Hannah Sachs-Wetstone

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 Gates Foundation, the Novo Nordisk Foundation, and Wellcome announced the launch of the Gram-Negative Antibiotic Discovery Innovator, a new $50 million effort to boost the discovery of new antibiotics for gram-negative bacteria as the global threat of antimicrobial resistance continues to rise and there remains a lacking pipeline of novel antibiotics. The effort will function as a consortium, where multiple funders, research institutions, and industry partners share data and work collectively. Specifically, the project will focus on the discovery of direct-acting small-molecule antibiotics with broad-spectrum activity against Enterobacteriaceae, with Klebsiella species selected as the pathogen to be used in all proposed projects.An innovative, one-dose vaccine designed to offer high-level protection against malaria could transform global malaria efforts if proven effective in further studies. The Sanaria® PfSPZ-LARC2 Vaccine, designed by Sanaria and the Seattle Children’s Research Institute’s Center for Global Infectious Disease Research, uses advanced genetic engineering to delete two critical genes from the malaria parasite, ensuring that the parasite cannot advance to the blood stage and that the vaccine cannot cause or transmit disease. A pivotal study published last month demonstrated the remarkable potential of this approach, and clinical trials are scheduled for later this year.Last week, the Coalition for Epidemic Preparedness Innovations (CEPI) announced $5 million in funding to Ethris to support proof-of-concept research of spray-dried RNA vaccines that remain stable at room temperature and are suitable for mucosal delivery, an approach that could make these vaccines more accessible in low-resource settings and faster to roll out during outbreaks. The spray-drying technique is widely used for other health technologies and applying it to RNA vaccines helps minimize dependence on cold storage and complex delivery systems, especially in low-resource settings. Nasal delivery medicines are also well-established but used with RNA vaccines, this approach could also support their ability to remain stable and could help to offer mucosal immunity, which scientists believe can help reduce virus transmission.

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. On World Neglected Tropical Diseases (NTDs) Day last week, the Global Health Innovative Technology (GHIT) Fund announced that it is investing $12.7 million across eight projects to further the development of new technologies to help address NTDs and a range of other diseases. Specifically, the funding aims to further the development of new diagnostics and drugs for leishmaniasis, dengue, malaria, Lassa fever, Rift Valley fever, Ebola, and Marburg, which is being led by various global product development partnerships and companies, including Medicines for Malaria Venture, PATH, and the Drugs for Neglected Diseases initiative.   Newly published research led by the global collaborative endTB project found three new safe and effective drug regimens to treat tuberculosis (TB) resistant to rifampin, the most effective first-line TB antibiotic currently available. These findings help expand the toolkit of treatments for patients with drug-resistant TB in the face of rising resistance globally, offering regimens that are shorter, less toxic, and do not require injections compared to currently available options. The new regimens use two drugs, bedaquiline and delamanid, which have been in use for just over a decade, in combination with older medications. The trial, launched in 2017, involved hundreds of patients across seven countries, including populations often excluded from clinical trials: children, people infected with HIV or hepatitis C, and women who became pregnant while on treatment, ensuring these groups are not excluded from new treatment recommendations.A recently published study found that a prophylactic antibody-based immune therapy protected monkeys against severe disease caused by H5N1 avian influenza, as the outbreak in the United States continues to cause concern. The broadly neutralizing antibody targets a relatively stable region of the virus and is therefore less prone to losing its efficacy than antibodies targeting viral structures that are prone to mutate, helping to ensure that the protection conferred by the therapy can withstand the possible emergence of virus variants. If proven successful in further studies, the therapy could be used to prevent severe disease in at-risk populations and protect first responders and other health care providers in the early stages of an outbreak, and more broadly, this research helps set the stage for the development of medical countermeasures in the case of future outbreaks of influenza.

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 $729,000 to Immunartes to develop a monoclonal antibody designed to prevent infections caused by Staphylococcus aureus, a leading cause of bloodstream infections that is responsible for more than 1 million deaths every year. Methicillin-resistant S. aureus, or MRSA, is of particular concern; it is one of the five leading contributors to deaths from antimicrobial resistance. The antibody is designed to neutralize the bacterium’s abilities to evade the immune system and, if successful, could be a promising solution to protect high-risk populations from infection.  A recent study has suggested it might be feasible to develop a vaccine offering lifelong protection against the Nipah virus, one of the world’s deadliest pathogens for which there are no vaccines. The research team tracked 25 survivors from the original 1998 outbreak in humans of the virus in southern Malaysia, finding that 72 percent of the survivors still had detectable levels of virus-neutralizing antibodies in their blood that could help protect them from being infected again. These results suggest that there is an enduring immune response to the virus, and they can be used to ensure that the candidate vaccines in development are targeting the correct parts of the virus, as well as to help develop monoclonal antibodies to treat Nipah infections. The Coalition for Epidemic Preparedness Innovations is funding two promising vaccine candidates for Nipah virus, which have completed Phase 1 trials.A new European Union project called Comparative Signature of Marburg Virus Cell Activation as a Blueprint for the Identification of Antiviral Targets against Newly Emerging Viruses, or COMBINE, aims to better our understanding of how viruses enter cells to create tools that will improve our ability to combat emerging infectious diseases, as viral disease emergence is expected to accelerate in the coming years. The project will use the Marburg virus as a model to create a blueprint for identifying new targets for antiviral strategies. This blueprint will be used to establish the preclinical basis for the continued development of drugs and vaccines for Marburg and also to develop an innovative, experimental pipeline of countermeasures that can be rapidly applied to other emerging viruses, strengthening global readiness for future outbreaks of pathogens with pandemic potential.

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. Researchers at Penn State have discovered a new storage technique that can keep protein-based drugs and vaccines stable without requiring a cold chain. This method could make these products easier and cheaper to store and distribute, enabling greater access and generating cost savings. Currently, most biologic drugs and vaccines require temperature-controlled conditions throughout the supply chain, from production to administration to patients. Products preserved with this new method, which involves an oil-based solution and a molecule to coat the surface of the protein, were found in mice to be just as effective as refrigerated versions, and there were no signs of adverse health effects. The researchers are planning to test their method with additional proteins and are also working to secure patent rights and partner with pharmaceutical companies.The first patients have been enrolled in a pivotal clinical trial, supported by the Africa Centres for Disease Control and Prevention (Africa-CDC), the Institut National de la Recherche Biomédicale, and PANTHER, testing promising mpox therapeutic options. Mpox continues to pose a significant global health threat with no approved therapeutics specifically for the virus. The first drug being tested is brincidofovir, an antiviral from Emergent BioSolutions. The trial, which aims to bolster our ability to respond to mpox, also demonstrates Africa’s proactive role in partnering to tackle this ongoing challenge that has caused numerous outbreaks across the continent.The Global Antibiotic Research and Development Partnership (GARDP) and Debiopharm have signed a memorandum of understanding to develop Debio 1453, a novel compound representing a new antibiotic class that targets the Neisseria gonorrhoeae bacteria, as multidrug-resistant strains of N. gonorrhoeae emerging around the world make infections harder to treat. The partnership aims to develop Debio 1453 for regulatory approval and scale-up. The compound, with ongoing support from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), previously demonstrated efficacy in preclinical studies against N. gonorrhoeae strains resistant to ceftriaxone, the last available recommended treatment globally, and other multidrug- resistant strains.

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.