Breakthroughs Blog: Medicines

Last week, Cepheid announced that its Xpert Hemorrhagic Fever Panel test has received Emergency Use Listing from the World Health Organization, enabling the technology to be deployed to help identify suspected cases and support outbreak containment in the rapidly growing outbreak of Bundibugyo Ebola in the Democratic Republic of the Congo. The molecular panel test detects and identifies Ebola virus (multiple strains, including Bundibugyo), Crimean-Congo hemorrhagic fever, Marburg virus, and Lassa virus, providing results in around an hour. The test runs on Cepheid’s GeneXpert diagnostic technology system, which is already widely used across Africa, helping enable rapid implementation. Cepheid previously donated an initial shipment of tests cleared by the US Food and Drug Administration through the Department of War, and the new listing now enables further deployment. A Phase 2 clinical trial led by the Serum Institute of India found that an experimental monoclonal antibody for dengue virus was safe, well-tolerated, and provided evidence of efficacy in a Phase 2 clinical trial. Dengue affects more than 200 million people each year and is a growing global threat due to the expanding range of the virus-carrying mosquito species. There are several licensed vaccines for dengue but no licensed antiviral drugs. The experimental antibody previously neutralized all four serotypes of dengue virus in animal studies and demonstrated safety in a Phase 1 trial in healthy adults. Researchers at the National Institutes of Health (NIH) have discovered rare antibodies that could inform the development of a therapeutic or preventive intervention for alpha-gal syndrome, an emerging tick-bite-associated condition behind a growing number of cases in the United States and globally, which can lead to allergic reactions to a molecule in red meat and other animal products. The discovery was made through malaria research—the scientists were originally trying to find antibodies that could target alpha-gal (a sugar molecule) on malaria parasites as a potential strategy for malaria prevention. In laboratory tests, the rare antibodies successfully hindered human allergic antibodies from binding to red meat allergens. There are currently no specific treatments or preventions for alpha-gal syndrome.

Last week, the US Food and Drug Administration (FDA) approved Moderna’s flu vaccine for older adults, making it the first licensed mRNA flu shot. The approval follows objections raised by FDA earlier this year that put the future of the application in question. Compared to traditional influenza vaccines, mRNA vaccines can be produced much more quickly, allowing public health experts to wait longer before selecting strains to target for the upcoming flu season, increasing the likelihood that the vaccine will match the strains actually circulating. Beyond regular flu season, faster vaccine production and the approval of this seasonal shot could help speed up the development and approval of a pandemic flu vaccine. FDA specifically issued a standard approval for the vaccine for adults between 50 and 64 and an accelerated approval for adults 65 and older—Moderna has agreed to do a post-licensure trial to gather more data on effectiveness in this group. The company expects some doses will be available ahead of the upcoming flu season. The results of a Phase 3 clinical trial published in the New England Journal of Medicine last week showed that a once-weekly oral HIV treatment maintained viral suppression as effectively as a standard daily treatment regimen, pointing to a potential new treatment alternative for people living with HIV. This option could increase convenience for patients taking daily pills and doesn’t require the regular clinical visits associated with long-acting injectable options, especially for patients who experience stigma or have other health conditions requiring treatments to manage. The study regimen consisted of a once-weekly combination tablet containing islatravir and lenacapavir, which was evaluated in adults whose HIV had remained suppressed for at least six months through a daily regimen across 12 countries. The first participant has been dosed in a first-in-human trial of Moderna’s vaccine candidate against Bundibugyo, the strain of Ebola behind the deadly ongoing outbreak in the Democratic Republic of the Congo, which has now become the second-largest Ebola outbreak in history. There are currently no vaccines or treatments available for Bundibugyo Ebola. The vaccine candidate, mRNA 1469, uses Moderna’s mRNA platform, which is also used in the company’s COVID-19 vaccine. The Coalition for Epidemic Preparedness Innovations (CEPI)-supported trial is being conducted at three Canadian sites among healthy adult volunteers to assess the safety and tolerability of the candidate and evaluate immune response. If the vaccine candidate successfully advances to approval, Moderna has committed to working with CEPI to urgently make doses available to low- and middle-income countries at accessible prices.

