Breakthroughs Blog: Medicines

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. Following the remarkable success of the first COVID-19 vaccines, developed at unprecedented speeds, investment in next-generation shots has so far fallen short, according to some experts. Nasal vaccines, in particular, experts say could prove more effective at preventing COVID-19 infections than intramuscular shots, as they concentrate immune protection in the upper airway and induce mucosal immune responses where the virus typically enters the body. Several nasal vaccine candidates are in development in the United States—though primarily remain in preclinical or early-stage clinical trials—as well as globally, including phase 3 trials in India and China. The National Institute of Allergy and Infectious Diseases, for example, is funding early research on a protein-based nasal spray as well as an mRNA vaccine delivered into the nose using nanoparticles, though any successful nasal vaccine is likely years away from becoming available.As monkeypox cases continue to rise globally, experts and leaders are looking at health technologies with potential to combat the virus—including repurposed smallpox vaccines that have begun to be deployed, predominantly in high-income countries. In addition to vaccines, scientists are evaluating existing drugs that could serve as treatments against monkeypox, for which there are no specific treatments licensed. A recent study in JAMA analyzed several preexisting drugs, including antivirals brincidofovir and tecovirimat, both of which have been tested among monkeypox patients in the past with varying success. The ongoing uncertainty surrounding treatments for the new outbreak highlights the lack of evidence-based therapeutics for monkeypox, according to the journal article, as well as the inequities in the global response as countermeasures have been stockpiled by high-income countries but remain limited in monkeypox-endemic countries.In a new study, researchers describe how a Lassa virus protein drives infection by harnessing a cellular protein in human hosts, as well as identify how future therapies could target this interaction to treat patients. The research suggests that disrupting the link between Lassa polymerase—a protein encoded by the virus—and a specific host protein it interacts with—GSPT1—could stop Lassa virus infection. In pursuit of this, the research team identified an existing drug candidate, CC-90009, that has been shown to destroy GSPT1 proteins and is currently being examined in clinical trials as a cancer therapy. In early experiments, CC-90009 significantly reduced Lassa virus growth without obvious cell toxicity, and researchers plan to continue evaluation in animal models. There is currently no antiviral drug that specifically targets Lassa virus.

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 Wednesday, the Stop TB Partnership launched a new global plan to end tuberculosis (TB) by 2030. The plan requires a total of $250 billion in funding, $40.2 billion of which would go toward accelerating the research and development of new TB diagnostics, medicines, and vaccines—including a specific goal of developing a new TB vaccine by 2025. There is currently only one licensed TB vaccine, which was approved more than 100 years ago and has limited benefit in adult populations. Several promising candidates are in clinical trials, including four in advanced stages of development, making it possible to have a new TB vaccine by 2025—if sufficient funding and political will is present to push things forward.A new, “all-in-one” vaccine showed early promise in protecting against a variety of coronaviruses, including COVID-19, SARS, and MERS, according to preclinical study results published last week. The mosaic-8 vaccine was able to train immune systems to recognize eight viruses at once in animal studies, demonstrating proof of concept for its ability to block a range of betacoronaviruses—the subgroup containing the virus that causes COVID-19. The Coalition for Epidemic Preparedness Innovations (CEPI) has pledged $30 million to begin clinical trials of the experimental vaccine in humans. The phase 1 trial will take place at Oxford University, which collaborated with the California Institute of Technology to develop the vaccine, and will likely take at least a year.Advances in science, in conjunction with rising investment in research, have led to the development of promising new treatment candidates for several neglected tropical diseases (NTDs) in recent years—though little progress has been made on the NTD subset of parasitic worm diseases. In a new study published last week, researchers outline these NTD research trends, noting that despite a long-standing lack of innovation in drugs for neglected diseases, partnerships between public, private, and nonprofit entities have enabled major progress in developing treatments for several target NTDs like leishmaniasis, Chagas disease, and sleeping sickness. This same progress has not been seen, however, among parasitic worm diseases like schistosomiasis, as research is often left at early stages. Bolstered drug discovery efforts focused on these diseases are needed in order to combat their high global prevalence, the researchers conclude.

