Breakthroughs Blog: Ebola

Last week, the Global Health Innovative Technology (GHIT) Fund announced that it has awarded PATH and iBody JPY 99 million to support the development of a diagnostic tool to enable early detection of Nipah and Hendra virus outbreaks in rural and low-resource settings. Nipah and Hendra are high-priority zoonotic viruses with pandemic potential for which there are no specific medical countermeasures available, including diagnostics. Current diagnosis depends on centralized laboratory testing, which is slow, costly, and inaccessible in low-resource settings, which can delay diagnosis, increasing transmission risk and mortality, especially in outbreak scenarios. The partners aim to develop a rapid, point-of-care test that can detect and differentiate infections caused by the two viruses, which could help identify cases and outbreaks more quickly. IAVI, Hilleman Laboratories, SK bioscience, and IDT Biologika recently announced that IAVI has been awarded funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, to advance development of its one-dose vaccine candidate against Bundibugyo virus. Bundibugyo is the rare strain of Ebola virus behind the ongoing outbreak in the Democratic Republic of the Congo (DRC) for which there are no approved specific treatments or vaccines. IAVI will lead clinical and regulatory activities for the candidate, including its potential inclusion in a planned trial in the DRC following Phase 1 evaluation, and then, depending on its continued success, Hilleman Laboratories will support initial manufacturing and technology transfer, SK bioscience will lead manufacturing scale-up, and IDT Biologika will support final manufacturing for stockpiling. The US National Institutes of Health has announced $16.4 million over five years to establish a new center bringing together researchers across research universities and institutions to accelerate hepatitis C vaccine research and development. Chronic hepatitis C infection, which affects around 50 million people globally, can lead to severe disease. While antiviral drugs can successfully cure most infections, gaps in diagnosis, reinfection, and ongoing transmission persist, underscoring the need for a preventive vaccine. The virus has proved a challenging target for vaccine design because it is constantly mutating, making it hard to develop a broadly effective vaccine that can target regions of the virus that remain relatively stable across variants. Researchers from Scripps Research, the National Institute of Diabetes and Digestive and Kidney Diseases, the University of Pennsylvania, and the Oregon National Primate Research Center will collaborate to investigate how the virus escapes immune responses and design vaccine candidates using various platform technologies. The funding will also support the development of an online hepatitis C virus immune response database to inform the center’s work, which will also be made available to the broader hepatitis C vaccine development community to guide other research efforts. 

The Coalition for Epidemic Preparedness Innovations (CEPI) has launched a critical Phase 2/3 clinical trial to evaluate vaccine candidates for the Bundibugyo strain of Ebolavirus, which is responsible for the current outbreak in the Democratic Republic of the Congo and currently has no approved vaccine. The trial will assess the safety, immune response, and efficacy of multiple vaccine candidates in parallel, beginning with Merck’s Ervebo, which is approved for Ebola Zaire, with two Bundibugyo-specific candidates from Moderna and the University of Oxford/Serum Institute of India expected to enter the trial shortly. The organizers hope the trial will help curb transmission and save lives during the current outbreak, while strengthening preparedness for future outbreaks. Weill Cornell Medicine recently announced that it has received a four-year, $8.2 million grant from the National Institute of Child Health and Human Development at the US National Institutes of Health to further development of an experimental on-demand male contraceptive pill that temporarily renders sperm immobile. There is an urgent global need for new contraceptive options for men beyond condoms and vasectomy to enable men to share contraceptive and family planning responsibilities more equally with female partners and reduce the burden that has historically fallen on women. The researchers will now work toward advancing the technology into a Phase 1 trial, developing an oral formulation, setting manufacturing protocols, and establishing safety. A new study from a team of international researchers evaluating experimental methods to improve mRNA vaccine delivery identified a promising needle-free vaccination method, which could offer a new delivery method for mRNA technology, which is continuing to show promise across a range of health areas, as well as reduce unwanted inflammation. The method, which combines a high-pressure liquid jet that delivers mRNA alongside two substances that strengthen the immune response, was able to protect against the viruses that cause COVID-19 and flu in mice. The researchers will now evaluate the method in larger animals and, if it continues to prove successful, in human trials. 

