Hannah Sachs-Wetstone

The Drugs for Neglected Diseases initiative (DNDi) and the Serum Institute of India have announced a new licensing agreement covering clinical testing and future access for a promising treatment for dengue, a fast-growing global disease threat. There is no specific treatment for dengue and control efforts currently rely on targeting the mosquito populations that carry the virus and deploying new vaccines, which have varying effectiveness in certain populations and haven’t achieved widespread coverage. The Serum Institute developed and optimized the monoclonal antibody treatment, finding promising safety and efficacy results in preclinical and Phase 1 and 2 trials, and is currently carrying out a Phase 3 clinical trial in India. Under the agreement, DNDi will lead a Phase 3 clinical trial set to begin early next year in dengue-endemic countries, including Malaysia, Thailand, and Brazil, and, if the treatment is successfully approved, DNDi will support affordable access in low- and middle-income countries.A new study published in The Lancet Infectious Diseases demonstrated promising results for an investigational vaccine candidate for Shigella sonnei, an important step toward developing a vaccine for the disease-causing bacteria. Shigella sonnei is one of the four species of Shigella, a highly contagious bacteria that infects tens of millions of people around the world, causing diarrheal disease. There are no licensed vaccines for any of the Shigella species, two of which, including S. sonnei, are becoming increasingly resistant to first-line antibiotics. The investigational vaccine provided high-level protection, an estimated vaccine efficacy of 89 percent, in a Phase 2 trial conducted among healthy adult participants at two US sites. The next step for researchers is to optimize the dose level and evaluate the vaccine in larger trials in high-burden settings that include children, who are among the most affected by shigellosis.Last week, the South Africa Medical Research Council and the Unit of Viral Evolution and Transmission at IRCCS Ospedale San Raffaele initiated a Phase 1 clinical trial to assess the safety and pharmacokinetic profile of a promising broadly neutralizing antibody (bnAbs) for eventual use to prevent HIV acquisition by infants and young children. bnAbs, a type of naturally occurring antibody that can neutralize multiple strains of HIV, are considered a promising approach in HIV research and could potentially be utilized in a long-acting option to protect infants from HIV transmission during breastfeeding, helping close critical gaps in HIV care options and access. IAVI and partners developed the bnAb from blood samples taken from adult participants living with HIV around the world; it was selected for further development following evidence of strong potency in preclinical trials. The trial will initially enroll 26 healthy adult volunteers to collect data on dose section, administration strategies, and safety to inform the planned infant trial. 

On Thursday, the World Health Organization (WHO) announced the first patient enrollment in a critical clinical trial evaluating investigational antiviral therapies to treat Ebola caused by the Bundibugyo virus, as the worrying outbreak in the Democratic Republic of the Congo continues to grow. There are currently no approved treatments specifically for the Bundibugyo strain. The trial is supported by a range of multilateral, regional, national, and scientific partners and is being coordinated by the Institut National de Recherche Biomédicale, the Institute of Tropical Medicine and the University of Oxford. Two therapies, the monoclonal antibody MBP134 and remdesivir, which were selected by WHO technical advisors, are being evaluated for their ability to improve survival among patients, with the goal of saving lives and helping curb the spread of the current outbreak, as well as generating evidence to improve care for future outbreaks. A comprehensive review of COVID-19 mRNA vaccines published last week in The Lancet found that they are safe and effective, as skepticism around the safety and trustworthiness of the technology has persisted in recent years, while new research efforts have demonstrated the technology’s promise to address a range of priority disease and health challenges, including influenza and cancer. The researchers found that serious events are rare and the odds of them occurring were outweighed by significant protection against severe disease, hospitalization, and death. The researchers do acknowledge challenges with mRNA technology, including that they mRNA vaccines are not as effective at providing long-last immunity as they are at generating short-term responses and they have significant, expensive storage resource requirements, challenging access in low-resource areas. Sustained innovation and a commitment to improving access could help address these shortcomings and ensure the promise of mRNA technology is fully realized around the world.Early results from a new study published in Nature last week found that an investigational HIV vaccine demonstrated unprecedented success in primates in a preclinical trial. The vaccine, which was developed through a prolonged collaboration between scientists at La Jolla Institute for Immunology and Scripps Research, works by prompting the immune system to produce high numbers of broadly neutralizing antibodies, which are capable of neutralizing a wide range of strains of the virus and are recognized as a promising approach in the HIV vaccine development field. One of the challenges of developing a vaccine for HIV has been the genetic diversity of the virus, with various distinct strains circulating. People living with HIV naturally develop broadly neutralizing antibodies that can neutralize various strains but designing a vaccine that can induce them has proven to be a challenge for researchers. 