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. Biotech companies Afrigen Biologics and Univercells on Tuesday announced a collaboration to pave the way for the development of the first African-owned COVID-19 vaccine through open-access intellectual property. The companies will focus on the development of a novel mRNA vaccine, using intellectual property from partners, with an emphasis on tackling two major challenges that have hindered COVID-19 vaccine rollout in Africa and other low- and middle-income countries: cold or super-cold chain requirements and a lack of local cost-effective production. The collaboration will be hosted in Cape Town, South Africa, by Afrigen, which also hosts the World Health Organization’s (WHO) global mRNA vaccine technology transfer hub, and the new agreement will build on expertise developed using the hub.At last week’s Kigali Summit on Malaria and Neglected Tropical Diseases (NTDs), Novartis and GlaxoSmithKline (GSK) each pledged to make significant new investments in research and development (R&D) for neglected diseases. Novartis committed $250 million over a period of five years to support work on malaria, Chagas disease, leishmaniasis, dengue fever, and cryptosporidiosis. The funding announcement was made as part of Novartis’ endorsement of the Kigali Declaration, a commitment to ending NTDs. GSK’s pledge—$1 billion over ten years—will be used to accelerate R&D of infectious diseases that disproportionately affect lower-income countries. This research will focus on new and disruptive vaccines and medicines to prevent and treat malaria, tuberculosis, HIV, NTDs, and antimicrobial resistance (AMR).Development of new antibacterial treatments is inadequate to address the escalating threat of antibiotic resistance, according to an annual WHO pipeline report released Thursday. The report, which assesses antibacterial drugs in preclinical and clinical development, describes the pipeline as stagnant and far from meeting global needs. Since 2017, just 12 antibiotics have been approved, 10 of which belong to existing classes with established mechanisms of AMR—demonstrating a major gap in discovery of antibacterial treatments, especially innovative treatments. Urgent, concerted investments in R&D by governments and the private sector are needed to accelerate and expand the antibiotic pipeline, according to WHO, especially for products that can make an impact in low-resource settings, which are most affected by AMR.

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 US Food and Drug Administration (FDA) authorized Moderna’s and Pfizer’s COVID-19 vaccines for children as young as 6 months—making kids under 5 years old eligible for the first time. The decision followed a unanimous recommendation from a panel of independent advisers to the agency to authorize Pfizer’s three-dose vaccine for children 6 months to 4 years and Moderna’s two-dose vaccine for children 6 months to 5 years. The FDA also authorized on Friday Moderna’s vaccine, previously cleared in adults over 18, for children and adolescents ages 6 through 17 years old. Centers for Disease Control and Prevention Director Rochelle Walensky signed off on recommendation of the shots this past weekend, and vaccinations are beginning this week.The South African Health Products Regulatory Authority last week approved a sweet-tasting, heat-stable, “4-in-1” fixed-dose combination of four antiretroviral (ARV) treatments—abacavir, lamivudine, lopinavir, and ritonavir—specifically designed for infants and young children with HIV. The new formulation, developed by Cipla Limited and the Drugs for Neglected Diseases initiative (DNDi), does not require refrigeration, has a sweet taste, and is easy to administer to infants and children of different weights and ages, making it a significant improvement over existing pediatric ARV formulations. The accelerated review in South Africa is notable and encouraging for other countries with a high burden of HIV, according to DNDi, which also expressed hope that the necessary steps will be taken to ensure the broadest possible access to the treatment for children who need it.Japanese drugmaker Shionogi and the Global Antibiotic Research and Development Partnership (GARDP) announced Wednesday an agreement to expand access to a novel antibiotic for drug-resistant infections in lower-resource countries. The deal aims to provide access to cefiderocol, which is used to treat serious Gram-negative bacterial infections that may be resistant to other antibiotics, in countries that have experienced delayed or limited access to newer antibiotics. Under the agreement, GARDP will work with partners to manufacture and commercialize the antibiotic, developed by Shionogi, in up to 135 countries. The Clinton Health Access Initiative will also help navigate the technical, regulatory, legal, and economic barriers to getting the antibiotic to patients in these countries.