIV vaccine may take 10 years to perfect
23 October: Analysis: How to prepare for an HIV/AIDS vaccine?
Strengthening capacity for AIDS vaccine research: Analysis of the Pfizer global
health fellows program and the international AIDS Vaccine Initiative. Vian T et al.
BMC Health Services Research. 2 October 2013
Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. Hammer S et al. New
England Journal of Medicine. 7 October 2013. DOI: 10.1056/NEJMoa1310566
1 October: First-ever targeted roadmap outlines steps to end childhood TB deaths
1 October: New Tuberculosis Vaccine Developed
23 October: Gains in tuberculosis control at risk due to 3 million missed patients
and drug resistance
Effect of household and community interventions on the burden of tuberculosis in
southern Africa: the ZAMSTAR community-randomised trial. Ayles H et al. The
Lancet, Volume 382, Issue 9899, Pages 1183 - 1194, 5 October 2013
The Global Drug Facility and its role in the market for tuberculosis drugs.
Arinaminpathy N et al. The Lancet, Volume 382, Issue 9901, Pages 1373 - 1379, 19
October 2013
Effect of improved tuberculosis screening and isoniazid preventive therapy on
incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro,
Brazil: a stepped wedge, cluster-randomised trial. Durovni B et al. The Lancet
Infectious Diseases, Volume 13, Issue 10, Pages 852 - 858, October 2013
8 October: New funding for development of mucosal vaccines based on
nanoparticle technology
9 October: Newly accessible Japanese encephalitis vaccine will make saving
children easier in developing countries
17 October: GAVI begins roll-out of cheap HPV vaccine
25 October: Oral cholera vaccine proven effective and safe for five years
29 October: New partnership between GSK and the Bill & Melinda Gates
Foundation to accelerate research into vaccines for global health needs
15 October: EMA launches new database of clinical trial data
22 October: India's Supreme Court mandates videotaped consent in clinical trials
Mapping of available health research and development data: what's there, what's
missing, and what role is there for a global observatory? Rottingen J-A et al. The
Lancet, Volume 382, Issue 9900, Pages 1286 - 1307, 12 October 2013
24 October: GHTC releases new fact sheet on USAID and global health research
UPCOMING MEETINGS
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December 4 2013: EVI Rendez-Vous 2013. Heidelberg, Germany.
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December 5 2013: Best Science for the Most Neglected. Where Do We Stand 10 Years On? DNDi
& Institut Pasteur. Paris. France