Ansley Kahn

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. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing US$34 million into the German biotech company CureVac to develop vaccine “printing” technology that could rapidly manufacture vaccines to treat multiple diseases. Specifically, this funding will help CureVac work on a prototype of its RNA printer product, a transportable automated printing facility for molecules known as messenger RNA (mRNA)—used to transport genetic information from DNA into a cell, instructing it to produce a specific antigen to induce an immune response. As part of this three-year deal with CEPI, CureVac will use its mRNA platform to produce vaccines for Lassa fever, Rabies, and Yellow fever. If preclinical tests are successful, two of the vaccine candidates will be developed through early-stage safety trials in people. As epidemics of infectious diseases can be unpredictable and fast-moving, CureVac’s vaccine platform could help improve our ability to defend against such pathogens. Treating bednets with an antimalarial drug could be a promising new approach to controlling the disease. Although insecticide-treated bednets have been credited with averting 68 percent of all malaria cases since 2000, scientists believe mosquitoes are developing a resistance to pyrethroid, the insecticide predominantly used to treat bednets. Researchers at Harvard University demonstrated that an antimalarial drug can be transmitted to mosquitoes through brief direct contact and effectively halt the transmission of the malaria-causing parasite. In the study, researchers coated a petri dish with atovaquone, a commonly used antimalarial drug. Mosquitoes landed on the treated surface for approximately six minutes and were then fed a blood meal rife with the malaria parasite. Results showed that none of the mosquitoes treated with antimalarial drugs harbored the parasite and demonstrated proof of concept that antimalarial-treated bednets could be a powerful new tool in the fight against malaria. The US Food and Drug Administration has granted Fast Track designation to the Themis Bioscience chikungunya vaccine candidate, which allows the product to receive an expedited agency review given its potential to meet an unmet medical need. Themis hopes this designation will support its phase 3 development efforts for the vaccine, which showed encouraging results in phase 2. Two other chikungunya vaccine candidates have also received Fast Track designation, though the Themis vaccine is the most advanced in development. There are no current treatments or vaccines for chikungunya, a disease for which symptoms include debilitating joint pain.

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. Pregnant and breastfeeding women in Ebola-affected areas in the Democratic Republic of Congo (DRC) will now be able to receive the experimental Ebola vaccine—marking a reversal of a previous World Health Organization (WHO) decision. Due to the severity of the current Ebola outbreak in the DRC, the WHO Strategic Advisory Group of Experts (SAGE) on immunization recommended that pregnant and breastfeeding women should now be included in the vaccination campaign as long as they and their babies are monitored. Pregnant women have historically been excluded from similar immunization campaigns because vaccines against infectious diseases are rarely tested or approved for use in pregnant women. SAGE advised that the use of the experimental Ebola vaccine in pregnant and breastfeeding women should be continuously evaluated based on emerging data on its safety and efficacy—the review of which will inform vaccine recommendations for future outbreaks. For the first time, scientists have begun large-scale releases of genetically modified mosquitoes in a high-security laboratory in Terni, Italy. Using the powerful gene-editing technique known as CRISPR, scientists aim to see if they can eventually help to eradicate malaria by altering a gene in mosquitoes, known as “doublesex,” which impacts sexual development. This alteration causes the mouth of female mosquitoes to resemble that of a male—meaning they can’t bite and spread the malaria parasite—as well as deforms female mosquitoes’ reproductive organs so they cannot lay eggs. As more female mosquitoes inherit these modifications, more and more become sterile, which could eventually crash or drastically reduce populations of the Anopheles gambiae mosquito that spreads malaria. Researchers hope to know within six months whether these modified mosquitoes would be able to efficiently spread their lethal modifications in the wild, though a better understanding of the possible environmental impacts of their existence is necessary before any release would be permitted. Researchers at a half dozen universities are using the genome editing tool CRISPR to try to turn the immune system against viruses for which no vaccine exists. Vaccines work by inducing the immune system’s B cells to produce specific matching antibodies that bind to antigen molecules on a virus, setting the immune system into motion. However, to develop a vaccine, scientists have to identify the exact piece of an antigen that will trigger production of an effective antibody—an often challenging task. Researchers are trying to skip part of this process by instead using CRISPR to directly genetically reprogram B cells to produce the needed antibodies against viruses. CRISPR is used to splice open the DNA of B cells and then a harmless virus is used to introduce DNA for certain antibodies into the cells. The goal is for the cells to repair themselves and then start continuously producing the antibody. While the science still has a long way to go, researchers have achieved some promising early results in reprogramming mouse B cells against respiratory syncytial virus and human cells against HIV.

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.

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.

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. Scientists have discovered the Ebola virus in a Miniopterus inflatus bat in Liberia—marking the first time the virus has been found in a bat in West Africa. Though no human cases of Ebola are linked to this discovery, it is nonetheless a step forward in understanding where human Ebola cases come from—an unanswered question surrounding outbreaks of the virus. Though bats have long been a suspected reservoir for Ebola—meaning the virus can live and grow inside them without harming them—researchers still don’t know what animal or animals carry the virus or how it spreads to people. Notably, the Miniopterus inflatus is an insect-eating bat, whereas most experts say that the natural animal host for Ebola is some type of fruit bat, not one that eats insects. Experts claim more study is required to determine which, if any, bat species are a natural host for the Ebola virus. Researchers are also working to determine whether the virus found in the bat in Liberia is the same exact virus that caused the West Africa Ebola epidemic and the current Ebola outbreak in the Democratic Republic of Congo. Global investment in research and development (R&D) for neglected diseases reached an all-time recorded high in 2017 of US$3.5 billion, a seven percent increase from the previous year, according to the G-FINDER report by Policy Cures Research, which has tracked annual global investment for 11 years. Though the United States remained the largest funder, G-FINDER reported significant increases in funding contributions from other governments—including the United Kingdom, the European Commission, Germany, and India. Notably, despite a record high in funding for neglected disease R&D globally, no country reached the World Health Organization target for member states to spend 0.01 percent of their Gross Domestic Product on research for the health needs of developing countries. A phase 1 human clinical trial has begun for a freeze-dried, temperature stable formulation of a tuberculosis (TB) vaccine candidate. A freeze-dried powder vaccine—which does not require a temperature-controlled transportation system—can be distributed at a lower cost and with reduced logistical burdens, especially in low-resource settings. In this trial, researchers are examining if the vaccine candidate, ID93, and the adjuvant GLA-SE, an immune response-stimulating protein, can be combined into a single vial and remain as effective at inducing an immune response as the previously tested two-vial combination. This recombinant vaccine candidate is being developed as a vaccine that could be administered to people who have already been exposed to TB or those who have received the TB vaccine Bacillus Calmette-Guérin—which is commonly given to babies in TB-endemic regions but does not adequately prevent TB in adolescents or adults. Early stage clinical trials in South Africa and the United States have shown the recombinant vaccine candidate to be immunogenic and safe.