Breakthroughs Blog: NTDs

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. A team led by US Food and Drug Administration researchers last week published findings suggesting that three vaccines, already approved and stored in the Strategic National Stockpile, targeting earlier H5N1 clades that circulated in the early 2000s could provide some cross-neutralizing antibodies against the currently circulating 2.3.4.4b clade, which continues to infect dairy herds and some farm workers across the United States. Federal officials are already implementing a plan to produce 4.8 million doses of an updated vaccine targeting the current clade, with the first doses expected to be delivered this month, but, before being administered to people, the shots would still need to get regulatory approval. These new study results offer hope that the old vaccines could provide some protection if there is a need to start vaccinating humans before the updated vaccines become available.Recently published results from a Phase 2 clinical trial conducted in Sudan by the Drugs for Neglected Diseases initiative and the Institute of Endemic Diseases at the University of Khartoum found promising results for a new and improved treatment for people with post-kala-azar dermal leishmaniasis (PKDL), a serious condition that can develop after treatment for visceral leishmaniasis. The current treatment for PKDL is an injectable drug given for two to three months, which can cause life-threatening toxicity and must be administered under close supervision in a hospital. The new treatment is safer, shorter, cheaper, more effective, and more patient-friendly, only requiring patients to be admitted to the hospital for 14 days followed by an oral treatment that can be completed at home, offering hope of a new and improved tool for PDKL for affected populations, like in Sudan where nearly 20 percent of patients treated for visceral leishmaniasis will develop PKDL within six months post-treatment, the highest rate worldwide.The Sabin Vaccine Institute and the Makerere University Water Reed Project recently launched a Phase 2 clinical trial testing Sabin's vaccine against Sudan ebolavirus, which can cause deadly disease, as seen in the recent outbreak in Uganda that ended only last year. Although Sabin’s vaccine was one of three candidates chosen to be included in a trial during the outbreak, the outbreak ended before the trial could begin. The vaccine candidate, which is based on the same platform as Sabin’s Marburg vaccine candidate that is already undergoing its own Phase 2 trial, was found to be safe and elicit rapid, robust, and long-lasting immune responses in Phase 1 clinical and nonclinical studies. There is currently no approved vaccine for Sudan ebolavirus.

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. On Friday, the World Health Organization (WHO) released its updated Bacterial Priority Pathogens List 2024, which aims to guide investments and R&D in new antibiotics and promote international coordination to address the rising global threat of antimicrobial resistance (AMR). The updated list, which incorporates new evidence and expert insights, includes 15 families of antibiotic-resistant bacteria grouped into critical, high, and medium categories for prioritization based on their burden and ability to resist treatment and spread resistance to other bacteria. Five pathogen-antibiotic combinations were removed from the new list and four new combinations were added, reflecting the dynamic nature of AMR.Last week, WHO authorized a second vaccine for dengue, which will hopefully offer millions more worldwide protection against the mosquito-borne disease, which is currently behind a major outbreak in the Americas and rising cases globally. The two-dose vaccine, made by Takeda, protects against the four types of dengue and is recommended for use in children between six and sixteen years old in regions with high dengue rates. The decision opens the door for donors and other United Nations agencies to purchase the vaccine for high-burden countries.Last week, the US Food and Drug Administration approved the use of self-collected samples with Roche and BD’s HPV tests, a decision that hopefully will expand access and reduce barriers to HPV screening, allowing more people to detect and treat cervical cancer. Screening for HPV is used to identify those who may be at risk of developing cervical cancer, most cases of which are caused by persistent HPV infection. Traditional screening involves a speculum-involved pelvic exam to screen for cervical cancer, which can be painful or uncomfortable for many patients. Self-collection allows patients to collect their own vaginal samples for screening in a health care setting.

