Breakthroughs Blog

Last week, the Medicines for Malaria Venture (MMV) and GSK announced the world’s first deployment of a novel cure for Plasmodium vivax malaria, the predominant malaria species in Latin America. Pediatric tafenoquine, codeveloped by MMV and GSK, replaces a multiday regimen with a single-dose, child-friendly formulation, improving treatment completion and preventing relapse. P. vivax can remain dormant in the liver, so if patients don’t receive combination treatment for both the blood and liver stages of the disease, they could have multiple malaria relapses. Up until now, the lack of child-friendly tafenoquine formulation left younger kids at risk of the disease, which is associated with long-lasting cognitive impairment. The rollout is taking place among the Yanomami people, an Indigenous population living in the Yanomami Indigenous Territory in northern Brazil. Last Tuesday, Moderna announced the start of a late-stage study of its experimental mRNA vaccine candidate for bird flu, marking the first time a mRNA pandemic bird flu vaccine has reached late-stage trials. The trial is being supported by a $54 million investment by the Coalition for Epidemic Preparedness Innovations (CEPI) following last year’s cancellation by the US government of more than $700 million in contracts with Moderna supporting the late-stage development of the vaccine candidate. Moderna’s trial will evaluate the candidate, mRNA-1018, in 4,000 healthy adults in the United States and the United Kingdom. Under the agreement, Moderna also committed to, if the vaccine is approved and a flu pandemic is declared, setting aside 20 percent of its manufacturing capacity for supplying the vaccine to low- and middle-income countries at affordable prices. The US Food and Drug Administration recently approved Merck’s once-daily, oral combination treatment for HIV, offering patients another treatment option. The combination of doravirine and islatravir is being branded as Idvynso. In two large late-stage studies, the treatment combination demonstrated its ability to significantly suppress replication of HIV-1 in adults receiving another HIV treatment. While another late-stage study in adults living with HIV who had previously received treatment found that Idvynso was not inferior to Gilead’s HIV drug Biktarvy, the approval still provides another treatment option for patients. It is also currently being tested in multiple trials in combination with other antiretrovirals for potential daily and once-weekly HIV treatments. 

We have made significant global progress against malaria over the last few decades, with three countries officially eliminating the disease just last year, joining the ranks of nearly 50 countries worldwide that have now achieved malaria-free status. Yet, malaria remains a formidable global challenge, with an estimated 282 million cases and 610,000 deaths in 2024, roughly 9 million more cases than in 2023. Climate change, conflict and instability, and funding disruptions all contribute to this persistent threat.  The rise of drug and insecticide resistance, a decades-old obstacle, has drawn renewed attention as it threatens to erode years of momentum. New tools addressing resistance, including novel drug combinations and vector control tools, offer hope for regaining lost ground. The long history of antimalarial drug resistance and new innovations to curb its riseAntimalarial drug resistance dates back nearly 75 years. Resistance to chloroquine, once of the most widely used antimalarial drugs, was first detected in the 1950s and spread unchecked for decades, contributing to a global rise in malaria-related mortality. Varying degrees of resistance also emerged to the therapies introduced to replace chloroquine. By the time artemisinin-based therapies were widely introduced in the 1990s, the World Health Organization took proactive steps to protect their efficacy by recommending they be used only in combination with other drugs.Artemisinin-based combination therapies (ACTs) have since become the global standard treatment. However, partial resistance to artemisinin-based drugs has now been confirmed or suspected in at least eight African countries, and several of the drugs used in combination with artemisinin are also showing declining efficacy. Emerging therapies in late-stage development could help address these growing challenges.In fall 2025, Novartis announced positive Phase 3 results for a novel, non-artemisinin combination malaria therapy developed with the Medicines for Malaria Venture. Delivered as a once-daily packet of oral granules taken over three days, the therapy was found to be highly effective against multiple forms of the malaria parasite and was also able to kill drug-resistant strains. If approved, it would represent the first major innovation in malaria treatment since ACTs.Another promising approach in late-stage development is triple ACTs, which combine artemisinin-based drugs with two additional drugs to fend off the emergence of resistance. In fall 2025, the Mahidol Oxford Tropical Medicine Research Unit, with funding from the Global Health Innovative Technology Fund, launched the first Phase 3 trial of a fixed-dose triple ACT in Rwanda. Taken once daily for three days, the therapy is designed to be affordable, easy-to-administer, and suitable across age groups, supporting adherence and reducing the risk of incomplete treatment, a key driver of resistance.  Historical lessons and new frontiers in vector control tools to tackle insecticide resistance Beyond parasite resistance, widespread insecticide resistance in mosquito vectors—dating back to the 1950s—has reduced the impact of existing vector control tools. The widespread uptake of insecticide-treated bednets helped drastically reduce malaria cases in Africa over recent decades, but most nets deployed since 2000 relied on pyrethroid insecticides. Resistance to pyrethroids is now widespread.In response, the World Health Organization recommended the first next-generation insecticide-treated nets in 2017. Since then, global partners, including the Innovative Vector Control Consortium, PATH, and the Gates Foundation, have collaborated to deploy more than 56 million of these new-generation nets, which have been shown to significantly improve malaria control outcomes.Additional innovations in the pipeline could complement these next-generation bednets. One promising group of tools is endectocides, or medicines taken by humans that kill mosquitoes when they bite. Ivermectin, an antiparasitic drug long used in mass drug administration campaigns for neglected tropical diseases, is the most studied endectocide to date. A 2025 study led by the Kenya Medical Research Institute, the Barcelona Institute for Global Health, and the Manhiça Health Research Center found that mass administration of ivermectin reduced new malaria infections by 26 percent when implemented alongside standard vector control measures. Unlike bednets or indoor residual spraying, which are limited to certain places or times of day, endectocides can protect people from malaria wherever they are.Early-stage research is also exploring gene drive technology, which genetically modifies mosquito populations to reduce their ability to transmit malaria. Target Malaria is investigating several gene drive approaches, including one of its most promising strategies: modifying male mosquitoes to carry a gene that causes some females to become sterile. Another approach involves genetically modifying males to produce predominantly male offspring, which can decrease mosquito numbers over time and reduce parasite transmission, since only female mosquitoes bite and transmit malaria. While still early in development, these tools could one day offer a transformative way to control mosquito populations.Drug and insecticide resistance represent some of the most urgent threats to the global fight against malaria, but they are not insurmountable. History shows that sustained innovation can blunt the impact of emerging resistance and help restore progress. Increased investment in new tools, alongside global coordination to ensure rapid and equitable deployment, will be essential to accelerating progress against malaria in the years ahead.

