Breakthroughs Blog: NTDs

A Phase 1 clinical trial testing an experimental monoclonal antibody for malaria found that the highest dose of the treatment studied was highly effective in preventing malaria. Researchers from the University of Maryland, Sanaria, the Vital Narrative consultancy, and the Gates Medical Research Institute tested the monoclonal antibody, MAM01, in 37 adults who had never been exposed to malaria, who received either a single dose of varying sizes or a placebo, and then were infected by the bites of infected mosquitoes. None of the three recipients who received the highest dose had malaria parasites in their blood after infection. The monoclonal antibody could prove to be an important treatment option that provides immediate, high-level, and long-lasting protection with just one doseA Japanese research team has isolated natural compounds from marine sponges that demonstrate an ability to kill parasites that cause leishmaniasis, which affects approximately 12 million people around the world. Current treatments are highly toxic, cause serious side effects, and can be prohibitively expensive, leaving patients, particularly in low-income communities, which face a disproportionate burden of leishmaniasis, unable to access or complete treatment. Drug resistance is also complicating leishmaniasis treatment efforts. These findings could guide research into new treatment approaches and could potentially also be applied to other protozoan diseases like Chagas disease and African sleeping sickness. A new CRISPR-based RNA test could help track the parasites that spread Human African trypanosomiasis, or sleeping sickness, which affects around 500 people per year and many more livestock animals. The test can identify parasite species living in an animal’s blood, helping public health workers carry out targeted treatment of infected animals and prevent transmission to humans. This One Health approach to zoonotic or parasitic diseases could also be rolled out to address other diseases, such as Chagas disease or leishmaniasis.  

Last week, French biopharmaceutical company Osivax announced that it received a $19.5 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to further develop its broad-spectrum influenza A candidate vaccine for pandemic and seasonal flu preparedness. The vaccine is designed to target a part of the virus that is highly conserved and less likely to mutate, hopefully offering a broader, more universal immune response, and it has demonstrated promising results in early clinical trials. BARDA’s funding will support ongoing clinical development and large-scale trial and manufacturing preparation, with potential options for future funding to support Phase 2b and scale-up activities. A team of researchers at the University of Nottingham successfully produced antibodies that kill the parasite that causes Chagas disease, an important step toward the development of a much-needed vaccine. Chagas is a serious neglected tropical disease, which causes 56,000 cases and 12,000 deaths every year. The researchers developed antibodies targeting two key proteins in the parasite that were found to be extremely effective at neutralizing the parasite in a crucial developmental phase when it’s capable of infection, which is key for vaccine development.   A University of Maryland research team developed an artificial intelligence (AI) tool that can quickly scan electronic medical records to identify high-risk patients who may be infected with H5N1 avian flu, as this year’s outbreak highlights the need for more robust screening interventions to ensure infections are not going undetected. The researchers used their generative AI large-language model to analyze the records of more than 13,000 adults who had visited the emergency department in Maryland in 2024 for acute respiratory illness and common H5N1 symptoms. With less than half an hour of human input, the model found 76 records that mentioned a lifestyle risk factor for H5N1, 14 of which were confirmed to have a recent exposure to animals that transmit H5N1. The tool highlights the shortcomings of the response to the latest outbreak and offers a potential new tool to help improve surveillance and testing in future outbreaks of H5N1 and other infectious diseases.

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. Last week, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced that it is awarding $3 million to Baxiva to support the development of a vaccine that targets the most common serotypes associated with invasive Escherichia coli infections. E. coli is the leading cause of urinary tract infections around the world and a common cause of neonatal sepsis infections, particularly in low- and middle-income countries. The candidate uses new targets that haven’t been used in other vaccines and targets several bacterial strains. The company’s rapid development platform also enables it to quickly design vaccines targeting various types of bacteria.The Coalition for Epidemic Preparedness (CEPI) last week announced a global collaborative effort to carry out epidemiological and computational modelling projects to help strengthen scientific understanding of the Rift Valley fever and its impact across Africa, helping guide the planning of future clinical trials assessing much-needed vaccine candidates for the disease. Despite major Rift Valley fever outbreaks seen in Africa and beyond and global recognition of the need to boost R&D efforts, there are large gaps in our knowledge about the burden and spread of the disease. The two projects, led by institutions in Kenya and Tanzania and supported by global partners, will assess the impact of the disease across Africa, as well as forecast its future burden, providing crucial data for vaccine developers to plan large-scale trials when the virus is widely circulating.A new study from the University of Alabama at Birmingham demonstrates that an antibody designed to target the dengue virus could also block the spread of the Zika virus, an important finding that could inform the development of much-needed treatments for Zika. There are no approved treatments for Zika, a dangerous virus that can pose severe risks to pregnant people and their babies. In a novel preclinical in vivo model, the antibody helped stop the virus from spreading, particularly in vulnerable parts of the body, leading to improved survival rates.

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. Last week, the Drugs for Neglected Diseases initiative (DNDi) and AN2 Therapeutics announced a new collaboration to advance clinical development of AN2’s oral drug candidate for the treatment of chronic Chagas disease, which can remain asymptomatic for years while the infection wreaks irreversible damage in the body, potentially leading to the development of life-threatening conditions. The drug candidate, AN2-502998, is currently being tested in a Phase 1 first-in-human clinical study, scheduled for later in 2025, with a Phase 2 proof-of-concept study expected to commence next year. The partnership will leverage DNDi’s established network of clinical trial sites throughout Latin America and Spain, established through its previous Chagas clinical trial work.A team of researchers shared last week that they have developed a special kind of floss that could serve as a vaccine delivery method, delivering proteins and inactive viruses to the gums and triggering immune responses that can protect against infectious disease. While scientists have long been investigating alternatives to syringes like oral and nasal vaccine delivery methods, a challenge they’ve come across is that the mouth and nose have naturally tough defenses against foreign molecules. The flossing approach overcomes this challenge by targeting the pockets of gum between the teeth that are better at absorbing molecules. The approach proved successful in mice in multiple tests where researchers coated the floss in protein and inactive flu virus, and researchers have also tested the feasibility in humans, finding positive results. Further research will help determine if the technique will work in humans with a wide variation in gum health, including people with gum disease.Study results presented at the recent International AIDS Society Conference in HIV Science found that more than half of people living with HIV who received a pair of broadly neutralizing antibodies plus the drug N-803 experienced delayed viral rebound or maintained a low or suppressed viral load during interruption from antiretroviral treatment. While antiretroviral treatment can keep HIV suppressed indefinitely, the long-lasting viral reservoir maintained in the body has confounded researchers efforts to eliminate it, putting a cure out of reach. A small proportion of individuals naturally make unique broadly neutralizing antibodies that target key parts of the virus, which researchers have been trying to replicate with a manufactured drug. N-803, which is approved as a treatment for bladder cancer and is being studied in both cancer and HIV research, appears to be able to both reactivate dormant HIV and clear the virus out of hiding. Further research and an analysis across studies testing the approach will help confirm the underlying mechanisms of the effects researchers are seeing and determine whether the drug could be part of a future cure.