Breakthroughs Blog: Research Roundup

Sino Biological, Inc. recently announced an effort to accelerate the development of critical research tools to support the global scientific community in advancing Nipah virus research, as new cases of the deadly pathogen have raised international concerns. Sino Biological has launched a series of proteins, which researchers can use in the lab to better understand how the virus infects cells and how to design antibodies that might successfully target the virus. These proteins are based on the currently circulating Nipah virus strains, so could help boost the accuracy and relevance of research efforts. There are currently no approved vaccines or specific antiviral treatments for Nipah, underscoring the importance and urgency of research and development efforts to advance vaccines and therapies. Newly shared results from the first blinded, randomized non-inferiority trial comparing one versus two doses of HPV vaccine show that a single dose provided similar protection to the two-dose schedule. These results verify a previous study, which undergirded the World Health Organization’s 2022 recommendation of the lower-dose regimen, which has since led to its adoption by almost 90 countries. The lower-dose regimen can help boost access and uptake of the HPV vaccine by reducing the cost and complexity of vaccination for public vaccine procurers, health care providers, and patients. Specifically, the researchers found that a single dose was 97 percent effective against HPV infections in a large study with 20,000 participants, who were studied for up to five years post-vaccination. Last week, the Drugs for Neglected Diseases initiative (DNDi) announced a new memorandum of understanding with the African Population and Health Research Center aimed at helping translate African-led research into transformative innovations and health policies. Specifically, the agreement involves coordination to promote joint research, advance evidence-based programming and policymaking, and facilitate capacity-building. The memorandum also outlines collaborative commitments to ethical, value-enhancing data-sharing activities, including generating high-quality evidence and creating a robust system to preserve and share findings. 

The Coalition for Epidemic Preparedness Innovations (CEPI) is providing $30 million to support the collaborative development of an updated Ebola vaccine, enhancing global preparedness against this deadly health threat. The updated vaccine will build on Merck’s vaccine, which has a complex and expensive manufacturing process that is vulnerable to supply chain disruptions, as well as logistical challenges, including an ultra-cold storage requirement, which is unsustainable in remote, low-resource settings that have a higher likelihood of outbreaks. The partners will update the current manufacturing processes, hopefully lowering costs and making the vaccine easier to manufacture and store. The reduced production costs are expected to enable Merck to make the vaccine available in low- and middle-income countries at a more affordable price. The updated vaccine will be compared against the current vaccine in a Phase 3 trial, also funded by CEPI. A new study led by the University of Cambridge suggests that mpox may be capable of spreading asymptomatically, meaning that transmission may be more widespread in Africa than previously thought. The researchers analyzed blood samples from 176 healthy adults with no known exposure or history of infection in Nigeria, which has experienced intermittent outbreaks of the virus for decades. At least five participants had mpox antibodies in their blood, suggesting recent infection, but none of them reported any symptoms. These findings will inform how public health authorities track the spread of the virus, which has been behind several major outbreaks in recent years. This research also underscores the urgent need for improved vaccines and other tools for mpox. ENABLE-2, an antibiotic drug development engine backed by the Swedish Research Council and the National Research Programme on Antibiotic Resistance, is supporting the Global Antibiotic Research & Development Partnership (GARDP) to develop a novel class of antibiotics. The researchers plan to use an innovative approach by targeting a specific protein complex that bacteria use to strengthen their outer membrane. The ultimate goal of the work is to develop a new treatment for priority antibiotic-resistant bacterial pathogens. GARDP also aims to ensure the new treatment can be made accessible globally, including in low- and middle-income countries, which face a particular threat from antibiotic resistance. 

Last week, the Global Antibiotic Research & Development Partnership (GARDP) and Debiopharm announced a new partnership to advance the development of Debio1453, a novel, first-in-class antibiotic targeting Neisseria gonorrhoeae, as rising cases and the continued spread of multidrug-resistant strains have turned gonorrhea into a growing health challenge globally. Almost all the antibiotics used to treat gonorrhea caused by N. gonorrhoeae have been rendered ineffective due to antimicrobial resistance, with the bacteria now beginning to develop resistance to the last remaining effective treatment. If successful, this drug candidate could help revive the critically lacking pipeline of new antibiotics, one of many new drugs that will be needed to ensure that innovation can outpace the rapid emergence of antibiotic resistance.  Sedia Biosciences announced last week that the World Health Organization (WHO) has granted prequalification status for its rapid, oral HIV test, enabling global procurers to buy the test and ensure widespread access to the technology. The single-use test, which detects antibodies to HIV-1 and HIV-2 in as little as 20 minutes, is intended for health care providers to be able to use at the point of care in resource-limited settings. Beyond its rapid readout time, the test is less invasive, complicated, and painful than blood testing because it uses oral fluid (saliva), making it simpler and more tolerable for patients. With support from the Coalition for Epidemic Preparedness Innovations (CEPI), the Serum Institute of India and the University of Oxford are partnering to create the largest-ever reserve of an investigational vaccine for Rift Valley fever, against the backdrop of a deadly ongoing outbreak and the threat of future outbreaks of the disease, for which there are no licensed human vaccines. The Serum Institute will manufacture up to 100,000 doses of the University of Oxford’s ChAdOx1 RVF candidate, which is among the most advanced investigational vaccine candidates in the pipeline. Ten thousand doses are set to be used in a planned clinical trial of the candidate in outbreak-affected areas, while the remaining doses will serve as a reserve available for clinical testing during future outbreaks. 

GSK has shared the results of two highly anticipated Phase 3 studies investigating its potential “functional cure” for chronic hepatitis B, which affects more than 250 million people worldwide and is a leading cause of liver cancer. The drug bepirovirsen was found to be safe and more effective than the current standard of care in the studies, which included more than 1,800 patients across 29 countries. Bepirovirsen was also found to be capable of achieving a “functional cure,” defined in the studies as no hepatitis B surface antigens (a marker of active infection) detectable in the blood and no detectable genetic material from the virus for at least 24 weeks after treatment ends. The drug, if successfully approved, has the potential to transform treatment for people with chronic hepatitis B. Last week, IAVI announced that the first doses of experimental HIV vaccine antigens were administered in a Phase 1 trial designed to advance a new strategy for HIV vaccine development. Researchers from IAVI and Scripps Research are investigating the hypothesis that highly specialized vaccine immunogens, delivered in a specific sequence, can target critical cells in the immune system and train them to produce broadly neutralizing antibodies against HIV, which scientists widely agree could provide broad protection against the virus. The trial will take place at six clinical sites in South Africa, carried out by a group of African clinical research centers. A team of researchers led by the University of Virginia has shared findings that could transform the treatment of sepsis, the leading global cause of death, in Africa. With a research grant from the US National Institutes of Health, the scientists followed patients with HIV-related sepsis in eastern Africa for five years. They found that the most common cause of sepsis was tuberculosis and that immediate treatment, even before tuberculosis diagnosis, significantly improved survival rates. The findings show that this strategy of immediate tuberculosis treatment could save lives, as well as underline the need for more accurate rapid diagnostic tests for tuberculosis.