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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.

Withdrawal from the World Health Organization (WHO) threatens to undermine America’s health security, weaken our leadership in global health innovation, and jeopardize access to lifesaving tools that directly benefit Americans.   WHO plays a vital role in protecting the health of Americans by coordinating global efforts to fight infectious diseases and accelerate the development of new health technologies. For example, during the 2014-2016 Ebola outbreak and the recent Marburg outbreak, WHO helped convene nations, scientists, and research funders to advance vaccines and treatments. Thanks to these efforts, the United States now stockpiles Ebola vaccines and therapies—proven effective through WHO-supported trials—that would safeguard American lives if an outbreak reached our shores.   WHO’s work also directly informs US public health efforts. Operating the world’s largest flu surveillance network, WHO tracks dominant flu strains globally, guiding the annual development of flu vaccines used by millions of Americans. WHO’s disease surveillance for polio, measles, and other global health threats similarly enables US officials to better protect our communities.   In addition to protecting public health, WHO helps drive innovation that supports American businesses and jobs. WHO partners with 70 US research centers across 18 states to support health research and innovation in the United States and globally. American companies benefit from these efforts: WHO recently prequalified a Hepatitis self-test made by OraSure Technologies in Bethlehem, Pennsylvania and an innovative mpox diagnostic developed by Cepheid in Sunnyvale, California.  By opening pathways to reach other nations, WHO expands global markets for American-made products.  Withdrawing from WHO cuts the United States off from these benefits and diminishes our influence in global health. America’s leadership has been critical to WHO’s successes in advancing research, coordinating disease surveillance, and responding to global emergencies. By stepping back, we forfeit the opportunity to shape these efforts and protect American lives, businesses, and innovation.   Continued partnership with WHO is essential to safeguarding the health of Americans, preparing for future pandemics and health emergencies, and ensuring US leadership in global health innovation.  

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. The US Food and Drug Administration granted Fast Track authorization to LimmaTech Biologics' vaccine candidate targeting the Staphylococcus aureus bacterium, which is a major source of sickness and death around the world, causing infections that are becoming harder to treat as the pathogen develops resistance to traditional antibiotic treatments. There is currently no vaccine to prevent infections caused by S. aureus. The authorization will expedite the review process for the product, which will undergo Phase 1 clinical trial testing later this year.  In two Phase 3 trials, a new combination treatment for patients with virologically suppressed HIV-1 demonstrated promising results, underlining the potential of islatravir in combination with other antiretrovirals to address the treatment needs of people living with HIV. The once-daily, oral, two-drug, single-tablet regimen consists of the investigational drug islatravir and doravirine, which was approved in 2018 as a single-agent treatment and in combination with other drugs. Islatravir is also being studied in other early- and late-stage HIV combination treatment trials.  A recently published study found that an mRNA vaccine designed by the US Centers for Disease Control and Prevention and Moderna successfully protected ferrets from the avian influenza virus, which continues its worrying spread across the United States. Blood serum taken from immunized ferrets was also able to neutralize a sample of the virus taken from a patient who contracted bird flu after coming into contact with dairy cows, which have been at the center of the outbreak. While there are three avian influenza vaccines approved in the United States, they were designed for past variants of the virus rather than the clade behind the current outbreak, and they are not mRNA vaccines, which, as demonstrated during the COVID-19 pandemic, can be rapidly produced and scaled up in the face of an emergency.