A new study from a research team at Houston Methodist found that a new AI-powered tool could help accelerate the development of treatments targeting antibiotic-resistant bacterial pathogens, as the global threat of antimicrobial resistance continues to grow. The AI-based platform integrates machine learning with biologically informed features to evaluate and rank libraries of candidate peptides—small proteins that are part of the body’s immune system—based on their potential to address these bacterial pathogens. The researchers used the platform to identify a promising candidate peptide that demonstrated an ability to effectively target methicillin-resistant Staphylococcus aureus (MRSA) at low concentrations in lab tests.  Last week, the Coalition for Epidemic Preparedness Innovations and the Pan American Health Organization (PAHO) announced an expanded collaboration to strengthen regulatory systems and pharmacovigilance programs across Latin America and the Caribbean, supporting rapid, equitable access to safe vaccines, including during pandemics. Specifically, the funding will support workforce training, enhanced collaboration among national regulatory authorities, and regulatory capacity-strengthening, enabling more efficient and aligned pathways toward the evaluation and approval of safe and effective vaccines during outbreaks. This collaboration builds on a broader partnership, first forged in 2024.  A Phase 3 trial conducted in India found that two tuberculosis (TB) vaccine candidates did not show efficacy against all forms of TB, including pulmonary TB and latent TB, but they did demonstrate safety and offer limited protection against a more severe form of the disease. The PreVenTB trial, led by the Indian Council of Medical Research, evaluated the efficacy of VPM1002 and Immuvac, which represent 2 of the 16 vaccine candidates in the pipeline for TB aiming to become the first new vaccine for TB in more than 100 years. The only current licensed offers inconsistent protect against pulmonary TB in adults. 

Last week, Shionogi announced that its US subsidiary has received a $119 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to boost production and advance development of a key antibiotic, helping improve US preparedness for future outbreaks of drug-resistant bacterial pathogens. Specifically, the funding will go toward the establishment of a US manufacturing site and procurement of cefiderocol, an antibiotic that has the ability to target difficult-to-treat, multidrug-resistant infections, which is already approved for several indications. The award will also fund the development of cefiderocol to respond to high-priority bacterial threats. In a newly published study, a Cornell University research team shared the results of a long-term study that could be a first step toward developing the first safe, reversible, long-acting, and 100 percent effective nonhormonal male contraceptive. In a proof-of-principle study in mice, the researchers targeted a natural checkpoint in meiosis, the reproduction process for sex cells, and were able to safely stop sperm production and, importantly, then recover normal meiosis and complete sperm function, with no impacts on other functions or on offspring. If this approach continues to demonstrate success in further studies, it could eventually be utilized in an every-three-month injection or patch contraceptive product. IAVI recently announced that the first participants have been vaccinated in a Phase 1 clinical trial evaluating the safety and immunogenicity of its investigational vaccine for Marburg virus disease, a highly fatal, high-priority disease, which has been behind a growing number of outbreaks in sub-Saharan Africa in recent years and for which there are no specific approved vaccines. In nonclinical studies, the candidate demonstrated consistently strong efficacy results: a single intramuscular vaccination protected 100 percent against lethal challenge with the virus. IAVI is simultaneously continuing to work with partners in sub-Saharan Africa to ensure the availability of candidate doses for evaluation during future Marburg outbreaks.