For decades, the United States has led the world in public investment in global health research and development (R&D). Federal support enabled the development of breakthrough technologies that are saving and improving lives in the United States and around the world. US government investment in global health R&D has also generated billions in domestic economic activity, created American jobs, and laid the foundation for future discoveries that will catalyze billions more in economic benefits in the years ahead. America’s leadership in global health R&D reflects the country’s values, entrepreneurial spirit, and commitment to improving lives globally. This year, to mark America’s birthday and celebrate the nation’s extraordinary contributions to advancing lifesaving innovation, GHTC is spotlighting four game-changing global health technologies developed by US innovators with federal support.A DR-TB drug transforming the global fight against TB Tuberculosis (TB) remains the world’s deadliest infectious disease, killing 1.23 million people in 2024 alone, with growing resistance making it even more deadly and difficult to treat.  Historically, treatment for drug-resistant TB (DR-TB) required up to 20 or more pills a day over the course of 18 months or more, and patients often experienced severe side effects, such as hearing loss. Even then, nearly half of patients who were able to access treatment went uncured.Pretomanid, developed by TB Alliance, a New York-based nonprofit product development partnership, represents a major advance in DR-TB therapy. As part of a six-month, all-oral combination regimen, it has drastically reduced treatment duration, complexity, and toxicity for patients.  This innovation was made possible through funding from the US Agency for International Development and the National Institute of Allergy and Infectious Diseases and was advanced in partnership with a broad coalition of American companies, nonprofits, and universities. Since its approval, TB Alliance has strived to make pretomanid-containing regimens more affordable and accessible, improving access to high-quality DR-TB treatment in the places that need it most.A groundbreaking HIV prevention drug poised to revolutionize the fight An estimated 40.8 million people globally are living with HIV/AIDS, and 1.3 million people became newly infected in 2024. Despite decades of progress, momentum toward ending HIV as a public health threat has slowed in recent years, and major gaps remain in our arsenal of prevention tools.  Gilead Sciences, a California-based biopharmaceutical company, developed lenacapavir, a groundbreaking new HIV prevention drug that requires just two injections per year. It offers discreet, long-acting protection, making HIV prevention more accessible and easier to sustain.  Developed using evidence from National Institutes of Health-funded research, lenacapavir is now being scaled up globally through a US Department of State-led partnership, helping ensure this innovation reaches communities in need. A next-generation polio vaccine bringing us closer to eradication The first polio vaccine, introduced in the 1950s, transformed polio from a disease that caused frequent, devastating epidemics into one on the brink of global eradication. However, outbreaks of vaccine-derived poliovirus in under-immunized communities globally have posed a major challenge to vanquishing the disease for good.To address this, PATH, a Washington-based nonprofit developer, partnered with the University of California, San Francisco; the Gates Foundation; and global collaborators to develop nOPV2, a next-generation oral polio vaccine. nOPV2 retains the advantages of the original oral vaccine but has been specifically engineered to reduce the risk of vaccine-derived outbreaks. This breakthrough benefitted from critical development support from the US Centers for Disease Control and Prevention.  More than 1 billion doses of nOPV2 have been administered in countries around the world, with an expanded network of manufacturers helping ensure global access and prevent outbreaks.  First FDA-approved Ebola treatment continuing to offer hope As the current outbreak of the Bundibugyo strain of Ebola in the Democratic Republic of the Congo (DRC) reminds us, Ebola outbreaks can rapidly escalate into international health emergencies. When the 2018-2020 outbreak of Zaire ebolavirus began in the DRC—the world’s second largest Ebola outbreak—there were no approved Ebola treatments. Inmazeb®, a novel antiviral medicine developed by Massachusetts-based Regeneron in collaboration with the Biomedical Advanced Research and Development Authority, was evaluated in a National Institutes of Health-supported trial during the outbreak. The strong results from that trial supported approval by the US Food and Drug Administration (FDA) in 2020, making Inmazeb the first FDA-approved treatment for Ebola, which has since been deployed in Ebola outbreaks in the DRC and Guinea. The most potent antibody in Inmazeb has now been recommended for priority evaluation during the current outbreak after demonstrating broad activity against multiple Ebola strains, including Bundibugyo, for which no approved therapeutics exist—highlighting how US-backed innovation continues to pay off and why sustained investment is needed to stay ahead of future threats.  Ensuring continued US leadership through sustained investment From transforming DR-TB treatment and HIV prevention to accelerating polio eradication and delivering the first Ebola therapy, the United States has long been at the forefront of global health innovation. These successes reflect the best of America: leadership, ingenuity, compassion, and a commitment to improving lives. Sustaining this impact will require continued investment and support in the programs, partnerships, and people that make such breakthroughs possible.