A study from the University of California, San Francisco found that a new long-acting HIV combination treatment could provide an alternative, more accessible option for some people with HIV. Long-acting treatment options can provide a simpler, more convenient alternative to daily pills for people living with HIV, but the only approved long-acting combination includes rilpivirine, which is not available in low- and middle-income countries, and the virus has been known to develop resistance to it and similar drugs. The new combination under study replaces rilpivirine with lenacapavir, which uses a different mechanism to target the virus. In the study, all participants achieved and maintained control of the virus. Additional clinical trials are planned to evaluate the approach more comprehensively, but, in the meantime, these findings could help guide care.  A team of researchers at the Massachusetts Institute of Technology has found a way to keep mRNA vaccines stable at higher temperatures, which could drastically lower costs and improve access to the technology in low-resource settings around the world. mRNA vaccines must be kept at extremely cold temperatures during transport and storage, requiring high costs and continuous monitoring. The researchers adjusted the formulation of the tiny particles that carry the mRNA, making them more resistant to heat. The vaccines the team produced can be stored at room temperature for up to a year or at nearly 100 degrees Fahrenheit for two months. Even after storage, the shots elicited equivalent immune responses in mice to the original formulations.The Medical Research Council/Uganda Virus Research Institute and the London School of Hygiene and Tropical Medicine have launched a Phase 1 clinical trial in Uganda evaluating the safety and immune response of a vaccine candidate for Bundibugyo, the severe strain of Ebolavirus behind the ongoing outbreak in the Democratic Republic of the Congo for which there are currently no licensed vaccines. Conducted in partnership with the Oxford Vaccine Group and Pandemic Science Institute at the University of Oxford, the trial builds on an ongoing Phase 1 trial of the same candidate in the United Kingdom. Both trials are funded by the Coalition for Epidemic Preparedness Innovations (CEPI). The candidate, ChAdOx BDBV, was developed by scientists at the University of Oxford and uses the same platform as the Oxford/AstraZeneca COVID-19 vaccine. 

Recently published results from a large multi-country study found that pooled tuberculosis (TB) testing could greatly reduce costs and boost access to diagnosis. Access to the gold standard of rapid molecular testing is limited—only just over half of people diagnosed with TB in 2024 were first tested using the technology. Instead, they were diagnosed using older technology, which can take weeks to produce results, during which the infection could progress or be transmitted to others. Millions of additional individuals with TB go completely undiagnosed. A major contributing challenge is that rapid molecular testing requires an expensive diagnostic cartridge for each sample. Pooled testing involves testing samples from multiple individuals with one cartridge. Patients are only retested individually if the result is positive. Unlike new diagnostic technologies, like AI-enabled portable X-ray machines, that are promising but would require additional funding to implement, pooled testing could be scaled up rapidly without new funding because it utilizes technologies that many labs already have.Medicines for Malaria Venture (MMV) is advancing the novel, first-in-class antimalarial compound, cabamiquine, into the next stage of clinical development, with the hope that the compound could be part of a single-dose, long-acting treatment for the prevention and treatment of malaria, which could greatly simplify care compared to current options. Cabamiquine was discovered by researchers at the University of Dundee, with financial and scientific support from MMV, and then advanced by Merck to proof of concept. Recently published results from two Phase 2a trials showed that a regimen of cabamiquine and pyronaridine was able to clear uncomplicated Plasmodium falciparum malaria in more than 90 percent of participants and demonstrated a strong safety profile. MMV will now lead Phase 2b clinical development of the compound. The Biomedical Advanced Research and Development Partnership (BARDA) recently announced that it has awarded Scynexis a $214 million contract for the development of an antifungal to treat and prevent invasive fungal infections, the less common but more serious form of fungal infection that penetrates deep into the tissues of the body. Fungal infections are a growing global challenge, but there is a significant gap in the pipeline of new tools to address them. Last year, the company reported positive findings from a Phase 1 trial of an oral dose of the candidate and is currently conducting a Phase 1 trial of an intravenous formulation. The award includes initial funding to advance the company’s antifungal candidate into Phase 2 trial, with an option for additional, longer-term funding.