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Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. On Friday, February 15, President Trump signed into law a spending bill covering funding for State & Foreign Operations (SFOPs) for fiscal year (FY) 2019. The bill provides US$8.8 billion to the overall Global Health Programs account at the State Department and US Agency for International Development (USAID), which is a $150 million increase from the FY18 enacted level and $2.1 billion above the President’s FY19 request. Funding for all global health programs at the State Department and USAID either increased or remained flat compared to the FY18 enacted level and were also well above the President’s budget request. The World Health Organization (WHO) is working to contain an unprecedented outbreak of Lassa fever in West Africa, which has killed 59 people in recent weeks. This Ebola-like virus is transmitted to humans via exposure to contaminated rate urine and droppings, as well as from person-to-person. Although Lassa fever is endemic in parts of West Africa with outbreaks occurring yearly, health officials have confirmed at least 275 cases in Nigeria—the epicenter of the outbreak—since the beginning of the year. WHO has expressed concern regarding the high number of cases so early in the Lassa fever season, which is due to last another four months. Controlling Lassa fever is a challenge because its symptoms can be vague, such as headaches and chest pain, making the disease difficult to diagnose, and there is no licensed vaccine yet available. To contain the current outbreak, WHO is forming a regional coordination mechanism to share, process, and evaluate information regarding suspected cases and is also intensifying public awareness efforts about how to deter rats. In experimental studies conducted in mice, an antibiotic drug called AN12855 was shown to be more effective against tuberculosis (TB) than isoniazid, one of the standard treatments available. The new drug demonstrated both a much lower tendency to develop resistance, and it remained in the tissues where the bacteria that causes TB resides for longer, thus killing the bacteria more effectively. Further studies are required to determine if these outcomes will translate to improvements in treatments for humans. Current treatment for TB can range from six months to more than a year; thus, researchers are working to develop new drug regimens that shorten and simplify treatment.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email.Over the next three years, Wellcome has committed to provide the Drugs for Neglected Diseases initiative (DNDi) more than £10 million to develop new oral treatments for leishmaniasis, a parasitic disease transmitted by the bite of a sandfly that affects over one billion people worldwide and causes tens of thousands of reported deaths each year. Until now, DNDi’s leishmaniasis research and development efforts have focused mostly on improving existing treatments, which can involve toxic drugs and often long, painful treatment courses. Bernard Pécoul, executive director of DNDi, said he is hopeful this new collaboration will enable DNDi to “radically overhaul the treatment landscape, by developing entirely innovative oral drugs that are safe, effective, affordable, and easy to administer.” Scientists at the Fred Hutchinson Cancer Research Center constructed an atlas of HIV mutations that they believe could aid researchers working to develop an effective vaccine. One of the challenges to developing vaccines against HIV is the virus’ ability to mutate in order to evade broadly neutralizing antibodies released by the immune system. Mutations can occur in the virus’ “envelope,” a protein layer that shuttles the virus into host cells and interacts with antibodies. Using a deep mutational scanning technology, researchers created a library of viruses with all the possible mutations that occur in the gene that encodes HIV’s envelope protein, and then by testing those against broadly neutralizing antibodies, were able to observe how each mutation affected the virus’ ability to escape the immune response. With more research, the scientists were able to pinpoint the structural area that contributed to the antibodies’ ability to block HIV. Broadly neutralizing antibodies remain a focus of HIV research, though drug makers have had limited success in developing vaccines focused on the viral envelope. Scientists at M.I.T., Harvard, and Novo Nordisk have developed a device capable of delivering medicines made of molecules too large to be absorbed through the stomach or intestines, such as insulin, without injections. Inspired by the angled shape of a leopard tortoise’s shell, which helps the tortoise roll onto its feet no matter which way it falls, the Soma device is designed to predictably land on the stomach wall after being swallowed. Within the device is a small post containing an insulin needle held in place by a thin disc of sugar. After five minutes, the disc dissolves and the post is cued to painlessly inject the insulin into the wall of the stomach, where it is able to enter the bloodstream. The device then travels through the colon and is eventually eliminated by the patient. The Soma device has proven to work in rats and pigs though more safety testing is required. Researchers hope to start testing this device in humans in three years and hope that it can be used for an array of injectable drugs.