An international clinical trial led by the Global Antibiotic Research and Development Partnership (GARDP) seeking improved antibiotic treatments for newborn sepsis has expanded to India. Neonatal sepsis is one of the leading causes of newborn deaths worldwide and is becoming harder to treat due to rising antibiotic drug resistance. Newborns have long been underrepresented in antibiotic research, leaving health care providers without an evidence-based standard-of-care treatment. The lack of a standard treatment has in turn complicated neonatal sepsis research because there is no obvious treatment to use as a comparison in trials. The trial aims to test and rank multiple potential antibiotic combinations for neonatal sepsis.Last week, the World Health Organization announced that a clinical trial evaluating two potential antiviral therapeutics for the Bundibugyo strain of Ebola will be launched in the Democratic Republic of the Congo next week amid the ongoing outbreak. There are currently no approved vaccines or therapeutics for the Bundibugyo strain, which is only known to have caused three outbreaks in history. The trial will evaluate the ability of Mapp Biopharmaceutical’s MBP134 and Gilead Sciences’ remdesivir to reduce mortality in patients, alone and in combination. The United States and Gilead Sciences are donating all the doses that will be used in the trial.The US Food and Drug Administration (FDA) has approved the first generic version of rifapentine as part of combination treatment regimens for active and latent pulmonary tuberculosis (TB). Rifapentine was first approved by FDA in 1998 to treat pulmonary TB. For active pulmonary TB cases in patients 12 or older, the generic antibiotic is approved only in combination with one or more anti-TB drugs, while for latent TB cases, the generic is approved in combination with isoniazid to treat patients 2 or older at high risk of progressing to TB disease.

Last week, the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend approval of Moderna’s mRNA influenza vaccine for older adults. In a Phase 3 trial in more than 40,000 adults in 11 countries during the 2024-2025 flu season, the vaccine demonstrated significantly better protection than standard-dose shots. Moderna's vaccine also uses mRNA technology, meaning it can be updated more quickly to match circulating flu strains compared to traditional vaccines that use egg-based methods. After initially agreeing to review the vaccine, the FDA had previously raised concerns about the Phase 3 trial for the vaccine, prompting backlash from vaccine and public health experts, before deciding to go ahead with its review. Following the recommendation, the FDA will make a final decision on approval, which is expected by early August.The Global Health Innovative Technology (GHIT) Fund has started an emergency framework to surge support and funding for the development of rapid and point-of-care diagnostic technologies in response to the Ebola outbreak caused by the Bundibugyo virus in the Democratic Republic of the Congo and Uganda. There are currently no approved vaccines, therapeutics, or point-of-care diagnostics for Bundibugyo virus. GHIT Fund is prepared to support fast-track funding for infections caused by filoviruses, which include Ebola, with the aim of advancing a diagnostic test, particularly one that is suited to low- and middle-income countries with limited infrastructure, that can improve control capacity for this and future outbreaks.  Inflammatix is collaborating with the University of Nebraska Medical Center to explore the use of the company’s diagnostic test platform for hantaviruses after the recent hantavirus outbreak exposed gaps in testing capacity due to limited technology and testing standards. Inflamattrix’s TriVerity test is a blood-based test that used machine learning to detect infection. It previously received clearance from the US Food and Drug Administration as a sepsis test in 2025. The partners are aiming to develop a tool that can assess the early signatures of infection in people with high-risk exposure to the virus, which could help improve early response capacity in future outbreaks.  