Last week, the Merck-Wellcome joint venture Hilleman Laboratories announced that it will manufacture doses of a promising vaccine candidate for the Bundibugyo strain of Ebola, which is behind the worrying outbreak in the Democratic Republic of the Congo. There are no specific vaccines or treatments available for Bundibugyo, so global partners have worked rapidly to advance candidates into testing since the declaration of the outbreak. Hilleman Laboratories will manufacture doses of IAVI’s single-dose vaccine candidate, which uses the same vaccine platform as Merck’s approved vaccine for the more common Zaire strain of Ebola and has been identified by the World Health Organization as the most promising candidate currently in development. The lab expects to be able to produce tens of thousands of doses to be used in early-stage trials, potentially by the end of this year. Alveo Technologies is partnering with the University of Texas Medical Branch to develop a molecular point-of-care diagnostic test for Lassa fever, a hemorrhagic illness endemic in parts of West Africa for which access to laboratory testing is limited. Improving access to reliable, point-of-care testing could greatly improve Lassa control in endemic regions, as well as limit its potential to spread more widely—the virus has been designated as a dangerous pathogen with pandemic potential. The diagnostic test will be evaluated at clinical sites in Nigeria and Sierra Leone. The partners are also collaborating on field testing of Alveo’s diagnostic platform for avian influenza surveillance in Peru. The Global Antibiotic Research & Development Partnership (GARDP) announced last week that the Thai Food and Drug Administration has approved zoliflodacin, a first-in-class, single-dose, oral antibiotic for gonorrhea treatment, marking the drug’s second global approval. Zoliflodacin, developed as part of a public-private partnership between GARDP and Innoviva Specialty Therapeutics, was approved earlier this year by the US Food and Drug Administration. Beyond the potential of this innovative treatment to help address the rising global threat of antibiotic resistance, the rapid follow-up approval of the drug beyond the high-income market also represents an important step toward ensuring expedited global access to innovative new antibiotics.

Interim study findings that will be presented at this week’s AIDS 2026 conference show that a new, once-weekly antiretroviral combination pill for HIV seems to be effective and well tolerated, with comparable results to currently available daily pills. The findings are from two ongoing large, multi-country Phase 3 trials comparing the new combination pill to current treatment options. The new combination treatment has the potential to greatly simplify HIV treatment for patients and health care providers by reducing treatment frequency—and potentially cost—which could help improve access and adherence. A new study in humans suggests that Merck’s Ervebo vaccine, which is licensed for the Zaire strain of ebolavirus, could offer some protection against the Bundibugyo strain of ebolavirus, fueling a growing number of calls to evaluate Ervebo in a clinical trial in the Democratic Republic of the Congo (DRC), the site of the rapidly expanding outbreak of Bundibugyo, for which there are no licensed vaccines. The World Health Organization has so far prioritized evaluation of Bundibugyo-specific vaccines, but the few in development are still months away from clinical trials in the DRC. A trial of Ervebo could provide some protection to people at risk in the outbreak sooner, since there is an international stockpile of Ervebo doses. The Africa Centres for Disease Control and Prevention is planning a trial that would test a two-dose vaccine regimen of Ervebo and an experimental vaccine targeting Sudan Ebola in health workers. Last week, IAVI and Biofabri announced that their Phase 2b clinical trial of tuberculosis (TB) vaccine candidate MTBVAC has reached full enrollment. The trial is evaluating the safety and efficacy of MTBVAC in preventing active TB disease in adolescents and adults with latent TB infection, as well as an additional cohort of participants who have never been exposed to TB infection, across 16 clinical research centers in South Africa, Kenya, and Tanzania. The current TB vaccine is more than 100 years old and provides incomplete protection in young children and does not prevent TB disease in adolescents and adults. MTBVAC, which is single-dose and well-suited for use in remote locations, could be a game-changer for TB control.