Breakthroughs Blog: Research Roundup

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Johnson & Johnson announced that it will share detailed information on its clinical trials through Yale University’s Open Data Access Project. This will include data on all Johnson & Johnson medical devices, diagnostics, and drugs approved since the beginning of 2014. "An open data movement is really gaining momentum," according to Dr. Victor Dzau, president of the Institute of Medicine, however "we need to develop a culture that supports data sharing, and we need to provide incentives and develop trust." The European Medicines Agency, which regulates drug approvals in Europe, is also contributing to the open data movement, and plans to publish detailed data for all new drugs approved by the agency. The Japan Times took an in-depth look at the Global Health Innovation Technology Fund (GHIT), a Tokyo-based member of the Global Health Technologies Coalition and a partnership between the Japanese government, five major pharmaceutical companies, the Bill & Melinda Gates Foundation, and the United Nations Development Program. GHIT seeks to promote the research and development of treatments for infectious diseases by subsidizing the costs for biotech companies and facilitating partnerships between the private and public sector. The Fund has contributed to the development of 30 drugs since its establishment in 2013, including several neglected tropical diseases such as leishmaniasis, schistosomiasis, and dengue fever. The ONE blog identified five major, deadly diseases for which vaccines are currently being developed. The blog highlights challenges to development and provides updates on leading vaccine candidates for HIV and AIDS, Malaria, Tuberculosis, Ebola, and cancers, including liver cancer caused by hepatitis C.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Kathy Neuzil, director of Vaccine Access and Delivery at PATH, reflects on the lessons learned from Meningitis Vaccine Project (MVP) in light of the achievement of its final milestone: World Health Organization prequalification of an infant version of the meningitis A MenAfriVac® vaccine. MenAfriVac® was approved for people aged 1 to 29 years in 2010, and has since been used to effectively protect 215 million people in sub-Saharan Africa. Neuzil attributes MVP’s success to the tenacity of its team and the inclusion of country partners at every stage from product development to distribution. A new type of antibiotic may be the key to treating drug-resistant infections, according to a study published in Nature last week. The antibiotic, teixobactin, was extracted from dirt, and fights infections by targeting the fatty molecules that bacteria use to build their cell walls. While most antibiotics target the bacteria’s DNA, which can be easily mutated, the study’s lead researcher, Kim Lewis, believes it would take at least 30 years for the fatty molecules to mutate and thus develop resistance to teixobactin. The antibiotic has been successfully tested on mice with no side effects, and could be available for use in humans in five to six years. Johnson & Johnson has started human trials of an experimental Ebola vaccine in the United Kingdom, and hopes to expand testing to approximately 2,000 people by mid-February. Johnson & Johnson has produced over 400,000 courses of the vaccine and has invested significantly in the Danish pharmaceutical company Bavarian Nordic to develop a booster shot to enhance the efficacy of the vaccine and to promote long-term protection against Ebola. Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), sat down with Ryan Hohman of Friends of Cancer Research last week to discuss hot topics in FDA drug policy. Hamburg affirmed the FDA’s commitment to expediting research and development of new treatments, stating that in this “critical time for biomedical research and innovation” the FDA has a role to play in “translating all of the exciting new discoveries and opportunities and science into real world products that matter for people.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Independent examined what’s known about the effectiveness of an experimental Ebola treatment involving blood transfusions from survivors of the virus to current patients. The treatment—known as passive immunotherapy—was first tested by doctors in 1995 during an outbreak in what is now the Democratic Republic of Congo. Of the eight patients who received blood transfusions, only one died, while the rest recovered completely, a 12.5 percent mortality rate during an epidemic with an 80 percent mortality rate. While some researchers argue these results make a case for wider use of passive immunotherapy, others note that very little is known about the efficacy and safety of the treatment, particularly in the current epidemic. The race to develop an Ebola vaccine is gaining momentum. The results from the first African trials of an Ebola vaccine—which ended in 2010—were published last week. The US National Institutes of Health had used knowledge gained from these trials to develop a more potent vaccine candidate, which recently completed Phase 1 trials and will begin Phase 2 trials in West Africa early this year. Another vaccine candidate, developed by NewLinks Genetics Corp and Merck & Co., is undergoing trials in Geneva and has been granted US$30 million from the US Biomedical Advanced Research and Development Authority for further testing. Mitchell Warren, executive director of AVAC, highlights some of the advancements in HIV prevention research that will be forthcoming this year. In the first quarter of the year, results from the FACTS001 study—which is looking at the effectiveness of tenofovir antiviral gel in preventing HIV transmission before and after sex—will be announced. Results from two other microbicides trials are also expected to be released in late 2015 or early 2016. This year, an AIDS vaccine trial will begin in South Africa which will follow up on 2009 vaccine trial in Thailand which demonstrated some level of protection against HIV. It was a strong year from drug approvals at the US Food and Drug Administration. The agency approved 41 new drugs in 2014, a 52 percent increase from the 27 approved in 2013, and the highest count since 1996. Approximately 40 percent of the new medicines approved were for rare diseases, which highlights the industry’s focus on this research area for which the competition is limited and the cost per patient is high. Kat Kelley is GHTC's Senior Program Assistant.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. According to a recent study out of Oxford University, rapid evolution of the HIV virus is slowing the virus’s ability to cause AIDS. In this study of 2,000 women in South Africa and Botswana, researchers found that the HIV virus had evolved to adapt to a specific gene known as HLA-B*57, which provides some protective effect against HIV, slowing the progress to AIDS. As the virus has adapted to reduce this protective effect in individuals, the virus has also reduced its ability to replicate, making it less virulent over all. Last Thursday, the UN Secretary-General launched his synthesis report for the sustainable development goals. In this report, Secretary General Ban Ki-moon reaffirmed his support for the 17 goals and 160 targets proposed by the United Nations Open Working Group, despite concerns from some member states that the current list is too long. Of the 17 proposed goals, two contain targets related to the research and development of new technologies. Researchers are developing a powdered form of the measles vaccine which could make it easier and safer to deliver the vaccine to people in developing nations. The current FDA-approved measles vaccine is a live virus that has been freeze-dried into a powder, which requires reconstitution with water before being administered via syringe. The new vaccine under development is a powder that can be inhaled. This new formulation would eliminate the need for sterile water and needles, as well as cold-chain storage. A modified regimen of the HIV vaccine candidate RV144 was shown to be safe and capable of inducing a robust immune response in safety trials in South Africa. RV144—which was developed by the US and Thai military—showed early promise in clinical trials, but it was found to lose efficacy over time. This new regime is the same earlier RV144 vaccine regime with an added booster shot one year later. Further clinical trials of this new regime are set to begin in South Africa in early 2015.