On February 5, President Trump delivered his second State of the Union address. Among the long list of policy proposals and pledges in the speech was one of great interest to the global health research community—an announcement of a new whole-of-government plan to eliminate HIV transmission in the United States by 2030. Though just a few sentences long, this announcement hinted at a much-anticipated budget increase for HIV and AIDS efforts and linked the feasibility of this goal to “scientific breakthroughs”—many driven directly by US government investments in research for new tools to diagnose, treat, and prevent HIV and AIDS. As the President put it, “In recent years we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once-distant dream within reach. My budget will ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years. We have made incredible strides. Incredible. Together, we will defeat AIDS in America. And beyond.”Though the announcement and the associated plan released shortly thereafter by the Department of Health and Human Services (HHS) is squarely focused on eliminating HIV transmission within the US, the wording of the statement and a subsequent editorial published in the Journal of the American Medical Association penned by key agency officials both connect to international efforts and reference advances in HIV research and product development supported by the US government.At this moment of excitement—a “once-in-a-generation opportunity,” as Alex Azar, HHS Secretary, put it in the release of the plan—it is worth noting how our “chance to end the HIV epidemic for the next generation” is based on decades of patient, bipartisan commitment by the US government to advancing our understanding of HIV and AIDS and our ability to diagnose, treat, and prevent it through the development of cutting-edge tools.As the AIDS crisis was growing in the 1980s, NIH research led to the development of the first screening tests to detect the virus in the blood supply and the first antiretroviral treatment, AZT. Later, NIH research led to strategies to prevent maternal-to-child transmission, improved combination therapies, and the discovery that antiretroviral therapies could be used to prevent and treat the disease—research that was foundational to the development of pre-exposure prophylaxis (PrEP). CDC research has expanded our understanding of the epidemiology of the disease, improved prevention and treatment programs, and supported the development of a novel diagnostic that can, for the first time, identify whether an infection is recent or longstanding to improve contact tracing.While many don’t associate the Defense Department with health research, the US Military HIV Research Program has been on the forefront of the battle against HIV to both protect US troops and reduce the global impact of the disease. The program supported a large-scale HIV and AIDS vaccine trial in Thailand that was the first to show that a safe and effective HIV vaccine is possible and continues to advance HIV vaccine research. The US Agency for International Development (USAID), in addition to funding the implementation of the President’s Emergency Plan for AIDS Relief (PEPFAR) programs in nearly 100 countries, has also supported HIV vaccine research, as well as the development of microbicides to reduce transmission among women—including a microbicide-based vaginal ring. The US Food and Drug Administration has also played a crucial role in ensuring the availability of HIV treatment and prevention tools for those in need globally. The agency operates a program to facilitate the “tentative approval” of antiretroviral drugs for purchase by PEFPAR programs and recently launched a pilot program with the World Health Organization (WHO) to expedite the review of HIV drug applications through WHO’s prequalification program.The progress we have achieved through sustained whole-of-government investment in HIV research is astounding, but a need for new and improved HIV and AIDS prevention and treatment tools, including a vaccine, remains. As President Trump said, we can end the HIV epidemic—through both the scale-up of existing interventions and continued investment in the development of new tools. Even a cursory glance at the history of HIV and AIDS shows that every new product developed for treatment or prevention has both increased our ambition to end the epidemic and fundamentally altered our approach. We cannot know for certain that the tools we have in hand today are the most effective we will ever have, so our continued commitment to discover the next game-changer must ramp up in tandem with our efforts to expand access to existing interventions.While the President’s pledge to end HIV and AIDS in the US and his acknowledgement of the importance of scientific breakthroughs is encouraging, his past actions have failed to match this rhetoric. In 2017 and 2018, the administration proposed the elimination of HIV and AIDS vaccine and microbicides funding at USAID and deep cuts to NIH and CDC programs that fund HIV research. As the President prepares to release his fiscal year 2020 budget request, we hope it will include the resources necessary to realize the goals of this welcome pledge, including strong funding for the programs which develop and deliver the tools needed to end AIDS domestically and globally. This is an area of historically bipartisan consensus that offers a rare but important chance at this moment of divided government for Congress and the administration to work together to achieve a bold vision: defeating AIDS in America—and beyond.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email.In what is being heralded as an “enormous breakthrough” in the fight against malaria, scientists for the first time have successfully sequenced DNA from a single mosquito. Previous DNA models have been comprised of a patchwork of dozens of mosquitoes due to the difficulty of sequencing an insect that small in size. This advancement will enable scientists to create a full, high-quality picture of a mosquito’s genetic sequence—enabling researchers to study how mosquitoes spread disease, adapt to insecticides, and reproduce. This could help inform approaches to vector and malaria control. The Drugs for Neglected Diseases initiative and Medicines for Malaria Venture (MMV) launched the Pandemic Response Box, which offers researchers free access to 400 diverse compounds to be used for screening against infectious and neglected diseases to accelerate development of new treatments for life-threatening pandemic diseases. In return for free access to these compounds, researchers are expected to publish their findings in an open access journal two years following data generation—encouraging transparency and collaboration in drug development research. Timothy Wells, Chief Scientific Officer at MMV noted, “The hope is that these efforts will contribute to the discovery and development of next generation therapies to manage a future pandemic as well as existing threats such as the Zika virus and Ebola.” An experimental Ebola treatment, mAb114, passed an early stage human clinical trial, according to a study in The Lancet. Developed by the National Institute of Allergy and Infectious Diseases Vaccine Research Center, mAb114 prevents Ebola from infecting human cells by “tying itself to the core receptor binding domain of its surface protein.” The experimental vaccine is currently being offered to Ebola patients in the Democratic Republic of Congo as part of a phase 2/3 clinical trial, with an additional phase 1 trial planned to take place in Africa. The vaccine has the potential to make combating Ebola outbreaks quicker and easier as it is not restricted to freezer storage—reducing the logistical burden of transport.