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Last week, Shionogi announced that its US subsidiary has received a $119 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to boost production and advance development of a key antibiotic, helping improve US preparedness for future outbreaks of drug-resistant bacterial pathogens. Specifically, the funding will go toward the establishment of a US manufacturing site and procurement of cefiderocol, an antibiotic that has the ability to target difficult-to-treat, multidrug-resistant infections, which is already approved for several indications. The award will also fund the development of cefiderocol to respond to high-priority bacterial threats. In a newly published study, a Cornell University research team shared the results of a long-term study that could be a first step toward developing the first safe, reversible, long-acting, and 100 percent effective nonhormonal male contraceptive. In a proof-of-principle study in mice, the researchers targeted a natural checkpoint in meiosis, the reproduction process for sex cells, and were able to safely stop sperm production and, importantly, then recover normal meiosis and complete sperm function, with no impacts on other functions or on offspring. If this approach continues to demonstrate success in further studies, it could eventually be utilized in an every-three-month injection or patch contraceptive product. IAVI recently announced that the first participants have been vaccinated in a Phase 1 clinical trial evaluating the safety and immunogenicity of its investigational vaccine for Marburg virus disease, a highly fatal, high-priority disease, which has been behind a growing number of outbreaks in sub-Saharan Africa in recent years and for which there are no specific approved vaccines. In nonclinical studies, the candidate demonstrated consistently strong efficacy results: a single intramuscular vaccination protected 100 percent against lethal challenge with the virus. IAVI is simultaneously continuing to work with partners in sub-Saharan Africa to ensure the availability of candidate doses for evaluation during future Marburg outbreaks. 

IAVI recently announced the start of a first-in-human clinical trial evaluating a combination injection of four broadly neutralizing antibodies, with the aim of eventually developing a tool to prevent HIV transmission in infants during the postnatal period. The combination shot includes four antibodies that target different HIV receptors, including IAVI’s broadly neutralizing antibody ePGT121v1-LS. The current trial is evaluating safety, dosing, pharmacokinetics, durability, and efficacy in 118 adult participants across the United States and Peru, and, if successful, could pave the way for future studies in infants. A research team has identified a bacterium strongly associated with noma, a potentially fatal infection for which the underlying cause is poorly understood. The researchers used metagenomic sequencing and machine learning algorithms to analyze saliva samples from children with acute noma. They identified a bacterial species that may be responsible for the disease, which was detected in the early stages of infection and does not carry known antibiotic resistance genes, suggesting that infection could be effectively treated with existing antibiotics if detected early enough. These findings also pave the way for the development of diagnostic tools that can detect noma early on, when treatment is most effective and before irreversible damage has been done. Last week, Butterfly Network shared that it received regulatory clearance from the US Food and Drug Administration for its artificial intelligence (AI)-powered ultrasound, offering a critical new tool to improve maternal care in low-resource settings with limited access to prenatal imaging. Compared to traditional ultrasounds that rely on expensive technology, the new device is more affordable and provides results in less than two minutes with fewer inputs. The tool has already been deployed in Malawi and Uganda, and this latest approval will enable its widespread rollout in the United States. 

A new study led by the Harvard T.H. Chan School of Public Health found that Anopheles darlingi mosquitoes, a leading malaria vector in South America, are evolving resistance to insecticides, creating serious challenges for malaria control efforts in the region. Insecticide resistance has only been periodically documented in Anopheles darlingi populations, which have not been heavily targeted with insecticides for vector control, suggesting that some of the resistance may be driven by insecticides used in agriculture. The study is the first to sequence a large number of complete genomes of Anopheles mosquitoes in the Americas, looking at the genomic sequences for more than a thousand mosquitoes across six countries. The research provides a template for additional vector studies and paves the way for future studies that could help inform and improve malaria control efforts and policies to reduce the emergence and spread of dangerous resistant strains of the malaria parasite. Last week, Intelligenome announced that it has been awarded funding through a subaward agreement with Cornell University to develop a rapid, low-cost portable diagnostic test for tuberculosis (TB). The company will contribute its point-of-care testing platform to support the development of a portable, rapid assay capable of detecting TB in non-sputum respiratory and blood samples, which is designed specifically for low-resource settings. This approach integrates a CRISPR-based detection approach. The project is part of a program funded by the US National Institutes of Health aimed at improving access to innovative health technologies.Basilea recently announced that the first participant has been dosed in its first-in-human Phase 1 study of BAL2420, a novel antibiotic designed to treat serious bacterial infections. The antibiotic specifically targets infections, including drug-resistant infections, caused by bacteria in the Enterobacteriaceae family—that includes Escherichia coli and Klebsiella pneumoniae—which are considered high-priority threats for which new treatment options are urgently needed. BAL2420 is part of a novel class of antibiotics with a novel mode of action and has demonstrated promise in preclinical studies. Since 2020, BAL2420’s development has been supported by the Combating Antibiotic Resistant-Bacteria Biopharmaceutical Accelerator (CARB-X).  

A new real-world study found that a recently approved vaccine designed to reduce deadly meningitis in Africa is safe when used at scale. Neisseria meningitidis, or meningococcus, is a bacterium that is the leading cause of bacterial meningitis, a dangerous infection, in Africa. The African meningitis belt, which encompasses 26 countries in sub-Saharan Africa, has the highest rates of meningococcal disease, facing frequent epidemics. Since 2010, the introduction of a vaccine targeting one of the 12 bacterial strains has dramatically reduced meningitis in the region. The newer vaccine targets the five subtypes that are responsible for almost all epidemic meningitis in the region, and it was shown to be safe in a study analyzing data from more than 4.8 million people vaccinated during outbreak response campaigns in Nigeria and Niger in 2024. A research team has developed a breath-based test for diagnosing bacterial infections that showed promise in early studies in mice, which could eventually offer a non-invasive, portable, and quick alternative to the current toolbox of blood tests, imaging, cultures, and molecular diagnostics that can be slow, non-specific, and expensive. The researchers were inspired by a breath test for Helicobacter pylori, which works by a patient drinking a liquid containing traceable substances metabolized by H. pylori and then exhaling into a device that measures the components of their breath, indicating if an infection is present. Aiming to develop a breath-based test for a broader range of infections, the team developed a prototype using sugar and sugar alcohols tagged with a traceable form of carbon that bacteria metabolize but is not harmful to human cells, analyzing the breath using a simple technique. A team of researchers has designed a vaccine that turns mosquitoes into delivery vehicles to immunize bats against rabies and Nipah virus. Bats host a wide range of dangerous pathogens, which are increasingly spilling over into human and livestock populations. Researchers have previously tried testing experimental vaccines on captive bats, but the vaccines haven’t worked as effectively in the wild. Culling bat populations is another way to reduce disease transmission, but this can cause disruption to the ecosystem and can inadvertently heighten virus transmission by increasing human exposure. The new method involves an experimental vaccine that is delivered via the saliva of mosquitoes, which is transferred when bats eat the mosquitoes or the mosquitoes feed on the bats, directly targeting the natural reservoirs of these viruses to prevent spillover transmission.