Breakthroughs Blog

Amid the ongoing outbreak of the Bundibugyo strain of Ebola—for which there are no specific approved vaccines or therapies—in the Democratic Republic of the Congo and Uganda, the World Health Organization (WHO) has collaborated with outside experts to identify priority Ebola treatments and vaccines for clinical trials. On the treatment side, WHO recommended prioritizing Mapp Biopharmaceutical’s MBP134, Regeneron’s maftivimab, and Gilead Sciences’ antiviral remdesivir. For prevention, Gilead's experimental oral antiviral obeldesivir was highlighted as a priority for post-exposure use in contacts of confirmed cases. IAVI’s rVSV Bundibugyo was identified as the most promising vaccine candidate, but Oxford University and the Serum Institute of India’s ChAdOx1 Bundibugyo vaccine candidate could be available for testing sooner following additional animal testing. WHO is now working with authorities in Congo and Uganda and other partners to design and implement ethical clinical trials during the outbreak. An experimental drug for chronic hepatitis B could potentially serve as a functional cure for the virus, as demonstrated in recently published results from two international studies. For many, hepatitis B only causes short-term illness, but for some, it can become a chronic infection, gradually damaging the liver and, without treatment, leading to liver cancer, liver failure, or even death—it causes around 1.1 million deaths globally each year. Chronic infection requires lifelong therapy in the form of daily pills to reduce viral levels and prevent liver damage, which can be hard to adhere to or access in some countries. Bepirovirsen, developed by GSK and Ionis Pharmaceuticals, was able to reduce the virus in around one in five patients to levels low enough for the immune system to keep it under control without treatment. The drug is under fast-track review by the US Food and Drug Administration, which is expected to make a decision later this year, and is also being considered by international regulators in Japan, China, and Europe. A research team at Georgia State University has developed a promising antiviral drug candidate that could help treat measles, croup, and related viral diseases that cause contagious and life-threatening respiratory infections, as falling coverage of the vaccine for measles, mumps, and rubella raises the risk of infection. The drug, GHP-88310, was designed to be a once-a-day oral pill for vulnerable patent groups, like children and immunocompromised patients, which make up the majority of croup and measles cases. GHP-88310 has been shown to be well-tolerated in rats, mice, ferrets, and dogs at higher concentrations. 

Last week, the Global Health Investment Corporation announced the launch of the Global Health Security Fund, which will strategically invest in companies to accelerate the development of technologies that strengthen global health security. The investments will focus on companies developing vaccines, therapeutics, diagnostics, and enabling technologies with impact and commercial potential, addressing critical gaps in global health preparedness and response. The fund has received support from the US Biomedical Advanced Research and Development Authority (BARDA), as well as investors including the Coalition for Epidemic Preparedness Innovations (CEPI), Flu Lab, Eli Lilly and Company, Meiji Seika Pharma Co., The MITRE Corporation, and the Wisconsin Alumni Research Foundation. A research team at the La Jolla Institute for Immunology has shared promising research that could inform the development of a vaccine that provides protection against a host of viruses in the arenavirus family. Arenaviruses, which are most common in West Africa, are considered to be a viral family with significant pandemic potential and are very similar to hantaviruses, the virus family behind a current worrying outbreak, in how they spread and function. The researchers demonstrated how harnessing T cells could be critical to designing vaccines that can combat many different species of virus at once, an approach that could be applied to other viral families as well. BARDA is working with US-based company Mapp Biopharmaceutical to supply its experimental Ebola treatment for potential use in people who may have been exposed in the current outbreak of Bundibugyo ebolavirus, a strain for which there are no specific vaccines or treatments available. Mapp’s investigational monoclonal antibody treatment was developed through a longstanding public-private partnership supported by BARDA to address Ebola Sudan, which is closely related to other ebolaviruses, Laboratory studies suggest the treatment has the potential to be effective against the Bundibugyo strain. 