Fatherhood is often framed as a life milestone, but far less attention is paid to men’s role in deciding if or when that milestone occurs. Nearly half of all pregnancies, around 121 million globally each year, are unintended, highlighting major gaps in contraceptive access and limitations in today’s methods. Boosting investment in the research and development (R&D) of new and improved contraceptive options, including for men, offers a critical opportunity to strengthen reproductive autonomy, advance gender equality, and help prevent unintended pregnancy. The gendered burden of pregnancy prevention Without male contraceptive options beyond condoms and vasectomy, the physical, financial, logistical, and emotional burden of pregnancy prevention has long fallen on women.  While a wide range of options exist for women, from pills to injections, patches, and implants, an estimated 257 million women worldwide who want to avoid pregnancy are not using safe, modern methods of contraception due to a combination of social barriers (such as cultural or religious opposition), structural challenges (including limited access to high-quality services or education), and technological limitations (such as unpleasant side effects or short duration of protection). These barriers are especially pronounced in low- and middle-income countries—in sub-Saharan Africa, nearly one in four women has an unmet need for contraception.  Addressing this gap requires expanding options for women, such as methods that are longer acting, more discreet, have fewer side effects, and require fewer health care provider visits, as well as expanding contraceptive choice for men. New male contraceptive options to replace or complement female contraceptives could help rebalance the shared responsibility for family planning, empower men to have greater autonomy over their own reproductive health decision-making, and contribute to reducing unintended pregnancy. The gap in male contraception Limited innovation in male contraception reflects decades of underinvestment—not a lack of demand. Research shows strong interest in male contraceptives among men in diverse settings worldwide, alongside high trust in male partner birth control use among female partners, with preferred product types and attributes varying across contexts. Despite this clear demand, progress in male contraceptive innovation has been slow, in part due to the limited funding landscape. Contraceptive R&D has relied heavily on public and philanthropic funding, with the Gates Foundation playing a lead role. Private-sector engagement has remained limited due to perceived uncertainty about the potential market, unclear regulatory pathways, high development costs, and the broader historical underinvestment in contraception R&D. The continued success of products currently in clinical development has the potential to spark greater engagement in the field from diverse investors. Male contraceptive innovations on the horizon  While the pipeline lags behind demand, several exciting and innovative tools and approaches are advancing through clinical development.  The most advanced product in development is a reversible hormonal gel, NES/T, which can be applied once daily to the upper arms and shoulders. The gel is absorbed through the skin and suppresses sperm production. Originally developed by the Population Council and the US National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development, it is now being advanced by Contraline, which recently announced the launch of Phase 3 trial planning. Nonhormonal male contraceptive options are another promising area of research because they target sperm function directly, avoiding hormone-related side effects. Contraline’s ADAM™ is a nonhormonal injectable device that blocks sperm flow for an extended period before dissolving. It has demonstrated encouraging safety and efficacy data in a first-in-human trial, with Phase 2 planning underway. YourChoice Therapeutics and Columbia University’s YCT529 is a first-in-class nonhormonal daily pill that suppresses sperm production and has shown positive results in a small, early human trial.  The path ahead When the US Food and Drug Administration approved the first oral contraceptive pill for women in 1960, its rapid, widespread adoption transformed reproductive autonomy and expanded economic, education, and career opportunities for women, carrying benefits that reverberated across entire economies and contributed to broader gender equality. Continued innovation in female contraceptives remains essential to ensure options better fit the needs and lifestyles of women worldwide.  But this progress should also be matched by investment in novel male contraceptives. Ensuring that everyone who wants to use contraception can access safe, effective, and acceptable options will expand choice, strengthen reproductive autonomy, and contribute to a more equitable and resilient future for family planning at a time when reproductive health protections are increasingly constrained worldwide.