TOKYO, JAPAN (September 16, 2014)--The Global Health Innovative Technology Fund (GHIT Fund), a new public health partnership that is bringing Japanese know-how and investment to the global fight against infectious diseases, today announced seven grant investments totaling US$15.3 million to speed the development of promising drugs and vaccines to battle three insect-borne diseases--malaria, dengue and Chagas disease. The announcement marks the GHIT Fund's third round of grant investments since November 2013--totaling $33.5 million--aimed at diseases that sicken and kill the world's poorest of the poor.
"Still breathless from global efforts at elimination, today the world confronts a disturbing reemergence of infectious disease that knows no borders. In response and recognition, today we announce a total portfolio of 29 partnerships representing over $33 million in investments. This portfolio is a testament to our commitment to investing in the health of the more than 4 billion people who battle daily against infectious diseases," said Dr. BT Slingsby, CEO of the GHIT Fund.
Grants were awarded to the following partnerships for dengue, malaria and Chagas disease:
- $3.45 million to KAKETSUKEN (Japan); Center for Vaccine Development at the Institute of Molecular Biosciences at Mahidol University (Thailand)
Chagas Disease Vaccine
- $2 million to Sabin Vaccine Institute (USA); Baylor College of Medicine (USA); Eisai Co., Ltd. (Japan); Aeras (USA)
- $0.76 million to PATH Malaria Vaccine Initiative (USA); Ehime University (Japan)
- $1 million to European Vaccine Initiative (Germany); Research Institute for Microbial Diseases at Osaka University (Japan); Centre National de Recherche et de Formation sur le Paludisme (Burkina Faso)
- $3.8 million to St. Jude Children's Research Hospital (USA); Eisai Co., Ltd. (Japan); Medicines for Malaria Venture (Switzerland)
- $1.3 million to Medicines for Malaria Venture (Switzerland); Takeda Pharmaceutical Co., Ltd. (Japan)
- $3 million to Broad Institute (USA); Eisai Co., Ltd. (Japan)
Preventing Symptomatic Dengue
The GHIT Fund will invest $3.45 million in the pre-clinical development of a Dengue tetravalent combination vaccine in partnership with KAKETSUKEN and Mahidol University. The investment will support assay validation and dose ranging efficacy studies in non-human primates using optimally attenuated strains confirmed through ongoing screening studies.
Dengue is mosquito-borne and one of the most widespread tropical diseases. Before 1970, nine countries had experienced severe dengue epidemics, according to the World Health Organization. Today, it is endemic in more than 100 countries and infects up to 100 million people annually. An estimated 500,000 people are hospitalized, and many tens of thousands die each year--a large proportion are children. The grant investment will fund development of a tetravalent vaccine that contains all four serotypes of the virus to protect children and adults.
Developing an Effective Vaccine for Chagas Disease
The grant investment for $2 million to the Sabin Vaccine Institute, in collaboration with Baylor College of Medicine, Eisai Co., Ltd. and Aeras, will fund technologies being developed to advance a vaccine to treat Chagas disease, which is vector-transmitted by insects often dubbed "kissing bugs." Chagas disease kills more people in Latin America than any other parasitic disease. More than 7.5 million people are infected globally, many unknowingly, leading to a lack of treatment which can cause severe heart damage and intestinal problems, the greatest cause of death and disability from Chagas. The overall goal of the project is to develop a new vaccine formulation that includes a novel adjuvant, a critical component of a future vaccine that aims to halt or delay Chagas' heart complications, potentially preventing at least 10,000 deaths annually.
New Tools to Defeat Malaria
The GHIT Fund also invests $10 million in the research and development of two malaria vaccines and three malaria drugs. Malaria kills more than 600,000 people every year, most of them young children in sub-Saharan Africa. Though great progress had been made over the past decade in reducing malaria deaths, challenges such as resistance to insecticides and malaria medicines pose growing concerns. To control malaria and move toward eliminating and eradicating the disease, new drugs and vaccines are urgently needed. The GHIT Fund's investments support five potential new tools in this global effort.
Malaria Vaccines Critical to Eliminating Malaria
A first malaria grant investment goes to the PATH Malaria Vaccine Initiative (MVI) and Ehime University for $766,000 to fast-track the research and manufacture of a novel malaria vaccine candidate called Pf75. This new vaccine approach--called a transmission-blocking vaccine--is targeted at blocking malaria parasite transmission from humans to mosquitoes. The transmission-blocking vaccine―to be used along with currently available interventions, such as bed nets, insecticide and antimalarial drugs―is essential to eliminating malaria. The project addresses one of the main challenges in developing malaria transmission-blocking vaccines--that is that very few potential target antigens aimed at interrupting transmission have yet been developed. GHIT investment will enable the partnership of MVI and Ehime University to streamline Pf75 product development as a vaccine candidate for clinical studies with pre-specified stage-gate for each developmental phase.
A second malaria grant investment of $1 million related to the development of a malaria vaccine has been made to a consortium involving the European Vaccine Initiative (EVI), Germany; the Research Institute for Microbial Diseases at Osaka University (RIMD), Japan; and the Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Burkina Faso. The project has the goal to clinically test in children in Africa a novel malaria vaccine candidate intended to protect them from the disease. The vaccine candidate, called BK-SE36, would primarily target young children, who account for most malaria deaths. The project follows up on promising results of a previous clinical trial in Uganda by conducting a new trial in Burkina Faso, where the vaccine candidate will be tested in younger children, aged 0-5 years, generating more safety and efficacy data. In addition, partners will conduct a follow-up study on Japanese men that previously had been immunized with the vaccine containing a different "adjuvant," a substance that enhances a person's response to the vaccine. The grant follows a $750,000 GHIT investment in 2013 for the development of the newly adjuvanted BK-SE36.
Faster, Stronger and Longer-lasting Malaria Drugs
A third $3.8 million grant investment in St. Jude Children's Research Hospital's partnership with Eisai Co., Ltd. and the Medicines for Malaria Venture (MMV) will go toward developing a novel drug that is fast-acting and safe, has a long duration of action and can potentially block transmission/prevent relapse with just one dose. The goal is to develop the fastest, safest antimalarial drug for use in disease endemic regions. Its fast-acting compound, SJ733, which would likely be combined with another key drug component, is not artemisinin-based, thus it is not at risk for emerging resistance to existing malaria medicines.
A fourth $1.3 million grant investment in the Medicines for Malaria Venture (MMV) in partnership with Takeda Pharmaceutical Co., Ltd. is awarded for the study of the effects of a new malaria drug candidate DSM265 as part of a combination therapy. This follows up on an investment from GHIT to the partnership in 2013, which allowed the acceleration of the first-in-human studies, and an innovative new volunteer study which confirmed the activity of DSM265 in humans. The new study builds on these data, and will establish whether DSM265 has the potential to be part of a single-dose antimalarial cure when combined with other investigational new medicines. This drug combination therapy is aligned with the World Health Organization's recommendation that malaria be treated with a combination of effective antimalarials to reduce the development of drug resistance.
A final $3 million grant investment for malaria research was awarded to the Broad Institute and Eisai Co., Ltd. The research will focus on further evaluating a series of previously identified compounds in order to identify the best candidate for clinical trials. One of the study's goals is to identify potential oral therapeutics that could cure malaria rapidly and prevent relapses by blocking transmission of the parasite.