Preeclampsia affects millions of pregnancies around the world, claiming the lives of 42,000 women each year and contributing significantly to fetal and newborn mortality and complications. Early detection and management are crucial to prevent progression to eclampsia, which is characterized by seizures and can be life-threatening.  The burden of preeclampsia is greatest in low- and middle-income countries (LMICs), where workforce shortages, limited laboratory capacity, and procurement challenges undermine the implementation of recommended tools and protocols.  Despite its global impact, preeclampsia remains under-researched and under-represented in the health innovation pipeline compared to conditions with similar prevalence that are not specific to women. These challenges have created critical gaps in screening, diagnosis, and treatment, but new tools in the pipeline could help transform care, particularly in low-resource settings worldwide. Rethinking preeclampsia screening and diagnosis Preeclampsia screening aims to identify high-risk pregnant women before symptoms appear and before they can be formally diagnosed, enabling closer monitoring and preventive care. Screening has traditionally relied on a checklist to evaluate patient history and risk factors. While simple, this approach has shown limited effectiveness and depends heavily on the accuracy of assessment.Newer recommended approaches that combine risk-factor screening with biomarker testing offer improved predictive performance. However, they require medical and laboratory imaging infrastructure that is not widely available in LMICs, limiting their uptake.  Preventive therapies, including low-dose aspirin, calcium supplements, and antihypertensive medications, are recommended for women identified as high risk, but they are not consistently offered to women in LMICs. As a result, many women are diagnosed later in pregnancy, when risks are greater.  The Accelerating Innovation for Mothers project identified 89 preeclampsia risk screening tools in the R&D pipeline but concluded current approaches are unlikely to adequately address the needs of women in LMICs, underscoring the need for greater investment in tools explicitly designed to address their realities.  Artificial intelligence (AI) is emerging as a promising tool to bridge screening and diagnosis gaps. With support from the Gates Foundation, Siemens Healthineers is developing an AI-driven tool that leverages data from blood tests already routinely performed as part of prenatal care to screen for both preeclampsia and anemia. By using existing samples and integrating screening for multiple conditions, this tool could enable more efficient and scalable screening in resource-limited settings. Confirmatory preeclampsia diagnosis relies on detecting elevated blood pressure and the presence of protein in urine, alongside the potential presence of severe symptoms. This requires trained health care workers and access to laboratory equipment, which can hinder accurate, timely diagnosis in resource-challenged environments. Monod Bio, with Gates Foundation support, is developing a rapid, point-of-care diagnostic test that can deliver results in less than 15 minutes. Using an AI-derived algorithm to analyze results, this tool could significantly reduce workforce and equipment needs. Together, these innovations reflect a promising shift toward designing tools specifically to address the needs of low-resource environments, rather than adapting tools used in high-income contexts, a shift essential to closing global gaps in care. Expanding the treatment pipeline There is currently no specific cure for preeclampsia other than early delivery, which can be dangerous for both mother and baby, especially in low-resource settings. Existing treatments focus on managing symptoms, including preventing seizures with magnesium sulfate and controlling blood pressure with antihypertensive medications. A new generation of therapies aims to go further by addressing underlying disease causal pathways, rather than managing symptoms alone.  A research team at the University of Nebraska Medical Center, supported by a Gates Foundation grant, is advancing an innovative treatment based on a naturally occurring compound that reduces the levels of a protein that plays a key role in the development of preeclampsia. In preclinical studies, the compound has improved vascular function, reduced inflammation, and lowered blood pressure. Importantly, it is also stable at room temperature and inexpensive to produce, making it well-suited for settings with limited resources. Another Gates-supported team at the Medical College of Wisconsin has launched a clinical trial evaluating a promising supplement for preeclampsia. The compound, which occurs naturally in foods, has been shown to improve vascular functions in animal models and early human studies. It is also shelf-stable and inexpensive. These novel therapeutics could help transform preeclampsia care by slowing or halting the progression of the condition, rather than simply responding to the presence of symptoms. Their affordability and suitability for austere settings could also help expand access for women who currently lack effective treatment options. Looking ahead Preeclampsia mortality rates remain far too high, reflecting long-standing gaps in research advancing women’s health and a lack of tools suited to low-resource settings. Innovations that leverage emerging technologies like AI and respond to the needs of pregnant women everywhere could help save more mothers and babies worldwide. Solutions designed for LMIC health systems could also strengthen care in underserved or overstretched settings in high-income countries like the United States, where rising health care costs, workforce shortages, and even conflict-related supply chain disruptions are straining health care service delivery.  Turning this potential into impact will require sustained investment to ensure innovations are not only developed but designed for and delivered to the women who need them most. 

Last week, SC Johnson; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and the US Department of State announced a new agreement to accelerate access to an innovative malaria vector control tool in high-burden countries. This marks the second such partnership between the State Department, the Global Fund, and a US company to expand global access to new products under the department’s global health strategy, after one with Gilead for lenacapavir for HIV prevention. This initiative will scale up the SC Johnson Guardian™ spatial repellant tool, a small mesh fabric sealed inside a pouch that is hung indoors, releasing an active ingredient that repels mosquitoes for up to a year. The tool was recommended by the World Health Organization last year, the first new category of vector control products to be recommended in 25 years. The partners aim to reach 60 million people across ten-high burden countries with 30 million products over three years, with manufacturing based in Nairobi, Kenya. A new observational study found that even with only moderate levels of malaria vaccine coverage achieved, the initial introduction of the RTS,S/AS01 malaria vaccine in high-burden African countries has contributed to a significant reduction in deaths among children. Specifically, despite only moderate uptake of three doses and low uptake of the fourth, the vaccine was found to have saved the lives of one in eight eligible children in the first three African countries to offer the vaccine from 2019-2023, which represents a 13.2 percent reduction in death. These results add to the evidence supporting continued scale-up of RTS,S—one of two malaria vaccines now included in national immunization schedules in 25 sub-Saharan African countries—and underscore the promise of continued investment in developing new and improved malaria vaccines. Nonprofit Caring Cross has shared an early copy of data showing that, in a small study, a single infusion of engineered immune cells suppressed HIV long term in several patients, offering proof-of-concept for a single-shot functional cure. The approach, adapted from cancer research, involves extracting immune cells from participants living with HIV, engineering the cells to carry molecules that simultaneously kill infected cells and prevent the immune cells from becoming infected, and injecting them back into participants. HIV is notoriously hard to control because the virus persists in hard-to-eliminate latent reservoirs, requiring lifelong ongoing treatment to suppress the virus.  This research could pave the way for the development of a single, low-cost intervention that could sustain viral suppression without the need for regular therapy. The research, which is still in the very early stages, is scheduled to be presented at an upcoming scientific conference.