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 Global Health Innovative Technology (GHIT) Fund awarded a two-year grant to the Drugs for Neglected Diseases initiative (DNDi) and its partner Mitsubishi Tanabe Pharma Corporation to continue lead optimization work on a novel compound to target the Trypanosoma cruzi parasite that causes Chagas disease, a neglected parasitic disease that affects an estimated 6 million people globally every year. Current treatments for Chagas, which were developed decades ago, need to be administered for eight weeks, can have serious and potentially toxic side effects, and have not been proven effective in people with severe chronic symptoms. The partners hope their work will lead to preclinical development candidate compounds and, eventually, a new medicine for Chagas disease that is safe and effective for all patients, including pregnant individuals.Researchers have developed an experimental vaccine that has the potential to protect against a broad range of coronaviruses, including known and as-of-yet-unknown varieties. The experimental vaccine was made by taking harmless proteins shared across different coronaviruses and attaching them to minuscule nanoparticles that are then injected to prime the body’s immune system to broadly target both known and unknown viruses in the same family. The vaccine induced a broad immune response to coronaviruses in mice, including to the pathogen that caused the 2003 Sars outbreak, even though proteins from that virus were not added to the vaccine. If proven safe and effective in humans, this and other proactive vaccines designed to target separate pathogens could be stockpiled by countries along with clear plans to quickly scale up production if a new pandemic-potential pathogen emerges. The universal vaccine can be made in existing facilities for microbial fermentation, and the researchers are already working with industrial partners on how to scale up production. There would need to be new processes designed with medical regulators before approval because there are no current procedures for the regulation of proactive vaccinology.Last Monday, the Biomedical Advanced Research and Development Authority announced the launch of the next generation of its accelerator network, which will include a diagnostics and medical devices program and a therapeutics hub. The former will be called the International Consortium for Research, Engineering, Acceleration of Technology Excellence and will support the development and acceleration of new diagnostics and medical devices aimed at improving health security. Along with three more hubs expected to be announced later this year, these hubs will create a global network to foster the growth of the health security innovation ecosystem, including support across the entire process, from development and evaluation to validation and commercialization of new technologies.

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. As the dengue outbreak in Latin America has continued to grow and the threat of dengue continues to rise globally due to climate change, better and cheaper vaccines are on the horizon but are unlikely to be available soon enough to address the current crises. Currently approved vaccines for dengue include one expensive two-shot regimen and one that can only be given to people who have already been infected. A new, single-dose vaccine designed to target all four strains of the dengue virus, which was created by the US National Institutes of Health and licensed for development by the Brazilian Instituto Butantan, provided strong protection in a Phase 3 trial. The institute plans to submit the vaccine to Brazil’s regulatory agency for approval within the next few months, and if approved, the institute could start producing tens of million doses next year. Merck also licensed the vaccine technology and is developing a related vaccine for the rest of the world but has yet to test it in a clinical trial. In the meantime, the Brazilian government bought global supply of Takeda’s Qdenga vaccine, which, at a steep per-dose price, will provide some protection during the current outbreak. Takeda’s vaccine has also been licensed to an Indian generic drugmaker, but a slow start-up process means that is unlikely to be available before 2030.Pfizer recently announced that its RSV vaccine demonstrated the potential to protect adults between 18 and 50 at high risk of severe illness in a late-stage clinical trial, offering the promise of a tool to protect a far broader population against the virus that not only causes thousands of hospitalizations and deaths among older Americans and hundreds among infants every year but also can also cause severe illness in younger adults with weakened immune systems or underlying chronic conditions. Abrysvo is currently approved in the United States and elsewhere for adults 60 and older and expectant mothers. Pfizer announced plans to submit the final results from the trial for expanded approval of Abrysvo, although a timeline for submission has not yet been disclosed. Last fall, GSK released late-stage trial data demonstrating that its RSV vaccine could protect adults between 50 and 59 years old, and the US Food and Drug Administration is expected to make its decision on that vaccine in June.A research team from the Centre for Clinical Microbiology at University College London has developed a new method for testing tuberculosis (TB) that would allow lower-resourced laboratories in low- and middle-income countries (LMICs) to process samples safely, with the method primarily aimed at use for monitoring drug treatment response and clinical trials. The World Health Organization recommends monthly treatment monitoring with sputum culture to ensure patients are adhering to treatment to reduce the emergence of multidrug- or rifampicin-resistant TB, but monitoring with culture is often unavailable or incredibly slow in LMICs. The new method cuts out the need for a culture; uses common instrumentation available in most laboratories, even in LMICS; does not have high energy requirements; and takes only three or four hours to return a result. The method is already being used in clinical studies.