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.Last week, the US Food and Drug Administration ended the emergency authorization for Eli Lilly’s bebtelovimab, due to new variants against which the treatment is ineffective. Prior to this, bebtelovimab was the only COVID-19 antibody therapy still cleared for use. This news comes after several other antibody therapies were also made ineffective by the growth of new subvariants. While there are other updated antibody therapies in development, they will likely not be authorized for some time. Other COVID-19 treatments, including Paxlovid and Remdesivir, remain available although limitations prevent their wide use. The Coalition for Epidemic Preparedness Innovations (CEPI) has published a new plan for the development of a vaccine for “Disease X,” a pathogen with pandemic potential that has yet been identified. The plan calls for a vaccine within 100 days of the release of its genetic sequence. It was developed in collaboration with international health bodies, vaccine producers, researchers, and regulatory authorities, and identifies steps and investments needed far in advance of the identification of a disease outbreak.New results from a small trial found that a single pill of acoziborole given to participants with sleeping sickness (human African trypanosomiasis) in the late stages of infection has a 95 percent success rate at 18 months posttreatment and a 100 percent success rate among participants with an early-to-intermediary infection. The study, carried out by the Drugs for Neglected Diseases initiative, identifies the dug as a safe, effective oral therapy with incredible strengths compared to the currently used treatment, fexinidazole, which has a lower efficacy rate, must be taken more often, and has several common side effects.

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 Wednesday, Moderna released preliminary results on its updated COVID-19 vaccine booster targeting omicron showing a significantly stronger immune response against the variant than the existing vaccine. The results come from a clinical trial among 814 volunteers testing a booster dose that combines the original vaccine with one that specifically targets omicron. The updated booster shot followed three earlier doses of Moderna’s vaccine. Among individuals with no evidence of prior COVID-19 infection, the new combination produced 1.75 times the level of neutralizing antibodies against omicron as the existing vaccine did alone. While the updated booster is promising against the omicron variant, some experts noted the evolving virus continues to lead to new variants and subvariants, potentially outpacing the ability to modify vaccines. US Food and Drug Administration advisers are set to meet June 28 to discuss which vaccine formulation would work best as a booster in the fall.The World Health Organization (WHO) published new guidelines last week for the treatment of people coinfected with visceral leishmaniasis and HIV, recommending better treatments based on studies conducted by the Drugs for Neglected Diseases initiative (DNDi), Médecins Sans Frontières, and partners in Ethiopia and India. In the Indian study, the new recommended treatment—a combination of injectable liposomal amphotericin B and oral miltefosine—demonstrated 96 percent efficacy after 210 days, compared to 88 percent for the current standard treatment. In the Ethiopian study, the new treatment demonstrated 88 percent efficacy after 58 days, compared to 55 percent for the standard treatment. The new regimen also reduces the use of injectable drugs and shortens the duration of treatment. Researchers plan to continue efforts to develop an even better treatment that will be completely oral, safe, and efficacious.The first participants have been vaccinated in a phase 3 study of an influenza vaccine developed by Moderna based on mRNA technology used in its COVID-19 vaccine. The vaccine, mRNA-1010, encodes for hemagglutinin glycoproteins of the four influenza strains recommended by WHO for the prevention of influenza. mRNA-1010 is the first of several influenza vaccine candidates intended to improve upon traditional vaccines, according to Moderna, by inducing broad, robust immune responses and employing the flexibility and speed of the mRNA platform manufacturing process. The trial will enroll around 6,000 adults in the southern hemisphere to evaluate the safety and immunological efficacy of the vaccine in comparison to a licensed seasonal flu vaccine. The company plans to run a confirmatory efficacy study for the vaccine as early as the 2022-23 northern hemisphere flu season.