Breakthroughs Blog: Ebola

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 new study explores the novel use of artificial intelligence (AI) to screen for antimicrobial compound candidates that could be developed into new tuberculosis (TB) drug treatments, as the rise of drug-resistant strains of TB underscores the urgent need for new drug candidates. While discovering new TB drug candidates through traditional laboratory methods is laborious and time-consuming, sensitive machine learning is better and faster at helping interpret complicated images of the Mycobacterium tuberculosis bacterium, accelerating TB research capabilities and helping identify optimal candidate compounds for drug development.A COVID-19 nasal vaccine will enter a Phase 1 clinical trial conducted by the National Institute of Allergy and Infectious Diseases in the United States this spring. While COVID-19 cases have fallen dramatically since the height of the pandemic, the virus continues to circulate and cause severe illness and death. The nasal vaccine is designed to induce strong immunity in the nose and upper respiratory tract where the virus enters the body, aiming to not only reduce serious illness and death but also to stop transmission in the first place, which cannot be achieved through COVID-19 vaccines that are injected into the body. If proven successful, the technology could also be adopted for other common respiratory viruses, including seasonal influenza, avian flu, and respiratory syncytial virus.Uganda recently launched a trial of IAVI’s experimental vaccine targeting the Sudan virus, which causes Ebola disease, following the identification of an outbreak in the country that has, so far, killed one person and infected two others. There are no currently approved vaccines for Sudan virus, although there is a vaccine for the Zaire strain of Ebola, highlighting the urgent need to generate data about vaccine candidates in the pipeline when outbreaks arise. Ugandan health authorities and research teams have rapidly jumped into action to prepare for the trial—2,160 doses of the trial vaccine and treatments arrived in Uganda’s capital, Kampala, over the weekend.

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 Wednesday, the World Health Organization (WHO) announced that it had prequalified a point-of-care assay that can help guide the treatment of Plasmodium vivax malaria. The assay, developed by SD Biosensor and PATH, detects glucose-6-phosphate dehydrogenase deficiency, which can lead to severe anemia in patients taking certain drugs to treat P. vivax malaria. This designation aims to improve access to the diagnostic in countries facing a high burden of malaria, enabling improved treatment for patients. The announcement arrives shortly after WHO prequalified two drugs for the treatment of P. vivax malaria last month.Researchers at the University of Minnesota and the Midwest Antiviral Drug Discovery Center have developed the first nanobody-based inhibitors targeting the Ebola virus, a deadly pathogen with a fatality rate of about 50 percent. Nanobodies are small antibodies derived from animals that can penetrate areas of viruses and human tissues that larger antibodies cannot reach, providing protection against infection. The team, which previously developed nanobodies to target COVID-19, found promising results for their nanobodies in lab tests in Ebola-infected mice. If this research continues to be successful, it could pave the way for treatments not only for Ebola but also for other viruses in the same family, including Sudan ebolavirus and Marburg virus.Last week, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced $2.6 million in funding to Clarametyx Biosciences to develop an anti-biofilm vaccine that could help prevent serious bacterial infections and mitigate the rise of antibiotic resistance. Specifically, the funding will support the further development of the company’s pathogen-agnostic vaccine candidate designed to prevent the formulation of bacterial biofilms, which are protective layers that bacteria use to shield themselves from antibiotics and the immune system, therefore allowing the body’s immune system to clear infections without the use of antibiotics. Hard-to-treat bacterial infections associated with biofilms are estimated to be responsible for up to 80 percent of bacterial infections and are known to contribute to the emergence of antibiotic resistance.

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) announced the prequalification of Bavarian Nordic’s MVA-BN vaccine for mpox, the first-ever vaccine for the virus on the prequalification list. Prequalification status is anticipated to facilitate timely and increased access to the vaccine, helping to contain the current outbreak on the African continent by accelerating procurement by governments and international agencies and enabling national regulatory authorities to fast-track additional approvals. The vaccine has been licensed for use in people 18 years and older with a two-dose schedule given a month apart. However, the WHO Strategic Advisory Group of Experts has specifically recommended the use of the vaccine for people at a high risk of exposure in the context of an outbreak; thus, the vaccine has been used in infants, children, adolescents, and pregnant and immunocompromised people. It has also recommended single-dose use to stretch limited supplies while also urging the need to collect additional data about the vaccine’s safety and efficacy in these circumstances.Last week, Gilead published new results from the highly anticipated PURPOSE 2 trial, the second Phase 3 study of its twice-yearly, long-acting drug for HIV pre-exposure prophylaxis (PrEP), lenacapavir. The trial showed that the drug was able to reduce HIV infections by 96 percent compared with background HIV incidence and was 89 percent more effective than Gilead’s already available PrEP drug, Truvada. The study, which included more than 3,000 cisgender men, transgender men and women, and gender non-binary individuals aged 16 and older across seven countries, was unblinded early to offer lenacapavir to all patients in the study. This news follows the exciting results from the PURPOSE 1 trial of the drug in cisgender women and adolescent girls, which demonstrated 100 percent efficacy and was also unblinded early. Lenacapavir is currently available for use alongside other agents in patients with multidrug-resistant HIV, which make up only 2 percent of adults living with HIV, but, if approved for additional populations, the drug could be available as soon as 2025 and could be a game-changer for the HIV epidemic. Emergent BioSolutions last week announced that the Biomedical Advanced Research and Development Authority (BARDA) awarded the company a $41.9 million research and development option to its existing ten-year contract to further the development, validation, commercialization, and scale-up of the company’s monoclonal antibody treatment for Ebola virus infection. The treatment, Ebanga, was initially developed by Ridgeback Biotherapeutics with support from BARDA and was approved by the US Food and Drug Administration as a single infusion for the treatment of Ebola Zaire virus infection in 2022. The award is part of BARDA’s broader strategy to support treatments that can be deployed during virus outbreaks.

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.